XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

K193319 · Vasoptic Medical, Inc. · HKI · Jun 1, 2020 · Ophthalmic

Device Facts

• Record ID: K193319
• Device Name: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
• Applicant: Vasoptic Medical, Inc.
• Product Code: HKI · Ophthalmic
• Decision Date: Jun 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1120
• Device Class: Class 2

Intended Use

The XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.

Device Story

XyCAM RI is a non-invasive retinal blood flow imaging system. It uses Laser Speckle Contrast Imaging (LSCI) with a 785 nm near-infrared laser diode to illuminate the retina and a high-speed camera to capture image stacks. The system PC processes these images by analyzing spatio-temporal pixel intensity variations to calculate a Blood Flow Velocity index (BFVi). The device is used in a clinical setting by an operator to generate maps of retinal blood flow velocity. It includes gaze fixation targets for the patient. The output is displayed on a monitor for the clinician to assess spatial and temporal trends in blood flow. It does not provide automated diagnostics or clinical decision support; it serves as an imaging tool to assist clinicians in monitoring retinal blood flow. Optional accessories include a pulse oximeter.

Clinical Evidence

Clinical validation involved 20 healthy subjects (9 male, 11 female; mean age 46.9 ± 16.6 years). Study assessed repeatability and reproducibility of blood flow measurements across different operators and imaging sessions (Optic Nerve Head and macula). Results showed mean intra-session coefficient of variation (CV) of 2.883% (ONH) and 2.782% (macula), and mean inter-session CV of 7.069% (ONH) and 6.447% (macula). Bench testing using a calibrated flow pump confirmed reliability with intra-session CV < 10%.

Technological Characteristics

Non-invasive ophthalmic camera using Laser Speckle Contrast Imaging (LSCI). Illumination: 785 ± 10 nm near-infrared laser diode. Field angle: 20-25 degrees. Working distance: 21 mm. Connectivity: System PC with keyboard/mouse/monitor. Standards: ANSI/AAMI ES60601-1 (safety), IEC 60601-1-2 (EMC), ANSI Z80.36-2016 (ophthalmic), IEC 60825-1 (laser safety). Software: Moderate level of concern.

Indications for Use

Indicated for capturing, storing, and displaying images of dynamic blood flow changes in the human retina and providing quantitative relative blood flow information in patients.

Regulatory Classification

Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Special Controls

*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.

Predicate Devices

• Retinal Functional Imager 3000 (RFI 3000), K080180

Reference Devices

• Laser Speckle Flowgraphy LSFG-NAVI, K153239

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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.

June 1, 2020

Vasoptic Medical Inc. Abhishek Rege President 1215 East Fort Avenue, Suite 304 Baltimore, Maryland 21230

Re: K193319

Trade/Device Name: XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: Class II Product Code: HKI Dated: November 27, 2019 Received: December 2, 2019

Dear Abhishek Rege:

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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K193319

Device Name XyCAM™ Retinal Imager - XyCAM RI

Indications for Use (Describe)

The XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.

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 text "K193319" on the left side of the image. To the right of the text is a blue logo that looks like a stylized "W". Below the logo is the text "VASOPTIC MEDICAL INC.". The logo and text are likely the logo for the company Vasoptic Medical Inc.

# 510(k) Summary

#### I. Submitter Details

| Submitter Name | Vasoptic Medical Inc. |
|------------------------|-------------------------------------------------------|
| Submitter Address | 1215 East Fort Avenue, Suite 304, Baltimore, MD 21230 |
| Submitter Phone Number | 443-961-3591 |
| Primary Contact Person | Abhishek Rege |
| Primary Contact Email | [e-mail] |
| Date Prepared | November 27, 2019 |

#### II. Device Information

| Device Name | XyCAM Retinal Imager (XyCAM RI) |
|---------------------------|---------------------------------|
| Device Identification | Ophthalmic Camera Device |
| Product Code | HKI |
| Regulation Number | 21 CFR 886.1120 |
| Regulatory Classification | II |

#### III. Predicate Device

| Predicate Device | Retinal Functional Imager 3000 (RFI 3000), K080180 |
|------------------|----------------------------------------------------|
| Reference Device | Laser Speckle Flowgraphy LSFG-NAVI, K153239 |

#### IV. Device Description

The XyCAM™ RI System (or XyCAM RI) is a non-invasive retinal blood flow imaging device. It generates images of one or more regions of the retina by using an imaging technique called Laser Speckle Contrast Imaging (LSCI). This technique utilizes a lowintensity laser beam to illuminate the back of the eye and a high-speed, high-sensitivity camera to acquire a stack of images. The captured image stack is then processed such that the intensity at every image pixel is processed in conjunction with the intensities of other spatio-temporally adjacent pixels to obtain a speckle contrast value at the said pixel. which is indicative of blood flow velocity at the said pixel. Accordingly, the XyCAM RI is able to generate and display a map of Blood Flow Velocity indices within the imaged field of view.

The XyCAM RI System consists of following modules:

- The XyCAM RI contains a module to provide illumination to the back of the eye, ● various optical components to manipulate light along the illumination and imaging path, a high-speed camera to capture images, visual targets for the imaged subject to fixate his/her gaze on during imaging, and electronic and mechanical components for control and operation.

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Image /page/4/Picture/0 description: The image shows the logo for Vasoptic Medical Inc. The logo features a stylized letter "W" in blue gradient, with a small gray circle to the right of the "W". Below the "W", the text "VASOPTIC MEDICAL INC." is written in a simple font.

- System PC contains the XyCAM RI Software. The Operator uses the XyCAM RI ● System PC keyboard, mouse, and monitor to interact with the XyCAM RI Software, which controls the XyCAM RI operation including management of user and patient information, control of image acquisition, facilitation of image analysis, and generation of imaging results.
- Accessories include an imager station and an external hard drive.
- A pulse oximeter is included as an optional third-party device.

The XyCAM RI Software outputs Blood Flow Velocity indices (arbitrary units) that can be assessed for spatial and temporal trends in user defined regions.

- V. Intended Use
The XyCAM RI System is intended to capture, store, and display images of dynamic blood flow changes in the human retina, and to provide quantitative outputs of relative blood flow information.

| Feature | XyCAM RI System | RFI 3000<br>(Predicate Device) | LSFG-NAVI<br>(Reference Predicate) |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)<br>Number | K19xxxx | K080180 | K153239 |
| Product Code | HKI (Primary) | HKI (Primary),<br>HLI (Secondary) | HKI (Primary),<br>HLI (Secondary) |
| Classification<br>Name | Ophthalmic Camera<br>Device; AC Powered<br>(21 CFR 886.1120) | Ophthalmic Camera Device; AC Powered (21 CFR 886.1120) Ophthalmoscope (21 CFR 886.1570) | Ophthalmic Camera Device; AC Powered (21 CFR 886.1120) Ophthalmoscope (21 CFR 886.1570) |
| Class | II | II | II |
| Method | Imaging is performed<br>using coherent<br>illumination (laser<br>diode). | Imaging is performed<br>using illumination<br>similar to<br>conventional fundus<br>camera. | Image using Diode<br>Laser.<br>A mydriatic agent is<br>not required in a<br>darkroom (displayed<br>on PC monitor). |
| Feature | XyCAM RI System | RFI 3000<br>(Predicate Device) | LSFG-NAVI<br>(Reference Predicate) |
| | A mydriatic agent is not<br>necessary, but may be<br>used if needed. | A mydriatic agent is<br>required. | |
| Indication for Use | The XyCAM RI system<br>is intended to capture,<br>store and display images<br>of real time dynamic<br>blood flow changes in<br>the human retina, and to<br>provide quantitative<br>outputs of relative blood<br>flow information. | The RFI 3000 is<br>intended to observe,<br>capture, display, and<br>store images of<br>patients' fundus<br>(retina) under<br>mydriatic conditions<br>to aid in diagnosing<br>or monitoring<br>diseases of the eye<br>that may be observed<br>and photographed. | The LSFG-NAVI<br>system is intended to<br>capture and display the<br>blood flow distribution<br>in the human retina in<br>real time, and to<br>monitor the blood flow<br>in retinal vessels for<br>their quantitative<br>evaluation. |
| Observation<br>System | Software live view | Through eyepiece<br>with reticle or<br>through software live<br>view | Software live view |
| Imaging Light<br>Source | Near-Infrared (785 ± 10<br>nm) Laser Diode | Xenon flash lamp<br>420WS (multi-flash) | Laser Diode (830 nm) |
| Flash<br>Exposure | Continuous exposure | Automatic, 1 ms per<br>pulse, train of up to 8<br>pulses, repetition rate<br>17.5ms. | Continuous exposure |
| Focusing<br>Light Source | Focusing illumination is<br>the same as imaging<br>illumination | 12 V Halogen lamp | LED (940 nm) |
| Focusing | On-system gaze fixation<br>targets and manual<br>focusing by the operator | Matching two<br>oscillating points | Matching two laser<br>spots |
| Field Angle | 20 to 25 degrees | 50, 35, 20 degrees | 21 degrees<br>(Horizontal: 21<br>degrees; Vertical: 12<br>degrees) |
| Feature | XyCAM RI System | RFI 3000<br>(Predicate Device) | LSFG-NAVI<br>(Reference Predicate) |
| Working<br>Distance | 21 mm | 40 mm | 44 mm |
| Principle of<br>Blood Flow<br>Measurement | Laser Speckle Contrast<br>Imaging | Frame mapping of<br>xenon flash lamp<br>illumination | Laser Speckle<br>Flowgraphy |
| Measurement<br>Duration | 3 to 6 seconds at 82 Hz | 125 ms for data<br>acquisition | 30 Hz (typically 4 to 6<br>seconds) |
| Measurement<br>Results | Relative value | Given in mm/sec | Relative value |
| Numerical<br>Data | Blood flow velocity<br>index (BFVi) | Velocity flow rate | Blood flow Index |
| Graphical<br>Data | Blood Flow Velocity<br>map of retina<br>Blood Flow Velocity<br>map of select<br>regions/vessels<br>Spatial trend of BFVi<br>Temporal trend of BFVi | Path of flow | Perfusion map of<br>retina<br>Time variation of<br>blood flow index |
| Essential<br>Performance<br>and Electrical<br>Safety<br>Standard | • ANSI/AAMI ES60601-1:<br>2005 (3rd Edition)<br>• IEC 60601-1-2: 2014<br>(4th Edition) | • IEC 60601-1: 1st<br>Edition<br>• IEC 60601-1-2: 1st<br>Edition | • IEC 60601-1:2012<br>• IEC 60601-1-2: 2007 |
| Other<br>Performance<br>Standard | • ANSI Z80.36-2016<br>• IEC 60825-1: 2007<br>• ISO 14971: 2007 | • ISO 15004-2: 2007<br>• ISO 10940: 1998<br>• ANSI RP-27-1-96:<br>1st Edition<br>• ISO 14971: 2000 | • ISO 15004-2:2007<br>• ISO 10940: 1998<br>• ISO 60825-1: 2007<br>• ISO 14971: 2007 |

- VI. Comparison of Technological Characteristics with Predicate Device and Reference Predicate

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Image /page/5/Picture/0 description: The image shows the text "K193319" on the left side of the image. To the right of the text is a blue logo that looks like a stylized letter "W". Below the logo is the text "VASOPTIC MEDICAL INC."

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Image /page/6/Picture/0 description: The image shows the text "K193319" on the left side of the image. To the right of the text is a blue logo that looks like a stylized "W". Below the logo is the text "VASOPTIC MEDICAL INC.". The logo and text are likely associated with the company Vasoptic Medical Inc.

While the underlying technologies of XyCAM RI (assessment of blurring in the speckle pattern) and of the predicate (temporal changes in reflectance photographic frames) are different in some aspects, they are substantially equivalent in their approach, the risk profile, and efficacy of producing blood flow information. The measurement output of

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Image /page/7/Picture/0 description: The image shows the text "K193319" on the left side of the image. To the right of the text is a blue logo that looks like a stylized letter "W". Below the logo is the text "VASOPTIC MEDICAL INC."

the XyCAM RI is a blood flow velocity index (BFVi), a quantitative measure of relative blood flow information, that has been shown to possess repeatability and reproducibility characteristics that are on par or better than the predicate, and conveys substantially equivalent information pertaining to the flow of blood in the human retina. The technological differences do not raise new concerns of safety or effectiveness in the intended use of the XyCAM RI to provide quantitative outputs of relative blood flow information in the human retina. The XyCAM RI has established safety and effectiveness through design verification of the system including software, electromagnetic compatibility, medical product safety, substantial equivalence in output performance, and system validation via clinical testing.

#### VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### Illumination Classification and Safety

The XyCAM RI is classified as a Class 1 Laser Product and Group 1 Ophthalmic Instrument as defined by IEC 60825:2007 and ANSI Z80.36-2016. respectively. Refer to Section 18.1 for a complete illumination classification and safety analysis.

### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the XyCAM RI System. The system complies with the ANSI/AAMI ES60601-1 standard for product safety and the IEC 60601-1-2 standard for EMC.

### Software Verification and Validation Testing

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 to be a "moderate" level of concern, since a failure or latent flaw in the software could directly result in minor injury to the patient or operator. The XyCAM RI System is designed to provide quantitative outputs of relative blood flow velocity information to clinicians and is not intended to provide any diagnostics or clinical decision support. However, the software is considered to possess a moderate level of concern because a failure or latent flaw could indirectly result in minor injury through the action of a care provider.

### Bench Testing

XyCAM RI bench testing involved the use of a calibrated flow pump which provided baseline velocity measurements to analyze against. The results of bench testing demonstrated the XyCAM RI is able to reliably capture retinal blood flow with an intrasession coefficient of variation significantly less than 10%.

Comparative assessment was conducted between the XyCAM RI output of blood flow velocity index (BFVi, in arbitrary units) and RFI 3000 output of blood velocities (in mm/s) when imaging the same tubular blood flow. The results demonstrated substantial

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Image /page/8/Picture/0 description: The image shows the text "K193319" on the left side of the image. To the right of the text is a blue logo that looks like a stylized letter "W". Below the logo is the text "VASOPTIC MEDICAL INC."

equivalence between the two outputs and consistent repeatable measurements of physiologically relevant blood flow velocities obtained using the XyCAM RI.

## Clinical Studies

Clinical testing was conducted to validate that the XyCAM RI is consistently able to generate images of the back of the eye in a diverse range of subjects, and to characterize the repeatability and reproducibility of blood flow measurements when used in the clinic as intended.

Twenty (20) healthy subjects were recruited and imaged, with strict adherence to inclusion and exclusion criteria which were developed to obtain data from a cohort that is representative of the general population. There were 9 male subjects and 11 female subjects imaged, with a combined average age of 46.9 ± 16.6 years. The demographic distribution of subjects is displayed in the table below.

| Number of subjects | Age Range | | | |
|--------------------|-----------|----------|------|-------|
| Race | 21 to 40 | 40 to 60 | > 60 | Total |
| African American | 2 | 4 | 1 | 7 |
| Caucasian | 4 | 0 | 5 | 9 |
| Asian | 2 | 2 | 0 | 4 |
| Total | 8 | 6 | 6 | 20 |

To assess measurement errors across imaging sessions and operators, all subjects were divided into three groups: A1 (n=10), A2 (n=5), and A3 (n=5). All subjects in Group A1 was imaged with the field of view centered on the Optic Nerve Head (ONH) and on the macula by one operator. All subjects in Group A2 and A3 were imaged by three operators with the field of view centered on the ONH in Group A2 and centered on the macula in Group A3. To assess repeatability, multiple imaging sessions were conducted by each operator. For each imaging session, five regions of interest (ROIs) were assessed using the XyCAM RI Software, and analyzed across multiple cardiac cycles within an imaging session for intra-session repeatability and across multiple imaging sessions for intersession repeatability.

Over all regions analyzed, the XyCAM RI's mean intra-session CV was 2.883 ± 1.049% and the mean inter-session CV was 7.069 ± 2.018% in imaging centered around the ONH region and the mean intra-session CV was 2.782 ± 2.044% and the mean inter-session CV was 6.447 ± 3.778% in imaging centered around the macular region.

#### VIII. Conclusion

The XyCAM RI is substantially equivalent to the predicate device's intended use, functionality and performance. The XyCAM RI successfully passed required verification, validation and product safety testing to demonstrate overall device safety and effectiveness.