The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retina, retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy.

Device Description

The Topcon 3D OCT-1000 is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases, including but not limited to macular edema and central serous retinopathy. The 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.

AI/ML Overview

The provided 510(k) summary for the Topcon 3D OCT-1000 MARK II indicates that its acceptance criteria and the study proving it meets these criteria are based on demonstrating substantial equivalence to a legally marketed predicate device, the 3D OCT-1000. This is not a study proving clinical diagnostic performance against specific acceptance criteria for a new clinical claim, but rather a technical comparison.

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (3D OCT-1000) for: - Intended Use - Indications for Use - Technological Characteristics - Engineering Design and Specifications - Software Design and Specifications - Laser Classification	The 3D OCT-1000 MARK II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are identical, with the exception of the scan pattern light source (continuous wave for predicate, pulsed lighting for 3D OCT-1000 MARK II). Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.

Acceptance Criteria

Reported Device Performance

Substantial Equivalence to Predicate Device (3D OCT-1000) for: - Intended Use - Indications for Use - Technological Characteristics - Engineering Design and Specifications - Software Design and Specifications - Laser Classification

The 3D OCT-1000 MARK II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are identical, with the exception of the scan pattern light source (continuous wave for predicate, pulsed lighting for 3D OCT-1000 MARK II). Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.

Study Details

The "study" in this context is a comparison to a predicate device, not a typical clinical trial assessing diagnostic accuracy against an established ground truth.

Sample Size used for the test set and the data provenance:
- No specific sample size for a "test set" (in the sense of patient data for diagnostic accuracy) is mentioned.
- The document implies a technical comparison and validation of the device's imaging capabilities against the predicate. Data provenance is not specified other than it being from performance and software validation testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as a traditional "test set" with expert-established ground truth for diagnostic accuracy was not performed in this 510(k) submission. The "ground truth" for the device's performance was its agreement with the predicate device's output.
Adjudication method for the test set:
- Not applicable for the reasons stated above.
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 study was conducted or reported. This device is an imaging system, not an AI-powered diagnostic tool requiring human reader assistance assessment.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No "standalone" algorithm performance study (in the context of automated diagnosis) was performed. The device itself is an imaging system, and its performance was assessed in terms of its ability to acquire images and its agreement with the predicate device's image acquisition.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission was the performance and output of the legally marketed predicate device, the Topcon 3D OCT-1000. The new device's images and performance were compared for "sufficient agreement" with the predicate.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set of data.
How the ground truth for the training set was established:
- Not applicable as there was no training set.

Summary

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510(k): K093316

MAR 1 3 2009

5. 510(k) Summary as required by 21 CFR 807.92(c)

510(k) Owner: Topcon Corporation. 75-1 I-lasunuma-cho, Itabashi-ku Tokyo, Japan 174
U.S. Facility: Topcon Medical Systems, Inc. 37 West Century Road Paramus, New Jersey 07652 (201) 599-5153 Telephone: Facsimile: (201) 599-5240

Barbara S. Fant, Pharm.D. Contact person: Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 Phone: (513) 961-8200 Facsimile: (513) 961-2858

October 12, 2008 Date:

3D OCT-1000 MARK II Trade Name:

Optical Coherence Tomography System Common names: OCT Mark II

Classification Name: Tomography, Optical Coherence 21 CFR§886.1570 Ophthalmoscope
Product Code: OBO (Tomography, Optical Coherence)

Identification of a Legally Marketed Predicate Device

The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K063388, FDA Product Code OBO.

General Description

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510 (k): k-083316

The 3D OCT-1000 Mark II has the same intended uses and indications for use as the 3D OCT-1000. The technological characteristics are the identical for the two devices, with the exception that during OCT imaging, the scan pattern for the 3D OCT-1000 is delivered as continuous wave (CW) light source; whereas, it is delivered as pulsed lighting in the 3D OCT-1000 Mark II.

Intended Use

Performance Data

Software validation testing and image capture testing were performed on the 3D OCT-1000 MARK II. Test results for the 3D OCT-1000 MARK II demonstrated sufficient agreement with captured images from the 3D OCT-1000. The results of performance testing and software validation testing did not raise any issues on the safety or effectiveness of the device.

Basis of Substantial Equivalence

The 3D OCT-1000 MARK II is substantially equivalent to the 3D OCT-1000 Optical Coherence Tomography System marketed by Topcon, 510(k) Premarket Notification Number K-63388, FDA Product Code OBO, and regulation 21CFR8886.1570 (Ophthalmoscope) in technological characteristics, engineering design and specifications, software design and specifications, laser classification and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines that curve and converge. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

MAR 1 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Topcon Medical Systems, Inc c/o Barbara S. Fant, Pharm.D. Clinical Research Consultants, Inc.

310 Terrace Avenue, Suite 201 Cincinnati, OH 45220

Re: K083316

Trade Name: 3D OCT-1000 Optical Coherence Tomography System Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO Dated: October 12, 2008 Received: November 12, 2008

Dear Dr. Fant:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Egbertms, mD

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 Statement র .

510(k) Number (if known): __ k 083316

Device Name: 3D OCT-1000 MARK II --

Indications for Use:

The Topcon 3D OCT-1000 MARK II is a non-contact ophthalmic imaging system for the viewing and axial cross sectional imaging of posterior ocular structures. It is used for in vivo imaging of the retinal nerve fiber layer and optic disc. It is intended for use as a diagnostic device to aid in the detection and management of ocular discases, including but not limited to macular edema and central serous retinopathy.

Prescription Use_

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K093316

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.