The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retinal nerve fiber layer, and optic disk measurements in the human eve to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

Device Description

The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE.

The RTVue XR OCT Avanti is a computer controlled ophthalmic imaging system. The device scans the patient's eye using a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The computer has a graphic user interface for acquiring and analyzing the image. The line-scan camera operates at approximately 70,000 A-lines per second.

The RTVue XR OCT Avanti offers three scan types: Retina, Glaucoma, and Cornea. For the cornea and anterior eye scans, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM auxiliary attachment (Cornea Anterior Module). The CAM software module provides for menu selections in the graphical user interface, which are selected by the operator to label corresponding corneal landmarks instead of those of the retina.

With the normative database (NDB), the RTVue XR OCT Avanti can compare the measured data from the GCC, the RNFL, the full retinal thickness, optic disc cup and optic disc rim measurements to the normative database. The device will provide the analysis information to he used as a clinical reference to aid in the diagnosis and management of ocular diseases.

The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

AI/ML Overview

This document does not contain the detailed acceptance criteria or a study proving the device meets specific performance criteria in a quantitative manner as typically presented for AI/ML device submissions. This is a 510(k) summary for a medical device (RTVue XR OCT Avanti with AngioVue Software) filed in 2016, which predates the FDA's specific guidance for AI/ML medical devices.

The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Optovue, Inc. RTVue XR OCT, K120238) rather than presenting a performance study with detailed acceptance criteria and corresponding results for the AngioVue software module.

However, based on the provided text, here's an attempt to answer your questions, highlighting the limitations of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) for the AngioVue software's performance in visualizing vascular structures. Instead, the performance is described qualitatively by comparing AngioVue scans with fluorescein angiography images.

Feature/Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Visualization of vascular structures	Aid in visualization of vascular structures of the retina and choroid.	"The images demonstrate that the RTVue XR OCT Avanti angiography in combination with OCT intensity-based information can give non-invasive three-dimensional information regarding retinal microvasculature in the retina and choroid." (Qualitative claim, no specific metrics provided).
Artifact reduction (Motion Correction)	Minimize potential artifacts caused by blinks and eye motion.	"AngioVue image processing can employ a proprietary motion correction technology (MCT) to reduce potential artifacts caused by blinks and eye motion during scan acquisition." "The MCT performs motion correction based on minimization of the overall difference between the two scan volumes acquired during OCT angiography image capture." (Qualitative claim, no specific metrics provided for reduction percentage).
Safety and Effectiveness	As safe and effective as the predicate device (RTVue XR OCT).	"All testing deemed necessary was conducted and the results demonstrated that the RTVue XR OCT Avanti with AngioVue Software is as safe and as effective as the predicate device for the intended use." "Testing, risk analysis and image comparison to fluorescein angiography also confirmed that no new questions of safety or effectiveness were identified."
Equivalence to Predicate	Substantially equivalent in design, features, performance, etc.	"Based upon no significant differences between the proposed device and the predicate device, the RTVue XR OCT Avanti with AngioVue Software is substantially equivalent in design, features, performance, fundamental scientific technology, and is appropriate for the proposed indications for use."

2. Sample size used for the test set and the data provenance

The document states: "In case examples of a variety of retinal diseases, RTVue XR OCT Avanti with AngioVue Software cube scans were compared with fluorescein angiography images." This implies a qualitative comparison using a case series, rather than a formal, statistically powered test set with a specified sample size.

Sample size: Not specified. The phrase "case examples" suggests a small, illustrative set of cases, not a statistically robust sample.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the document. The ground truth appears to be implicitly established by "fluorescein angiography images," which are a recognized clinical standard for vascular visualization. It's not stated whether these images were reviewed by experts for an adjudicated ground truth for the purpose of this submission.

4. Adjudication method for the test set

Not explicitly stated. The comparison was made against "fluorescein angiography images," which serve as a reference. There is no mention of a formal expert adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study is not mentioned in this document. The focus is on the device's capability to visualize structures, not on how its assistance improves human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The "AngioVue software module" is described as providing "visualization of vascular structures." The performance discussed ("can give non-invasive three-dimensional information") refers to the output of the algorithm. Therefore, the visualization capability of the algorithm itself was assessed, but not against quantitative standalone performance metrics like sensitivity/specificity for detecting specific pathologies. The comparison to fluorescein angiography implies a standalone assessment of the image output.

7. The type of ground truth used

The ground truth used for comparison with the AngioVue images was fluorescein angiography images. This is an established clinical imaging modality for visualizing retinal and choroidal vasculature.

8. The sample size for the training set

The document does not provide any information about a training set or its sample size. This is typical for submissions of this era and type, where the software functionality is described as a "visualization aid" rather than a classification or diagnostic algorithm requiring extensive training data disclosures. The motion correction technology (MCT) is proprietary, and its development (which would involve data for "training" or optimization) is not detailed.

9. How the ground truth for the training set was established

Since there is no mention of a training set, the method for establishing its ground truth is also not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, possibly black or dark blue. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 11, 2016

Optovue, Inc. Mr. Edward J. Sinclair VP, Regulatory and Quality Affairs 2800 Bavview Drive Fremont, CA 94538

Re: K153080

Trade/Device Name: RTVue XR OCT with Avanti with AngioVue Software Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI, OBO Dated: January 13, 2016 Received: January 14, 2016

Dear Mr. Sinclair:

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. 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.

{1}------------------------------------------------

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K153080

Device Name

RTVue XR OCT Avanti with AngioVue Software

Indications for Use (Describe)

The RTVue XR OCT Avanti with AngioVue Software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary (K153080)

Submitter Information

Company:	Optovue, Inc.2800 Bayview DriveFremont, CA 94538(510) 897-1575Edward J. SinclairVice President, Regulatory and Quality Affairs
Date Prepared:	January 12, 2016

Device Name and Classification

Common Name:	Optical Coherence Tomography
Proprietary Name:	RTVue XR OCT Avanti with AngioVue™ Software
Classification Name:	Tomography, Optical Coherence
Product Code:	OBO, HLI
Regulation Number:	886.1570
Class:	II

Predicate Device

Optovue, Inc. RTVue XR OCT (K120238)

Reference Device

Carl Zeiss Meditec, Inc. CIRRUS HD-OCT with Software Version 8 (K150977)

Intended Use

The RTVue XR OCT Avanti with Normative Database is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disc as a tool and aid in the diagnosis and management of retinal diseases by a clinician. The RTVue XR OCT Avanti with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disc measurements in the human eye to a database of known normal subjects. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases.

The RTVue XR OCT Avanti with AngioVue™ software is indicated as an aid in the visualization of vascular structures of the retina and choroid.

{4}------------------------------------------------

Device Description

1. RTVue XR OCT Avanti (without AngioVue™ software module)
  The RTVue XR OCT Avanti is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and measurement of the retinal nerve fiber layer and optic disc with micrometer range resolution as a tool and aid in the diagnosis and management of retinal disease. Imaging and measurements include but are not limited to the internal limiting membrane (ILM), the retinal nerve fiber layer (RNFL), the ganglion cell complex (GCC), the retinal pigment epithelium (RPE), the outer retinal thickness, the total retinal thickness and optic disc structures including the cup and neuroretinal rim as an aid in the diagnosis and management of retinal disease. The measurements for the ILM and RPE are height measurements relative to the RPE reference plane. The RNFL, GCC and outer retinal thickness and total retinal thickness are thickness measurements where RNFL is the thickness of the RNFL layer, the GCC is the thickness from the ILM to the inner plexiform layer (IPL), the outer retinal thickness is the thickness from the IPL to the RPE, and total retinal thickness is the thickness from the ILM to the RPE.

There are two device configurations available, depending on the input voltage requirements at the facility intended for installation of the device:

Model Number	Power Requirements
	Voltage	Frequency	Current
RTVue XR 100-1	100-120 VAC	50/60 Hz	8.33 A
RTVue XR 100-2	200-240 VAC	50/60 Hz	4.38 A

{5}------------------------------------------------

1. RTVue XR OCT Avanti with AngioVue™ angiography software module
  The RTVue XR OCT with AngioVue™ has an additional software module to aid in the visualization of vascular structures of the retina and choroid using a motion-contrast techniques without the need for intravenous dyes.

Summary of Technological Characteristics

The RTVue XR OCT Avanti with AngioVue Software uses the same hardware as the previously cleared RTVue XR OCT. The RTVue XR OCT Avanti with AngioVue Software uses the previously cleared RTVue XR software with the addition of the AngioVue software module for OCT angiography scans. The AngioVue software uses motion contrast techniques to aid in the visualization of vascular structures of the retina and choroid.

The AngioVue scan performs sequential OCT cross-sectional scans to detect the motion of scattering particles such as red blood cells within the eye's vasculature. The software module also provides the ability to visualize the three-dimensional microvasculature of the retina and choroid. AngioVue image processing can employ a proprietary motion correction technology (MCT) to reduce potential artifacts caused by blinks and eye motion during scan acquisition.

Performance Testing

The RTVue XR OCT device with normative database was previously verified for performance and functionality to assure conformance to the requirements for its basic intended use. Biocompatibility, electromagnetic compatibility, and electrical safety testing was conducted on the previously cleared RTVue XR OCT device. Since there were no hardware changes, these performance and safety tests were not required to be repeated.

The RTVue XR OCT Avanti with AngioVue Software has the additional OCT angiography software module. Software documentation was prepared and submitted for a "moderate" Level of Concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Device software was verified and validated to support the proposed indications for use according to IEC 62304:2006 Medical device software - Software life cycle processes and FDA's General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

Risk Analysis

The new software module was assessed to make sure all the risks were sufficiently mitigated and that no new hazards were introduced as a result of the new software features according to the intended use. Identification of the associated hazards has been performed in order to evaluate, estimate and control the associated risks in accordance with EN ISO 14971 Application of risk analysis to medical devices.

Summary of Changes

{6}------------------------------------------------

The new AngioVue™ OCT angiography software module can be installed on the previously cleared RTVue XR OCT device to provide a three-dimensional image of the microvasculature of the retina and choroid. The AngioVue software features include data acquisition options as well as data review reports.

Additionally, a proprietary motion correction technology (MCT) will be used in conjunction with AngioVue OCT angiography images to minimize potential artifacts caused by blinks and eye motion during scan acquisition. The MCT performs motion correction based on minimization of the overall difference between the two scan volumes acquired during OCT angiography image capture.

Conclusions From Data

All testing deemed necessary was conducted and the results demonstrated that the RTVue XR OCT Avanti with AngioVue Software is as safe and as effective as the predicate device for the intended use. Testing, risk analysis and image comparison to fluorescein angiography also confirmed that no new questions of safety or effectiveness were identified. Previously submitted testing that originally supported use of the RTVue XR OCT remains sufficient and unchanged in the modified device software.

Based upon no significant differences between the proposed device and the predicate device, the RTVue XR OCT Avanti with AngioVue Software is substantially equivalent in design, features, performance, fundamental scientific technology, and is appropriate for the proposed indications for use.

In case examples of a variety of retinal diseases, RTVue XR OCT Avanti with AngioVue Software cube scans were compared with fluorescein angiography images. The images demonstrate that the RTVue XR OCT Avanti angiography in combination with OCT intensitybased information can give non-invasive three-dimensional information regarding retinal microvasculature in the retina and choroid. RTVue XR OCT Avanti angiography is not intended as a substitute for fluorescein angiography. Vascular findings on fluorescein angiography may be absent, poorly defined, or variably defined on RTVue XR OCT Avanti with AngioVue Software angiography scans. Additionally, dye leakage, staining, and pooling are not features of OCT angiography.

Regulation Number and Section

§ 886.1570 Ophthalmoscope.

(a)
Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.(b)
Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.