(221 days)
MHRC-C1 (K200254)
Not Found
No
The summary describes a fundus camera that captures images at multiple wavelengths. There is no mention of any AI or ML algorithms being used for image analysis, interpretation, or any other function. The focus is on the image acquisition process and hardware.
No.
The device is described as a fundus camera intended to capture images of the retina for diagnostic purposes, not for treating any condition.
Yes
Explanation: The device captures images of the retina, which are then used by healthcare practitioners for consultation. The intended use of capturing images for "eye care practitioners (optometrists and ophthalmologists)" implies the images will be used to assess the health or condition of the retina, which is a diagnostic purpose. While the device itself doesn't perform the diagnosis, it provides the necessary data for a diagnosis to be made.
No
The device description clearly outlines hardware components such as a camera, chinrest, forehead rest, positioning system, external fixation target, focus wheel, monitor, and a Tunable Laser Source (TLS). The performance studies also include electrical safety, electromagnetic compatibility, and biocompatibility testing, which are associated with hardware devices. While there is software involved for image acquisition and visualization, the device is fundamentally a hardware system with integrated software.
Based on the provided information, the Optina-4C™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Optina-4C™ Function: The Optina-4C™ is a fundus camera that captures images of the retina in vivo (within the living body). It does not analyze biological specimens outside of the body.
- Intended Use: The intended use is to "capture images of the retina," which is a direct imaging function, not an analysis of a biological sample.
Therefore, the Optina-4C™ falls under the category of an in vivo imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
Product codes
HKI
Device Description
Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series 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 Optina-4C™ 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 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 Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ 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 images, Fundus Camera
Anatomical Site
Retina
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)
- Software evaluation: Optina-4C™ uses embedded Off-The-Shelf software and Software-of-Unknown-Provenance. This software was evaluated for use in accordance with the FDA's Guidance for Industry "Off-The-Shelf Software Use in Medical Devices" (September 2019) based on a "Moderate Level of Concern" and IEC 62304:2006 + A1:2015 based on a "Safety class B".
- Electrical safety and electromagnetic compatibility: It was verified that the Optina-4C™ 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: Optina-4C™ was found to comply with the recognized consensus standard ISO 15004-1:2020 specifying general requirements 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.
- 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.
- Evaluation of recognized consensus standards for ophthalmic cameras: 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: 2021 specifying fundamental requirements for optical radiation safety for ophthalmic instruments.
- Key Results: The performance testing supports that the Optina-4C™ 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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MHRC-C1 (K200254)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Optina Diagnostics Inc. Sarah Lemaire QA/RA Manager 8200 Decarie Boulevard Montreal, QC H4P 2P5 Canada
Re: K231230
Trade/Device Name: Optina-4C (MHRC-C1N) Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 6, 2023 Received: November 7, 2023
Dear Sarah Lemaire:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerelv.
Elvin Y. Ng-S
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
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Indications for Use
510(k) Number (if known) K231230
Device Name Optina-4C (MHRC-C1N)
Indications for Use (Describe)
Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
| 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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K231230
Image /page/3/Picture/1 description: The image contains the logo for Optina Diagnostics. The logo consists of a blue circular graphic on the left and the company name on the right. The word "Optina" is in gray, and the word "DIAGNOSTICS" is in a smaller, teal font below it.
Special 510(k): Device Modification
Optina-4C™ Model: MHRC-C1N
510(k) Summary
| APPLICANT: | Optina Diagnostics, Inc | ||
|---|---|---|---|
| 8200 Decarie Blvd, Suite 220 | |||
| Montreal (QC) | |||
| H4P 2P5 | |||
| Phone: 514-394-0797 | |||
| ESTABLISHMENT | |||
| REGISTRATION | |||
| NUMBER | Registration Number: 3014606890 | ||
| Owner Operator Number: 10081796 | |||
| DATE PREPARED: | August 5, 2022 | ||
| CONTACT PERSON: | Sarah Lemaire | ||
| QA/RA Manager | |||
| Email: slemaire@optinadx.com | |||
| Phone: 579-421-0126 | |||
| TRADE NAME: | Optina-4C™ | ||
| MODEL: | MHRC-C1N | ||
| COMMON NAME: | Fundus camera | ||
| CLASSIFICATION | |||
| NAME: | Camera, Ophthalmic, Ac-Powered (21 CFR | ||
| 886.1120, Product Code HKI) | |||
| DEVICE | |||
| CLASSIFICATION: | Class II | ||
| PREDICATE DEVICES | MHRC-C1 (K200254) |
1. Description of the Modified Device
Optina-4C™ (model: MHRC-C1N) is a mydriatic fundus camera (also called retinal camera) that presents eye care practitioners (optometrists and ophthalmologists) with a series 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
4
Image /page/4/Picture/1 description: The image shows the logo for Optina Diagnostics. On the left side of the logo is a blue circular design that is made up of several overlapping circles. To the right of the circular design is the company name, "Optina", in gray text, with the word "DIAGNOSTICS" in smaller, teal text underneath.
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 Optina-4C™ 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 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 Optina-4C™ acquisition software. The retinal images captured by Optina-4C™ 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
Optina-4C™ is intended to capture images of the retina at multiple wavelengths (colors) under mydriatic conditions.
3. Technological Characteristics
Optina-4C™ is similar in fit, form, and function to the predicate mydriatic fundus cameras. The main elements of the hardware including contact areas, the illumination of the retina, and the monochromatic images obtained with Optina-4C™ are the same as for the predicate device.
In comparison with the predicate device, Optina-4C™ has updated software and labeling and features network connectivity. 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.
● Software evaluation
Optina-4C™ uses embedded Off-The-Shelf software and Software-of-Unknown-Provenance. This software was evaluated for use in accordance with the FDA's Guidance for Industry "Off-The-Shelf Software Use in Medical Devices" (September 2019) based on a "Moderate Level of Concern" and
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Image /page/5/Picture/1 description: The image contains the logo for Optina Diagnostics. On the left side of the logo is a blue circular graphic that is made up of many overlapping circles. To the right of the graphic is the company name "Optina" in gray, with the word "DIAGNOSTICS" in a smaller font size and blue color underneath.
IEC 62304:2006 + A1:2015 based on a "Safety class B".
● Electrical safety and electromagnetic compatibility
lt was verified that the Optina-4C™ 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
Optina-4C™ was found to comply with the recognized consensus standard ISO 15004-1:2020 specifying general requirements for ophthalmic instruments.
The following performance data were conducted on the marketed device (MHRC-C1). No changes that can affect the evaluation or results of these recognized consensus standards were implemented on the Optina-4C™.
● 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.
● 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.
● Evaluation of recognized consensus standards for ophthalmic cameras
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: 2021 specifying fundamental requirements for optical radiation safety for ophthalmic instruments.
5. Substantial Equivalence
In conclusion, the performance testing support that the Optina-4C™ 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 device.
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