SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK

K973290 · Vaughan Weeks · MPA · Nov 14, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973290
• Device Name: SYNTEC TRUE LIGHT ENDOILLUMIINATOR WITH PICK
• Applicant: Vaughan Weeks
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Nov 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Syntec, Inc. True Light Endoilluminator with Pick is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to manipulate tissue, during vitreoretinal surgery.

Device Story

The Syntec, Inc. True Light Endoilluminator with Pick is a surgical instrument used during vitreoretinal surgery. It consists of a handpiece handle, tube, fiberoptic cable, cable sheath, and connector. The device functions by delivering visible spectrum light into the intraocular portion of the eye to improve visualization for the surgeon; it also features a pick component for tissue manipulation. It is intended for use by ophthalmic surgeons in a clinical or surgical setting. The device is a passive instrument; it does not involve electronic processing, software, or automated algorithms. It provides a direct visual aid to the surgeon, who manually operates the device to illuminate and manipulate ocular structures, thereby assisting in the performance of vitreoretinal procedures.

Clinical Evidence

Bench testing only. The device was evaluated for biocompatibility (USP Class VI) and performance characteristics, including light output intensity and spot size, which were found to be equivalent to the predicate device. No clinical data was required or provided.

Technological Characteristics

Components: handpiece handle, tube, fiberoptic cable, sheath, connector. Materials: surgical grade stainless steel (tube), polystyrene core/polymethylmethacrylate cladding (fiberoptic cable), PVC (sheath), zinc (connector). Sterilization: ethylene oxide gas (overkill method). Biocompatibility: USP Class VI. Connectivity: None. Energy: External light source (visible spectrum).

Indications for Use

Indicated for use in patients undergoing vitreoretinal surgery to provide illumination of the intraocular space and facilitate tissue manipulation.

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

• Grieshaber Disposable Standard Micro Lite Pipe with Pic (K875004)

Reference Devices

• Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick

Submission Summary (Full Text)

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NOV 1 4 1997

Section 9 - Summary of Safety and Effectiveness

August 3, 1997 Date of Preparation:

Syntec, Inc. True Light Endoilluminator with Pick Device Name:

Opthamalic Endoilluminator, 86MPA Classification Name:

Syntec, Inc. is located at 733 Mansion Road, Manufacturer: Winfield, MO 63389. Telephone [phone] and Fax number is [phone].

- Syntec, Inc. is located at 733 Mansion Road, 510(k) Submitter: Winfield, MO 63389. Telephone [phone] and Fax number is [phone].
Nathan H. Lewis Contact Person:

- Grieshaber Disposable Standard Micro Lite Pipe Predicate Devices: with Pic, catalog numbers 630.06 20G and 631.06 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. This device was the subject of Premarket Notification K875004.
Gamp & Associates Disposable Fiberoptic Endoilluminator with Pick. 16818 Kingstowne Way Drive, Ballwin, MO 63011.

The Endoilluminator with Pick is comprised of Device Description: five basic components: the handpiece handle, the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.

- The Syntec, Inc. Disposable Endoilluminator Intended Use: with Pick is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to manipulate tissue, during vitreoretinal surgery.
Clinical and Non-Clinical Similarities and Differences:

The Endoilluminator with Pick is comprised of five basic components: the handpiece tube, the fiberoptic cable, the fiber optic cable sheath and the connector.

The Syntec, Inc. Endoilluminator with Pick is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.

The Syntec, Inc. True Light Endoilluminator with Pick, the Grieshaber Endoilluminator with Pick, and the Gamp & Associates Endoilluminator with Pick are all substantially equivalent in that they are used for the same clinical purpose, ie: to illuminate with visible spectrum light the intraocular portion of the eye for

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improved visualization and to manipulate tissue during vitreoretinal surgery.

The devices are of a similar design and are made using the same materials except for the zinc connector used with the Syntec design. The handpiece tube is made of surgical grade stainless The fiberoptic cable is made with a polystyrene core and a steel. polymethylmethacrylate cladding. The fiber optic cable sheath is made of PVC tubing.

The device is biocompatible with the body tissue and fluids with which it comes in contact as it is made of the same materials as the predicate device. These materials meet US Pharmacopoeia Class VI criteria and are widely used in many other medical products. The device is sterilized using ethylene oxide gas which is then validated by the overkill method.

The light output intensity and spot size is the same as the predicate device. The only device differences are cosmetic.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 1997

Mr. Vaughan Weeks 7346 West River Rd. Caledonia, WI 53108

Re: K973290

Trade Name: Syntec, Inc., True Light Endoilluminator with Pick. Regulatory Class: II Product Code: 86 MPA Dated: September 2, 1997 Received: September 2, 1997

Dear Mr. Weeks:

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 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 - Mr. Weeks

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,

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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Section 8 - Indications for Use Statement

510(k) Number(if known): _____________________________________________________________________________________________________________________________________________________

Syntec, Inc., True Light Endoilluminator with Pick Device Name:

The Syntec, Inc. True Light Endoilluminator Indications for Use: with Pick is used to illuminate with visible spectrum light the intra ocular portion of the eye for improved visualization and manipulation during vitreo-retinal surgery.

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

Sta C. Callaway
(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number_ K 9 732 90

1 Prescription Use . (Per 21 CFR 801.109)