(85 days)
The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and ccamera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical reans. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo, K950091.
The device permits visual inspection and photography of corneal endothelium and measurement of the corneal the thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
The provided document, a 510(k) summary for the Konan Noncon Robo Pachy, primarily focuses on establishing substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, detailed study designs, and human reader performance is not explicitly available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|---|
| Pachymetry Accuracy | Accuracies sufficient for clinical pachymetry measurements (inferred from "more accurate sensors" and clinical comparison) | "gives at least an accuracy equivalent to the DGH 2000 [ultrasonic pachymeter]" |
| Safety | Meets requirements of JIS T 1001-1988 (Safety Code for Medical Devices) and JIS T 1002 (General Rules of Testing Methods for Safety of Medical Electrical Equipment); Meets EMC Directive 89/336/EEC | "The system meets the requirements of the standards JIS T 1001-1988, Safety Code for Medical Devices, and JIS T 1002, General Rules of Testing Methods for Safety of Medical Electrical Equipment, and the standards of the EMC Directive 89/336/EEC." |
| Software Validation | New software validation test performed | "A new software validation test has been done, to validate the new software." |
| Substantial Equivalence | Equivalent in safety and efficacy to legally marketed predicate devices | "The Konan Noncon Robo Pachy is equivalent in safety and efficacy to the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 100 patients for the clinical comparison of pachymetry measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, the device manufacturer is Konan Inc. (Japan), and the correspondent is based in New Jersey, USA. Given the context of a 510(k) submission to the FDA, it's likely the clinical data would need to be representative of relevant populations. The study is described as comparing current measurements, suggesting a prospective or cross-sectional design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the test set.
- The "ground truth" for pachymetry accuracy was established by comparison to a predicate device (DGH 2000 ultrasonic pachymeter) and an accurately machined phantom, not human experts for interpretation.
4. Adjudication Method for the Test Set
- Not applicable/Not mentioned. The study involved direct measurement comparisons, not expert adjudication of classifications or diagnoses.
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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is for examination and measurement (specular microscopy and pachymetry), with "Cell counting and analysis programs" included. There is no indication of an AI-assisted human reader study or associated effect sizes.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The document implies standalone performance for the pachymetry measurement, as it's compared directly to another device and a phantom. The "Cell counting and analysis programs" are also functions of the algorithm. However, no specific details on standalone performance metrics (e.g., sensitivity, specificity for cell counting) are provided beyond the general statement that they are "indicated when it is desired to analyze the images."
7. The type of ground truth used
- For pachymetry accuracy:
- Comparison to a legally marketed predicate device (DGH 2000 ultrasonic pachymeter).
- Measurements on an "accurately machined phantom."
- For safety: Conformance to international safety and EMC standards.
- For software validation: Internal software validation tests.
8. The sample size for the training set
- The document does not specify a sample size for a training set. The device is primarily described as an "improvement" to an existing device (Konan Noncon Robo, K950091) with "more accurate sensors" and modified software to control the pachymeter feature. While there are "Cell counting and analysis programs," the document doesn't detail a machine learning-based approach that would typically involve a separate training set. The emphasis is on hardware and software for measurement and image acquisition/display.
9. How the ground truth for the training set was established
- Not applicable, as a discrete training set for a machine learning model is not explicitly mentioned or the focus of the submission. The "ground truth" for the device's functionality (like pachymetry) appears to be based on physical standards (phantom) and comparison to established medical devices.
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Image /page/0/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 a caduceus, which is a symbol of medicine and health.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2004
Konan, Inc. c/o George H. Myers, Sc.D. Medsys Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604
Re: K980357
Trade/Device Name: Konan Noncon Robo Pachy Specular Microscope Regulation Number: CFR 886.1850 Regulation Name: AC-powered slitlamp biomicroscope Regulatory Class: Class II Product Code: NOE Dated: January 28, 1998 Received: January 29, 1998
Dear Dr. Myers:
This letter updates our substantially equivalent letter of April 24, 1998 regarding the product code and classification regulation of your device. Specular microscopes are now regulated under §886.1850 (AC-powered slitlamp biomicroscope) and are listed under a new product code (NQE). This letter is for informational purposes. No further action is required on your part at this time.
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 indictions 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 (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 mistranding and adviteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations of educations of ecting 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
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Page 2 - George H. Myers, Sc.D.
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 100-100.
This letter will allow you to continue 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 and additionally Part 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 device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Naver M. Wistle
L.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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Konan Medical 510(k) Submission
Page 1 of
| 510(k) Number (if known): | K980351 |
|---|---|
| --------------------------- | --------- |
Device Name: Konon Noncon Robo Pachy
Indications for Use:
The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and ccamera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical reans. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Enette I Been
(Division Sign-Off)
Division of Ophthalmic Devices
| 510(k) Number | K980357 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 810.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
| Over-the-Counter Use (Optional Format 1-2-96) | |
|---|---|
| ----------------------------------------------- | -- |
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Konan Noncon Robo Pachy
Page A 3
Konan Medical Inc. Konan NonCon Robo Pachy 510 (k) Submission
APR 2 4 1998
510 (k) Summary
- (1) Submitter Information
Name: Konan Inc.
Address: 10-29 Miyanishi-Cho Nishimomiya 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: December 12, 1997
(2) Name of Device: Trade Name: Konan NonCon Robo Pachy Specular Endothelial Microscope and Camera Common Name : and optical pachymeter Classification Name: Camera, Ophthalmic, AC-powered
(3) Equivalent legally-marketed devices:
- Konan Noncon Robo, K950091
-
- DGH 2000 ultrasonic pachymeter, K920906
(4) Description
- DGH 2000 ultrasonic pachymeter, K920906
The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo, K950091.
The device permits visual inspection and photography of corneal endothelium and measurement of the corneal the thickness without any object contacting the eye. It features
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Konan Noncon Robo Pachy
K98U357
Page A 4
focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
(5) Intended Use
The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and camera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical means. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
-
(6) Technological characteristics
The Konan Noncon Robo Pachy is technically the same as the predicate device, the Konan Noncon Robo, with the addition of more accurate sensors to provide sufficient accuracy for clinical pachymetry measurements. The original Noncon Robo, sold as a specular microscope, had the ability to measure corneal thickness, but the measurements were not accurate enough for clinical use. The "Pachy" version has more accurate sensors. The computer program that controls the system has been modified to permit display and control of the pachymeter feature. -
(b) Performance data
- (1) Non-clinical tests
The non-clinical tests done for the original Noncon Robo also apply to the Noncon Robo Pachy, since the device is essentially the same. A new software validation test has been done, to validate the new software. The system meets the requirements of the standards JIS T 1001-1988, Safety Code for Medical Devices, and JIS T 1002, General Rules of Testing Methods for Safety of Medical Electrical Equipment, and the standards of the EMC Directive 89/336/EEC. The original 510(k)
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Konan Noncon Robo Pachy
has the certificates and details on the tests. The bench test section has a Declaration of Conformity to the EEC tests. The accuracy of the pachymetry system has been established by tests on an accurately machined phantom, and are in the Bench Test Section.
(2) Clinical tests
Corneal thickness measurements made on 100 patients have been compared with measurements on the same patients using the DGH 2000 ultrasonic pachymeter. This test shows that the Noncon Robo Pachy gives at least an accuracy equivalent to the DGH 2000.
(3) Conclusions
The Konan Noncon Robo Pachy is equivalent in safety and efficacy to the legally marketed predicate devices.
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.