RTVUE

K062552 · Optovue, Inc. · OBO · Oct 6, 2006 · Ophthalmic

Device Facts

• Record ID: K062552
• Device Name: RTVUE
• Applicant: Optovue, Inc.
• Product Code: OBO · Ophthalmic
• Decision Date: Oct 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for 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.

Device Story

RTVue is a computer-controlled, non-invasive ophthalmic imaging system using Fourier Domain-Optical Coherence Tomography (OCT) technology. It directs a low-coherence light beam (super luminescent diode) into the patient's eye to measure retinal tissue reflectivity. The system captures cross-sectional retinal structures as sequences of A-scans. Operated by clinicians in a clinical setting, the device uses a motorized table, forehead/chin rest, and joystick for alignment. A graphical user interface allows for image acquisition and analysis. Compared to mechanical-scan predecessors, the Fourier Domain approach increases scan speed by approximately 65 times and utilizes a broader spectral bandwidth for higher resolution. Output images allow clinicians to visualize intraretinal morphology, aiding in the diagnosis of conditions like macular edema, epiretinal membranes, and macular holes, and monitoring disease progression or therapeutic efficacy.

Clinical Evidence

No clinical data required. Substantial equivalence supported by non-clinical bench testing, including accuracy tests, optical emission safety analysis, electrical safety, electromagnetic compatibility, and software validation. Clinical performance was supported by literature comparisons demonstrating that higher resolution images provide comparable or superior diagnostic information for retinal pathologies compared to standard-resolution OCT.

Technological Characteristics

Fourier Domain-OCT system; super luminescent diode (SLD) light source with broad spectral bandwidth; non-mechanical depth scanning; motorized patient table with chin/forehead rest; joystick alignment; computer-controlled with GUI; near-infrared radiation emission; complies with ophthalmic instrument exposure limits.

Indications for Use

Indicated for in vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disk to aid in the diagnosis and management of retinal diseases in patients requiring ophthalmic evaluation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Humphrey® OCT3 (K012727)

Submission Summary (Full Text)

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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.<br>41752 Christy Street,<br>Fremont, CA 94538<br>Phone: [phone]<br>Fax: [phone]<br>Registration No.: |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jay Wei<br>CEO/President<br>Optovue, Inc.<br>Phone: [phone] x102<br>e-mail: [e-mail] |
| 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

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].

## 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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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Evenette T. Beus PhD

Image /page/4/Picture/7 description: The image contains a handwritten word, "for", in cursive script. The letter "f" is larger and more elaborate, with a prominent loop extending above the rest of the word. The "o" and "r" are connected and smaller in size, completing the word. The writing appears to be done with a pen or marker, and the overall impression is casual and informal.

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:

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.

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