Corporation
              TERMINATION,
      PURCHASE AND LICENSE AGREEMENT
 
 This
Termination, Purchase and License Agreement ("Agreement") is made as of
____________________, 2008 ("Effective Date"), by and between Boston Scientific
Corporation, One Boston Scientific Place, Natick, MA 01760 ("Seller"), and Bovie
Medical Corporation, 7100 30th
Avenue-North, St. Petersburg, FL  33710 ("Buyer") for the purpose of
purchase and sale of certain rights and assets related to the Program (as
defined in Section 1.1) and use of the rights and assets in the development,
manufacture and sale of the Product (as defined in Section 1.2); assignments and
licenses for certain intellectual property of the Parties; and termination of
that certain Distribution Agreement between the Parties dated as of October 6,
2006, as amended on August 23, 2007 (the “Distribution Agreement”), all in
accordance with this Agreement.  Buyer and Seller are herein referred
to collectively as “Parties” and individually as a “Party.”
  MAILING
ADDRESSES AND FAX NUMBERS FOR NOTICES, ETC. UNDER
AGREEMENT
 Buyer:
                    Bovie
      Medical Corporation
                    7100
      30th
      Avenue North
                    St.
      Petersburg, FL 33710
                    Attn:  Moshe
      Citronowicz, COO
                    Fax:  (727)
      344-3876
                  
                  with copy
      to:
                    Bovie
      Medical Corporation
                    7100
      30th
      Avenue North
                    St.
      Petersburg, FL 33710
                    Attn:
      General Counsel
                    Fax:  (727)
      344-3876Seller:
                    Boston
      Scientific Corporation
                    100
      Boston Scientific Way
                    Marlborough,
      Massachusetts  01752
                    Attn:  Michael
      Phalen, President Endoscopy
                    Fax:  (508)
      683-5316
                  
                  with copy
      to:
                    Boston
      Scientific Corporation
                    One
      Boston Scientific Place
                    Natick,
      Massachusetts  01760-1537
                    Attn:  General
      Counsel
                    Fax:  (508)
      650-8956
  NOW, THEREFORE, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto agree as follows:
  1.           Purchase and
Sale
  1.1           Program.  For
purposes of this Agreement, “Program” means the SEER
Sintered Tip Resection Device, BSC Project # M0380.
  1.2           Product.  For
purposes of this Agreement, “Product” means any medical
device having a sintered, conductive metal tip in accordance with the Product
Specifications attached hereto as Exhibit A (Revisions
A-1 & A-2) for use in the Field.  Product specifically does not
include any generator or generator accessories.  “Field” means liver, pancreatic
and kidney tumor, orthopedic, and blood vessel sealing, therapy by delivery of
RF current and sterile saline for resection, hemostatic sealing and coagulation
of soft tissue in open surgery and/or laparoscopic surgery.
  1.3           Assets.  At
the closing, and upon the terms and conditions of this Agreement, Seller hereby
sells, transfers, conveys, assigns and delivers to Buyer, and Buyer purchases
from Seller, free and clear of any and all liabilities, obligations, liens and
encumbrances, all right, title and interest in and to the following Program
assets of Seller (collectively, the “Purchased Assets”), wherever
located, :
  (a)           All
equipment, machinery, prototypes, tooling, supplies, and other personal property
of the Seller predominantly related to the Program and the design, development
and manufacture of the Product, including all records related thereto, as set
forth on Exhibit
X hereto;
  BUYER:
      ________
                Page 1 of
      8
                SELLER:
      ________
  
  (b)           all
of Seller’s rights and interest in and under the contracts, licenses, leases and
other agreements and instruments predominantly related to the Program and the
design, development and manufacture of the Product, as set forth onExhibit X hereto,
together with true, complete and accurate copies of the same(the “Transferred
Contracts”);
  (c)           to
the extent assignable, approvals, clearances, authorizations, licenses and
registrations required by any governmental authority, predominantly related to
the Program and to permit the design, development, pre-clinical and clinical
testing, manufacturing, labeling, sale, distribution, and promotion of the
Product as set forth on Exhibit X hereto,
together with true, complete and accurate copies of the same (the “Transferred
Permits”);
  (d)          all
scientific, clinical, technical, marketing, pre-sales and other data,
predominantly related to the Program and the design, development and manufacture
of the Product, including, without limitation, files, formulas, compositions,
computer discs and tapes (and reasonable use of the means to access or convert
them to a form useable by Buyer, if necessary), laboratory notebooks, design
histories, operating manuals and procedures, instructions for use, device
history records, bills of materials, and manufacturing, inspection and quality
control records and procedures, as set forth on Exhibit X
hereto;
  (e)           the Generated Product IP (as defined in Section
2.1), together with true, complete and accurate copies of the documents
pertaining thereto including, without limitation, documents used by Seller (or
its counsel) in the preparation and prosecution of the patents comprising the
Generated Product IP, except as to the excluded document categories set forth on
Exhibit X
hereto;
  (f)           all guarantees,
warranties, indemnities and similar rights in favor of Seller with respect to
any Purchased Asset; and
  (g)          all rights to causes of
action, lawsuits, judgments, claims and demands of any nature available to, or
being pursued by, Seller, with respect to the Purchased Assets, whether arising
by way of counterclaim or otherwise.
  1.4           Delivery of Purchased
Assets.No later than _____ (_)
business days after the closing, Seller shallpackage and ship (or cause to be packaged and shipped)
to Buyer all tangible personal property elements of the Purchased Assets not in
Buyer’s possession and custody as of the closing, at Seller’s
expense.
  2.           Assignment of Intellectual
Property; Cross-Licenses.
  2.1           Assignment of Generated
Product IP.  At the closing, and upon the terms and conditions
of this Agreement, Seller hereby sells, transfers, conveys and assigns to Buyer,
and Buyer purchases from Seller, free and clear of any and all liabilities,
obligations, liens and encumbrances, all right, title and interest in and to any
and all Intellectual Property Rights (as defined below) generated in the
performance of the Program and as a result of development work on the Product by
or on behalf of either Party (collectively, the “Generated Product IP”),
including but not limited to:
  (a)           **   **
  (b)           US2007/0156134,
filed December 29, 2005, **   **
  (c)           U.S.
Patent #7,282,051, filed February 4, 2004, issued October 16, 2007, and
continuation 11/550,374 (US2007/0123848); and
  (d)           **   **
..
  For
purposes of this Agreement, “Intellectual Property Rights”
means intellectual property or proprietary rights of any description worldwide
including without limitation (i) rights in any patent, patent registration,
patent application, copyrights, industrial designs, trademarks, (ii) trade
secrets, moral rights, shop rights and publicity rights, (iii) inventions,
discoveries, know-how, techniques, methodologies, designs or data, whether or
not patented, patentable or copyrightable, (iv) rights to sue for and remedies
against past, present and future infringements or misappropriations thereof, and
rights of priority and protection of interests therein under the laws of any
jurisdiction worldwide and all tangible embodiments thereof, and (v) goodwill
related to any of the foregoing.
 
 BUYER:
      ________
                Page 2 of
      8
                SELLER:
      ________
  
  2.2           License to Generated Product
IP.At
the closing, and upon the terms and conditions of this Agreement, Buyer hereby
grants to Seller a non-exclusive, fully paid up, royalty-free, worldwide,
perpetual, irrevocable license to the Generated Product IP solely to make, have
made, use, offer for sale, sell, have sold, import and export any Seller
Products.  For purposes of this Agreement, “Seller Products” means any
product or device of Seller, provided however, such product or device shall be
for use in applications outside of a Product for the Field.  As of
January 1, 2016, the license granted to Seller under this Section 2.2 shall
cease to include the limitation in the previous sentence, i.e., “for use in
applications outside of a Product for the Field.”  The license granted
to Seller hereunder is not sublicensable, but is transferable by Seller to a
buyer only in connection with the sale of all or substantially all of the assets
relating to any Seller Product.
  2.3           License to Existing Product
Patents.  At the closing, and upon the terms and conditions of
this Agreement, Seller hereby grants to Buyer a non-exclusive, fully paid up,
royalty-free, worldwide, perpetual, irrevocable license to Existing Product
Patents solely to make, have made, use, offer for sale, sell, have sold, import
and export the Product for use in the Field.  For purposes of this
Agreement, “Existing Product
Patents” shall include any of Seller’s invention disclosures, trade
secrets and patent applications (but not to the extent of disclosing non-public
details of such disclosures, trade secrets, or patent applications), and issued
and issuing patents existing as of the Effective Date, including continuations
and foreign counterparts thereof obtained thereafter, necessary for the
non-infringing manufacture, use and sale of the Product.  The
foregoing license is not sublicensable but is transferable by Buyer to a buyer
only in connection with the sale of all or substantially all of the assets
relating to the Product.
  3.           Termination of Distribution
Agreement and Releases.
  3.1           Termination.  The
Distribution Agreement is hereby terminated as of the Effective
Date.
  3.2           Releases.  Each
Party, along with its employees, officers, directors, affiliates,
subcontractors, agents, successors or assigns, hereby releases and discharges
the other Party, along with its employees, officers, directors, affiliates,
subcontractors, agents, successors or assigns, of any and all obligations,
liabilities and claims, whether known or unknown, accrued or not accrued,
contingent or otherwise, arising prior to the Effective Date, directly or
indirectly, out of or related to, the Distribution Agreement, the performance of
the Distribution Agreement or the termination of the Distribution
Agreement.
  4.           Confidential
Information
  4.1           Confidential
Information.
  (a)           "Confidential Information"
means all proprietary information disclosed by or on behalf of either Party
hereto (a “Disclosing Party”) to the other Party hereto (a “Receiving Party”),
or any of the Disclosing Party’s or Receiving Party’s employees, officers,
directors, affiliates, subcontractors, agents, successors or assigns
(collectively “Representatives” and together
with the Disclosing Party, the “Disclosing Group” or together
with the Receiving Party, the “Receiving Group”), including
information relating to the matters that are the subject of this Agreement,
including the terms, existence and nature of this Agreement, or relating to the
Disclosing Party’s other past, present or future research, technology, know-how,
ideas, concepts, designs, products, markets, customer information, computer
programs, prototypes, processes, machines, articles of manufacture, compositions
of matter, business plans and operations, technical information, drawings, or
specifications; except information which is:  (i) at the time of
disclosure, or thereafter becomes lawfully part of the public domain through no
act or omission by the Receiving Party; (ii) lawfully in the possession of
Receiving Party prior to disclosure by or on behalf of Disclosing Party, as
shown by written records; (iii) lawfully disclosed to the Receiving Party by a
third party which did not acquire the same under an obligation of
confidentiality from or through the Disclosing Group; or (iv) independently
developed by the Receiving Party without use of Confidential Information, as
shown by written records.  If a Receiving Party believes in good faith
that it is required by law to disclose any Confidential Information, it shall
provide notice to the Disclosing Party, prior to making such disclosure so as to
allow Disclosing Party time to undertake legal or other action, to prevent such
disclosure or otherwise obtain confidential treatment of such
disclosure.
  BUYER:
      ________
                Page 3 of
      8
                SELLER:
      ________
  
  (b)           A
Receiving Party shall not, without the prior consent of the Disclosing Party,
disclose any Confidential Information to anyone for any reason at any time or
use any Confidential Information for any purpose except as requested by the
Disclosing Party.  The Receiving Party shall limit dissemination of
Confidential Information to only those of the Receiving Group having a "need to
know."  A Receiving Party shall not, except as permitted under this
Agreement:  (i) appropriate or use a Disclosing Party’s Confidential
Information in Receiving Party’s own manufacture of products for itself or for
any third party or for any other purpose; or (ii) obtain any title to, or any
interest or license in, any Confidential Information of a Disclosing
Party.
  (c)           Neither
Party shall issue a press release or other public announcement concerning this
Agreement (or any term sheet, bids, negotiations or other related information),
the transactions contemplated herein, or the relationship between the Parties
without the prior written approval of an authorized representative of the other
Party, which such approval the other Party shall not unreasonably withhold or
delay, provided however, a Party may issue a press release, public announcement
or disclosure of this Agreement if required by the regulations of a securities
exchange on which such Party’s securities are listed if (i) it gives the other
Party prompt notice of such requirement and (ii) it cooperates with the other
Party with respect to reasonable requests for revisions to any announcement or
reasonable requests for confidential treatment of certain sections of this
Agreement.
  (d)           Neither
Party shall:  (i) disclose to the other Party any confidential or
proprietary information belonging to any third party without the consent of such
third party; nor (ii) represent as being unrestricted any designs, plans,
models, samples, or other writings or products that the Disclosing Party knows
or has reason to know are covered by Intellectual Property Rights of a third
party.
  5.           Indemnification.
  (a)           Buyer
shall indemnify, defend and hold harmless Seller and its affiliates and their respective
directors, officers, employees and agents from and againstany claim,
action, suit, demand, damage, expense or losses (including reasonable attorneys’
fees) by a third party (collectively, "Claims") resulting from or to
the extent relating to: (i) Buyer’s manufacture, use, sale and marketing of the
Product, including but not limited to Claims relating to personal injury; or
(ii) infringement or alleged infringement of any third party Intellectual
Property Rights with respect to the sale of the Product.
  (b)           Seller shallindemnify, defend and hold harmless Buyer and its affiliates and their respective
directors, officers, employees and agents from and againstany Claims
resulting from or to the extent relating to Seller’s material breach of this
Agreement including, without limitation, any material inaccuracy of Seller’s
representations or warranties, or material breach of Seller’s covenants, under
Section 7 hereof.
  (c)           Either
Party’s (the “indemnifying
Party”) obligations to the other Party (the “indemnified Party”) under this
Section 5 are conditioned upon the indemnified Party:  (i) providing
written notice to the indemnifying Party of any Claims promptly, but not later
than fifteen (15) calendar days after the indemnified Party knows of such Claim;
(ii) permitting the indemnifying Party to assume full responsibility for the
defense of such Claim; (iii) assisting the indemnifying Party in defense of such
Claim at the indemnifying Party’s expense; and (iv) not compromising or settling
any such Claim without the indemnifying Party’s prior written
consent.  Indemnifying Party may not settle a Claim without the
indemnified Party’s prior written consent, which consent shall not be
unreasonably withheld or delayed, unless such settlement includes a full release
of the indemnified Party from all liability and without any condition of future
consideration.  Notwithstanding the foregoing, the indemnified Party’s
failure to give the notice specified in this Section or delay in giving such
notice, shall not affect the indemnified Party’s right to indemnification under
this Section except to the extent that indemnifying Party has been prejudiced by
such failure or delay.
  6.           Remedies.Termination
of this Agreement, or the exercise of any other remedy, shall not be deemed to
be an exclusive remedy hereunder, and shall be in addition to any other remedies
available at law or in equity (including a Party’s right to obtain specific
performance and other equitable relief for other Party’s material breach
hereof).
  7.           Representations and
Warranties; Covenants.  Each Party hereby represents and
warrants to the other that:  (a) the execution and delivery of
and performance under this Agreement by such Party does not, and will not,
conflict with or violate any other agreement or obligations with third parties
or any restrictions of any kind or any law to which it is bound or subject; and
(b) it has the unrestricted right to disclose any information it submits to the
other Party, free of all claims of third parties, and that such disclosures do
not breach or conflict with any confidentiality provisions of any agreement to
which it is a party.
  BUYER:
      ________
                Page 4 of
      8
                SELLER:
      ________
  
  7.1           Purchased
Assets.  Seller hereby represents and warrants to Buyer that
Seller has good title to the Purchased Assets, and that the Purchased Assets
transferred or otherwise conveyed hereunder to Buyer are and shall be free and clear of any and allliabilities, obligations, liens and encumbrances.
  7.2           Further
Assurances.  Following the closing,
Seller shall, from time to time, execute and deliver such additional
instruments, documents, conveyances or assurances, and take such other actions
as shall be reasonably necessary, or otherwise reasonably requested by the
Buyer, to confirm and assure the rights and obligations provided for in this
Agreement and to render effective the consummation of the transactions
contemplated hereby.
  7.3           Authorization. Each Party has the corporate power and
authority to execute and deliver this Agreement, to perform fully its
obligations hereunder, and to consummate the transactions contemplated thereby.
The execution and delivery by each Party of this Agreement, and the consummation
of the transactions contemplated hereby, have been duly authorized by all
requisite corporate action of each Party.  This Agreement constitutes
legal, valid and binding obligations of each Party, enforceable against it in
accordance with the terms and conditions hereof.
  7.4           Litigation. There is no action, claim, demand,
suit, proceeding, arbitration, grievance, citation, summons, subpoena, inquiry
or investigation of any nature, civil, criminal, regulatory or otherwise, in law
or in equity, pending or threatened against Seller in connection with the
Purchased Assets, and Seller does not know or have reason to be aware of any
basis for the same.
  7.5           Brokers,
Finders. All negotiations
relating to this Agreement have been carried on without the participation of any
person acting on behalf of Seller or its affiliates in such manner as to give
rise to any valid claim against the Buyer for any brokerage or finder's
commission, fee or similar compensation, or for any bonus payable to any
officer, director, employee, agent or sales representative of or consultant to
Seller or their respective affiliates upon consummation of the transactions
contemplated hereby.
  7.6           Liability
for Transfer Taxes. In the
event any sales (including, without limitation, bulk sales), use, value-added,
documentary, stamp, registration, transfer, conveyance, excise, recording,
license and other similar taxes and fees (collectively, "Transfer Taxes"),
arising out of or in connection with or attributable to the transactions
effected pursuant to this Agreement are due, the Parties shall agree as to which
Party shall prepare any required returns or notices and the Parties shall evenly
split the cost of preparing such returns and the amount of any Transfer Taxes
due.
  8.  
          Miscellaneous
  8.1           Except
as specifically set forth in Sections 2.2 and 2.3 neither Party shall assign
this Agreement or its obligations hereunder, whether voluntarily or
involuntarily, without the express prior written consent of the other
Party.
  8.2           This
Agreement is fully binding upon the Parties’ successors and permitted
assigns.
  8.3           All
requests, approvals, consents and notices must be in writing and will be
effective as of the date actually received and, unless otherwise specified in
this Agreement, shall be sent as follows: (i) certified mail - return receipt
requested; (ii) a nationally recognized overnight delivery service that
guarantees overnight delivery and requires the signature of recipient; or (iii)
facsimile, transmission confirmed; to the addresses and fax numbers indicated on
the first page of this Agreement; provided, however, that in the
case of a facsimile transmission a copy is also sent one of the foregoing
methods of subsection (i) or (ii), above.
  8.4           This
Agreement:  (i) is governed by the laws of The State of New York,
without reference to its internal principles of conflicts of laws, any disputes
shall be brought exclusively in a federal or state court residing in New York,
and the parties agree without objection to the jurisdiction and venue of such
court; (ii) together with all Exhibits thereto (which are hereby incorporated
into this Agreement) is the entire and exclusive set of terms and conditions and
supersedes all prior agreements and understandings, both written and oral,
between the Parties with respect to the subject matter of this Agreement and
termination of the Distribution Agreement; and (iii) may only be modified by a
writing signed by both Parties.
  8.5           Headings
of the articles, sections and subsections of this Agreement, and the name of
this Agreement, are for reference purposes only and shall not limit or affect
the meaning or construction of the terms and conditions
hereof.  Whenever the words “include”, “includes” or “including” are
used in this Agreement, they shall be deemed in each instance to be followed by
the words “without limitation.”
  BUYER:
      ________
                Page 5 of
      8
                SELLER:
      ________
  
  8.6           No
failure of either Party to enforce any right under this Agreement shall be
deemed a waiver thereof.
  8.7           All
obligations and rights which are by their nature continuing, including the
obligations contained in Sections 2.2, 2.3, 4, 5, 7, and 8 shall survive the
expiration or termination of this Agreement.
  ACCEPTANCE
OF AGREEMENT
 By
signing below the undersigned acknowledge and accept all terms and conditions of
this Agreement.
  BUYER:   BOVIE
      MEDICAL CORPORATION
                                    SELLER:  BOSTON
      SCIENTIFIC CORPORATIONBy
                                    /S/
      Moshe Citronowicz
                                    
                                    By:
                                    /S/
      Michael P. Phalen(Signature)
                                    
                                    Signature)
  Print
      Name:
              /S/ Moshe Citronowicz
  Print
      Name:
              /S/ Michael P. Phalen
  Title:
                Vice President / COO
                
                
                Title:  Title:
                Pres, Oncology
 
 Date
      signed:
                4-29-08
                
                
                Date
      signed:
                4-30-08
 
 BUYER:
      ________
                Page 6 of
      8
                SELLER:
      ________
 
 Exhibit X: Purchased
Assets
 
 Sect
1.3a)            
Equipment, machinery, prototypes, tooling, supplies, and other personal property
predominantly related to the Program
 
 Prototypes
 
 12
      assembled prototypes in trays
                (BSC)60
      porous tips w/o powder coat
                (BSC)20
      short samples – blue powder coat
                (BSC)20
      laser and resistance welded samples
                (BSC)1
      laparoscopic prototype
                (BSC)3
      bipolar prototypes
                (BSC)Any
      prototype from **  **
                (Bovie)Any
      prototype with **   **
                (Bovie)Any
      packaging prototypes
                (Bovie)
 
 PDM Project
Files
 
 See 1.3d, below
 
 Equipment
 
 None
 
 Tooling and
Molds
 
 All
      of BSC’s right, title and interest in component tooling with
      MottHandle
      Molds    -9 tools
                **   **Packaging
      Molds
                **   **
 
 Components and Test
Fixtures
 
 Any
      components with **   **
                (Bovie)Any
      components with **  **
                (Bovie)
 
 Sect.
1.3b)       Seller’s right and interest in
and under the contracts, licenses, leases and other agreements and instruments
predominantly related to the Program
 
 Contracts
 
 Mott
      letter with terms and Conditions
                (BSC)PO’s
      to Mott
                (BSC)Mott
      quotes
                (BSC)
 
 Section
1.3c)      Approvals, clearances, authorizations,
license and registrations required by any governmental authority, predominantly
related to the Program
 
 None
 
 Section
1.3d)     Clinical, technical, marketing, pre-sales and
other data, predominantly related to the Program and the design, development and
manufacture of the Product
 
 BUYER:
      ________
                  Page 7 of
      8
                  SELLER:
      ________
 
  
  Product and Marketing
Specifications
 
 Product
      Spec attached as part of contract
                (Bovie)Drawings
                (Bovie)Customer
      Input
                (BSC)BSC
      PDM Files
                (BSC)Design
      History File
                (Bovie)
 
 Technical Documents,
Testing, Notebook Entries, Schedules and Activities
 
 BSC
      PDM Files
                (BSC)Personal
      Files
                (BSC)Network
      Drives
                (BSC)Mott
      Documents
                (BSC)**   **
      Documents
                (BSC)**   **Documents
                (BSC)
 
 Meeting Minutes,
Presentations, Trip Reports, Quality Documents, Design
Control
 
 BSC
      PDM Files
                (BSC)Personal
      Files
                (BSC)Network
      Drives
                (BSC)Mott
      Documents
                (BSC)**   **
      Documents
                (BSC)
 
 Animal and Bench Testing,
Regulatory Documents, Physician Feedback
 
 Video
      and Photos
                (BSC)Includes
      **   ** demoBSCPDMFiles
                (BSC)Personal
      Files
                (BSC)Network
      Drives
                (BSC)
 
 Marketing Data, Customer
Input
 
 Personal
      Files
                (BSC)Network
      Drives
                (BSC)
 
 1.3e)        Generated
Product IP
 
 Excluded Document
Categories
 
 Only documents or portions thereof, to
the extent they incorporate attorney-client privileged legal analysis, prepared
in response to BSC’s request to its internal or external counsel, related to the
General Product IP.  Nothwithstanding the foregoing, patent search
results and drafts of unfiled patent applications shall not be
excluded.
 
 BUYER:
      ________
                  Page 8 of
      8
                  SELLER:
      ________





Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              1-12Title:Product
      Specification: Resection
Device





EXHIBIT A
Version A-1 to Exhibit 10.14 – Redacted









BOVIE
–


Resection
Device





Product
Specifications





BOVIE MEDICAL
CORPORATION


CONFIDENTIAL


FOR INTERNAL USE
ONLY




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.







Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              2-12Title:Product
      Specification: Resection
Device





Table of
Contents





1     INTRODUCTION
              41.1Purpose
              41.2Scope
              42     APPLICABLE
      DOCUMENTS
              42.1Standards
              43.0
      GENERAL DESCRIPTION
              43.1
      Concept Drawing
              53.2
      Application
              53.2.1
      Intended Use
              53.2.2
      Intended Users
              63.3
      Quality System Requirements
              63.3.1
      US Requirements
              63.3.2
      Canadian Requirements
              63.3.3
      European Classifications
              73.3.4
      Quality System Requirements
              74     PRODUCT
      DOCUMENT STRUCTURE
              74.1Project
      Documentation
              74.2Model Number
      Format
              75     PRODUCT
      REQUIREMENTS
              85.1Electrical and
      Mechanical
              85.1.1Insulated
      Handle
              85.1.2Shaft
      and Electrode Tip
              95.1.3Shipping
      and Handling
              105.1.4Sterilization
              106     Protection
      Against Hazards
              107     Packaging
              107.1Labeling
              107.2Packaging
      Configuration
              117.3Manufacturing
              11




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              3-12Title:Product
      Specification: Resection
Device




List
of Tables


Table
      One – Standards
                    Page
      4Table
      Two – Device Classifications
                    Page
      6Table
      Three – Model Number Format
                    Page
      7List
      of FiguresFigure
      One – Concept Drawing
                    Page
      5




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              4-12Title:Product
      Specification: Resection
Device




1
                INTRODUCTION


1.1
                Purpose


This
Product Specification defines preliminary product requirements and constitutes a
part of the Design Inputs for the Resection Device Project for Boston Scientific
Corporation (“BSC”).




1.2
                Scope


This
Product Specification sets forth the requirements, provided by BSC, for the
Resection Device, (the “Device”).




2
                APPLICABLE
      DOCUMENTS


The
following is a list of all documents and other sources of information referenced
in this Product Specification.




2.1
                Standards


Standard
                      
                      Version/Date
                      
                      Description21
      CFR Part 820
                      
                      
                      
                      Medical
      Devices, Current Good Manufacturing Practices, Final Rule, Quality System
      Regulation.HF-18
                      
                      2001
                      
                      AAMI/ANSI
      Electrosurgical Devices10993-1
                      
                      3;
      Date 8-1-03
                      
                      AAMI/ANSI/ISO
      Biological evaluation of medical devices – Part 1: Evaluation and
      TestingEN
      980
                      
                      2003
                        04/16/2003
                      
                      Graphical
      symbols for use in the labeling of medical devicesEN
      ISO 14971
                      
                      2000
      AMD 1 2003
                        03/01/2003
                      
                      Medical
      devices – Application of risk management to risk management to medical
      devices (ISO 14971:2000)ISTA
      2A 2006
                      
                      2006
                      
                      Performance
      Test for Packaged-Products Weighing 150 lbs (68 kg) or
  Less


Table 1 -
Applicable Standards for Medical Devices (US)




3.0
                GENERAL
      DESCRIPTION


The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
(“RF”) current and sterile saline for hemostatic sealing and coagulation of soft
tissue in accordance with instructions and user procedures provided by
BSC.  The device is not intended for any other unspecified uses.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              5-12Title:Product
      Specification: Resection
Device




3.1
                Concept
      Drawing





Figure 1




3.2
                Application


3.2.1
                Intended
      Use


The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
current and sterile saline for hemostatic sealing and coagulation of the soft
tissue in accordance with instructions and user procedures provided by BSC. The
device is not intended for any other unspecified uses.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              6-12Title:Product
      Specification: Resection
Device




3.2.2
                Intended
      Users


Users of
this Device will be healthcare professionals such as medical doctors and nurses,
who are qualified and trained in electrosurgical procedures.




3.3
                Quality
      System Requirements


The
Device has the following classifications for FDA, CMDR, and MDD
classification.




Device
                      
                      US Classification
                      
                      Canada
                        Classification
                      
                      MDD
                        ClassificationResection
      Device
                      
                      II
                      
                      III
                      
                      IIb




Table 2 -
Device Classifications




3.3.1
              US
      Requirements


To market
medical products, the Food and Drug Administration (FDA) must determine that a
medical device is substantially equivalent to similar marketed medical
devices.  The Bovie Regulatory department intends to use the
dissecting sealer device manufactured by TissueLink as a predicate
device.




3.3.1.1
                Classification


The
Device’s classification is Class II.




3.3.1.2
                Safety
      and Effectiveness
requirements


The
Device will meet electrical safety requirements (ANSI/AAMI
HF-18:2001).




3.3.1.3
                Quality
      System Requirements


Quality
system requirements are specified as part of 21 CFR Part 820, Quality System
Regulation.




3.3.2
                Canadian
      Requirements


To market
medical products in Canada, a license application must be presented to Health
Canada. Once the license application is approved, the medical product can be
labeled and made available for sale in the Canadian provinces.




3.3.2.1
                Classification


Class
III




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              7-12Title:Product
      Specification: Resection
Device




3.3.2.2
                Safety
      and Effectiveness
requirements


Safety
and effectiveness requirements closely correspond to the essential requirements
of the Medical Device Directive.  A list of Health Canada recognized
standards has been issued as of April 11, 2002 in Policy on Recognition and Use
of Standards under Medical Device Regulations.




3.3.2.3
                Quality
      System Requirements


Health
Canada requires manufacturers of Class II, III and IV device to demonstrate that
their devices are manufactured in accordance with internationally recognized
standards.  Demonstration of compliance with the quality system
requirements will be required at the time an application is made for a medical
device license.




3.3.3
                European
      Classifications


3.3.3.1
                Classification


The
Device is classified IIb (Rule 9 ) in accordance with the Medical Devices
Directive Annex IX.




(Reference:
Guidelines for the Classification of Medical Devices – MEDDEV 2.4/1 Rev. 8, July
2001)




3.3.3.2
                Conformance
      Assessment Route


The
Device assessment route will be via Annex II (full quality assurance
system).




3.3.4
                Quality
      System
Requirements




Bovie
Medical Corporation (“Bovie”) has been certified to ISO13485




4
                PRODUCT
      DOCUMENT STRUCTURE


4.1
                Project Documentation


Documents
will be in standard Bovie document format.




4.2
                Model Number Format


The
following table lists the Device’s model number and corresponding product /
catalog code.




Catalog #
                    
                    CommentsTBD
                    
                    Laparoscopic  Monopolar
      DeviceTBD
                    
                    Open
      Abdominal Monopolar
Device


Table
Three




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              8-12Title:Product
      Specification: Resection
Device




5
                PRODUCT
      REQUIREMENTS


The
following section will describe requirements for the insulated handle and shaft
with electrode tip.




5.1
                Electrical
      and Mechanical


The
Device hardware is comprised of two (2) major components: (i) an Insulated
Handle and (ii) a Shaft with Electrode Tip. RF energy is passed through the
Insulated Handle through the Shaft to the Electrode Tip by a powered lead from
an electrosurgical generator.




5.1.1
                Insulated
      Handle


The
Insulated Handle encases the controlling mechanism for the flow of saline, and
activation and selection of the RF current for the Device.




5.1.1.1
Insulated Handle and Power Cord Insulation Resistance




The
insulation of the Insulated Handle and Power Cord shall meet Requirements of
Section 4.2.5.4 Dielectric withstands of accessories ANSI/AAMI
HF-18:2001




5.1.1.2
Insulated Handle Ergonomics




The
Insulated Handle shall be designed for comfortable and efficient hand
operation.  It will incorporate an over-mold to give the body an
elegant feel and soft touch.




5.1.1.3
Insulated Handle Electrical Cord




The
Insulated Handle Electrical Cord shall be approximately ten (10) feet in length
and incorporate a 3-prong electrical plug.




5.1.1.4
Insulated Handle Flow Control Mechanism




The
Device will have a flow control mechanism, either on the tubing or in the handle
itself so the flow can be regulated by the user within the sterile
field.




5.1.1.5
Insulated Handle Tubing Length




The
tubing length should be approximately seven (7) feet in length and incorporate
an I.V. spike on the end to attach directly to a hanging IV bag.




5.1.1.6
Insulated Handle Tubing Material




The
tubing material should be a material that will resist kinking but should not
have so strong a memory as to pull the probe off of the sterile
field.




5.1.1.7
Insulated Handle Activation Buttons








BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              9-12Title:Product
      Specification: Resection
Device




5.1.1.8
Insulated Handle Compatibility




·
            The
      Insulated Handle should have compatibility with standard RF generators
      used for electrocautery and standard grounding
  pad.




·
            The
      Insulated Handle should have compatibility with standard 0.9% saline I.V.
      bag.




5.1.2
                Shaft
      and Electrode Tip


The Shaft
and Electrode Tip provide the actual working portion of this
system.




5.1.2.1
Saline Flow Rate of Device




The
Saline flow rate prior to use will be
**       **




5.1.2.2
Device (Shaft) Length




The
Device should be straight and have two (2) lengths: one for laparoscopic
monopolar procedures (approximately thirty-two (32) cm) and one for open
monopolar procedures (approximately fourteen (14) cm).




5.1.2.3
Shaft Configuration




The Shaft
will be hollow to allow for fluid to flow to the sintered stainless steel tip.
The inside diameter of the Shaft should be equal to the inside diameter of the
tubing that feeds fluid to the Shaft to minimize any flow restriction in the
fluid circuit.




5.1.2.4
Tip Material




The Tip
shall be made of **       **




.




5.1.2.5
Tip Strength




The
porous blade tip to shaft tensile bond strength (axial mode) must be greater
than **       **




after
being subjected to a full-power simulated use duty cycle.




The
porous blade tip to shaft bond strength in an flexural mode must be greater than
**       **








BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              10-12Title:Product
      Specification: Resection
Device




5.1.2.6
Tip performance




·
            Bovie
      will exert its best efforts to meet the design goal that tip cutting
      performance be superior to competitive devices with respect to cutting
      speed. Tip will have the ability to coagulate soft tissue when performed
      in a suitable simulated use
environment.




5.1.3
                Shipping
      and Handling


4.1.3.1
Shipping Temperatures




Tropical
(Wet and Dry) Conditions and Winter (Frozen) Conditions per ISTA
2A.




4.1.3.2
Transportation Testing




The Final
Product Packaging Configuration for the Device shall meet the finished device
requirements after being subjected to Simulated Transportation Conditioning per
ISTA 2A.




5.1.4
                Sterilization


5.1.4.1
Withstand 2x ETO Sterilization.




5.1.4.2
EN 550: 1994 – Sterilization of Medical Devices – Validation and routine control
of ethylene oxide sterilization.




5.1.4.3
AAMI/ANSI/ISO 11135 -1994 Medical Devices – Validation and routine control of
ethylene oxide sterilization.




6
                Protection
      Against Hazards


A
Hazard/Risk Analysis will be performed throughout the design
process.  The Hazard/Risk Analysis will be documented and filed as
part of the design history file.




7
                Packaging


7.1
                Labeling


7.1.1
Package must be labeled in accordance with both BSC and Bovie Labeling
Standards.





7.1.2 BSC and Bovie branding, including mutually approved trademarks, will
be on the Handle and/or the shaft.





7.1.3 The Device is to have a three (3) year shelf life under normal storage
conditions.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              11-12Title:Product
      Specification: Resection
Device




7.2
                Packaging Configuration


·
            The
      Tip and Shaft protector shall be included into the
  Design.


·
            The
      Scratch Pad shall be packaged with the
Device.


·
            The
      Device will be packaged in a Sterile
Pouch.


7.3
                Manufacturing


Final
assembly and packaging will be performed by Bovie.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.









Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-1
            Page
              12-12Title:Product
      Specification: Resection
Device





APPROVALS





AuthorThomas
      Feldhaus
                            
                            DateSales
      & MarketingRick
      Pfahl
                            
                            DateRegulatoryRick
      Kozloff
                            
                            DateQualityJohn
      Woody
                            
                            DateManufacturingLillian
      Eshem
                            
                            DateEngineeringFred
      Baron
                            
                            Date




BOVIE
MEDICAL CONFIDENTIAL
 THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.










Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              1-11Title:Product
      Specification: Resection Device




EXHIBIT A
Version A-2 to Exhibit 10.14 – REDACTED









BOVIE
–


Resection
Device





Product
Specifications





BOVIE MEDICAL
CORPORATION


CONFIDENTIAL


FOR INTERNAL USE
ONLY




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              2-11Title:Product
      Specification: Resection Device




Table of
Contents





1     INTRODUCTION
              41.1      Purpose
              41.2      Scope
              42      APPLICABLE
      DOCUMENTS
              42.1      Standards
              43.0
      GENERAL DESCRIPTION
              43.1
      Concept Drawing
              53.2
      Application
              53.2.1
      Intended Use
              53.2.2
      Intended Users
              53.3
      Quality System Requirements
              63.3.1
      US Requirements
              63.3.2
      Canadian Requirements
              63.3.3
      European Classifications
              73.3.4
      Quality System Requirements
              74      PRODUCT
      DOCUMENT STRUCTURE
              74.1      Project
      Documentation
              74.2      Model
      Number Format
              75      PRODUCT
      REQUIREMENTS
              75.1
      Electrical and
      Mechanical
              85.1.1 Insulated Handle
              85.1.2
      Shaft and Electrode Tip
              95.1.3
      Shipping and Handling
              105.1.4
      Sterilization
              106      Protection
      Against Hazards
              107      Packaging
              107.1      Labeling
              107.2      Packaging
      Configuration
              107.3      Manufacturing
              10




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              3-11Title:Product
      Specification: Resection Device




List
      of TablesTable
      One – Standards
                    Page
      4Table
      Two – Device Classifications
                    Page
      6Table
      Three – Model Number Format
                    Page
      7List
      of FiguresFigure
      One – Concept Drawing
                    Page
      5




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              4-11Title:Product
      Specification: Resection Device




1
                INTRODUCTION


1.1
                Purpose


This
Product Specification defines preliminary product requirements and constitutes a
part of the Design Inputs for the Resection Device Project for Boston Scientific
Corporation (“BSC”).




1.2
                Scope


This
Product Specification sets forth the requirements, provided by BSC, for the
Resection Device, (the “Device”).




2
                APPLICABLE
      DOCUMENTS


The
following is a list of all documents and other sources of information referenced
in this Product Specification.


2.1
                Standards


Standard
                      
                      Version/Date
                      
                      Description21
      CFR Part 820
                      
                      
                      
                      Medical
      Devices, Current Good Manufacturing Practices, Final Rule, Quality System
      Regulation.HF-18
                      
                      2001
                      
                      AAMI/ANSI
      Electrosurgical Devices10993-1
                      
                      3;
      Date 8-1-03
                      
                      AAMI/ANSI/ISO
      Biological evaluation of medical devices – Part 1: Evaluation and
      TestingEN
      980
                      
                      2003
                        04/16/2003
                      
                      Graphical
      symbols for use in the labeling of medical devicesEN
      ISO 14971
                      
                      2000
      AMD 1 2003
                        03/01/2003
                      
                      Medical
      devices – Application of risk management to risk management to medical
      devices (ISO 14971:2000)ISTA
      2A 2006
                      
                      2006
                      
                      Performance
      Test for Packaged-Products Weighing 150 lbs (68 kg) or
  Less




Table 1 -
Applicable Standards for Medical Devices (US)


3.0
GENERAL DESCRIPTION





The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
(“RF”) current and sterile saline for hemostatic sealing and coagulation of soft
tissue in accordance with instructions and user procedures provided by
BSC.  The device is not intended for any other unspecified uses.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              5-11Title:Product
      Specification: Resection Device




3.1
Concept Drawing







Figure
1


3.2
Application


3.2.1
Intended Use


The
Device is a sterile, single use electrosurgical device intended to be used in
conjunction with an electrosurgical generator for the delivery of radiofrequency
current and sterile saline for hemostatic sealing and coagulation of the soft
tissue in accordance with instructions and user procedures provided by BSC. The
device is not intended for any other unspecified uses.


3.2.2
Intended Users


Users of
this Device will be healthcare professionals such as medical doctors and nurses,
who are qualified and trained in electrosurgical procedures.






BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              6-11Title:Product
      Specification: Resection Device




3.3
Quality System Requirements




The
Device has the following classifications for FDA, CMDR, and MDD
classification.




Device
                          
                          US
      Classification
                          
                          Canada
                            Classification
                          
                          MDD
                            ClassificationResection
      Device
                          
                          II
                          
                          III
                          
                          IIb




Table 2 -
Device Classifications


3.3.1
US Requirements




To market
medical products, the Food and Drug Administration (FDA) must determine that a
medical device is substantially equivalent to similar marketed medical
devices.  The Bovie Regulatory department intends to use the
dissecting sealer device manufactured by TissueLink as a predicate
device.




3.3.1.1
Classification


The
Device’s classification is Class II.




3.3.1.2
Safety and Effectiveness requirements


The
Device will meet electrical safety requirements (ANSI/AAMI
HF-18:2001).




3.3.1.3
Quality System Requirements


Quality
system requirements are specified as part of 21 CFR Part 820, Quality System
Regulation.


3.3.2
Canadian Requirements


To market
medical products in Canada, a license application must be presented to Health
Canada. Once the license application is approved, the medical product can be
labeled and made available for sale in the Canadian provinces.




3.3.2.1
Classification


Class
III




3.3.2.2
Safety and Effectiveness requirements


Safety
and effectiveness requirements closely correspond to the essential requirements
of the Medical Device Directive.  A list of Health Canada recognized
standards has been issued as of April 11, 2002 in Policy on Recognition and Use
of Standards under Medical Device Regulations.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              7-11Title:Product
      Specification: Resection Device


3.3.2.3
Quality System Requirements


Health
Canada requires manufacturers of Class II, III and IV device to demonstrate that
their devices are manufactured in accordance with internationally recognized
standards.  Demonstration of compliance with the quality system
requirements will be required at the time an application is made for a medical
device license.




3.3.3
European Classifications


3.3.3.1
Classification


The
Device is classified IIb (Rule 9 ) in accordance with the Medical Devices
Directive Annex IX.




(Reference:
Guidelines for the Classification of Medical Devices – MEDDEV 2.4/1 Rev. 8, July
2001)


3.3.3.2
Conformance Assessment Route


The
Device assessment route will be via Annex II (full quality assurance
system).




3.3.4
Quality System Requirements


Bovie
Medical Corporation (“Bovie”) has been certified to ISO13485




4
                PRODUCT
      DOCUMENT STRUCTURE


4.1
                Project
      Documentation


Documents
will be in standard Bovie document format.




4.2
                Model
      Number Format


The
following table lists the Device’s model number and corresponding product /
catalog code.




Catalog
      #
                    
                    CommentsTBD
                    
                    Laparoscopic  Monopolar
      DeviceTBD
                    
                    Open
      Abdominal Monopolar
Device




Table
Three


5
                PRODUCT
      REQUIREMENTS




The
following section will describe requirements for the insulated handle and shaft
with electrode tip.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              8-11Title:Product
      Specification: Resection Device




5.1
                Electrical
      and Mechanical




The
Device hardware is comprised of two (2) major components: (i) an Insulated
Handle and (ii) a Shaft with Electrode Tip. RF energy is passed through the
Insulated Handle through the Shaft to the Electrode Tip by a powered lead from
an electrosurgical generator.


5.1.1
                Insulated
      Handle




The Insulated Handle encases the controlling
mechanism for the flow of saline, and activation and selection of the RF current
for the Device.




5.1.1.1
Insulated Handle and Power Cord Insulation Resistance




The
insulation of the Insulated Handle and Power Cord shall meet Requirements of
Section 4.2.5.4 Dielectric withstands of accessories ANSI/AAMI
HF-18:2001




5.1.1.2
Insulated Handle Ergonomics




The
Insulated Handle shall be designed for comfortable and efficient hand
operation.  It will incorporate an over-mold to give the body an
elegant feel and soft touch.




5.1.1.3 Insulated Handle Electrical
Cord




The
Insulated Handle Electrical Cord shall be approximately ten (10) feet in length
and incorporate a 3-prong electrical plug.




5.1.1.4
Insulated Handle Flow Control Mechanism




The
Device will have a flow control mechanism in the handle so the flow can be
regulated by the user within the sterile field.




5.1.1.5 Insulated Handle Tubing
Length




The
tubing length should be approximately ten (10) feet in length and incorporate an
I.V. spike on the end to attach directly to a hanging IV bag.




5.1.1.6
Insulated Handle Tubing Material




The
tubing material should be a material that will resist kinking but should not
have so strong a memory as to pull the probe off of the sterile
field.




5.1.1.7 Insulated Handle Activation
Buttons




The
Device should have an activation button. The activation button must be easy to
operate.




5.1.1.8
Insulated Handle Compatibility






BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              9-11Title:Product
      Specification: Resection Device




·
            The
      Insulated Handle should have compatibility with standard RF generators
      used for electrocautery and standard grounding
  pad.




·
            The
      Insulated Handle should have compatibility with standard 0.9% saline I.V.
      bag.




5.1.2
                Shaft
      and Electrode Tip




The Shaft
and Electrode Tip provide the actual working portion of this
system.




5.1.2.1
Saline Flow Rate of Device




The
Saline flow rate prior to use will be
**       **.




5.1.2.2
Device (Shaft) Length




The
Device should be straight and have two (2) lengths: one for laparoscopic
monopolar procedures (approximately thirty-two (32) cm) and one for open
monopolar procedures (approximately fourteen (14) cm).




5.1.2.3
Shaft Configuration




The Shaft
will be hollow to allow for fluid to flow to the sintered stainless steel tip.
The inside diameter of the Shaft should be equal to the inside diameter of the
tubing that feeds fluid to the Shaft to minimize any flow restriction in the
fluid circuit.




5.1.2.4
Tip Material




The Tip
shall be made of **       **.




5.1.2.5
Tip Strength




The
porous blade tip to shaft tensile bond strength (axial mode) must be greater
than **       ** after being subjected to a
full-power simulated use duty cycle.




The
porous blade tip to shaft bond strength in an flexural mode must be greater than
**       ** after being subjected to a
full-power simulated use duty cycle.




5.1.2.6
Tip performance




·
            Bovie
      will exert its best efforts to meet the design goal that tip cutting
      performance be superior to competitive devices with respect to cutting
      speed. Tip will have the ability to coagulate soft tissue when performed
      in a suitable simulated use
environment.




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document Number
            Rev
              Level
      A-2
            Page
              10-11Title:Product
      Specification: Resection Device




5.1.3
                Shipping
      and Handling


4.1.3.1
Shipping Temperatures




Tropical
(Wet and Dry) Conditions and Winter (Frozen) Conditions per ISTA
2A.




4.1.3.2
Transportation Testing




The Final
Product Packaging Configuration for the Device shall meet the finished device
requirements after being subjected to Simulated Transportation Conditioning per
ISTA 2A.




5.1.4
                Sterilization


5.1.4.1
Withstand 2x ETO Sterilization.




5.1.4.2
EN 550: 1994 – Sterilization of Medical Devices – Validation and routine control
of ethylene oxide sterilization.




5.1.4.3
AAMI/ANSI/ISO 11135 -1994 Medical Devices – Validation and routine control of
ethylene oxide sterilization.




6
                Protection
      Against Hazards


A
Hazard/Risk Analysis will be performed throughout the design
process.  The Hazard/Risk Analysis will be documented and filed as
part of the design history file.




7
                Packaging


7.1
                Labeling


7.1.1
      Package must be labeled in accordance with both BSC and Bovie
      Labeling Standards.





7.1.2
      BSC and Bovie branding, including mutually approved trademarks, will
      be on the Handle and/or the shaft.





7.1.3
The Device is to have a three (3) year shelf life under normal storage
conditions.


7.2
                Packaging
      Configuration





·
            The
      Tip and Shaft protector shall be included into the
  Design.


·
            The
      Scratch Pad shall be packaged with the
Device.


·
            The
      Device will be packaged in a Sterile
Pouch.


7.3
                Manufacturing




Final
assembly and packaging will be performed by
Bovie.







BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.








Author
              Thomas
      Feldhaus
            Document
      Number
            Rev
              Level
      A-2
            Page
              11-11Title:Product
      Specification: Resection Device





APPROVALS





AuthorThomas
      Feldhaus
                                                
                                                DateSales
      & MarketingRick
      Pfahl
                                                
                                                DateRegulatoryRick
      Kozloff
                                                
                                                DateQualityJohn
      Woody
                                                
                                                DateManufacturingLillian
      Eshem
                                                
                                                DateEngineeringFred
      Baron
                                                
                                                Date




BOVIE
MEDICAL CONFIDENTIAL


THIS
DOCUMENT IS THE PROPERTY OF BOVIE MEDICALCORPORATION AND MUST BE ACCOUNTED
FOR.  INFORMATION HEREIN IS CONFIDENTIAL.  DO NOT REPRODUCE,
USE, OR CONVEY ANY PORTION OF THIS DOCUMENT TO UNAUTHORIZED PERSONS, WITHOUT
PROPER AUTHORIZATION.