(49 days)
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Not Found
No
The description focuses on the physical components and intended uses of a fiber-optic microendoscope, with no mention of AI, ML, or image processing capabilities.
No.
The device is used for visualization, introducing micro instruments, or introducing laser fibers, which are diagnostic or surgical aids, not direct therapeutic actions by the device itself.
No
The device is primarily for visualization, introduction of instruments, and introduction of laser fibers, not for diagnosing conditions.
No
The device description clearly outlines physical components such as a fiber-optic microendoscope, imaging fiber bundle, illumination fiber, working channel, video adapter, video camera, and connections to light sources and laser fibers. This indicates it is a hardware device with optical and mechanical components, not solely software.
Based on the provided information, the Ophthalmic Technologies i-Scope™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states visualization of intra-ocular structures, introduction of micro instruments, and introduction of laser fibers. These are all procedures performed in vivo (within a living organism), not in vitro (outside of a living organism, typically on biological samples).
- Device Description: The description details a fiber-optic microendoscope used for imaging and introducing tools into the eye. This aligns with an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, or urine), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the Ophthalmic Technologies i-Scope™ is an ophthalmic surgical device used for visualization and intervention within the eye, not an IVD device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
86 MPA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intra-ocular structures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests presented:
- Resolution with test pattern
- Light output compared to other devices
Clinical tests: Not required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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
-
- Submitter Information
a. Name: Ophthalmic Technologies Inc.
- Submitter Information
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
-
- 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
-
- Description of the device
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
1
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.
2
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.
3
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
4
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:
.
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.
(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) | ✓ |
|---|---|
| --------------------------------------- | ---------------------------------------------------- |
OR
| Over-the-Counter Use | |
|---|---|
| ---------------------- | --------------------------------------------------- |
(Optional Format 1-2-96)