STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
Device Facts
| Record ID | K960007 |
|---|---|
| Device Name | STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR |
| Applicant | Storz |
| Product Code | MPA · Gastroenterology, Urology |
| Decision Date | Mar 26, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
Intended Use
The MVS 1011A is intended to be used as an accessory to the Storz PREMIERE® and Storz DAISY™ Microsurgical Systems, as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures.
Device Story
Fiberoptic endoilluminator accessory for Storz PREMIERE® and DAISY™ microsurgical systems; provides illumination for posterior segment ophthalmic surgery. Device consists of optical fiber in plastic tubing, molded nylon proximal connector, and molded acetal distal end with stainless steel housing. Sterile, single-use device. Surgeon uses device during surgery to visualize ocular structures. Benefits include improved surgical field visibility.
Clinical Evidence
Bench testing only.
Technological Characteristics
Materials: polymer optical fiber, molded nylon, molded acetal, stainless steel, epoxy. Form factor: 74-inch length. Connectivity: connects to Storz PREMIERE® and DAISY™ microsurgical systems. Sterilization: provided sterile. Single-use.
Indications for Use
Indicated for use as a light source to facilitate viewing of the posterior segment of the eye during ophthalmic surgical procedures.
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
- Storz MVS 1011 Fiberoptic Endoilluminator (K854587)
Related Devices
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- K151604 — 23ga Chandelier Illuminator, 25ga Chandelier Illuminator · Peregrine Surgical , Ltd. · Sep 11, 2015
- K970882 — ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.) · American Medical Devices, Inc. · Jun 24, 1997
- K970875 — ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) · American Medical Devices, Inc. · May 20, 1997
