S-357 VIDEO IMAGING SYSTEM

K962684 · Del Medical Systems Corp. · GCJ · Oct 15, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962684
• Device Name: S-357 VIDEO IMAGING SYSTEM
• Applicant: Del Medical Systems Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Device Story

S-357 Video Imaging System; captures video images for medical visualization; used by practitioners in clinical settings; design and technology comparable to existing market devices; output used for visual assessment; intended to provide imaging capabilities similar to established endoscopic/surgical video systems.

Clinical Evidence

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

Technological Characteristics

Video imaging system; design and specifications comparable to existing endoscopic/surgical video imaging 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

• Circon/ACMI
• Storz
• Stryker
• Smith & Nephew
• Olympus

Submission Summary (Full Text)

{0}

Revised Summary for S-357
S10(k)
Summary (Revision 1)
OCT 15 1996 K962684

Del Medical Systems feels the S-357 Video Imaging System is substantially equivalent to the many marketed devices already in commercial distribution. The legally marketed devices already in commercial distribution are: Circon/ACMI, Storz, Stryker, Smith & Nephew and Olympus, just to name a few.

The design of the S-357 is virtually identical to the comparative device as slisted in the above paragraph. Since the design is comparable, technology virtually identical, the specifications very similar, and the intended use the same as those above listed devices, 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 led to the safe use of the device in many practitioner's hands.