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. 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).

AI/ML Overview

The provided text is a 510(k) summary for the Bioptigen Spectral Domain Ophthalmic Imaging System. It outlines the device's technical specifications and compares them to predicate devices to establish substantial equivalence. However, the document explicitly states that clinical tests were "Not required" and therefore does not contain information about acceptance criteria or a study proving the device meets those criteria using expert review of clinical data.

The device gained clearance based on non-clinical tests demonstrating conformance to safety and performance standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2) and a technological comparison to predicate devices, showing that differences in resolution, acquisition rate, and internal fixation did not raise new questions of safety and effectiveness.

Therefore, many of the requested details cannot be extracted from this document, as they pertain to clinical performance evaluations which were not conducted or reported for this submission.

Here's a breakdown of what can and cannot be answered from the provided text:

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

Since no clinical performance study was conducted or required for this 510(k) submission, there are no acceptance criteria related to a specific clinical performance metric (e.g., sensitivity, specificity, accuracy against a clinical ground truth). The "performance" described pertains to technical specifications compared against predicate devices.

Specification	Acceptance Criteria (Predicate)	Reported Device Performance (Bioptigen SDOCT)
Optical power	<= 750 microwatts at cornea	<= 750 microwatts at cornea
Longitudinal resolution	20 um in tissue	20 um in tissue
Axial resolution	<= 10 um in tissue	<= 6 um in tissue
Scan pixels	1,024 (axial) x 128-768 (trans.)	512 (axial) x 10-10,000 (trans.)
Depth range	2 mm in tissue	2.2 mm in tissue
Scan rate	400 A scans/s	20,000 A-scans/s
Minimum pupil diameter	3.2 mm	3 mm
Processor	2.4 GHz Pentium IV	Dual 3.4 GHz Xeon Processors
Operating system	Windows 2000	Windows XP
Memory	512 Mb	2 GHz

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (defined here as technical specifications substantially equivalent to or improved over predicate devices) is the non-clinical technical comparison and conformance to standards (ISO 10942, ISO 15004-1, and ISO 15005-2.2). The submission argues that even with technological differences (e.g., improved axial resolution, higher scan rate), these do not present new questions of safety and effectiveness, thus demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set was required or used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or expert-established ground truth was required for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication was required for this 510(k) submission.

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

Not applicable. This device is an imaging system, not an AI-powered diagnostic aid or reader assistance tool. No MRMC study was performed or required.

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

Not applicable. This device is an imaging system, not an algorithm/AI with standalone diagnostic performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth was required for this 510(k) submission, as it relied on technical specifications and conformance to international safety/performance standards.

8. The sample size for the training set

Not applicable. This device is an imaging system, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is an imaging system, not an AI/ML algorithm requiring a training set.

Summary

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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/Manufacturer:	Bioptigen, Inc.104 T.W. Alexander DrivePark Research Center, Building 2Research Triangle Park, NC 27709Ph: 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: 202-546-3848 E-mail: rpagano@MSquaredAssociates.com

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 RetinalImaging System
K number	K012727	K033123	Not assigned
Indication for Use	Viewing and axial crosssectional imaging ofposterior ocular structures. Itis used for in vivo imagingand measurement of theretina, retinal nerve fiberlayer and optic disk.	Same- includes RNFL andMacula Normative Database	The Bioptigen SpectralDomain OphthalmicImaging System is intendedto acquire, process, display,and save depth-resolvedimages of ocular tissuemicrostructure using SpectraDomain Optical CoherenceTomography.
Category	Specification	Specification	Specification
Optical power	<= 750 microwatts at cornea	<= 750 microwatts at cornea	<= 750 microwatts at cornea
Longitudinalresolution	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 patternsavailable	Line, circle, concentric rings,radial lines	Line, circle, concentric rings,radial lines	Line, circle, concentric rings,radial lines
Scan pixels	Adjustable from 1,024 (axial)x 128 (transverse) to 1,024(axial) x 768 (transverse)	Adjustable from 1,024 (axial)x 128 (transverse) to 1,024(axial) x 768 (transverse)	Adjustable from 512 (axial) x10 (transverse) to 2,048(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 fixationExternal fixation	32 x 16 LED dot matrixSlit lamp type adjustableblinking LED	32 x 16 LED dot matrixSlit lamp type adjustableblinking LED	220 x 200 Color LCDvSlit lamp type adjustableLED
Minimum pupildiameter	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 XeonProcessors
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 (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/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

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.