S-41 & S-41S VIDEO IMAGING SYSTEM

K962020 · Del Medical Systems Corp. · GCJ · Aug 30, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962020
• Device Name: S-41 & S-41S VIDEO IMAGING SYSTEM
• Applicant: Del Medical Systems Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Device Story

S-41 and S-41S Video Imaging Systems; intended for video imaging in medical procedures. Device captures visual data via camera; processes signals for display. Used in clinical settings by practitioners. Output provides visual feedback to assist clinicians during procedures. System design and technology comparable to existing market video imaging systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological comparison to legally marketed predicate devices.

Technological Characteristics

Video imaging system; camera-based input; electronic signal processing. Technical specifications described as virtually identical to predicate and reference devices.

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

• MSV-2000 (K942924)

Reference Devices

• Storz video imaging system
• Olympus video imaging system
• MP Video video imaging system
• Richard Wolf video imaging system
• Medical Dynamics camera (K903339)
• Dyonics video imaging system

Submission Summary (Full Text)

{0}

Exhibit 9

K962020

AUG 30 1996

510(k) Summary

DMS will provide a 510(k) Summary and allow for the "public" to request this information.

We have taken the terminology from the Reference Manual-"Premarket Notification 510(k): Regulatory Requirements for Medical Devices" (FDA 92-4158).

## Summary

Del Medical Systems feels the S-41 and S-41S Video Imaging System are substantially equivalent to the MSV-2000 marketed by Del Medical Systems under K942924 and also to many legally marketed devices already in commercial distribution such as: Storz, Olympus, MP Video, Richard Wolf, Medical Dynamics and Dyonics, just to name a few. Medical Dynamics market's their camera in conjunction with a laparoscope under K903339.

The design of the S-41 and S-41S is virtually identical to the comparative devices, which are listed and displayed in Exhibits 2 and 3. Since the design is comparable, technology virtually identical, the specifications very similar, and the *intended use* the same, DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.

For information purposes and completeness, Del Medical Systems has also incorporated other legally marketed devices in this filing to illustrate the wide, general use of similar other devices. This wide use has lead to the safe use of the device in many practitioner's hands.