(84 days)
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.
This document describes a premarket notification for a fiberoptic endoilluminator. It compares a new device (Storz MVS 1011A) to a predicate device (Storz MVS 1011).
The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. It is a 510(k) summary for a medical device (Storz MVS 1011A Fiberoptic Endoilluminator) and focuses on demonstrating substantial equivalence to a predicate device (Storz MVS 1011).
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies, as that information is not present in the provided text. The document primarily describes the device, its intended use, and a comparison to a predicate device.
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MAR 26 1996
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
December 29, 1995 Date Prepared:
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
Audrey Swearingen Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
35 Troo Correndastral Blvd 10 - 130 - 120 - 12 - 134 . D: : 201 : 0 : 0317 : 0 17
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Storz MVS 1011A Fiberoptic Endoilluminator
Device Comparison Chart
| Device Characteristic | Storz MVS 1011A FiberopticEndoilluminator | Storz MVS 1011 FiberopticEndoilluminator |
|---|---|---|
| Intended Use | Light source for posteriorophthalmic surgery | Light source for posteriorophthalmic surgery |
| Recommended MicrosurgicalSystem | Storz PREMIERE® andStorz DAISYTM | Storz PREMIERE® andStorz DAISYTM |
| Device Components | Molded distal and proximalends, polymer optical fiber,stainless steel tubing, epoxy,tip protector | Molded distal and proximalends, polymer optical fiber,stainless steel tubing, epoxy,tip protector |
| Total Device Length | 74 inches | 74 inches |
| Tip Protector Description | Molded, vented plastic; 2.75inch length | Silicone tubing; 3.0 inchlength |
| Provided Sterile? | Yes | Yes |
| Intended to be Reusable? | No | No |
| Device Packaging | Double pouch | Single pouch |
| Performance Specification? | Y es | No |
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.