This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance
Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach satisfies the requirements
of the applicable statute, regulations, or both. This guidance will be updated in the next revision to
include the standard elements of GGP's.
THIRD PARTY REVIEW GUIDANCE FOR
PHACOFRAGMENTATION SYSTEM DEVICE
PREMARKET NOTIFICATION (510(k))
This document is intended to provide guidance in the preparation of a
regulatory submission.  It does not bind the FDA or the regulated industry in
any manner.
Diagnostic and Surgical Devices Branch
Division of Ophthalmic Devices
Office of Device Evaluation
Document Issued on: January 31, 1997
While this guidance document represents a final document, comments and
suggestions may be submitted at any time for Agency consideration by writing to
Mr. Denis L. McCarthy, Division of Ophthalmic Devices (HFZ-460), Center for
Devices and Radiological Health, 9200 Corporate Boulevard, Rockville, Maryland
20850.  For questions regarding the use or interpretation of this guidance, contact
Mr. Denis L. McCarthy at (240) 276-4262 or denis.mccarthy@fda.hhs.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Center for Devices and Radiological Health                            TABLE OF CONTENTS
                 SECTION I - INTRODUCTION
                 SECTION II - DESCRIPTION OF DEVICE
                 SECTION III - CLASSIFICATION & TIER OF THE DEVICE
                 SECTION IV - REQUIRED 510(K) INFORMATION
                 SECTION V - TRUTHFUL & ACCURATE STATEMENT
  Page 3
 I.  INTRODUCTION
A.  Guidance Introduction and Purpose
This document reflects the current review guidance for the Phacofragmentation
System device.  It is based on 1) current scientific knowledge, 2) clinical
experience, 3) previous submissions by manufacturers to the Food and Drug
Administration (FDA), and 4) the Food, Drug and Cosmetic Act, as amended, the
Safe Medical Devices Act of 1990 as amended, and FDA regulations in the Code
of Federal Regulations (CFR).  Following advances in science and medicine, and
any new amendments by the Congress to the device acts, these review criteria will
be reevaluated and revised as necessary.
This document is an adjunct to the CFR and other FDA Guidance documents for
the preparation and review of 510(k) submissions.  It does not supersede those
publications, but provides additional clarification on what is necessary before
the FDA can clear a device for marketing.  The submission must provide evidence
(21 CFR 807.92 (a)(3)) that the device is SUBSTANTIALLY EQUIVALENT to
a device legally marketed in the United States.  In some cases, the performance of
the device can be established by comparison of the device to a standardized
reference method, in addition to the comparison to a legally marketed device.
The primary reference for the information required in a premarket notification
(510(k)) for a device is found in 21 CFR 807.87.  Substantial equivalence to a
legally marketed device is to be established with respect to, but not limited to,
intended use, design, energy used/delivered, materials, performance, safety,
effectiveness, labeling, and other applicable characteristics.
B.  Product Introduction
The Phacofragmentation System device is described in the FDA regulation, 21
CFR 886.4670 (a) as "an AC powered device with a fragmenting needle intended
for use in cataract surgery to disrupt a cataract with ultrasound and extract
the cataract".
C.  Regulatory Background
The invention and use of the Phacofragmentation System Device for cataract
removal in 1967 by Charles Kelman, M.D. predates the May 28, 1976 effective
date of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. 
FDA has classified this generic type of device as a Class II medical device
and regulates it under the provisions of Subchapter H, Part 807, Subpart E of
the Medical Device Regulations.  This provision is known as "Premarket Page 4
Notification Procedures" and is more commonly referred to as "510(k)".  The
latter refers to that part of the Medical Device Amendments legislation which
pertains to devices which have been in commercial distribution prior to the
inception of the Medical Device Regulations.
II.  DESCRIPTION OF DEVICE
The invention of the Phacofragmentation System device provided an alternative in
the surgical technique employed for cataract removal.  The device allows for the
use of a small incision on the order of 3.0 millimeters or less which helps to
eliminate many of the wound healing complications associated with other surgical
methods of cataract removal requiring larger size incisions.  The small dimension
incision has been reported in the medical literature to provide for rapid healing and
visual recovery by patients.  The terms used to describe this device, 
"phacofragmentation and phacoemulsification", are employed interchangeably to
describe a process which consists of the application of ultrasonic energy combined
with the mechanical action of the vibrating tip applicator (phaco tip) to the
cataractous lens of the eye.  The lens undergoes fragmentation and emulsification
and is rapidly removed from the eye by aspiration.
The Phacofragmentation System device is complex in terms of its engineering
design.  The system includes: the console for controlling the functions and for
powering the device; an irrigation line and system for supply of irrigating solution
to the operative site; an aspiration line and system for removing the fragmented
lens, which also removes solution from the operative site; and, the
phacofragmentation handpiece for fragmenting and emulsifying the cataractous
lens.  The console may contain microprocessor control of the functions, fluidic
connections, disposable fluid aspiration drainage cassettes, automated irrigation
functions, remote control functions and other features.  Although complex, the
phacofragmentation system provides the following basic functions:
(1)  Phacofragmentation of the cataractous lens - This is accomplished by the
action of the phaco tip, a hollow needle located centrally in the device
handpiece.  The phaco tip is piezoelectronically oscillated longitudinally at
an ultrasonic frequency of about 40,000 hertz.  When the device is used in the
phacofragmentation mode both irrigation and aspiration occur simultaneously.
The irrigating solution enters the eye via a collinear axial lumen, which encircles
the phaco tip.  The irrigation flow rate is adjustable and pressure limited to
25.0 millimeters of mercury.  The fragmentation process is the result of
combined mechanical and ultrasonic action induced by the oscillating phaco tip.
The cataractous lens and its fragments are engaged by the phaco tip during the
procedure due the pump suction at the phaco tip orifice and assures for a very
efficient surgical procedure.  The electromechanical ultrasonic oscillation of the Page 5
phaco tip generates a significant volume of heat; therefore, to preclude adverse
thermal tissue effects, these devices incorporate cooling mechanisms.
(2)  Aspiration of fluid containing "emulsified" and fragmented cataractous
lens material - This is accomplished by means of a constant volume peristaltic
or venturi type pumping system.  The aspirated material is collected in a
"drainage bag".  Various positions of the device foot pedal control allow for
simultaneous irrigation and aspiration, or simultaneous aspiration, irrigation
and phacofragmentation.  When the phaco tip lumen engages a piece of the
fragmented cataractous lens, the lumen opening may be occluded, if the lens
fragment is large, causing the pump-induced vacuum to build up.  The vacuum
build up generally causes the occluding fragment to be aspirated; if the fragment is
too large, the hand piece vent may be employed to release the fragment, thereby
breaking the vacuum.  Most phacofragmentation systems are designed to preclude
excessive vacuum build up, because it could cause collapse of the anterior chamber
of the patient eye.
(3)  Irrigation of the operative surgical site - This is accomplished through
the use of a bottled source of irrigating solution, which is connected via tubing
through the device console to the operative handpiece; the handpiece contains a
lumen which allows the solution transport access to the surgical site.  Normally,
the solution bottle is suspended on an intravenous (IV) "pole" attached to the
device housing.  The bottle must be carefully positioned so that the "zero point" of
the IV pole is located at the level of the patient eye.  For proper gravity induced
solution flow, the fluid level of the bottle is set at 65.0 centimeters above the zero
point.  The flow of solution is controlled by a physician through a solenoid-
activated pinch valve, which applies or releases pressure on the connective tubing.
The solenoid-activated pinch valve is located within the device console and is
controlled by the device foot pedal control.
Phacofragmentation System devices are generally furnished with a variety of
handpieces.  These handpieces generally fall into three functional classes: irrigation
only, irrigation and aspiration only, and phacofragmentation with
simultaneous irrigation and aspiration.  Irrigation only handpieces may be
furnished in a number of configurations to provide for various surgical functions,
such as one with a bent tip for use in anterior and posterior capsulotomy or one
with provisions for attachments, such as a cystotome or capsule polisher.  The
irrigation and aspiration only handpiece is generally used after the
phacofragmentation process has been completed.  It is used to remove remaining
residual tissue.  Tips are furnished in various lumen sizes, ranging from 0.2 to 0.7
millimeters.  Some Phacofragmentation System devices are provided with a
vitreous aspiration and cutting handpiece.  This device is also a Class II medical
device and is subject to another FDA review guidance document.  The addition of Page 6
this type of handpiece would make the Phacofragmentation System device
multifunctional and therefore would convert the device to a combination device. 
Combination devices are not currently eligible for Third Party review.
Phacofragmentation System devices are designed with many technologically
advanced features, such as vacuum and irrigation/aspiration select switches,
programmable microprocessor controls, modularized fluidic connections with
disposable cassettes, automated IV irrigation pole components, and provisions for
remote control of the device from outside the sterile operative environment.  These
features must be carefully reviewed during the process of establishing the
substantial equivalence of this generic type of device.
III.  CLASSIFICATION AND TIER OF DEVICE
This device has been placed in Class II under section 513 of the Federal
Food, Drug, and Cosmetic Act.  Devices such as the Phacofragmentation System
device are often placed in Tier II.  The appropriate panel is the Ophthalmic
Devices Panel and the device classification is located in Part 886 of 21 CFR
(Code of Federal Regulations).  The device is specifically identified under
regulation number 886.4670.
IV.  REQUIRED 510(K) INFORMATION
A.  Introduction to Review
The following sections describe information needed to evaluate a 510(k) premarket
notification.  The purpose of the review is to determine substantial equivalence to a
legally marketed device.  For further information refer to the 510(k) manual,
Premarket Notification 510(k): Regulatory Requirements for Medical Devices,
which is available from the Division of Small Manufacturers Assistance (DSMA). 
DSMA may be reached at (800) 638-2041 or (301)443-6597. 
The premarket notification for a device, device modification or accessory should
be dated and must be signed by the applicant.  It should contain a table of contents
and a listing of tabs and appendices.  It should have sequential page numbers. 
The premarket notification must include a statement that the submitter believes, to
the best of his/her knowledge, that all data and information submitted are truthful
and accurate, and that no material fact has been omitted as set forth in 21 CFR
807.87(j).
B.  Device Name Page 7
Both the trade name or proprietary name and the classification name of the
device must be specified.
C.  Classification
This device has been placed in Class II under section 513 of the Federal Food,
Drug, and Cosmetic Act.  The submission should specify the correct class.  This
device has been placed in Tier II.  The tier should also be specified in the
submission.
The Division of Small Manufacturers Assistance (DSMA) may be contacted for
assistance in determining classification of devices.  DSMA may be reached at
(800) 638-2041 or (301)443-6597.
D.  Applicant/Contact Person
The premarket notification should list the applicant's name and address, and specify
a contact person and telephone number.  The name and address of the
manufacturer should be specified, including the establishment registration number,
if applicable.  (Ref. 21 CFR 807.87(b)).
E.  Device Description
The physical description of each device to be marketed should be provided.  This
should include a labeled diagram, photograph, schematic, etc., which includes all
internal, external, assembled, unassembled, and interchangeable parts.  The
physical description should include the dimensional specifications such as length,
width, height, diameter, weight, etc. and electrical specifications (i.e., power
requirements).  Hardware/software components, if applicable to the device or
accessories, also should be specified.  Any parts that are disposable such as tubing
sets, couplers, etc. should be identified.
If the device is sold in a set that includes accessories, the accessories are
considered to be part of the device.  They  also should be identified and described
with the same detail as above.  Accessories that might be provided with this device
might include irrigation, and aspiration handpieces.  Labeling should state whether
the accessory is sterile or non-sterile, single use or reusable.  If any of the
accessories have been previously marketed for the same intended use, certification
of the preamendments status or the 510(k) number should be furnished, if known.
Malfunctions associated with devices can sometimes be attributed to user error.  Page 8
Therefore, ergonomics should be considered in the device design.  A description of
the ergonomic features (e.g. audible/visible alarms, control panel design, data
presentation, etc.) should be provided, if appropriate.
The size and location of parts, and the readability of labeling and instructions for
use, may also effect the safety and efficacy of the device, and should be discussed
as appropriate.  In some cases, testing of instructions may be necessary.
  F.  Description of Quality Assurance Program
An adequate summary description of the manufacturers quality assurance
program should be provided.
G.  Clinical Indication
The proposed clinical indications of the device should be clearly noted in the
submission.  They must be consistent with the design of the device and with
proposed labeling.  Clinical indications should be reflected (if necessary) in
laboratory and clinical study design and must be supported by the results.
H.  Device Materials
An exact identification of all materials used to fabricate the device and its
accessories should be provided, with a statement regarding any differences from
pre-amendment devices or the proposed predicate device.  If the materials are
identical to those used in the pre-amendment or predicate device and are
identically processed and sterilized, then this should be explicitly stated.  This
information should include all direct and indirect (e.g., through fluids) patient
contacting materials.
If the direct or indirect patient contacting materials are reusable, then instructions
on reuse and evidence that the components can be safely disinfected and/or
sterilized should be provided along with a justification for the proposed level of
disinfection/sterilization.
If the device includes an antimicrobial agent or other drug component that is
subject of an approved new drug application (NDA) or over the counter (OTC)
monograph, the application should provide a reference to those documents. 
Specify any differences between the approved drug product and the agent used
in the device.
I.  510(k) Summary or 510(k) Statement Page 9
The safe Medical Devices Act of 1990 (SMDA) requires all persons
submitting a premarket notification submission to include either (1) a
summary of safety and effectiveness information in the premarket notification
upon which an equivalence determination could be based (510(k) summary) or (2)
a statement that safety and effectiveness information will be made available to
interested persons upon request (510(k) statement).  Safety and effectiveness
information refers to information in the premarket notification submission,
including adverse safety and effectiveness information, that is relevant to an
assessment of substantial equivalence.  The information could be descriptive
information about the new and predicate device(s), or performance or clinical
testing information.
J.  Testing Results and Performance Data
When testing results and /or performance data are required to demonstrate the
substantial equivalence of the device which is subject of the manufacturers
premarket notification (510(k)) to legally marketed device, the requirements listed
below should be followed.
1.  Presentation of Data
Tables and Graphs:  Data should be provided in clearly labeled tables.  Any
symbols used should be keyed to a footnote or convenient reference page and
described fully.  Graphs may supplement data tables, but do not replace them.
Graphs must be clearly labeled.
Published Literature:  Published data or methods that are referenced in the
submission should be provided.  Reprints should be appended to the section in
which they are referenced.  All referenced reports and data should be summarized,
and include an explanation of how they relate to the current submission.
Referenced citations should be complete (e.g., title, author, volume, page, year).
Protocols and Data Analysis:  Reports of any testing conducted with the device
must include the study protocol (objectives, precise description of materials,
experimental methods, controls), data/observations, statistical methods and
analysis, results/conclusions, and comments.  Raw data should not be submitted
unless requested.
Reference to Submitted Data:  In support of a 510(k) submission, an applicant
may refer to information submitted to FDA in the past.  If someone other than
the applicant submitted the previous information, then a letter of authorization is
required.  The letter may come through the applicant, or directly from the original Page 10
submitter.  Including a copy of this information with the new submission will
facilitate the review.
2.  Biocompatibility Testing
Biocompatibility testing data should be provided on any direct or indirect patient-
contacting materials that are not the same as the pre-amendment or predicate
device or are differently processed or sterilized.  If data is not provided, a
justification should be included explaining why these data are not needed. 
Guidance for this type of testing is provided in the document entitled International
Standards Organization ISO-10993, Biological Evaluation of Medical Devices
Part 1: Evaluation and Testing.  This document is used in conjunction with the
ODE Guidance Memorandum #G95-1, Use of ISO-10993".  Copies of the above
may be obtained from DSMA.
An exact identification of all colorants (inks, dyes, markings, radiopaque materials,
etc.) used to fabricate the device or accessory should be provided, if applicable.  If
the colorants are identical to the pre-amendments or substantially equivalent
device, then this should be explicitly stated.  A statement regarding any
colorant changes from the pre-amendments or substantially equivalent device
should be included.  The manufacturer should provide biocompatibility testing
data on any colorant changes that have been implemented that will contact the
patient directly or indirectly.  The information should indicate how the
markings are processed (etched, bands, etc.) and whether the colorant contacts
skin, mucosa, etc.
3.  Electrical Safety
A certification that the device complies with an appropriate domestic or
internationally recognized electrical safety standard should be provided.
Alternatively, the manufacturer may supply electrical safety data to document the
electrical safety of the device.
K.  Performance Data
When necessary, the following data should be provided to demonstrate substantial
equivalence to the predicate device with respect to functional performance: (1)
bench testing, (2) preclinical/animal testing, (3) clinical testing, (4) postmarket
testing, (5) software testing, (6) sterility information.  These tests should be
conducted in a manner similar to the actual use of the device.  Where appropriate, 
statistically valid data should be collected to establish device performance.  It is
required that all preclinical/animal testing be performed in compliance with 21 CFR
Part 58 Good Laboratory Practices (GLP) for nonclinical laboratory studies, or the Page 11
testing must have requirements that are equivalent to those contained in the above
cited regulation. 
Bench testing should be conducted in accordance with accepted industry
standards, or a description of the test methods and a justification for their
use must be provided.  Sampling (when necessary) should include a range of
devices representative of the product line. 
The compliance or noncompliance of the device with any available standards
or guidance should be discussed, including performance, design, and testing
provisions.  If available standards or guidance are not used, an explanation
should be provided.
Guidance for the information required in a premarket notification of a software
controlled device is provided in the FDA document entitled "Reviewer Guidance
For Computer Controlled Medical Devices Undergoing 510(k) Review (draft
8/29/91)."  A copy may be obtained from DSMA.
Complete information regarding the device and/or accessories that may be
sold sterile should be provided, including: the sterilization method, sterilization
cycle, validation method, specification of packaging materials, a description of the
packaging integrity to ensure that sterility is maintained, sterility assurance level
(SAL).  The radiation dose should be provided for devices sterilized with radiation,
and, for ethylene oxide (ETO) sterilized devices, the maximum levels of residuals
of ETO, ethylene chlorohydrin, and ethylene glycol should be provided.  If only
parts of the device are sold sterile, the labeling should clearly identify the parts that
are sterile and non-pyrogenic.  Devices labeled as non-pyrogenic (pyrogen free)
will require documentation of this claim.  A description of the method used to
make the determination of non-pyrogenicity (i.e., LAL or rabbit test) must be
provided.
If the device and/or accessories are sold and labeled non-sterile or can be
reprocessed, instructions on disassembly, cleaning, disinfection and/or
sterilization should be provided.  If appropriate, a statement that the device
requires high level disinfection should be provided and compatible solutions
and/or procedures for high level disinfection and/or sterilization should be
identified.  Accessories that are disposable should be labeled as single use.
Guidance on sterility issues is described in the ODE Bluebook Memo K90-1
"510(k) Sterility Review Guidance (2/12/90)."  A copy may be obtained from
DSMA.
It should be noted that the Phacofragmentation System device often has labeling Page 12
sterilization instructions for "flash sterilization" by autoclaving.  Flash sterilization
may not be the sole method cited in the device sterilization instructions; it may be
included along with other traditional steam or other methods of sterilization.  The
manufacturer is required to provide adequate instructions for flash sterilization
including the autoclaving parameters, such as the recommended time, temperature
etc., and whether or not the device should be wrapped. 
The Association for Practitioners in Infection Control (APIC) and the Center for
Disease Control (CDC) have established definitions and guidelines for the selection
and use of disinfectants.  Both APIC and the CDC have identified this
device as critical.  It should be noted critical items are objects which enter sterile
tissue or the vascular system.  Critical devices must be free of all microorganisms,
including bacterial spores, and require sterilization that is expected to destroy all
microorganisms and bacterial spores.  Sterilization can be performed using steam
under pressure, radiation, ETO gas, and chemical sterilants.
Attached to this document is a checklist form which may be utilized to assist
in the review of 510(k) submission for the Phacofragmentation System Device.
L.  Labeling
Proposed labels, labeling, educational materials, user manuals, provided with the
device, and advertisements and promotional literature must be provided. 
Literature and labeling may not imply approval of the device in any manner.
 
The Phacofragmentation System Device must be labeled with the caution
statement as delineated in 21 CFR 801.109(b)(1):  "CAUTION:  Federal law
restricts this device to sale by or on the order of a physician."
A label includes any identification on the device itself and on the package in
which it is stored and shipped.  If possible, the label on the device should
include the device name, company name, address, and phone number.  The
package label should include the items listed above, and the sterility status,
expiration date, use status (single use/disposable etc.), quantity enclosed, size,
intended use, and any other pertinent device specific information, such as electrical
specifications (i.e., energy used/delivered).
Device labeling includes all the information required under 21 CFR 801.
1.  The intended use statement should include specific indications,
clinical setting, target population, anatomical sites, etc.
2.  Directions for use should include, but are not necessarily limited
to:  a) instructions on how to prepare the device for use, b) how to Page 13
operate the device, c) how to stop operation, d) a statement of which
parts are single use/disposable or reusable, e) functional test
procedures for the device prior to use.
If the device is to be labeled as reusable, adequate instructions about
how to clean, disinfect, and sterilize the device must be included. 
Validation of changes expected in device function secondary to
reprocessing must be described.
Maintenance and troubleshooting procedures (where necessary) should be
outlined, with instructions on how to perform the maintenance and how
often, how and when to replace parts, instructions for purchase of
replacement parts, and a company contact point if troubleshooting
procedures fail.
3.  Contraindications, precautions, warnings, and adverse effects
should be included in the labeling of the device.
Guidance on labeling issues is described in ODE Bluebook Memo G91-1 "Device
Labeling Guidance (3/18/91)."  A copy may be obtained from the Center for
Devices and Radiological Health's Division of Small Manufacturers Assistance
(DSMA) at (800) 638-2041 or (301) 443-6597.
M.  Summary of Equivalence
A Summary of Equivalence comparing similar devices that are legally marketed in
the United States must be provided.  This includes devices in commercial
distribution prior to May 28, 1976, the enactment date of the Medical Devices
Amendments, and any new Class I, or Class II devices introduced subsequently. 
The summary should clearly review similarities and differences between the device
proposed for marketing clearance and the predicate device to which it is
claimed to be substantially equivalent.  It may be appropriate to present this
material in table form.
The device comparison should include the following considerations:  intended
use, design (e.g., hardware, software, configuration, materials specifications,
mechanical and electrical specifications), sterilization method, biocompatibility
factors, and any other device factors of similarity between the proposed and
predicate devices and which form the basis for the claim of substantial 
equivalence.
The application should clearly state whether the substantially equivalent device is a
pre-amendments device or a device which has a prior history of processing via the Page 14
510(k) regulatory mode.  If the device has a 510(k) history, the document control
number for previously cleared device(s), if known, should be cited in the
application.
DEVICE MODIFICATION - For changes or modifications of existing devices that
could significantly affect the safety or effectiveness of the device, or for
marketing a device with a new indication for use, the 510(k) should include a
detailed description and rationale for the changes.
The submission must show that the applicant has considered the possible effects
of the change on the safety and effectiveness of the device, as described in 21 CFR
807.87(g).
Valid scientific evidence must be provided to demonstrate that these differences do
no affect the safety and effectiveness.  This may include the same types of testing
delineated in part K Performance Data, above.  Certification should be provided
regarding compliance with voluntary standards, if appropriate.
Additional guidance concerning device modifications is available in the draft FDA
guidance titled, "Deciding When to Submit a 510(k) for Change to an
Existing Device 1/10/97)."  A copy of this document may be obtained from
DSMA.
DEVICE KITS - If this device is to be marketed as a kit, all components of the
kit must be described.  The following is a recommended wording for a certification
describing the components:
I certify that the following components of my kit are either (1)
legally marketed pre-amendments devices, (2) exempt from premarket
notification (consistent with the exemption criteria described in the
classification regulation(s) and the limitations of exemptions from
Section 510(k) of the act (e.g. 862.9)), or (3) have been found to be
substantially equivalent through the premarket notification process for
the use(s) for which the kit is intended (i.e., I am not claiming or
causing a new use for the component(s)).
I further certify that these components are not purchased in "bulk" but
are purchased in finished form, i.e., they are packaged, labeled, etc.,
consistent with their pre-amendments, exemption, or premarket
notification criteria and status.
If the applicant cannot make the certification statement above (first paragraph) for
each component of the kit, the components should be itemized without a pre- Page 15
amendments, exemption, or premarket notification status.  These kit components
will undergo premarket notification review in parallel with the total kit review.
If the applicant cannot make the above referenced certification statement (second
paragraph) for each component of the kit, these components should be itemized
with a statement about whether they are pre-amendments, exempt, or have been
found substantially equivalent through the premarket notification process.  The
applicant should describe how they are further processed (e.g., sterilized /
resterilized, packaged/repackaged, labeled/relabeled, etc).
If the kit contains components which are subject to regulation as drugs, a
substantially equivalent determination will not apply to the drug component(s) of
the device.  Information on FDA requirements for marketing the drug
component(s) in the kit can be obtained from the Center for Drug Evaluation and
Research's Division of Drug Labeling Compliance at (301) 295-8063.
If the kit contains sutures, evidence must be provided that the sterilant employed
for the kit does not come into contact with the sutures during the sterilization
process.  If sutures are components of the kit, the following conditions are
required:
1.  The labeling, packaging, and method of sterilization of the sutures cannot 
2.  The suppliers of the sutures used in the kit cannot be changed
without prior notification, review, and approval by FDA.
VI.  TRUTHFUL AND ACCURATE STATEMENT
The submitter must provide a Truthful and Accurate Statement.  This is a
statement that the submitter believes to the best of his/her knowledge, that all data
and information submitted in the premarket notification are truthful and accurate
and that no material fact has been omitted as described in 21 CFR 807.87.
FOR MORE INFORMATION
For more information contact:
Mr. Denis L. McCarthy, Division of Ophthalmic Devices (HFZ-460),
Center for Devices and Radiological Health, 9200 Corporate Boulevard,
Rockville, Maryland  20850.  Telephone: (301) 594-2205 Page 16
     Device Review Checklist
YES NO
1-  Device Type
(a) handpiece --- ---
(b) divided system --- ---
(c) full function --- ---
2-  Intended Use
(a) same as predicate --- ---
3-  Components or Accessories
(a) cleared  --- ---
(b) disposables --- ---
(c) reusables --- ---
4-  Comparability Factors
(a) predicate --- ---
(b) materials same as predicate --- ---
(c) materials documented (toxicology, biocompatibility) --- ---
(d) design similar to predicate --- ---
(e) technological features same as predicate --- ---
(f) new technology raising new safety & effectiveness
    issues --- ---
5-  Sterility
(a) same materials, same sterility method as predicate --- ---
(b) different materials, same sterility method as
    predicate --- ---
    (1) new material compatible with sterility method --- ---
(c) same materials, different sterility method than
    predicate --- ---
    (1) sterility method compatible with materials --- ---
(d) different materials, sterility method different
    from predicate --- ---
    (1) sterility method compatible with materials --- ---
(e) other (i.e. device shipped non-sterile to be
    sterilized by user, or reusable device to be
    re-sterilized by user) --- ---
    (1) adequacy of recommended sterility method       
documented --- ---
    (2) user instructions for sterilization of device
     adequate --- ---
(f) complies with sterility informational requirements
    of Blue Book Memo 02/12-90-(K90-1)
6-  Labeling Status
(a) sample label(s) and labeling submitted --- ---
(b) labels, labeling provide adequate description of Page 17
    device, intended use, user instructions,
    contraindications, or device related risks
    delineated  --- ---