The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.

Device Description

RTVue, based on the same Optical Coherence Tomography (OCT) technology that is using in the predicate device Humphrey® OCT3 (K012727), is a non-invasive diagnostic device for withing the ocular tissue structure with micrometer range resolution. A brochure of the OCT3 system is in appendices [1]

The RTVue, like its predicate device Humphrey® OCT3 (K012727), is a computer controlled ophthalmic imaging system. The device scan a beam into patient's eye and use a low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of sequence of A-scans. It has a traditional patient and instrument interface like most ophthalmic devices. The device is mounted on a motorized patient table. The patient will rest their head on the forehead and chin rest. Operator uses joystick to align the device to patient's eye. The computer has a graphic user interface for acquire and analysis image.

The RTVue has improvements in image acquisition speed and image resolution over its predecessor. RTVue uses non-mechanic moving part in the depth scan, a branch of OCT technology called Fourier Domain-OCT, so the scan speed improves about 65 times faster than the mechanical limited scan speed in previous devices. A detail description of the technology improvement from predicate device is published in Optics Express, May 2004 by Leitgeb et. al. Appendices [2, a].

The RTVue also uses the same light source SLD (super luminescent diode) as in its predicate device but with broader spectral bandwidth. The broad spectral bandwidth provides higher image resolution than a narrow one based on the Optical Coherence Tomography principle. A paper desertes the technology improvement from predicate device is published in Optics Express, May 2004 by Ko et. al. Appendices [2,6] and in American Journal of Ophthalmology, September 2004 by Wojtkowski et. al. Appendices [2. c]. Ocular pathologies imaged with the Fourier domain OCT and ultrahigh resolution light source also has been published in Investigative Ophthalmolgy & Visual Science , Spierban 2005 by Schmidt-Erfurtb et. al. Appendices [2,d] and in American Academy of Ophthy Implomy. October 2005 by Wojtkowski, et. al Appendices [2,e].

AI/ML Overview

This document is a 510(k) Premarket Notification for the Optovue RTVue, an Optical Coherence Tomography (OCT) system. It focuses on demonstrating substantial equivalence to a predicate device, the Humphrey® OCT3.

NOTE: This 510(k) summary does not contain detailed acceptance criteria and a study proving the device meets specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence and improvements over a predicate device by referencing published scientific papers and general safety assessments. The FDA's decision letter indicates clearance of the device based on this submission.

Here's a breakdown of the requested information based on the provided text:

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

Since this is a substantial equivalence submission, specific numerical acceptance criteria (e.g., target specificity, sensitivity, accuracy) for disease diagnosis are not explicitly defined in the document. The performance claims hinge on the RTVue's technological improvements over the predicate device and the general clinical effectiveness of OCT technology.

Acceptance Criteria (Implied from Device Description & Predicate Equivalence)	Reported Device Performance
Safety: Device operates within applicable exposure limits for optical radiation.	"The Optovue Retinal OCT system emits near-infrared radiation from an SLD that is below all of the applicable exposure limits—including the guidelines for ophthalmic instrument exposure." (Safety analysis by Dr. Dave Sliney)
Effectiveness (Imaging & Measurement Capability): Capable of in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk as an aid in diagnosis and management of retinal diseases, comparable to or better than the predicate device.	- "RTVue has improvements in image acquisition speed and image resolution over its predecessor." (65 times faster scan speed due to Fourier Domain-OCT; higher image resolution due to broader spectral bandwidth).- "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers, such as the retina nerve fiber, inner and outer plexiform, and inner and outer nuclear." (Ko et al., 2005, Journal of Ophthalmology).
Basic Device Functionality: Accuracy tests, optical emission safety, electrical safety, electromagnetic compatibility, and software validation.	"The RTVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests." (No specific results provided, but stated as completed).

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

Test Set Sample Size: Not provided. The submission states "Clinic tests: Not Required" for the RTVue itself, as it relies on the predicate device's established clinical history and published studies using similar technology.
Data Provenance: The document references several published scientific papers (e.g., in Optics Express, American Journal of Ophthalmology, Investigative Ophthalmology & Visual Science, SPIE Proceeding) that investigated Fourier Domain-OCT and ultrahigh-resolution OCT in general, as well as comparative studies between high-resolution and standard-resolution OCT. The provenance of the data in these external studies (e.g., country of origin, retrospective/prospective) is not detailed in this 510(k) summary.

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

Number of Experts: Not applicable/Not specified. For the RTVue itself, no specific clinical "test set" with ground truth established by experts is described in this submission. The effectiveness claim is based on the general understanding of OCT technology and comparisons to published literature.
Qualifications of Experts: Not specified for a dedicated test set for the RTVue. However, the safety analysis was completed by "an international recognized expert in the fild of optical radiation hazards and safety Dr. Dave Sliney." The scientific papers referenced would have involved clinical experts in ophthalmology.

4. Adjudication method for the test set:

Not applicable/Not specified. As no specific clinical test set for the RTVue is detailed, no adjudication method is mentioned.

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:

No. This submission is for an imaging device (OCT) and its improvements in image acquisition and resolution, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study related to "human readers improve with AI vs without AI assistance" is not relevant or described.

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

No. This is not an algorithm submission; it's for an imaging device. The device provides images and measurements that clinicians (human-in-the-loop) use for diagnosis and management.

7. The type of ground truth used:

Not explicitly defined as a dedicated "ground truth" for the RTVue's specific clinical validation within this document. The effectiveness claims are based on:
- The established clinical utility of the predicate device (Humphrey® OCT3).
- The inherent ability of OCT technology (especially high-resolution versions) to visualize ocular tissue structures, as demonstrated in numerous published clinical papers.
- The conclusion from a comparative paper that "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers," implying that the improved resolution does not degrade essential diagnostic information and may enhance it.

8. The sample size for the training set:

Not applicable/Not provided. This is an imaging device, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The device's design and performance are based on optical physics and engineering, not pattern recognition trained on a dataset.

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

Not applicable/Not provided. (See point 8).

Summary

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Optovue RTVue 510(K) Premarket Notification

510(k) Summary

OCT - 6 2006

K062552

Optovue, Incorporated RTVue

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.41752 Christy Street,Fremont, CA 94538Phone: (510) 623-8868Fax: (510) 623-8668Registration No.:
Contact Person:	Jay WeiCEO/PresidentOptovue, Inc.Phone: (510)623-8868 x102e-mail: jay_wei@optovue.com
Device Information
Classification:	Class II
Trade Name:	RTVue
Common Name:	Optical Coherence Tomography (OCT)
Classification Name:	Ophthalmoscope, a-c powered (21 CFR§ 886.1570

Predicate Device

Humphrey® OCT3 (K012727)

Intended Use

. The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retinal nerve fiber layer, and optic disk as an aid in the diagnosis and management of retinal diseases.

Optovue, Inc.

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Device Description

Safety

The power of the scan beam enter into patient's pupil is at same level as predicate device. The detail safety analysis Appendices [3] is completed by an international recognized expert in the fild of optical radiation hazards and safety Dr. Dave Sliney. The conclusion of the analysis is "The Optovue Retinal OCT system emits near-infrared radiation from an SLD that is below all of the applicable exposure limits-including the guidelines for ophthalmic instrument exposure"

Effectiveness

The predicate device has been routinely used in clinic. Numerous clinic paper and data has been published over last 10 years. The comparison between high resolution and regular readlution OCCT image produced by predicate device shows same and in some cases better clinic diagnonistan Oe produced by the higher resolution device. A clinic evaluation of high resolution OCT image in diagnosis retinal diseases has been published in SPIE Proceeding vol. 4956, 2003 by Ko et. al. Appendices [2,f]. The summary of the paper is "Intraretinal architectural morphology associated with macular diseases such as macular edema, epiretinal membranes, and macular holes can be isualized

Optovue, Inc.

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with unprecedented resolution. Ultrahigh resolution ophthalmic OCT promises to improve the early diagnosis of retinal diseases as well as enable monitoring of disease progression and the efficacy of therapeutic intervention.".

Substantial Equivalence

The RTVue is substantially equivalent to the predicate device identified previously. The RTVue is substantially equivalent to the predicate device with regard to intended use, operating principle, function, material, and energy source. The only difference from the predicate device is that the RTVue has an increased scan rate and high image resolution. A comparison of ultrahigh resolution and Standard-resolution OCT (the predicate device) paper publish by Tony Ko et., appendices [2, al in Journal of Ophthalmology 2005 , concludes that "Ultrahigh-resolution OCT and standard resolution OCT exhibited comparable performance in differentiating thicker retinal layers, such as the retina nerve fiber, inner and outer plexiform, and inner and outer nuclear."

Performance Data

(a) Non-clinic tests:

The RTVue has had accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility test, and software validation tests.

(b)Clinic tests:

Not Required

Conclusion

As described in this 510(k) Summary, all testing and analysis were conducted on the RTVue to ensure that the device is safe and effective for its intended use when used in accordance with its instructions for use.

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JUN 1 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Optovue, Inc. c/o Mr. Tamas Borsai TUV Rheinland of North America 12 Commerce Road Newton, CT 06470

Re: K062552

Trade/Device Name: RTVue Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: II Product Code: OBO Dated: September 19, 2006 Received: September 21, 2006

Dear Mr. Borsai:

This letter updates our substantially equivalent letter of January 26, 2007.

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 (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.

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

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Page 2 - Mr. Tamas Borsai

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

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Evenette T. Beus PhD

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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

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Indications for Use

510(k) Number (if known): K062552

Device Name:_RTVue

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clay R. Buttner

510(k) Number K062552

Rev 09/15/06

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.