This document is a 510(k) summary for the INNOVATOME™ Microkeratome, submitted in 1997. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, and therefore, no specific acceptance criteria or study demonstrating device performance against such criteria are presented.

The manufacturer explicitly states that "Performance Data: None." and that "Because of this, performance data were not required." The basis for clearance is substantial equivalence, not performance against specific metrics.

Therefore, many of the requested sections below cannot be fulfilled from the provided document as this device falls under a "substantial equivalence" claim where performance data was not required.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
No explicit acceptance criteria provided in the document. The submission relies on substantial equivalence to predicate devices regarding specifications and intended use.	No performance data reported as it was not required due to substantial equivalence claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance data or test set was used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No performance data or test set was used for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance data or test set was used for this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No MRMC study was conducted. This device is a microkeratome, a surgical instrument, and not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a microkeratome, a surgical instrument, and not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance data or ground truth was established for this submission.

8. The sample size for the training set

Not applicable. No training set was used for this submission.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth was established for this submission.

Summary

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K913294/A'

510(K) Summary INNOVATOME™ MICROKERATOME

OCT - 3 1997

This 510(K) summary of safety and effectiveness for the INNOVATOME™ Microkeratorne is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(K) summary.

Innovative Optics, Inc

Address:	4307 Cedarwood DriveLilburn, GA 30247
Contact Person:	Mr. Larry HicksPresident
Telephone:	770-717-0707770-717-9386 - Fax
Preparation date:(of the summary)	August 1997
Device Trade Name:	INNOVATOMET™ Microkeratome
Common Name	Microkeratome
Classification Name:	Keratome Surgical Instrument :Ophthalmology (21 CFR 886.4370)
Class of Device:	Class I (AC powered or Battery powered)
Legally marketed predicate device:	Chiron Microkeratome: Plancon MicrolameKeratome

Description of the Device:

Intended use:

Applicant:

The INNOVATOME™ is a microkeratome that rotates at 14,000 rpm and is capable of creating lamella with diameters ranging from 8-10 mm.

The INNOVATOME™ microkeratome is indicted for the resection of a circular anterior lamellar flap.

This intended uses is the same or similar to that for the claimed predicate device.

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Comparison_of the InnovaTome™ and The rotational speed, the depth of cut to create a lamella, and the diameters legally marketed of the resulting lamellae are essentially predicate devices: the same for these devices.

There are no significant differences between these devices under conditions of intended use.

I NNOVATOME™ its INDICATIONS : The and claimed predicates have the same indication; i.e., used to create corneal lamellae, i.e., corneal resection.

Performance Data: None. The specifications and intended uses
of the INNOVATOME™ Microkeratome are the same as or very similar to those of the claimed predicate devices, e.g., the Chiron Microkeratome and the Plancon Microlamellar Keratome.
Because of this, performance data were not required.
CONCLUSION : Based on the foregoing, Innovative, Optics,
Inc. believes that the INNOVATOME™ microkeratome is substantially equivalent to the claimed legally marketed predicate devices, i.e. . . the Chiron Microkeratome and the Plancon Microlamellar Keratome.

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COMPARISON TO PREDICATE DEVICES

Comparison of specifications of INNOVATOME™ Microkeratome and claimed predicate devices:

Specification	INNOVATOMETMMicrokeratome	Chiron Microkeratome*	Plancon MicrolamellarMicrokeratome**
Keratome MaterialBlade	Stainless SteelSapphire	Stainless SteelSteel	Stainless SteelStainless Steel
Keratome	adjustable	adjustable	adjustable
Rotational SpeedUsual or recommend.	12,000 rpm; 24,000cuts per minute	14,000 rpm	0 - 20,000 rpm14,000 rpm
Diameter of lamella	8-10 mm	9.5-10.0 mm	not stated*
Thickness of lamella	175 microns	130-180 microns	not stated*
Indications	see below	see below	see below

a brochure covering the Chiron Microkeratome is attached *** for reference

copy of Safety and Effectiveness Summary for K960395 is * attached for reference - this document cites unnamed predicate devices

INDICATIONS

The INNOVATOME" microkeratome INNOVATOME™ Microkeratome: indicated for is anterior lamellar circular resection. Chiron Microkeratome: Lamellar circular resection Plancon Microlamellar Kerat.: Microlamellar keratoplasty

None. The specifications and intended uses
of the INNOVATOME™ microkeratome are the same Performance Data: very similar to those of the claimed or predicate devices, e.g., the Chiron the Plancon microlamellar microkeratome, keratome, and an unnamed device cited in K960395 (see attached document).
are no significant differences There in specifications of the cited devices or of intended use.

Because of this, performance data were not required.

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CONCLUSION : Based on the foregoing, Innovative Optics,
Inc. believes that the INNOVATOME" microkeratome is substantially equivalent to the claimed legally marketed predicate devices such as the Chiron microkeratome (K941550), the Plancon Microlamellar keratome (as described in K960395 and K970377), or the unnamed microkeratome cited in K960395.

Attachment 1 - Chiron Brochure (page 6 in this application) Attachment 2 - Public summary for K960395 (pages 7-8 in this application

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 1997

Mr. Larry Hicks President Innovative Optics, Inc. 4307 Cedarwood Drive Lilburn, GA 30247

Re: K973294 Trade Name: Innovatome™ Microkeratome Regulatory Class: I Product Codes: 86 HNO and 86 HMY Dated: September 2, 1997 Received: September 2, 1997

Dear Mr. Hicks:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Larry Hicks

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT D

INDICATIONS FOR USE STATEMENT

510(K) Number (if known): _________________________________ .. x

INNOVATOME™ MICROKERATOME Device Name:

Indications For Use:

The INNOVATOME™ microkeratome system is indicated for the resection of a circulal anterior lamellar flap.

Note: The device is labeled as a restricted device (21 CFR 801.109) - see Operator's Manual

(PLEASE DO NOT MRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 810.109) OR

Over-The-Counter-Use

Denis L. M° Carthy

Regulation Number and Section

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.