FIBER OPTIC ENDOILLUMINATION PROBE

K980636 · Dutch Ophthalmic USA, Inc. · FFS · May 20, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980636
• Device Name: FIBER OPTIC ENDOILLUMINATION PROBE
• Applicant: Dutch Ophthalmic USA, Inc.
• Product Code: FFS · Gastroenterology, Urology
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

Device Story

Device provides intraocular illumination during vitreoretinal surgery. Consists of flexible optical fiber threaded through illumination probe. Light transmitted from external source through fiber into eye. Used in clinical setting by ophthalmic surgeons. Facilitates visualization of intraocular structures during surgical procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: PMMA, fluoropolymer fiber, surgical stainless steel. Principle: Fiber optic light transmission. Sterilization: Validated ETO. Packaging: Validated heat-sealed Tyvek.

Indications for Use

Indicated for intraocular illumination during vitreoretinal surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Infinitech, Inc. Fiber Optic Probe (K870942)

Submission Summary (Full Text)

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510(k) Summary Fiber Optic Endoillumination Probe (per 21 CFR 807.92)

K980636

MAY 20 1998

### SUBMITTER NAME AND ADDRESS 1.

DUTCH OPHTHALMIC, USA One Little River Road P.O. Box 9866 6 Kingston, NH 03848 USA

Mark W. Furlong, President Contact Person: Telephone: [phone]

February 9, 1998 Date Prepared:

#### 2. DEVICE NAME

Fiber Probe Trade Name: Fiber Optic Endoillumination Probe Proprietary Name: Light, Surgical, Fiberoptic Classification name:

### PREDICATE DEVICE 3.

Infinitech, Inc. Fiber Optic Probe (K870942)

### DEVICE DESCRIPTION 4.

The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

#### INTENDED USE ട.

The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Operational and technological characteristics form the basis for the determination of substantial equivalence of the Fiber Optic Endoillumination Probe with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics.

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### COMPARISON TABLE

.

-้

| Comparison Criteria | Dutch Ophthalmic, USA<br>Fiber Optic<br>Endoillumination Probe | Infinitech, Inc.<br>Fiber Optic<br>Probe |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------|
| Device Type: Fiber Optic Probe | Yes | Yes |
| Indication: Intraocular illumination in vitreoretinal surgery | Yes | Yes |
| Patient Contact Materials:<br>PMMA and fluoropolymer fiber and medical grade<br>Surgical stainless steel | Yes | Yes |
| Sterilization Method | Validated ETO | Not Known |
| Packaging | Validated Heat Sealed<br>Tyvek | Not Known |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Mr. Mark W. Furlong ·President Dutch Ophthalmic, USA One Little River Road P.O. Box 968 Kingston, New Hampshire 03848

K980636 Re: Fiber Optic Endoillumination Probe Trade Name: Regulatory Class: II Product Code: FFS February 9, 1998 Dated: February 19, 1998 Received:

Dear Mr. Furlong:

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 (for the indications for use stated in the enclosure) 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 The general controls provisions of the Act 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. ਸੈ substantially equivalent determination assumes compliance with --the current Good Manufacturing Practice requirement, 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 "od and Drug Administration (FDA) will verify such assamptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

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### Page 2 - Mr. Furlong

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 510(k) Number (if known):

## Device Name: Fiber Optic Endoillumination Probe

## Indication For Use:

Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 0,0636 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)