SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR

K973293 · Vaughan Weeks · MPA · Nov 18, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973293
• Device Name: SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR
• Applicant: Vaughan Weeks
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Nov 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to irrigate tissue, during vitreo-retinal surgery.

Device Story

The Syntec True Light End Irrigating Endoilluminator is a surgical instrument used during vitreo-retinal surgery. It consists of a handpiece, handpiece tube, fiberoptic handle, fiber optic cable sheath, and light source connector. The device functions by transmitting visible spectrum light through a fiberoptic cable to illuminate the intraocular space, while simultaneously providing irrigation to the surgical site. It is operated by a surgeon in an operating room setting. The device provides improved visualization of the eye's interior, assisting the surgeon in performing delicate retinal procedures. It is a single-use, biocompatible instrument.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility confirmed via US Pharmacopoeia Class VI criteria. Sterilization validated using the overkill method with ethylene oxide gas.

Technological Characteristics

Components: handpiece tube (surgical grade stainless steel), fiberoptic cable (polystyrene core, polymethylmethacrylate cladding), fiber optic cable sheath (PVC), and zinc connector. Sensing/Actuation: fiberoptic light transmission and fluid irrigation. Sterilization: ethylene oxide gas (overkill method). Biocompatibility: US Pharmacopoeia Class VI compliant materials.

Indications for Use

Indicated for patients undergoing vitreo-retinal surgery requiring intraocular illumination and tissue irrigation.

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 End Irrigating Light Pipe catalog numbers 630.02G and 631.02 20G (K884043)

Submission Summary (Full Text)

{0}------------------------------------------------

Nov. 13 1997 05:08PM P2 K973293

1

Section 9 - Summary of Safety and Effectiveness 00 | 8 |997

8/10/1997 Date of Preparation:

Syntec, Inc. True Light End Irrigating Device Name: Endoilluminator.

Opthamalic Endoilluminator, 86MPA Classification Name:

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

Syntec, Inc. is located at 812 Truman Blvd. 510(k) Submitter: Crystal City, MO Telephone [phone]. and Fax number is [phone].

Nathan H. Lewis Contact Person:

This device is substantially equivalent to the Predicate Device: Grieshaber Disposable End Irrigating Light Pipe catalog numbers 630.02G and 631.02 20G manufactured by Grieshaber & Co. Inc. located at 1945 Vaughn Road, Kennesaw, GA 30144. This device was the subject of Premarket Notification K884043.

- The End Irrigating Endoilluminator Device Description: comprises of five basic components. The handpiece The handpiece tube. The fiberoptic handle. The fiber optic cable sheath and the cable. connector .
- Intended Use: The Syntec, Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to irrigate tissue, during vitreo-retinal surgery.

Clinical and Non-Clinical Similarities and Differences:

The Syntec Inc. True Light End Irrigating Endoilluminator six basic components: the handpiece tube, the fiberoptic cable, the fiber optic cable sheath, the light source connector, and the irrigant connection.

The Syntec Inc. True Light End Irrigating Endoilluminator is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization and to provide irrigation during vitreo-retinal surgery.

The Syntec, Inc. True Light End Irrigating Endoilluminator and the Grieshaber Disposable End Irrigating Light Pipe are

{1}------------------------------------------------

2

both 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 improved visualization and to provide irrigation during vitreo-retinal 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 steel. The fiberoptic cable is made with a polystyrene core and a polymethylmethacrylate cladding. The fiber optic cable sheath is made of PVC tubing.

The device is biocompatible with the body tissue and fluids that it contacts 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is in all capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1997

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

Re: K973293

Trade Name: Syntec, Inc., True Light End Irrigating Endoilluminator 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 Gbove 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.

{3}------------------------------------------------

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. Roerl. firenthal

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

Enclosure

{4}------------------------------------------------

Section 8 - Indications for Use Statement

510(k) Number(if known): __ K 97329 3

Syntec, Inc., True Light End Irrigating Device Name: Endoilluminator

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

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

Ja C. Callaway
(Division Sign-Off)

Division of Ophthalmic Devices K773297 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

8 ﻴﺐ