BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM

K063343 · Bioptigen, Inc. · HLI · Dec 13, 2006 · Ophthalmic

Device Facts

• Record ID: K063343
• Device Name: BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
• Applicant: Bioptigen, Inc.
• Product Code: HLI · Ophthalmic
• Decision Date: Dec 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1570
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Device Story

Noninvasive ophthalmic imaging device; utilizes Spectral Domain Optical Coherence Tomography (SD-OCT) to acquire depth-resolved images of ocular tissue microstructure. System components include host computer, OCT engine, and probe. Input: optical signals from ocular tissue; processed via computer-driven engine; output: tomographic images displayed and saved by user. Used in clinical settings; operated by eye care professionals. High-speed acquisition (20,000 A-scans/second) provides microscopic tomographic sectioning of retina (≤ 6 microns axial resolution). Healthcare providers use images to evaluate ocular tissue and aid in diagnosis of conditions affecting optical scattering properties. Benefits include high-resolution visualization of retinal, corneal, scleral, and conjunctival structures.

Clinical Evidence

No clinical data. Bench testing only. Conformance to ISO 10942, ISO 15004-1, and ISO 15005-2.2 standards confirmed safety and performance. Safety analysis verified energy exposure limits for human ocular tissue.

Technological Characteristics

Spectral Domain Optical Coherence Tomography (SD-OCT) system. Axial resolution ≤ 6 microns; scan rate 20,000 A-scans/second. Galvanometric mirror pair scanner. Optical power ≤ 750 microwatts at cornea. Dual 3.4 GHz Xeon processors; 2 GHz memory. Internal fixation via 220 x 200 color LCD. Standards: ISO 10942, ISO 15004-1, ISO 15005-2.2.

Indications for Use

Indicated for patients requiring evaluation of ocular tissue microstructure, including retina, cornea, sclera, and conjunctiva, during routine clinical examinations or as an aid in diagnosing conditions affecting optical scattering properties of ocular tissue.

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

• Carl Zeiss Meditec Stratus OCT (K033123)
• Carl Zeiss Humphrey OCT 3 (K012727)

Submission Summary (Full Text)

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K063343

# Section 5: 510(k) Summary

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

| Sponsor/<br>Manufacturer: | Bioptigen, Inc.<br>104 T.W. Alexander Drive<br>Park Research Center, Building 2<br>Research Triangle Park, NC 27709<br>Ph: 919-314-5504 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
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Russ Pagano Contact: M Squared Associates, Inc. 719 A Street, NE Washington, DC 20002 Ph: 202-546-1262 Ext. 259 Fax: [phone] E-mail: [e-mail]

Date Prepared: October 4, 2006

Proposed Class: =

Bioptigen Spectral Domain Ophthalmic Imaging System Proprietary Name:

Common Name: Ophthalmic Imaging Device

Classification Name: Ophthalmoscope, A-C powered

Regulation Number: 21 CFR 886.1570

Product Code: HFI

Predicate Device: Carl Zeiss Meditec Stratus OCT (K033123), Carl Zeiss Humphrey OCT 3 (K012727)

Intended Use: The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Device Description: The Bioptigen Spectral Domain Ophthalmic Imaging System is a noninvasive imaging device which provides microscopic tomographic sectioning of the retina with ≤ 6 microns axial resolution. The Bioptigen System is capable of 20,000 A-Scans/second due to the nature of spectral domain optical coherence tomography.

## DEC 1 3 2006

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The Bioptigen Spectral Domain Ophthalmic system is composed of a host computer, engine, and probe. The OCT engine is driven by instrument cards in the computer. The device software will allow a user to create, display, load, and save image files (OCT files).

Summary of non-clinical tests: Conformance to standards including ISO 10942, ISO 15004-1, and ISO 15005-2.2 confirms the safety and performance of the proposed device. Safety analysis concludes that under normal operating conditions the energy exposure to the eye does not exceed the limits for human ocular exposure.

| | Zeiss OCT 3 | Zeiss StratusOCT | Bioptigen SDOCT Retinal<br>Imaging System |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K012727 | K033123 | Not assigned |
| Indication for Use | Viewing and axial cross<br>sectional imaging of<br>posterior ocular structures. It<br>is used for in vivo imaging<br>and measurement of the<br>retina, retinal nerve fiber<br>layer and optic disk. | Same- includes RNFL and<br>Macula Normative Database | The Bioptigen Spectral<br>Domain Ophthalmic<br>Imaging System is intended<br>to acquire, process, display,<br>and save depth-resolved<br>images of ocular tissue<br>microstructure using Spectra<br>Domain Optical Coherence<br>Tomography. |
| Category | Specification | Specification | Specification |
| Optical power | <= 750 microwatts at cornea | <= 750 microwatts at cornea | <= 750 microwatts at cornea |
| Longitudinal<br>resolution | 20 um in tissue | 20 um in tissue | 20 um in tissue |
| Axial resolution | <= 10 um in tissue | <= 10 um in tissue | <= 6 um in tissue1 |
| Scanner type | Galvanometric mirror | Galvanometric mirror | Galvonometric mirror pair |
| Scan patterns<br>available | Line, circle, concentric rings,<br>radial lines | Line, circle, concentric rings,<br>radial lines | Line, circle, concentric rings,<br>radial lines |
| Scan pixels | Adjustable from 1,024 (axial)<br>x 128 (transverse) to 1,024<br>(axial) x 768 (transverse) | Adjustable from 1,024 (axial)<br>x 128 (transverse) to 1,024<br>(axial) x 768 (transverse) | Adjustable from 512 (axial) x<br>10 (transverse) to 2,048<br>(axial) x 10,000 (transverse)ii |
| Depth range | 2 mm in tissue | 2 mm in tissue | 2.2 mm in tissue |
| Scan rate | 400 A scans/s | 400 A scans/s | 20,000 A-scans/siii |
| Internal fixation<br>External fixation | 32 x 16 LED dot matrix<br>Slit lamp type adjustable<br>blinking LED | 32 x 16 LED dot matrix<br>Slit lamp type adjustable<br>blinking LED | 220 x 200 Color LCDv<br>Slit lamp type adjustable<br>LED |
| Minimum pupil<br>diameter | 3.2 mm | 3.2 mm | 3 mm |
| User Features | | | |
| Processor | 2.4 GHz Pentium IV | 2.4 GHz Pentium IV | Dual 3.4 GHz Xeon<br>Processors |
| Operating system | Windows 2000 | Windows 2000 | Windows XP |
| Memory | 512 Mb | 512 Mb | 2 GHz |

### Technological Comparison:

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### Summary of clinical tests: Not required

Conclusions from non-clinical tests: Conformance to standards including ISO 10942, ISO 15004-1, and ISO 15005-2.2 confirms the safety and performance of the proposed device for intended use. While there are technological differences in the resolution capabilities, acquisition rate, and internal fixation of the Bioptigen Spectral Domain Ophthalmic Imaging System and the predicate devices, these differences do not present new questions of safety and effectiveness; thus, the devices are considered to be substantially equivalent.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem that resembles an eagle or a stylized human figure. The emblem is composed of several curved lines and shapes, creating a sense of movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 3 2006

Bioptigen, Inc. c/o Jeffrey D. Rongero Underwriters Laboratories, Inc. 12 Laboratory Dr. Research Triangle, NC 27709

Re: K063343

Trade/Device Name: Bioptigen Spectral Domain Ophthalmic Imaging System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: HLI Dated: November 27, 2006 Received: November 28, 2006

Dear Mr. Rongero:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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### Page 2 - Jeffrey D. Rongero

This letter will allow you to begin 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/industry/support/index.html.

Sincerely yours.

M.B. Eycholmi S.M.D

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): K063343

Device Name: Bioptigen Spectral Domain Ophthalmic Imaging System

Indications For Use: The Bioptigen Spectral Domain Ophthalmic Imaging System is intended to acquire, process, display, and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography. It is primarily intended for the imaging of retinal tissue, but the cornea, sclera, and conjunctiva can also be imaged by changing the focal position. Indications for use include the evaluation of ophthalmic tissue in routine clinical examinations and as an aid in the diagnosis of conditions that affect the optical scattering properties of ocular tissue.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bruce Drum

ohthalmic and Throat Det