(90 days)
No
The summary describes a device for capturing and displaying images of the tear film, with basic measurement and output functions. There is no mention of AI, ML, image processing beyond simple display and clipping, or any data analysis that would suggest the use of such technologies. The performance studies focus on image quality, repeatability, and safety, not algorithmic performance.
No.
The device is used for observation and recording of tear film images for diagnostic purposes, not for providing therapy or treatment.
No
The device is described as an ophthalmic imaging device intended to observe and record images of the tear film. While it allows for visual monitoring and photographic documentation, it does not mention any analytical capabilities or direct output of a diagnosis based on the collected images. Its primary function is image acquisition, measurement of duration time, and output of images, rather than providing a diagnostic interpretation.
No
The device description explicitly states it is an "ophthalmic imaging device" and an "instrument," and the performance studies include testing related to hardware components like illumination area, image resolution, optical radiation safety, EMC, electrical safety, and biocompatibility of physical parts (forehead rest, chin rest). While it has software, it is clearly integrated with and dependent on hardware.
Based on the provided information, the KOWA DR-1a is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- KOWA DR-1a Function: The KOWA DR-1a is an ophthalmic imaging device that directly observes and records images of the tear film on the surface of the eye in a living patient. It does not analyze samples taken from the body.
- Intended Use: The intended use is to observe and record the tear film in vivo for visual monitoring and documentation by a physician.
Therefore, the KOWA DR-1a falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KOWA DR-1a is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
Product codes (comma separated list FDA assigned to the subject device)
HKI
Device Description
The KOWA DR-1a is ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by a physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
This instrument is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer
In addition, using the image currently being replayed, users can measure the duration time by specifying 2 different point of time. This instrument has a function that allows users to output a video or a still image clipped from the video to an external personal computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Specular (interferometric) observations of the tear film
Anatomical Site
Ocular surface / tear film
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Comparison with the Predicate Device:
Test was performed to evaluate performance of the KOWA DR-1a compared to the LipiView regarding Illumination area, Image resolution and Interference image.
Test results indicated that the KOWA DR-1a has similar Illumination area and Interference image to the LipiView and higher Image resolution than the LipiView.
Testing for Repeatability:
The repeatability was investigated by comparing the hue values measured with three units of DR-1α and by three examiners. Each measurement was repeated 5 times. The hue values obtained did not exceed the acceptance range.
Optical Radiation Safety:
KOWA performed estimation of the light hazard and evaluation as to whether the KOWA DR-1a satisfied the requirements of ANSI Z80.36-2016. As a result, the KOWA DR-1a is classified in Group 1 of the continuous wave instrument. Therefore, the KOWA DR-1a complies with ANSI Z80.36-2016.
EMC and Electrical Safety:
EMC and Electric safety were confirmed in accordance with IEC 60601-1-2.2007 and IEC 60601-1:2012, respectively.
Biocompatibility:
The biocompatibility evaluation for the forehead rest and chin rest was conducted in accordance with ISO 10993-1:2009 and referencing FDA guidance. Tests included Cytotoxicity, Sensitization, and Irritation.
Software validation:
The software of the proposed device has been validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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June 4, 2019
Kowa Company, Ltd. Nariaki Morita Manager of Development Management Dept. 3-1 Chofugaoka 3-Chome Chofu City Tokyo, 182-0021 JAPAN
Re: K190573
Trade/Device Name: KOWA DR-1α Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: December 14, 2018 Received: March 6, 2019
Dear Nariaki Morita:
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/ofdocs/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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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-devices/medical-device-safety/medical-devicereporting-mdr-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.
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190573
Device Name
KOWA DR-1a
Indications for Use (Describe)
The KOWA DR-1a is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
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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Image /page/3/Picture/1 description: The image shows the word "Kowa" in red, stylized font. The word is enclosed in a red oval. The font is bold and slightly italicized, giving it a dynamic appearance.
Kowa) Kowa Company. Ltd.
Chofu Factory
፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡፡
510k Summary
A. Owner/Company name, address
Kowa Company, Ltd.
3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021
Phone: +81-42-440-7612 +81-42-440-7618 Fax:
B. Contact
Nariaki Morita Kowa Company, Ltd. Medical Device Division 3-1, Chofugaoka 3-Chome Chofu Tokyo, JAPAN 182-0021 Phone: +81-42-440-7627 Fax: +81-42-440-7618 Email: n-morita@kowa.co.jp
C. Date prepared
December 14, 2018
D. Name of device
| Trade Name: | KOWA DR-1α |
|---|---|
| Regulation Number: | 21 CFR 886.1120 |
| Regulation Name: | Ophthalmic Camera |
| Regulatory Class: | II |
| Product Code: | HKI |
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E. Predicate and Reference Devices
| Predicate Device | |
|---|---|
| 510(k) number: | K091935 |
| Trade name: | LipiView Ocular Surface Interferometer |
| Regulation Number: | 21 CFR 886.1120 |
| Regulation Name: | Ophthalmic Camera |
| Regulatory Class: | II |
| Product Code: | HKI, HJO |
The predicate device is hereinafter called "the LipiView" in this submission.
Reference Device
The forehead rest of the proposed device is identical to the forehead rest of the reference device. Both proposed and reference devices are the ophthalmic cameras and a patient contacts the forehead rest for a very short time. In addition, both forehead rests are disinfected with rubbing alcohol.
| 510(k) number: | K112330 |
|---|---|
| Trade name: | KOWA VX-20 |
| Regulation Number: | 21 CFR 886.1120 |
| Regulation Name: | Ophthalmic Camera |
| Regulatory Class: | II |
| Product Code: | HKI |
F. Description of the device
The KOWA DR-1a is ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by a physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
This instrument is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer
In addition, using the image currently being replayed, users can measure the duration time by specifying 2 different point of time. This instrument has a function that allows users to output a video or a still image clipped from the video to an external personal computer.
5
G. Indications for Use Statement
The KOWA DR-1a is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
H. Discussion of substantial equivalence
Comparative Information
Both the KOWA DR-1a and the predicate device are an ocular surface interferometer. The indications for use statement of the KOWA DR-1a is virtually the same as for the LipiView. The differences of the indications for use statement are minor and do not alter the intended use.
Fundamental technology as ocular surface interferometer is similar between the two devices as shown below:
Technological Principle of the LipiView
The LipiView operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The patient's eye is positioned in front of an illumination source directed toward the tear film on the corneal surface. Light from the illumination source passes through the outer lipid layer of the tear film and is secularly reflected into a camera. The light reflecting through back the lens in the camera forms an interference pattern, called an "interferogram". The computer system captures a video image file that is recorded over time since the interference pattern changes as the lipid layer of the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.
Technological Principle of the KOWA DR-1α
The KOWA DR-1a is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer.
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The surface layer of the tear film layer is called the tear film lipid layer. It is a thin layer of approximately 100nm thick. When white light is irradiated on the tear film surface, several interference patterns appear by difference in two specular reflection light paths obtained between the surface and the back of the lipid layer. For the reflection light at the tear film layer, the KOWA DR-1a uses two polarizer (parallel), only the reflected image of the illumination light is captured by the camera, and the external light is not taken into the camera. As a result, background image such as iris and sclera does not appear and the interference image of the tear film layer can be efficiently observed.
The similarities between KOWA DR-1α and LipiView are:
- . Intended use
- Capability to record interference image ●
- Camera resolution ●
- Illumination source .
- Illumination area ●
- Interference image ●
- Power supply ●
The differences between KOWA DR-1α and LipiView are:
- Image resolution ●
- Dimension .
- Weight ●
- Power consumption ●
The differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The performance data to prove the safety and performance of KOWA DR-1a are provided in section of Performance data of this summary below.
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Following table shows comparison between the proposed and predicate devices.
| Proposed device | Predicate device | |
|---|---|---|
| Device name | KOWA DR-1a | LipiView Ocular Surface |
| Interferometer | ||
| 510(k) number | K190573 | K091935 |
| Indications for | ||
| use statement | The KOWA DR-1a is an ocular surface | |
| interferometer, which is an ophthalmic | ||
| imaging device that is intended for use | ||
| by physician in adult patients to observe | ||
| and record a video image of specular | ||
| (interferometric) observations of the tear | ||
| film, which can be visually monitored | ||
| and photographically documented. | The LipiView Ocular Surface | |
| Interferometer is an ophthalmic imaging | ||
| device that is intended for use by a | ||
| physician in adult patients to capture, | ||
| archive, manipulate and store digital | ||
| images of specular (interferometric) | ||
| observations of the tear film, which can | ||
| be visually monitored and | ||
| photographically documented. | ||
| Performance Specifications | ||
| Illumination area | Wide type (low magnification) | |
| Diameter: 8.0 mm | ||
| Height: 7.2 mm | ||
| Narrow type (high magnification) | ||
| Width: 3.4 mm | ||
| Height: 2.5 mm | Width: 9.5 mm | |
| Height: 4.6 mm | ||
| Image resolution | 45.3 line pairs / mm (Narrow) | |
| 18.0 line pairs / mm (Wide) | 14.3 line pairs / mm | |
| Other Specifications/Characteristics | ||
| Camera | ||
| resolution | 640 x 480 pixels | Same |
| Illumination | ||
| source | White LED | Same |
| Dimension | 290(W) x 365(D) x 455(H) mm | 430(W) x 720(D) x 430(H) mm |
| Weight | 14 kg | 24.95 kg |
| Power supply | AC100-240V, | |
| 50/60Hz | Same | |
| Power | 70VA | 80VA |
| consumption |
Table 1. Comparison Table
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I. Performance data
Dimension, weight and power consumption of the KOWA DR-1a are less compared to the LipiView. Such differences do not result in lower performance as shown in the comparison table. The comparison of quality of images obtained from the proposed and predicate devices was conducted because of the differences of Illumination area and Image resolution.
Performance Comparison with the Predicate Device
Test was performed to evaluate performance of the KOWA DR-1a compared to the LipiView regarding Illumination area, Image resolution and Interference image.
Test results indicated that the KOWA DR-1a has similar Illumination area and Interference image to the LipiView and higher Image resolution than the LipiView.
The following performance tests were conducted in support of the substantial equivalence determination.
Testing for Repeatability
The repeatability was investigated by comparing the hue values measured with three units of DR-1α and by three examiners. Each measurement was repeated 5 times. The hue values obtained did not exceed the acceptance range.
Optical Radiation Safety
KOWA performed estimation of the light hazard and evaluation as to whether the KOWA DR-1a satisfied the requirements of ANSI Z80.36-2016. As a result, the KOWA DR-1a is classified in Group 1 of the continuous wave instrument. Therefore, the KOWA DR-1a complies with ANSI Z80.36-2016.
EMC and Electrical Safety
EMC and Electric safety were confirmed in accordance with IEC 60601-1-2.2007 and IEC 60601-1:2012, respectively.
9
Biocompatibility
The forehead rest and the chin rest of the proposed device contact intact patient skin for a very short time. The biocompatibility evaluation for those parts were conducted in accordance with ISO 10993-1:2009 and referencing FDA guidance entitled "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were conducted to evaluate biocompatibility of the proposed device:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
Software validation
The software of the proposed device has been validated according to FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Conclusion J.
Based on the information described above, KOWA DR-1a is substantially equivalent to the predicate device in technical characteristics, operating principles and performance characteristics for the intended uses in the stated medical specialties. There are no new safety and effectiveness issues being raised.