SYNTEC, INC. DISPOSABLE BARE END FIBER
Device Facts
| Record ID | K971338 |
|---|---|
| Device Name | SYNTEC, INC. DISPOSABLE BARE END FIBER |
| Applicant | Syntec, Inc. |
| Product Code | MPA · Gastroenterology, Urology |
| Decision Date | May 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The Syntec, Inc. Disposable Bare End Fiber is used to illuminate with visible spectrum light the intraocular portion of the eye for improved visualization during vitreo-retinal surgery.
Device Story
Disposable ophthalmic endoilluminator; used during vitreo-retinal surgery to provide visible light for intraocular visualization. Device consists of handpiece tube, fiberoptic cable, cable sheath, and connector. Operates by transmitting light from an external source through the fiberoptic cable to the surgical site. Used by ophthalmologists in an operating room setting. Provides improved visualization of ocular structures, facilitating surgical procedures. Biocompatible materials ensure safety during contact with ocular tissues and fluids.
Clinical Evidence
Bench testing only. Biocompatibility confirmed via USP Class VI criteria. Sterilization validated using ethylene oxide gas overkill method. Performance equivalence (light output intensity and spot size) demonstrated against predicate device.
Technological Characteristics
Materials: surgical grade stainless steel (handpiece), polystyrene core/polymethylmethacrylate cladding (fiberoptic cable), PVC (sheath), 6063 aluminum (connector). Sterilization: ethylene oxide gas (overkill method). Biocompatibility: USP Class VI compliant.
Indications for Use
Indicated for patients undergoing vitreo-retinal surgery requiring intraocular illumination.
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 Monofilament (catalog number 630.78)
Related Devices
- K973293 — SYNTEC TRUE LIGHT END IRRIGATING ENDOILLUMINATOR · Vaughan Weeks · Nov 18, 1997
- K964555 — VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S) · Vitrotec, Inc. · Mar 31, 1997
- K980027 — PEREGRINE SHIELDED DIFFUSION PROBE · Peregrine Surgical , Ltd. · Mar 31, 1998
- K960007 — STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR · Storz · Mar 26, 1996
- K982462 — FIBER OPTIC ENDOILLUMINATION PROBE · Microvision, Inc. · Sep 14, 1998
