(84 days)
No
The description focuses on the hardware and image acquisition process. There is no mention of AI, ML, or any form of automated analysis or interpretation of the images using such technologies. The performance studies also do not indicate any evaluation of AI/ML model performance.
No.
The device is intended to capture images of the retina for diagnostic purposes, not to provide therapy or treatment.
Yes
The device captures images of the retina, which are then displayed and can be saved for future consultation by eye care practitioners. This process enables practitioners to observe and potentially identify abnormalities or conditions of the retina, thus serving a diagnostic purpose through image capture for medical assessment.
No
The device description clearly outlines hardware components such as a camera, chinrest, forehead rest, positioning system, external fixation target, focus wheel, and a Tunable Laser Source (TLS). Performance studies also include electrical safety, electromagnetic compatibility, and biocompatibility testing, which are relevant to hardware.
Based on the provided information, the Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "capture images of the retina at multiple wavelengths (colors) under mydriatic conditions." This describes an imaging device used to visualize anatomical structures.
- Device Description: The description details a fundus camera that captures images of the retina. It focuses on the optical and mechanical aspects of image acquisition.
- Lack of In Vitro Components: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) or performing tests on these samples outside of the body. IVDs are designed to perform tests on such samples.
- Performance Studies: The performance studies focus on aspects like biocompatibility, software evaluation, electrical safety, electromagnetic compatibility, and compliance with standards for ophthalmic cameras and fundus cameras. These are typical evaluations for medical imaging devices, not IVDs.
- Predicate and Reference Devices: The listed predicate and reference devices (KOWA VX-20 and Topcon TRC-50DX) are also fundus cameras, which are imaging devices, not IVDs.
In summary, the MHRC-C1 is a medical imaging device used to capture images of the retina in vivo (within the living body) for diagnostic purposes, but it does not perform in vitro tests on biological samples.
N/A
Intended Use / Indications for Use
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
Product codes
HKI, NFJ
Device Description
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of 92 images of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm.
Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15 diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.
The illumination light of the MHRC-C1 is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm to 450 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms.
The 92 images can be visualized one by one in the MHRC-C1 acquisition software. The retinal images captured by the MHRC-C1 are monochromatic images having a spectral bandwidth of ~10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Monochromatic light
Anatomical Site
retina, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioners (optometrists and ophthalmologists)
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)
Biocompatibility: The biocompatibility of the MHRC-C1 was assessed in accordance with ISO 10993-1:2018.
Software evaluation: The MHRC-C1 uses embedded Off-The-Shelf software. This software was evaluated for use in accordance with the FDA's Guidance for Industry "Off-The-Shelf Software use in Medical Devices" (September 1999) based on a "Moderate Level of Concern".
Electrical safety and electromagnetic compatibility: It was verified that the MHRC-C1 complies with the standard ANSI AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility.
Evaluation of recognized consensus standards for ophthalmic cameras: The MHRC-C1 was found to comply with the recognized consensus standard ISO 15004-1:2006 specifying general requirements for ophthalmic instruments. The MHRC-C1 was found to comply with the recognized consensus standard ISO 10940:2009 specifying product requirements for fundus camera. The MHRC-C1 was found to comply with the recognized consensus standard ANSI Z80.36:2016 specifying fundamental requirements for optical radiation safety for ophthalmic instruments.
Spectral accuracy and reliability of the retinal images: The spectral accuracy of the illumination light of the MHRC-C1 was verified using a spectrometer. The spectral accuracy and reliability of the retinal images were evaluated in an eye model using a reference material with tabulated spectral bands.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
April 27, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Optina Diagnostics % Elisa Harvey Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, #254 Annapolis, Maryland 21401
Re: K200254
Trade/Device Name: Mydriatic Hyperspectral Retinal Camera (MHRC-C1) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI, NFJ Dated: January 30, 2020 Received: February 3, 2020
Dear Elisa Harvey:
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
1
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 medical devices and radiation-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,
Elvin Ng Acting 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
2
Indications for Use
510(k) Number (if known) K200254
Device Name
Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
Indications for Use (Describe)
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
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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3
Image /page/3/Picture/1 description: The image shows the logo for Optina Diagnostics. The logo consists of a blue circular graphic on the left and the company name "Optina" in gray, with "DIAGNOSTICS" in blue underneath. To the right of the logo is the company's address: 7405 ROUTE TRANSCANADIENNE, #330, ST-LAURENT, QUÉBEC, H4T 1Z2, CANADA.
510(k) Summary
| APPLICANT: | Optina Diagnostics, Inc
7405 Route Transcanadienne, Suite #330
Montréal, Québec, Canada, H4T 1Z2
Phone : 514-394-0797 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| DATE
PREPARED: | April 24, 2020 |
| CONTACT
PERSON: | Jean-Philippe Sylvestre |
| TRADE NAME: | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) |
| COMMON NAME: | Fundus camera |
| REGULATION | Regulation Number: 21 CFR 886.1120
Regulation Name: Ophthalmic Camera
Product Code: HKI, NFJ |
| DEVICE
CLASSIFICATION: | Class 2 |
| PREDICATE
DEVICE
(PRIMARY) | KOWA VX-20 (K112330) |
| REFERENCE
DEVICE | Topcon TRC-50DX (K123101) |
Device Description 1.
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series of 92 images of the retina obtained sequentially at specific wavelengths (colors) in the spectral range 905 nm to 450 nm in steps of 5 nm.
Pictures of the retina are obtained on a field-of-view of 31.5° without contact with the eye. The patient is positioned in front of the device with the chin on the chinrest and forehead on the forehead rest and a positioning system is used to align the camera relative to the patient's eye. An external fixation target is available to guide the patient's eye. A focus wheel allows for the accommodation for eye refractive error in the range of -15 to +15
4
Image /page/4/Picture/1 description: The image shows the logo for Optina Diagnostics. The logo features a blue circular design on the left and the company name "Optina" in gray, with "DIAGNOSTICS" in a smaller font below. To the right of the logo, the text provides the company's address: 7405 ROUTE TRANSCANADIENNE, #, ST-LAURENT, QUÉBEC, H4T 1Z2, CANADA.
diopters. The images are displayed on a monitor and can be saved on the computer for future consultation.
The illumination light of the MHRC-C1 is provided by a Tunable Laser Source (TLS). The TLS selects a narrow band of light from a broadband white illumination source. Only a single monochromatic band can output the TLS at a time. The alignment of the retinal camera relative to the patient's eye phase is performed with the illumination light set at a wavelength of 700 nm. The image acquisition phase consists of the sequential acquisition of a series of 92 monochromatic images at wavelengths from 905 nm to 450 nm in steps of 5 nm. Each frame is captured with an exposure time of 10 ms, resulting in a total acquisition time of 920 ms.
The 92 images can be visualized one by one in the MHRC-C1 acquisition software. The retinal images captured by the MHRC-C1 are monochromatic images having a spectral bandwidth of ~10 nm centered on the wavelength indicated in the upper left corner of the visualization pane, with a spectral accuracy of 7.5 nm.
2. Indications for Use
The Mydriatic Hyperspectral Retinal Camera (MHRC-C1) is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
Technological Characteristics: 3.
The MHRC-C1 is similar in form and function to the predicate mydriatic fundus cameras (see Table 1 below). Indeed, the device is intended to obtain images of the retina with the use of a mydriatic. The contact areas of the patients are the same as for the predicate devices. The operator interface to perform retinal imaging is also similar to the predicate devices. Although there are differences in the technology to provide illumination of the retina. equivalent information may be inferred by scrolling through the monochromatic images obtained with the MHRC-C1 compared to what may be obtained in the color and red free monochrome imaging modes of the predicate devices. Performance testing was performed to verify that this technological difference raised no new concerns regarding the safety and efficacy of the device.
4. Performance Testing
The following performance data were conducted to support the substantial equivalence determination.
Biocompatibility
The intact skin from the chin and forehead of the patient is intended to contact the MHRC-C1 for a short period of time. The biocompatibility of the MHRC-C1 was assessed in accordance with ISO 10993-1:2018.
5
Image /page/5/Picture/1 description: The image shows the logo for Optina Diagnostics. The logo consists of a blue circular design on the left, followed by the word "Optina" in gray and "DIAGNOSTICS" in blue below it. On the right side, the text "OPTINA DIAGNOSTICS" is printed above the address "7405 ROUTE TRANSCANADIENN ST-LAURENT, QUÉBEC, H4T 1Z2 CANADA".
Software evaluation
The MHRC-C1 uses embedded Off-The-Shelf software. This software was evaluated for use in accordance with the FDA's Guidance for Industry "Off-The-Shelf Software use in Medical Devices" (September 1999) based on a "Moderate Level of Concern".
Electrical safety and electromagnetic compatibility
It was verified that the MHRC-C1 complies with the standard ANSI AAMI ES60601-1:2005/(R)2012+A1:2012 for electrical safety and with the standard IEC 60601-1-2:2014 for electromagnetic compatibility.
Evaluation of recognized consensus standards for ophthalmic cameras
The MHRC-C1 was found to comply with the recognized consensus standard ISO 15004-1:2006 specifying general requirements for ophthalmic instruments.
The MHRC-C1 was found to comply with the recognized consensus standard ISO 10940:2009 specifying product requirements for fundus camera.
The MHRC-C1 was found to comply with the recognized consensus standard ANSI Z80.36:2016 specifying fundamental requirements for optical radiation safety for ophthalmic instruments.
Spectral accuracy and reliability of the retinal images
The spectral accuracy of the illumination light of the MHRC-C1 was verified using a spectrometer.
The spectral accuracy and reliability of the retinal images were evaluated in an eye model using a reference material with tabulated spectral bands.
5. Substantial Equivalence
The MHRC-C1 is similar in form and function to the predicate and reference mydriatic fundus camera (see Table 1 below) and product testing was performed to demonstrate that the proposed device meets the recognized consensus standards related to a fundus camera. However, the MHRC-C1 uses "multiple wavelength (colors) imaging" which represents a hyperspectral feature that is a different technology in comparison to the proposed predicate device and reference device. Indeed, the technology to provide illumination of the retina in the proposed device consists in a tunable light source that sequentially present the retina with monochromatic light in the spectral range 905 nm to 450 nm in steps of 5 nm, while the predicate device and reference device use a xenon flash lamp with a broad white illumination spectrum. Despite this difference in technology, equivalent information may be inferred by scrolling through the monochromatic images obtained with the MHRC-C1 than what may be obtained in the color and red free monochrome imaging modes of the predicate and reference devices. Indeed, the images obtained with the MHRC-C1 cover the full visible spectral range that is covered in a color
6
Image /page/6/Picture/1 description: The image contains the logo for Optina Diagnostics. The logo features a blue circular design on the left, with the word "Optina" in gray and "DIAGNOSTICS" in a smaller blue font underneath. To the right of the logo, there is contact information including the company name, address (7405 ROUTE TRANSCANADIEN, ST-LAURENT, QUÉBEC, H4T 1Z), and country (CANADA).
fundus image, typically composed of 3 broad spectral bands (red, green and blue) covering the spectral range 450 nm to 750 nm. Similarly, scrolling the images obtained with the MHRC-C1 in the spectral range corresponding to the green color (500-565 nm) covers the typical spectral range used to obtain retinal images in the red free mode. Moreover, the testing conducted to verify the spectral accuracy and repeatability of the proposed device supports that an image with the central wavelength corresponding to a specific color would display the features expected for an image in the spectral range corresponding to the expected color, thus preventing misinterpretation of the retinal images by the eye specialist due to an error in the displayed wavelength for a given retina image. It follows that the new feature of the proposed device, therefore, did not raise new concern regarding its safety and efficacy.
In conclusion, the performance testing supports that the MHRC-C1 meets the recognized consensus standards for a fundus camera and that retinal imaging at multiple wavelengths (colors) may be accurately and reliably achieved. The proposed device did not raise new concerns regarding its safety and efficacy for its intended use and was therefore deemed substantially equivalent to the predicate devices.
| Device Name | MHRC-C1 | Kowa VX-20 | TRC-50DX |
|---|---|---|---|
| 510(k) number | K200254 | K112330 | K123101 |
| Regulation number | 21 CFR 886.1120 | 21 CFR 886.1120 | 21 CFR 886.1120 |
| Product code | HKI, NFJ | HKI, NFJ | HKI |
| Intended use | The MHRC-C1 is intended | ||
| to capture images of the | |||
| retina at multiple | |||
| wavelengths (colors) under | |||
| mydriatic conditions. | The device is intended for | ||
| taking pictures of fundus | |||
| images with mydriatic or | |||
| without mydriatic | The TRC-50DX Retinal | ||
| Camera is intended for use | |||
| in capturing images of the | |||
| retina and the anterior | |||
| segment of the eye and | |||
| presenting the data to the | |||
| eye care professional, with | |||
| the use of a mydriatic | |||
| Camera function | Mydriatic | Mydriatic or non-mydriatic | Mydriatic |
| Photography type | Monochrome (92 color | ||
| bands, 905 nm to 450 nm | |||
| in steps of 5 nm) | Color | ||
| Monochrome (Red free) | |||
| Fluorescence | |||
| Autofluorescence | Color | ||
| Monochrome (Red free) | |||
| Fluorescence | |||
| Autofluorescence | |||
| Observation media | Video feed on LCD monitor | Video feed on LCD monitor | |
| or Optical viewfinder | Optical viewfinder | ||
| Record media | Digital | Digital | Digital or 35 mm film |
| Contact areas with the | |||
| patients | Chin and forehead | Chin and forehead | Chin and forehead |
| Mean for alignment | Positioning base with | ||
| joystick | Positioning base with | ||
| joystick | Positioning base with | ||
| joystick | |||
| Field of View | 31.5 degrees | 50 / 30 degrees | 50 / 35 / 20 degrees |
| Working Distance | 46.7 mm | 39.0 mm | 39.0 mm |
| Minimum pupil diameter | 6 mm | 5.5 mm (4.0 mm in non- | |
| mydriatic mode) | 5.5 mm (4.5 mm in small | ||
| pupil mode) |
Table 1. Similarities and differences between the proposed device and the predicate device and reference device.
7
Image /page/7/Picture/1 description: The image shows the logo for Optima Diagnostics. The logo features a blue circle made up of several overlapping semi-transparent circles. Below the circle, the word "Optima" is written in gray, with the word "DIAGNOSTICS" written in a smaller font size below it.
OPTINA DIAGNOSTICS
7405 ROUTE TRANSCANADIENNE, #330
ST-LAURENT, QUÉBEC, H4T 1Z2
CANADA
| Eye Fixation Navigation | External fixation target | External or internal fixation
target | External or internal fixation
target |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------|
| Focusing | Focus wheel | Focus knob | Focus knob |
| Diopter compensation
range of patient's eye | -15D to + 15D | -32D to + 35D | -23D to + 41D |
| Alignment/visualization
light source | Monochromatic light (700
nm) | Halogen lamp | Halogen lamp |
| Photographing light
source | Monochromatic light
(sequential from 905 nm to
450 nm in steps of 5 nm) | Xenon lamp (flash) | Xenon lamp (flash) |
| Conformed performance
standards | ISO 10940:2009
ISO 15004-1:2006
ISO15004-2:2007
ANSI Z80.36
IEC 60601-1-2:2014
ANSI AAMI ES60601-
1::2005/(R)2012 and
A1:2012 | IEC 60601-1:1988
+A1:1991+A2:1995
IEC 60601-1-1:2007 | IEC 60601-1-1:2001
ISO 15004-1:2006
ISO15004-2:2007 |