← Product Code [MPA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/MPA) · K960007 # STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K960007) _Storz · MPA · Mar 26, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MPA/K960007 ## Device Facts - **Applicant:** Storz - **Product Code:** [MPA](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/MPA.md) - **Decision Date:** Mar 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for 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. ## Regulatory 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](/device/K854587.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K90007 MAR 26 1996 storz # Premarket Notification ## Storz Instrument Company ### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is submitted in accordance with the requirements of 21 CFR 807.92: **Contact Person:** Audrey Swearingen, Regulatory Affairs Associate **Date Prepared:** December 29, 1995 **Proprietary Names:** Storz MVS 1011A Fiberoptic Endoilluminator. **Common/Usual Names:** Fiberoptic Lightpipe **Classification Name:** Illuminator, Fiberoptic, Surgical Field; 79(HBI). **Device Description/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. The device consists of an optical fiber encased in plastic tubing; a molded nylon proximal end which connects the device to the microsurgical unit; and a molded acetal distal end, from which protrudes the fiberoptic enclosed within a stainless steel housing. The stainless steel tip, which is the point of light emission, is covered by a plastic protective sleeve that attaches to the molded distal end, and which is removed prior to use of the endoilluminator. **Predicate Device:** The Storz MVS 1011A Fiberoptic Endoilluminator is substantially equivalent to its predecessor, the Storz MVS 1011 Fiberoptic Endoilluminator (K854587). **Predicate Comparison:** A chart comparing the Storz MVS 1011A with the Storz MVS 1011, showing substantial equivalence, is attached. **Submitted by:** Audrey Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051 storz 48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48-48- {1} 56 # Storz MVS 1011A Fiberoptic Endoilluminator ## Device Comparison Chart | Device Characteristic | Storz MVS 1011A Fiberoptic Endoilluminator | Storz MVS 1011 Fiberoptic Endoilluminator | | --- | --- | --- | | Intended Use | Light source for posterior ophthalmic surgery | Light source for posterior ophthalmic surgery | | Recommended Microsurgical System | Storz PREMIERE® and Storz DAISY™ | Storz PREMIERE® and Storz DAISY™ | | Device Components | Molded distal and proximal ends, polymer optical fiber, stainless steel tubing, epoxy, tip protector | Molded distal and proximal ends, polymer optical fiber, stainless steel tubing, epoxy, tip protector | | Total Device Length | 74 inches | 74 inches | | Tip Protector Description | Molded, vented plastic; 2.75 inch length | Silicone tubing; 3.0 inch length | | Provided Sterile? | Yes | Yes | | Intended to be Reusable? | No | No | | Device Packaging | Double pouch | Single pouch | | Performance Specification? | Yes | No | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MPA/K960007](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/MPA/K960007) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com