(32 days)
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.
The VK-2s consists of five types of software models including the:
- VK-2s Standard .
- . VK-2s VX-20
- VK-2s nonmyd ●
- VK-2s nonmydWX
- VK-2s Viewer .
The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images:
VK-2s Standard
This software only supports images from:
- KOWA VX series cameras, ●
- KOWA nonmyd series cameras .
- and supports file import.
VK-2s VX-20
This software only supports images from:
- . KOWA VX-20 series cameras,
- and supports file import. ●
VK-2s nonmyd
This software only supports images from the KOWA nonmyd series cameras.
VK-2s nonmydWX
This software only supports images from the KOWA nonmydWX cameras.
VK-2s Viewer
This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture.
The VK-2s software also takes advantage of three software packages included with the VK-2s. These are:
VK-Montage Software
This software allows the operator to create montages using multiple images
VK-Scan
VK Scan is software which can be used to import images located in a specified folder.
VK-DDV
The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.
This document describes a 510(k) premarket notification for the Kowa VK-2s, a Picture Archiving and Communication System (PACS) for ophthalmic images. The provided text is a summary of the 510(k) and focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria for device performance.
Therefore, the following information cannot be fully extracted or is not applicable based on the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined for the Kowa VK-2s in this document. The document focuses on comparing functions and features to predicate devices to establish substantial equivalence.
- Sample sized used for the test set and the data provenance: No test set or related sample size is mentioned, as this is a comparison to predicate devices, not a new performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study information is provided.
- The type of ground truth used: No ground truth data is discussed.
- The sample size for the training set: Not applicable as no algorithm training is discussed.
- How the ground truth for the training set was established: Not applicable.
However, based on the provided text, here is what can be inferred about the device and its assessment:
1. Acceptance Criteria and Reported Device Performance:
While no numerical acceptance criteria or performance metrics are explicitly stated, the implicit acceptance criterion is "substantial equivalence" to the predicate devices. This means the Kowa VK-2s must have the "same indications for use, similar principles of operation, and similar technological characteristics" as the predicate devices, and the differences should not raise new questions of safety or effectiveness.
The "reported device performance" is a feature-by-feature comparison to predicate devices. The document highlights functional similarities and differences to argue for substantial equivalence.
Table 1: Comparison of KOWA VK-2s to Canon Ophthalmic Software Platform RX (Primary Predicate)
| Feature/Function | Proposed Device (KOWA VK-2s) | Predicate Device (Canon Ophthalmic Software Platform RX) | Differences (VK-2s vs. Canon) |
|---|---|---|---|
| Model | KOWA VK-2s | Ophthalmic Software Platform RX | - |
| Device Design | |||
| Type of Retinal Camera Image | Color | Color | - |
| Montage | - | VK-2s has Montage | |
| FAF | FAF | - | |
| FA | FA | - | |
| View Image | Single View | Single View | - |
| Full Screen (Frame Size) | Full Screen (Frame Size) | - | |
| Both Eyes | Both Eyes | - | |
| Multiple Images | Comparison | VK-2s has Multiple Images (Canon has Comparison) | |
| Loop | - | VK-2s has Loop | |
| - | Progression | Canon has Progression | |
| Drawing Function | - | Supported | Canon has supported Drawing Function |
| Image Processing | |||
| Sharpen Image | - | VK-2s has Sharpen Image | |
| Gamma Process | - | VK-2s has Gamma Process | |
| Zoom | Zoom | - | |
| RGB Filters | RGB Filters | - | |
| Enhance Image | - | VK-2s has Enhance Image | |
| Contrast | Contrast | - | |
| Analysis of RGB Color | - | VK-2s has Analysis of RGB Color | |
| Negative Image | - | VK-2s has Negative Image | |
| Edge Enhancement | - | VK-2s has Edge Enhancement | |
| Histogram Chart | - | VK-2s has Histogram Chart | |
| Flip Image | - | VK-2s has Flip Image | |
| - | Cobalt | Canon has Cobalt | |
| - | Emboss | Canon has Emboss | |
| - | Redfree | Canon has Redfree | |
| C/D Ratio | C/D Ratio | C/D Ratio | - |
| Image Measurement | |||
| Measure Distance | - | VK-2s has Measure Distance | |
| Measure Angle | - | VK-2s has Measure Angle |
Table 2: Comparison of KOWA VK-2s to KOWA portable VK-2 in KOWA nonmyd a-DIII (Secondary Predicate)
| Feature/Function | Proposed Device (KOWA VK-2s) | Predicate Device (KOWA nonmyd α-DIII) | Differences (VK-2s vs. nonmyd α-DIII) |
|---|---|---|---|
| Model | KOWA VK-2s | KOWA nonmyd α-DIII | - |
| Device Design | |||
| Type of Retinal Camerasoftware used in conjunction with | Mydriatic | VK-2s supports Mydriatic camera images (Predicate does not specify/implies non-mydriatic only) | |
| Non-mydriatic | Non-mydriatic | - | |
| Type of Retinal Camera Image | Color | Color | - |
| Montage | Montage | - | |
| FAF | FAF | - | |
| FA | - | VK-2s has FA image function | |
| Image Processing | |||
| Sharpen Image | Sharpen Image | - | |
| Gamma Process | Gamma Process | - | |
| Zoom | Zoom | - | |
| RGB Filters | RGB Filters | - | |
| Enhance Image | Enhance Image | - | |
| Contrast | Contrast | - | |
| Analysis of RGB Color | Analysis of RGB Color | - | |
| Negative Image | Negative Image | - | |
| Edge Enhancement | - | VK-2s has Edge Enhancement | |
| Histogram Chart | - | VK-2s has Histogram Chart | |
| Flip Image | Flip Image | - |
The key conclusion stated is that the differences "do not raise new questions of safety or effectiveness," thus satisfying the substantial equivalence requirement.
9. How the ground truth for the training set was established:
The software was subject to "Software verification and validation testing," which is a standard procedure for medical device software to ensure it performs as intended and meets its specifications. The software was considered a "moderate" level of concern. This indicates that a risk assessment was performed, and the testing was conducted according to established software development and quality assurance protocols (e.g., unit testing, integration testing, system validation). However, specific details about the methods or data used in this verification and validation are not provided in this summary. There is no mention of a "training set" in the context of an AI/ML algorithm.
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February 12, 2019
KOWA Co. Ltd. CHOFU % Ryan Bouchard VP, Medical Devices Ora, Inc. 300 Brickstone Square Andover, MA 01810
Re: K190056
Trade/Device Name: KOWA VK-2s Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: NFJ Dated: January 9, 2019 Received: January 11, 2019
Dear Ryan Bouchard:
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.
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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); medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely vours. Alexander Beylin -S 2019.02.12 16:15:48 -05'00'
for Malvina B. Eydelman, 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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Indications for Use
510(k) Number (if known) K190056
Device Name KOWA VK-2s
Indications for Use (Describe)
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic ophthalmic cameras.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
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510(k) SUMMARY
This summary of the 510(k) premarket notification for the Kowa VK-2s is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
a. Owner Company name, address
Kowa Company Limited 3-1, Chofugaoka 3-chome Chofu Tokyo 182-0021 Japan
Contact person:
Rinji Kondo Phone: +81-42-440-7612 +81-42-440-7618 Fax: Email: r-kondo@@kowa.co.jp
b. Contact/Application Correspondent
Ryan Bouchard
Ora, Inc.
300 Brickstone Square
Andover, MA 01810
Telephone: (978) 332-9574
Facsimile: (978) 689-0020
E-mail: rbouchard@oraclinical.com
c. Date Updated
February 1, 2019
d. Name of Device
| Trade Name: | Kowa VK-2s |
|---|---|
| Common Name: | VK-2s |
| Classification Name: | Picture archiving and communication systems |
| Classification Regulation: | 21 CFR 892.2050 |
| Product Code: | NFJ |
| 510(k) Number: | K190056 |
- e. Predicate Devices
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Primary: The VK-2s is substantially equivalent to the image management software system Canon Ophthalmic Software Platform RX cleared in K173689. As explained in more detail below, the Canon Ophthalmic Software Platform RX and the VK-2s software both have the same indications for use, similar principles of operation, and similar technological characteristics.
Secondary: The VK-2s is substantially equivalent to the KOWA portable VK-2 in the KOWA nonmyd a-DIII cleared in K083387. The KOWA portable VK-2 and the VK-2s software both have the same intended use, similar principles of operation, and similar technological characteristics.
Device Description f.
The VK-2s consists of five types of software models including the:
- VK-2s Standard .
- . VK-2s VX-20
- VK-2s nonmyd ●
- VK-2s nonmydWX
- VK-2s Viewer .
The VK-2s Standard, VK-2s VX-20, VK-2s nonmyd, and VK-2s nonmydWX are all software executed on a capture PC. The software acquires images from a retinal camera that the control software captures and puts on the capture PC. The software acquires images of the eye, stores images and processes images. The software displays acquired and processed images which are stored in a Server's database. The only difference between these four software programs are the devices that are supported for providing images:
VK-2s Standard
This software only supports images from:
- KOWA VX series cameras, ●
- KOWA nonmyd series cameras .
- and supports file import.
VK-2s VX-20
This software only supports images from:
- . KOWA VX-20 series cameras,
- and supports file import. ●
VK-2s nonmyd
This software only supports images from the KOWA nonmyd series cameras.
VK-2s nonmydWX
This software only supports images from the KOWA nonmydWX cameras.
VK-2s Viewer
{5}------------------------------------------------
This is a software executed on a viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in a server database. This software does not support image capture.
The VK-2s software also takes advantage of three software packages included with the VK-2s. These are:
VK-Montage Software
This software allows the operator to create montages using multiple images
VK-Scan
VK Scan is software which can be used to import images located in a specified folder.
VK-DDV
The detailed database viewer provides advanced searching, viewing, image processing, printing, and reporting for your VK-2s database.
Indications for Use g.
KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
h. Statement of Substantial Equivalence
Kowa's VK-2s is substantially equivalent to the image management software, Canon Ophthalmic Software Platform RX cleared in K173689. The VK-2s has the same indications for use, follows similar principles of operation, and has similar technological characteristics as the previously cleared software predicate device.
The VK-2s and the Canon Ophthalmic Software Platform RX are both ophthalmic image archiving and communications systems that collect, store, and manage digital images of the eye and both are indicated for use with mydriatic and non-mydriatic cameras.
In comparison between the KOWA VK-2s and the Canon Ophthalmic Software Platform RX there are differences in function in the following areas: (differences are in bold).
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| Proposed Device | Predicate Device | |
|---|---|---|
| Model | KOWA VK-2s | Ophthalmic Software Platform RX |
| Device Design | ||
| Type of RetinalCamera image | Color | Color |
| Montage | - | |
| FAF | FAF | |
| FA | FA | |
| View Image | Single View | Single View |
| Full Screen (Frame Size) | Full Screen (Frame Size) | |
| Both Eyes | Both Eyes | |
| Multiple Images | Comparison | |
| Loop | - | |
| - | Progression | |
| Drawing Function | - | Supported |
| Image Processing | Sharpen Image | - |
| Gamma Process | - | |
| Zoom | Zoom | |
| RGB Filters | RGB Filters | |
| Enhance Image | - | |
| Contrast | Contrast | |
| Analysis of RGB Color | - | |
| Negative Image | - | |
| Edge Enhancement | - | |
| Histogram Chart | - | |
| Flip Image | - | |
| - | Cobalt | |
| - | Emboss | |
| - | Redfree | |
| C/D Ratio | C/D Ratio | |
| Image Measurement | Measure Distance | - |
| Measure Angle | - |
Table 1: Comparison of KOWA VK-2s to Canon Ophthalmic Software Platform RX
The KOWA VK-2s functions of montage image, loop view, the image processing functions of sharpen image, Gamma process, enhance image, analysis of RGB color, negative image, edge enhancement, histogram chart and flip image and the measurement functions of measure distance and measure angle are not offered in the Canon device. The Canon Ophthalmic Software Platform RX device offers view progression, a drawing function, and the image processing functions of cobalt, emboss, and redfree which are not present in the VK-2s.
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Kowa's VK-2s is substantially equivalent to the KOWA portable VK-2 software in the KOWA nonmyd a-DIII cleared in K083387. The VK-2s has the same intended use, follows similar principles of operation, and has similar technological characteristics as the previously cleared software included in the predicate device.
The VK-2s and the KOWA portable VK-2 software in the KOWA nonmyd a-DIII are both ophthalmic image archiving and communications systems that collect, store, and manage digital images of the eye and are both are indicated for use with nonmydriatic cameras.
In comparison between the KOWA VK-2s and KOWA portable VK-2 in the KOWA nonmyd a-DIII there are differences in function in the following areas: (differences are in bold).
| Proposed Device | Predicate Device | |
|---|---|---|
| Model | KOWA VK-2s | KOWA nonmyd α-DIII |
| Device Design | ||
| Type of Retinal Camerasoftware used inconjunction with | Mydriatic | |
| Non-mydriatic | Non-mydriatic | |
| Type of Retinal Cameraimage | Color | Color |
| Montage | Montage | |
| FAF | FAF | |
| FA | - | |
| Image Processing | Sharpen Image | Sharpen Image |
| Gamma Process | Gamma Process | |
| Zoom | Zoom | |
| RGB Filters | RGB Filters | |
| Enhance Image | Enhance Image | |
| Contrast | Contrast | |
| Analysis of RGB Color | Analysis of RGB Color | |
| Negative Image | Negative Image | |
| Edge Enhancement | - | |
| Histogram Chart | - | |
| Flip Image | Flip Image |
The KOWA VK-2s functions of FA image and the image processing functions of edge enhancement and histogram are not offered in the KOWA portable VK-2 in the KOWA nonmyd a-DIII device.
The differences between the KOWA VK-2s and the two predicate software devices include the addition of Edge Enhancement and Histogram chart to the image processing of the VK-2s. The VK-2s does not support the image processing functions of cobalt, emboss and redfree and does not support the Drawing function which are functions of the Canon Ophthalmic Software Platform RX.
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The differences between the subject device and the predicate devices are considered to be minor and do not raise new questions of safety or effectiveness. The VK-2s is as safe and effective as the predicate devices, and thus may be considered substantially equivalent.
i. Performance Data
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Conclusions j.
Kowa's VK-2s is as safe and effective as the previously cleared Canon Ophthalmic Software Platform RX cleared in K173689 and the portable VK-2 component of the Kowa nonmyd α-DIII (K083387). The VK-2s has the same intended use and similar indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate device and is therefore substantially equivalent.
§ 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).