The RTVue XR 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 with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber laver, and optic disk 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.

Device Description

The RTVue XR is a non-invasive diagnostic device for imaging the cornea, anterior chamber, and retinal tissue structure with micrometer range resolution. The RTVue XR OCT is based on the same Optical Coherence Tomography (OCT) technology used in its predicate device, RTVue with NDB OCT. The RTVue XR 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 Ascans. 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. RTVue XR offers three scan types: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM (Cornea Anterior Module-cleared under K111505). The upgrade of the line scan camera is designed to provide faster image acquisition. The RTVue XR is an updated version of RTVue with NDB that operates at ~70,000 A-lines per second while the RTVue-100 operates at ~27,000 A-lines per second. The RTVue XR machines will be equipped with new line-scan cameras capable of operating at ~70,000 Alines per second while delivering equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second.

AI/ML Overview

The provided 510(k) summary for the Optovue RTVue XR OCT describes a special 510(k) notice for an upgrade to an existing device (RTVue with NDB). The primary change is the inclusion of a new line scan camera for faster image acquisition.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Safety	Meets safety requirements of IEC 60601-1 and IEC-60601-1-2	Elliot lab Certification Testing (ref: R64363 Rev.3 and R63863 Rev. 4)
Stability	Meets stability requirements of IEC 60601-1 and IEC-60601-1-2	Elliot lab Certification Testing (ref: R64363 Rev.3 and R63863 Rev. 4)
Equivalent Imaging Results	Delivers equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second	Bench test performed comparing RTVue XR with predicate device RTVue with NDB.

Study Details:

Sample size used for the test set and the data provenance:
- The document mentions a "Bench test" for comparing the RTVue XR with the predicate device. However, it does not specify the sample size of the test set (e.g., number of images, number of patients) or the data provenance (e.g., country of origin, retrospective/prospective nature of the data) for this bench test. The focus of this submission is on hardware upgrade and the claim of "equivalent imaging results."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The submission focuses on technical equivalence rather than a clinical performance study requiring expert ground truth for interpretation.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. As there's no mention of a human-centric clinical study requiring ground truth establishment, adjudication methods are not discussed.
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:
- No MRMC comparative effectiveness study was done or reported. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation, and the submission's purpose (hardware upgrade) does not necessitate such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or reported. The RTVue XR is an imaging device, not an algorithm, and the submission focuses on its technical performance (image acquisition speed and equivalence).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench test, the ground truth would inherently be instrument specifications and image quality metrics for comparing the new camera's output to the predicate device's output. It is not expert consensus, pathology, or outcomes data.
The sample size for the training set:
- Not applicable/Not mentioned. This submission is for a hardware upgrade of an imaging device, not an AI/algorithm-driven device requiring a training set. The device itself uses a "Normative Database" for comparison, but details about its construction (sample size, ground truth, etc.) are outside the scope of this specific 510(k) for a camera upgrade.
How the ground truth for the training set was established:
- Not applicable/Not mentioned. As a training set for an algorithm is not discussed, the establishment of its ground truth is also not. For the "Normative Database" mentioned in the Intended Use, the document states it's "a database of known normal subjects," implying a classification based on clinical normality, but further details are not provided in this submission.

Summary

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K120238

APR - 3 2012

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510(k) Summary Optovue, Incorporated

This 510(k) summary for the RTVue is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

General Information

Manufacturer:

Optovue, Inc. 45531 Northport Loop West, Fremont, CA 94538 Phone: (510) 623-8868 Fax: (510) 623-8668 Registration No .: 3005950902

Contact Person:

John J. Talarico VP Regulatory/Quality Assurance Optovue, Inc. Phone: (510)623-8868 x209 e-mail: john talarico@optovue.com

Device Information

Classification:

Trade Name:

Class II

RTVue>

Common Name:

RTVue XR Optical Coherence Tomography (OCT) Ophthalmoscope, a-c powered (21 C.F.R.

§ 886.1570)

Predicate Devices

Classification Name:

510(k) K101505 RTVue with NDB Optical Coherence Tomography (OCT)

Purpose of the Special 510(k) notice

The RTVue XR OCT is an upgrade to the current cleared device RTVue with NDB (K101505) with a new line scan camera for faster image acquisition.

Intended Use

45531 Northport Loop W. Fremont, CA 94538 Phone: (866) 344.8948; (510) 623-8868 Fax: (510) 623.8668

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Technological Characteristics

The RTVue XR 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 Ascans. 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.

RTVue XR offers three scan types: Retina, Glaucoma, and Cornea. For the Cornea scan, a lens must be attached to the front of the device for proper scanning. This lens is called the CAM (Cornea Anterior Module-cleared under K111505)

The upgrade of the line scan camera is designed to provide faster image acquisition. The RTVue XR is an updated version of RTVue with NDB that operates at ~70,000 A-lines per second while the RTVue-100 operates at ~27,000 A-lines per second. The RTVue XR machines will be equipped with new line-scan cameras capable of operating at ~70,000 Alines per second while delivering equivalent imaging results as the older generation RTVue line-scan cameras operating at ~27,000 A-lines per second.

Performance Data

Elliot lab Certification Testing and Report (ref: R64363 Rev.3 and R63863 Rev. 4) in accordance to IEC 60601-1 Amendment 1 and 2 and IEC-60601-1-2. In addition a Bench test was also performed, with the results for comparison of the RTVue XR with the predicate device RTVue with NDB. The RTVue XR meets the safety and stability requirements of IEC 60601-1and IEC-60601-1-2 as well as the bench test requirements results.

Substantial Equivalence

The RTVue XR has the same intended use and similar indications, principles of operation, and technological characteristics as the RTVue with NDB OCT. The minor difference in the RTVue XR OCT is a new line scan camera for faster image acquisition and this upgrade does not raise any new questions of safety or effectiveness. Performance data demonstrates that the RTVue XR is as safe and effective as RTVue with NDB OCT. Thus, the RTVue XR is substantially equivalent to its predicate devices.

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

Optovue, Inc c/o Mr. John Talarico VP Regulatory and Clinical Affairs 45531 Northport Loop W. · Fremont, CA 94538

Re: K120238

Trade/Device Name: RTVue XR OCT Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: February 23, 2012 Received: February 27, 2012

APR - 3 2012

Dear Mr. Talarico:

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.

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 (reporting of medical Of Ice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. John Talarico

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

Enclosure

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Indications for Use Statement

K120238 510(k) Number (if known):

Device Name: RTVue XR

Indications for Use:

The RTVue XR with Normative Database is also a quantitative tool for the comparison of retina, retinal nerve fiber layer, and optic disk 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.

Prescription Use (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aem

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120238

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.