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
  AGREEMENTBuyer:
                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 shall package 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 against any 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 against any 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 all liabilities, 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. PhalenTitle:
                Vice
      President / COO
                
                Title: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
                **     **Handle
      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
  **     **
      letter with terms and Conditions
                (BSC)PO’s
      to **     **
                (BSC)**     **
      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)**     **
                (BSC)**     **
      Documents
                (BSC)**     **
      Documents
                (BSC)
 
 Meeting Minutes,
Presentations, Trip Reports, Quality Documents, Design
Control
 
 BSC
      PDM Files
                (BSC)Personal
      Files
                (BSC)Network
      Drives
                (BSC)**     **
      Documents
                (BSC)**     **
      Documents
                (BSC)
 
 
 Animal and Bench Testing,
Regulatory Documents, Physician Feedback
 
 Video
      and Photos
                (BSC)Includes
      **  ** demoBSC
      PDM Files
                (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:
      __________


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.
 
 
 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
                  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
                  74.1
                  Project
      Documentation
                  74.2
                  Model
      Number Format
                  75  
      PRODUCT
      REQUIREMENTS
                  85.1
                  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
                  117.3
                  Manufacturing
                  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.
 
 2
 
 List
of Tables
  Table
      One – Standards
              Page
      4Table
      Two – Device Classifications
              Page
      6Table
      Three – Model Number Format
              Page
      7
 
 
 List
of Figures
 Figure
      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.
 3
  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.
 4
  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.
  5
  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.
 6
  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.
 
 7
  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.
 
 8
  The
Device should have a Cut and Coagulation Mode. “Cut”/”Coag” buttons must be easy
to operate.
  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.
 9
  . 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.
  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.
 10
  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.
 11
  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.
  12






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.











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.





2





List
of Tables




Table
      One – Standards
            Page
      4Table
      Two – Device Classifications
            Page
      6Table
      Three – Model Number Format
            Page
      7








List
of Figures




Figure
      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.


3




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.


4




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.


5




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.


6




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.


7




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.


8




·
            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.


9




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.




10





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.


11