(224 days)
The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
Konan Medical has developed the CellChek 20 rc to provide photographic data taken exclusively by the Konan Specular Microscope XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on Mar 26, 2020, to research and learning centers for the advancement of ophthalmic sciences and practice. The CellChek 20 rc was developed based on the software program of CellChek 20.
CellChek 20 rc is a software program to analyze ophthalmic images for examination of corneal endothelium. This has the cell counting analysis program, and allows for analysis of the images of the cell distribution of the eye.
The software program is installed on a general-use computer to analyze corneal endothelial images photographed exclusively by the Konan Specular Microscope XVII, CellChek 20. The analysis function is to calculate mainly the cell density, the coefficient of variation of cell area, and the percent hexagonality. In the manual methods, cornea endothelial cells and cell boundaries are actually identified by users. In the automatic methods, this software detects cells and cell boundaries, however, users can modify the detection results. During operating, the users interact with the software by visually placing dots in the center of each of cells and/or by tracing cell boundaries displayed on a computer screen, or use the automatic algorithm.
The provided document primarily focuses on the FDA 510(k) clearance process for the Konan Medical CellChek 20 rc software, establishing its substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria or an explicit study proving performance against those criteria.
However, it does mention that "CellChek 20 rc was developed according to the harmonized standard for software, IEC 62304, and FDA requirements for software and cybersecurity for the 510(k) clearance." It also states that "The following testing was performed on the CellChek 20 rc which was the same software function standard as those for CellChek 20: CellChek 20 rc device was subjected to software testing in accordance with IEC62304."
Based on the information available, here's what can be extracted and what is NOT available:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria with corresponding performance metrics is provided in the document. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to general software safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document mentions that users can identify cells and boundaries manually or modify automatic detections, implying human interaction with the software's analysis. However, it doesn't specify how ground truth for testing was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of an MRMC comparative effectiveness study in the document. The software allows for both manual and automatic methods for cell analysis, with user modification, but no study is described to quantify human performance improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions both "manual methods" where "cornea endothelial cells and cell boundaries are actually identified by users" and "automatic methods" where "this software detects cells and cell boundaries, however, users can modify the detection results." This implies the algorithm can operate somewhat standalone, but the user is always in a position to review and adjust. However, no formal standalone performance study results, such as sensitivity, specificity, or accuracy, are presented for the algorithm itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document. The document states that "CellChek 20 rc was developed based on the software program of CellChek 20," suggesting that any machine learning components (if present and requiring training data) would have been integrated or refined from the existing CellChek 20 platform.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of available information regarding acceptance criteria and study:
The document primarily focuses on regulatory clearance through the 510(k) pathway, emphasizing "substantial equivalence" to a predicate device and adherence to general software development and safety standards (IEC 62304). It does not detail specific performance studies with quantitative acceptance criteria, ground truth establishment, or human reader performance metrics that are typical for demonstrating the effectiveness of an AI-driven medical device. The "study" mentioned is general "software testing in accordance with IEC62304," which is a standard for medical device software life cycle processes, focusing on safety and quality, rather than clinical performance metrics.
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June 15, 2021
Konan Medical, Inc. % Alan Donald President Matrix Medical Consulting, INC. 8880 Rio San Diego Drive Suite 800 San Diego, California 92108
Re: K203244
Trade/Device Name: CellChek 20 rc Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ, NQE Dated: April 20, 2021 Received: April 21, 2021
Dear Alan Donald:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203244
Device Name CellChek 20 rc Software
Indications for Use (Describe)
The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Konan Medical. The word "KONAN" is in large, bold, sans-serif font, with the "O" in blue and the rest of the letters in black. Below "KONAN" is the word "MEDICAL" in a smaller, sans-serif font, also in black. A blue line is below the word "MEDICAL".
10-29. Mivanisl
The following 510(k) Summary is being submitted in accordance with the Requirements of MDA 1990 and CFR 807.92.
510(k) Summary
Submitter Information
| A. Company Name: | Konan Medical, Inc. |
|---|---|
| B. Company Address: | 10-29, Miyanishicho, Nishinomiya |
| Hyogo 662-0976, Japan | |
| C. Company Phone: | +81-798-36-3456 |
| D. Company Facsimile: | +81-798-26-1028 |
| E. Contact Person: | Runa Emura |
| F. Date Summary Prepared: | June 10, 2021 |
Device Identification
| A. Device Trade Name: | CellChek 20 rc |
|---|---|
| B. 510(k) number: | K203244 |
| C. Common Name: | Computer system for analysis of specularmicroscope images |
| D. Classification Name(s): | System, Image Management, Ophthalmic |
| E. Classification Regulation(s): | 892.2050 |
| F. Device Class: | Class 2 |
| G. Product Codes: | NFJ |
| H. Prescription (Rx) or OTC? | Rx |
| I. Advisory Panel: | Ophthalmic |
Identification of Predicate Device
The predicate device is the Image Storage System, Model KSS-400, which was cleared by FDA under 510(k) number K081797 on Jan 22, 2009.
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-29, Miyanishicho, Nishinomiya, Hyogo 662-0976, JAPAN
TEL +81-798-36-3456 FAX +81-798-26-1028
ldentification for Reference Device
The reference device is the Konan Specular Microscopy XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on March 26, 2020.
| A. Common Name: | Specular Microscope |
|---|---|
| B. Classification Name(s): | AC-powered slitlamp biomicroscope |
| C. Classification Regulation(s): | 886.1850 |
| D. Device Class: | Class 2 |
| E. Product Codes: | NQE |
| F. Prescription (Rx) or OTC? | Rx |
| G. Advisory Panel: | Ophthalmic |
Device Description
Konan Medical has developed the CellChek 20 rc to provide photographic data taken exclusively by the Konan Specular Microscope XVII, CellChek 20, which was cleared by FDA under 510(k) number K191558 on Mar 26, 2020, to research and learning centers for the advancement of ophthalmic sciences and practice. The CellChek 20 rc was developed based on the software program of CellChek 20.
CellChek 20 rc is a software program to analyze ophthalmic images for examination of corneal endothelium. This has the cell counting analysis program, and allows for analysis of the images of the cell distribution of the eye.
The software program is installed on a general-use computer to analyze corneal endothelial images photographed exclusively by the Konan Specular Microscope XVII, CellChek 20. The analysis function is to calculate mainly the cell density, the coefficient of variation of cell area, and the percent hexagonality. In the manual methods, cornea endothelial cells and cell boundaries are actually identified by users. In the automatic methods, this software detects cells and cell boundaries, however, users can modify the detection results. During operating, the users interact with the software by visually placing dots in the center of each of cells and/or by tracing cell boundaries displayed on a computer screen, or use the automatic algorithm.
| A. Common Name: | Computer system for analysis of specularmicroscope images |
|---|---|
| B. Classification Name(s): | System, Image Management, Ophthalmic |
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-29, Miyanishicho, Nishinomiya, Hyogo 662-0976, JAPAN
TEL +81-798-36-3456 FAX +81-798-26-1028
Image /page/5/Picture/3 description: The image shows the logo for Konan Medical. The word "KONAN" is in bold, with the "O" in blue. Below that, the word "MEDICAL" is in a smaller, thinner font. There is a blue line underneath the word "MEDICAL".
| C. Classification Regulation(s): | 892.2050 |
|---|---|
| D. Device Class: | Class 2 |
| E. Product Codes: | NFJ |
| F. Prescription (Rx) or OTC? | Rx |
| G. Advisory Panel: | Ophthalmic |
CellChek 20 rc was developed according to the harmonized standard for software, IEC 62304, and FDA requirements for software and cybersecurity for the 510(k) clearance. Additionally, risk analysis studies revealed no new risks for the CellChek 20 rc when compared to the predicate device.
As shown in the above, it is concluded that the safety and the performance of CellChek 20 rc is substantially assured.
Indication for Use
The CellChek 20 rc is a software program intended to analyze ophthalmic images captured by the Konan Specular Microscope XVII for examination of corneal endothelium.
Technological Characteristics
The CellChek 20 rc is substantially equivalent to the predicate device, the Image Storage System, Model KSS-400 as shown the below comparison table. Since the analytical functions of the CellChek 20 rc are the same as in the CellChek 20 (K191558), it is shown below as a reference device.
| Comparative Table of Predicate and Reference Devices for the CellChek 20 rc | |||
|---|---|---|---|
| Name | Model KSS-400 | CellChek 20 | CellChek 20 rc |
| 510(k) No.(ID No.) | K081797 | K191558 | K203244 |
| Device nameregistered | Image StorageSystem, ModelKSS-400 | Konan SpecularMicroscope XVII | CellChek 20 rc |
| Indications forUse | The KSS-400 ImageStorage System isintended to be used forautomated imageanalysis and data | The Konan SpecularMicroscope XVII,CellChek 20, is anon-contact ophthalmicmicroscope, optical | The CellChek 20 rc is asoftware programintended to analyzeophthalmic imagescaptured by the Konan |
Konan Medical, Inc.
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10-29, Miyanishicho, TEL +81-798
| Comparative Table of Predicate and Reference Devices for the CellChek 20 rc | |||
|---|---|---|---|
| Name | Model KSS-400 | CellChek 20 | CellChek 20 rc |
| storage for cornealimages taken withKonan specularmicroscopes. | pachymeter, andcamera intended forexamination of thecorneal endotheliumand for measurementof the thickness of thecornea. | Specular MicroscopeXVII for examination ofcorneal endothelium. | |
| Computer used | General-use computerby User. | This device has abuilt-in computer. | General-use computerby User. |
| Analysis | · Auto trace method | · Auto trace method | · Auto trace method |
| · Manual trace method | · Trace method | · Trace method | |
| · Auto center method | · Auto center method | ||
| · Center method | · Center method | · Center method | |
| · Auto F Center method | · Auto F Center method | ||
| · Flex Center method | · F Center method | · F Center method | |
| Display andStorage ofAnalysis resultsand Images | Yes | Yes | Yes |
| Print of Analysisresults andImages | Yes | Yes | Yes |
| Load (Import) ofImages | Yes (Load) | Yes (Import) | Yes (Import) |
| Outboard (Export)of Analysisresults andImages | Yes (Outboard) | Yes (Export) | Yes (Export) |
| Note | |||
| CellChek 20 rc was developed based on the software program of CellChek 20 (K191558). |
Summary of Testing
Non-Clinical Performance Testing
The following testing was performed on the CellChek 20 rc which was the same software function standard as those for CellChek 20.
- CellChek 20 rc device was subjected to software testing in accordance with IEC62304.
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Image /page/7/Picture/1 description: The image shows the logo for Konan Medical. The word "KONAN" is in bold, with the "KO" in blue and the "NAN" in black. The letters "MEDICAL" are in a smaller font size and are located below the word "KONAN". There is a blue line below the word "MEDICAL".
10-29, Miyanishicho, Nish TEL +81-798-36-3456
Conclusion
From the above, it is concluded that the CellChek 20 rc software is substantially equivalent in the intended use, Indications for Use, technology, and functionality of the predicate device, the Image Storage System, Model KSS-400.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).