KERATO ANALYZER (EKA)

K040373 · Konan Medical, Inc. · NQE · Mar 19, 2004 · Ophthalmic

Device Facts

• Record ID: K040373
• Device Name: KERATO ANALYZER (EKA)
• Applicant: Konan Medical, Inc.
• Product Code: NQE · Ophthalmic
• Decision Date: Mar 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1850
• Device Class: Class 2

Intended Use

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

Device Story

Konan Kerato Analyzer (EKA) is a specular microscope for eye bank use; functions as an inverted laboratory microscope. Input: preserved corneas in storage vials placed in a unit receptacle. Operation: manual focusing by operator. Output: corneal cell counts and thickness measurements. Benefit: allows assessment of preserved corneas without removal from storage vials, maintaining sterility and integrity. Used by eye bank technicians to evaluate donor tissue quality for transplantation.

Clinical Evidence

Bench testing only. Comparative study performed between the EKA and the predicate Noncon Robo using eye bank samples. Statistical analysis confirmed that both devices provided equivalent cell counts.

Technological Characteristics

Inverted laboratory microscope configuration; manual focusing mechanism; receptacle for storage vials; AC-powered. No specific materials or software architecture details provided.

Indications for Use

Indicated for use in eye banks to perform cell counts and thickness measurements on preserved corneas while contained within their storage vials.

Regulatory Classification

Identification

An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.

Special Controls

*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Predicate Devices

• Konan Noncon Robo (K950091)
• Hai Labs EB2000 xyz (K994340)

Submission Summary (Full Text)

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K040373

510(k) Submission Konan Kerato Analyzer (EKA) 510(k) Summary January 13, 2004

## (1) Submitter Information

Name: Konan Medical Inc.

Address: 10-29 Miyanishi-Cho Nishimomiya Hyogo 662 Japan

Telephone Number: 011-81-798363456

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Rt. 17 S Hasbrouck Heights, NJ 07604 201-727-1703

Date Prepared: February 4, 2004

- (2) Name of Device:
Trade Name: Konan Kerato Analyzer Common Name: Specular Microscope for Eye Banks. Classification Name: Camera, Ophthalmic, AC-powered

(3) Equivalent legally-marketed devices:

Konan Noncon Robo, K950091 Hai Labs EB2000 xyz, K994340

(4) Description

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of prescrved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

(5) Intended Use

The Konan Kerato Analyzer ("EKA") is a intended to make cell counts of preserved corneas in eye banks without removing the corneas from their storage vials.

(6) Technological characteristics

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The basic structure of the EKA is similar to that of an inverted laboratory microscope. With the EKA, all focusing is done manually by the operator; focusing is done automatically by the Noncon Robo. With the Noncon Robo, the patient looks into the device at a fixation target. For the EKA, vials containing the corneas are placed in a receptacle in the unit.

(b) Performance data

(1) Non-clinical tests

Cell counts on eye bank samples were done with the Noncon Robo and the EKA. Statistical analysis showed that the two devices gave the same counts.

(2) Clinical tests

Not required

(3) Conclusions

The Konan Kerato Analyzer is equivalent in safety and efficacy to the legally marketed predicate device.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2004

Konan Medical, Inc. c/o George H Myers, Sc.D. Medsys. Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K040373

Trade/Device Name: Konan Kerato Analyzer (EKA) Regulation Number: 21 CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NQE Dated: February 10, 2004 Received: February 17, 2004

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - George H Myers, Sc.D.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Aherl Rosenthal

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

Enclosure

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Page _________________________________________________________________________________________________________________________________________________________________________

\$10(k) Number (if known): K 040373 ____

Device Name: Konon Kerato Analyzer

Indications for Use:

The Konan Kerato Analyzer ("EKA") is a specular microscope used to make cell counts of preserved corneas in eye banks and to measure the thicknesses of the corneas without removing the corneas from their storage vials.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

| 510(k) Number | K040373 |
|---------------|---------|
|---------------|---------|

| Prescription Use (Per 21 CFR 810.109) | | OR | Over-the-Counter Use |
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