(31 days)
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.
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. 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. For the EKA, vials containing the corneas are placed in a receptacle in the unit.
The Konan Kerato Analyzer (EKA) is a specular microscope intended to make cell counts of preserved corneas in eye banks without removing the corneas from their storage vials.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to predicate device (Konan Noncon Robo, K950091, and Hai Labs EB2000 xyz, K994340) in cell counting of preserved corneas. | Statistical analysis showed that the EKA gave the same cell counts as the Konan Noncon Robo when tested on eye bank samples. |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states "Cell counts on eye bank samples were done with the Noncon Robo and the EKA." However, it does not specify the sample size of eye bank samples used for this comparison.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not detail the use of experts to establish ground truth for a test set. The comparison was made directly between the EKA and a predicate device (Noncon Robo). It's implied that the predicate device's measurements serve as the reference or "ground truth" for comparison.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the comparison was direct between the two devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study focused on the agreement between the EKA and a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance assessment was done. The EKA, as a device for automated cell counting, was evaluated on its own ability to perform these counts and was compared directly to a predicate device, without a human operator's interpretation as part of the core performance metric. While an operator manually focuses the EKA, the cell counting itself is an automated function of the device being assessed.
7. The Type of Ground Truth Used:
The ground truth for the comparison was established by the measurements obtained from a legally marketed predicate device, the Konan Noncon Robo. The assumption is that the Noncon Robo provides accurate cell counts.
8. The Sample Size for the Training Set:
The submission document does not specify a separate training set or its sample size. The focus is on the performance comparison of the new device (EKA) against a predicate device. This suggests a direct validation approach rather than a machine learning model that would require a distinct training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as a separate training set with its own ground truth establishment is not described in this 510(k) summary. The study is a comparative performance assessment against an existing device rather than the development and validation of a new algorithm requiring a training phase.
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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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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 | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ---------------------- |
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
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.(b)
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.