The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.

Device Description

The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.

AI/ML Overview

The K971679 510(k) submission for the Ophthalmic Technologies i-scope does not contain a study that establishes acceptance criteria for its device performance in the way a diagnostic AI device would. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and material comparisons, as clinical tests were not required. The device is an ophthalmic endoscope, not an AI-based diagnostic tool.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.

Here's an attempt to address the request with the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance	Study Type
Resolution comparable to predicate devices	Resolution with test pattern presented	Non-Clinical Test
Light output comparable to predicate devices	Light output compared to other devices presented	Non-Clinical Test
Materials used are safe and similar to predicate devices	All materials used have been used in predicate devices	Non-Clinical Test
Intended use aligns with predicate devices (visualization of intra-ocular structures, introduction of micro-instruments, introduction of laser fibers)	Device description and intended use provided	Device Description

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

Not Applicable. This submission does not describe a clinical test set with human or patient data for evaluating performance against predefined acceptance criteria. The "tests" mentioned are non-clinical, likely involving physical measurements or comparisons.

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

Not Applicable. Ground truth, in the context of diagnostic performance, is not established or reported in this submission for the evaluation of the device.

4. Adjudication method for the test set

Not Applicable. No test set requiring adjudication in the context of diagnostic performance is described.

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, a MRMC comparative effectiveness study was not done. This device is an ophthalmic endoscope, not an AI diagnostic tool, so such a study would not be relevant.

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

Not Applicable. The OTI i-scope is a physical medical device (endoscope), not an algorithm. Standalone algorithm performance is irrelevant.

7. The type of ground truth used

Not Applicable. For the non-clinical tests (resolution, light output), the "ground truth" would be the known physical properties or established measurement standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not Applicable. This device is not an AI algorithm that requires a training set.

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

Not Applicable. This device is not an AI algorithm and therefore has no training set or associated ground truth.

Summary

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K971679

Ophthalmic Technologies i-scope 510(k) submission p. A - 3

JUN 2 5 1997

Ophthalmic Technologies Inc. 37 Kodiak Crescent Unit 16 Downsview, Ontario M3J 3E5 Canada 416-631-6932 Revised 6/16/96 510 (k) Summary

1. Submitter Information
  a. Name: Ophthalmic Technologies Inc.

b. Address: Ophthalmic Technologies Inc. 30 Kodiak Crescent, Unit 16 Downsview, Ontario M3J 3E5, CANADA

c. Telephone Number: 416-631-6932
d. Contact Person: Dr. George Myers, 201-727-1703
e. Date Summary Prepared: March 31, 1997
1. Device Information
- a. Trade or proprietary name: OTI i-scope ophthalmic endoscope .
- b. Common name: Ophthalmic Endoscope
- c. Classification name: Endoscope, Ophthalmic

3. Predicate Devices:

a. ElectroFiber Optics Fiber Optic Endoscope
b. EndoOptiks Microprobe
1. Description of the device

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Ophthalmic Technologies i-scope 510(k) submission p. A - 4

replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.

5. Intended Use

The Ophthalmic Technologies i-Scope™ is intended to be for visualization of intra-ocular structures, as a used means to introduce micro instruments into the eye, or as a means to introduce laser fibers for photocoagulation.

6. Technological Characteristics

a. Comparisons

The i-scope is comparable to the EndoOptiks Microprobe, an ophthalmic endoscope, and the ElectroFiber Optics Fiber Optic Endoscope, a general-purpose endoscope. Its intended use and specifcations are very close to that of the EndoOptiks device. Materials and construction are also similar to that used in the ElectroFiber Optics device.

b. Data

(1) Non-Clinical Tests presented:
- (a) Resolution with test pattern
- (b) Light output compared to other devices
(2) Clinical tests: Not required

(3) Materials: All materials used in this device have been used in predicate devices.

c. Conclusion:

The tests provided show that the OTI i-scope is as safe and effective, and perform as well as or better than the legally marketed devices identified above.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three wavy lines that resemble a stylized bird or human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1100 - 5 1097

Ophthalmic Technologies, Inc. c/o Dr. George Myers Official Correspondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

Re: K971679 Trade Name: i-SCOPE Ophthalmic Endoscope Regulatory Class: II Product Code: 86 MPA Dated: April 4, 1997 Received: May 7, 1997

Dear Dr. Myers:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS)inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. George Myers

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971679

Ophthalmic Technologies i-scope 510(k) submission p. i - 4

Page of

510(k) Number (if known):

Device Name: i-scope Ophthalmic Endoscope_____________________________________________________________________________________________________________________________________

Indications for 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 Devices
510(k) Number	K971679

Prescription Use (Per 21 CFR 810.109)	✓
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Over-the-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.