(182 days)
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.
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.
- 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.
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.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
While explicit acceptance criteria (e.g., "CV must be less than X%") are not directly stated in the provided text as numerical targets prior to the results, the study design implicitly aims to demonstrate good repeatability and reproducibility. Therefore, the reported performance metrics serve as the de facto "met" acceptance criteria.
| Metric (Implicit Acceptance Criteria) | Reported Device Performance (XyCAM RI) |
|---|---|
| Intra-session Repeatability (ONH region) | Mean intra-session CV: 2.883 ± 1.049% |
| Inter-session Reproducibility (ONH region) | Mean inter-session CV: 7.069 ± 2.018% |
| Intra-session Repeatability (Macular region) | Mean intra-session CV: 2.782 ± 2.044% |
| Inter-session Reproducibility (Macular region) | Mean inter-session CV: 6.447 ± 3.778% |
| Bench Testing - Intrasession CV vs. Calibrated Flow Pump | "Intrasession coefficient of variation significantly less than 10%" |
| Bench Testing - Comparative assessment with RFI 3000 | "Demonstrated substantial equivalence between the two outputs and consistent repeatable measurements of physiologically relevant blood flow velocities" |
| Software Level of Concern | Moderate (addressed by verification and validation testing) |
| Electrical Safety and EMC Compliance | Complies with ANSI/AAMI ES60601-1 and IEC 60601-1-2 |
| Illumination Classification and Safety | Class 1 Laser Product (IEC 60825:2007) and Group 1 Ophthalmic Instrument (ANSI Z80.36-2016) |
2. Sample size used for the test set and the data provenance
- Sample Size for Clinical Test Set: 20 healthy subjects.
- Data Provenance: The text does not explicitly state the country of origin of the data. It is implied to be prospective since it describes "subjects were recruited and imaged" as part of the clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text does not mention the use of experts to establish a "ground truth" for the blood flow measurements in the clinical study. The study focuses on the device's own measurement repeatability and reproducibility, and its ability to generate images, rather than comparing its diagnostic output to an expert-validated diagnosis.
- Number of Experts: Not applicable/not mentioned for clinical ground truth.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication method for the test set
The text describes an assessment of measurement errors across imaging sessions and operators in the clinical study but does not detail an adjudication method for discrete classifications or diagnoses. The analysis involved calculating coefficients of variation (CV) for regions of interest (ROIs) across multiple cardiac cycles and imaging sessions.
- Adjudication Method: Not applicable/not mentioned for adjudicating a diagnosis or classification. The study focused on quantitative measurement variability. For the clinical performance, imaging sessions were conducted by one operator for Group A1 and by three operators for Groups A2 and A3 to assess operator variability.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study with human readers assessing improvement with AI assistance was not mentioned. The device, XyCAM RI, provides quantitative outputs of relative blood flow information and is not described as an AI-assisted diagnostic tool for human readers in the way a typical MRMC study would evaluate.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation described for the XyCAM RI System is a standalone performance assessment. The device itself (algorithm only, as it processes captured images) generates quantitative outputs (Blood Flow Velocity indices or BFVi). The clinical study evaluated the repeatability and reproducibility of these outputs when the device was used in a clinical setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The clinical study did not use an external "ground truth" such as pathology or expert consensus for the retinal blood flow measurements. Instead, the study's goal was to demonstrate the device's intrinsic reliability through repeatability and reproducibility of its own measurements in healthy subjects.
- For bench testing, a calibrated flow pump was used as a reference to analyze the device's ability to reliably capture retinal blood flow.
8. The sample size for the training set
The document does not explicitly state a training set size. The XyCAM RI System utilizes Laser Speckle Contrast Imaging (LSCI) for blood flow measurement, which is a physics-based imaging technique. While such systems might involve some internal calibration or model parameters, the document does not suggest a deep learning or machine learning model that would typically have a distinct "training set" in the context of diagnostic AI. The term "training set" is generally used for machine learning models, which is not clearly indicated as the core technology for the XyCAM RI.
9. How the ground truth for the training set was established
Since a "training set" in the context of machine learning is not explicitly mentioned or implied as part of the core technology described, the method for establishing its ground truth is also not provided. The system's operation is based on the physical principles of Laser Speckle Contrast Imaging.
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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 (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
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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 | Abhishek.Rege@vasoptic.com |
| 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(Predicate Device) | LSFG-NAVI(Reference Predicate) |
|---|---|---|---|
| 510(K)Number | K19xxxx | K080180 | K153239 |
| Product Code | HKI (Primary) | HKI (Primary),HLI (Secondary) | HKI (Primary),HLI (Secondary) |
| ClassificationName | Ophthalmic CameraDevice; AC Powered(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 performedusing coherentillumination (laserdiode). | Imaging is performedusing illuminationsimilar toconventional funduscamera. | Image using DiodeLaser.A mydriatic agent isnot required in adarkroom (displayedon PC monitor). |
| Feature | XyCAM RI System | RFI 3000(Predicate Device) | LSFG-NAVI(Reference Predicate) |
| A mydriatic agent is notnecessary, but may beused if needed. | A mydriatic agent isrequired. | ||
| Indication for Use | The XyCAM RI systemis intended to capture,store and display imagesof real time dynamicblood flow changes inthe human retina, and toprovide quantitativeoutputs of relative bloodflow information. | The RFI 3000 isintended to observe,capture, display, andstore images ofpatients' fundus(retina) undermydriatic conditionsto aid in diagnosingor monitoringdiseases of the eyethat may be observedand photographed. | The LSFG-NAVIsystem is intended tocapture and display theblood flow distributionin the human retina inreal time, and tomonitor the blood flowin retinal vessels fortheir quantitativeevaluation. |
| ObservationSystem | Software live view | Through eyepiecewith reticle orthrough software liveview | Software live view |
| Imaging LightSource | Near-Infrared (785 ± 10nm) Laser Diode | Xenon flash lamp420WS (multi-flash) | Laser Diode (830 nm) |
| FlashExposure | Continuous exposure | Automatic, 1 ms perpulse, train of up to 8pulses, repetition rate17.5ms. | Continuous exposure |
| FocusingLight Source | Focusing illumination isthe same as imagingillumination | 12 V Halogen lamp | LED (940 nm) |
| Focusing | On-system gaze fixationtargets and manualfocusing by the operator | Matching twooscillating points | Matching two laserspots |
| Field Angle | 20 to 25 degrees | 50, 35, 20 degrees | 21 degrees(Horizontal: 21degrees; Vertical: 12degrees) |
| Feature | XyCAM RI System | RFI 3000(Predicate Device) | LSFG-NAVI(Reference Predicate) |
| WorkingDistance | 21 mm | 40 mm | 44 mm |
| Principle ofBlood FlowMeasurement | Laser Speckle ContrastImaging | Frame mapping ofxenon flash lampillumination | Laser SpeckleFlowgraphy |
| MeasurementDuration | 3 to 6 seconds at 82 Hz | 125 ms for dataacquisition | 30 Hz (typically 4 to 6seconds) |
| MeasurementResults | Relative value | Given in mm/sec | Relative value |
| NumericalData | Blood flow velocityindex (BFVi) | Velocity flow rate | Blood flow Index |
| GraphicalData | Blood Flow Velocitymap of retinaBlood Flow Velocitymap of selectregions/vesselsSpatial trend of BFViTemporal trend of BFVi | Path of flow | Perfusion map ofretinaTime variation ofblood flow index |
| EssentialPerformanceand ElectricalSafetyStandard | • ANSI/AAMI ES60601-1:2005 (3rd Edition)• IEC 60601-1-2: 2014(4th Edition) | • IEC 60601-1: 1stEdition• IEC 60601-1-2: 1stEdition | • IEC 60601-1:2012• IEC 60601-1-2: 2007 |
| OtherPerformanceStandard | • ANSI Z80.36-2016• IEC 60825-1: 2007• ISO 14971: 2007 | • ISO 15004-2: 2007• ISO 10940: 1998• ANSI RP-27-1-96:1st Edition• ISO 14971: 2000 | • ISO 15004-2:2007• ISO 10940: 1998• ISO 60825-1: 2007• 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.
§ 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.