(31 days)
No
The summary explicitly states that all focusing is done manually by the operator and there are no mentions of AI, DNN, or ML.
No.
The device is used for diagnostic purposes (cell counts and thickness measurements of corneas) in eye banks, not for direct treatment or therapy.
No
The Konan Kerato Analyzer (EKA) is used to count cells and measure the thickness of preserved corneas in eye banks. This is a measurement tool for quality control of donated corneas, not a device used to diagnose a medical condition in a living patient.
No
The device description explicitly states it is a "specular microscope" and describes its physical structure and manual focusing, indicating it is a hardware device.
Based on the provided information, the Konan Kerato Analyzer (EKA) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EKA's Intended Use: The EKA is used to analyze preserved corneas in storage vials. While corneas are human tissue, the analysis is being performed on them ex vivo and in a preserved state, primarily for quality control and assessment within an eye bank setting.
- Lack of Diagnostic Purpose: The intended use describes making cell counts and measuring thickness. This information is used by eye banks to assess the suitability of the cornea for transplantation, not to diagnose a disease or condition in a living patient.
- No Analysis of Bodily Fluids or Samples: The device does not analyze blood, urine, or other typical bodily fluids or samples used for diagnostic purposes.
Therefore, the EKA falls outside the typical scope of an In Vitro Diagnostic device. It's more accurately described as a laboratory instrument used for quality control and assessment of preserved biological material.
N/A
Intended Use / 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.
Product codes
NQE
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneas (preserved)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye banks
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical tests: Not required
Key Metrics
Not Found
Predicate Device(s)
Konan Noncon Robo, K950091
Reference Device(s)
Hai Labs EB2000 xyz, K994340
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol. The seal is black and white.
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.
3
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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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 | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ---------------------- |