ES-3840, VIDEO SIGMOIDOSCOPE

K961567 · Pentax Precision Instrument Corp. · FAM · Jun 24, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961567
• Device Name: ES-3840, VIDEO SIGMOIDOSCOPE
• Applicant: Pentax Precision Instrument Corp.
• Product Code: FAM · Gastroenterology, Urology
• Decision Date: Jun 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs, tissues, and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Device Story

Flexible video sigmoidoscope; used for visualization and therapeutic access to lower GI tract (rectum, sigmoid colon). Input: light from 300W xenon lamp (via video processor); CCD collects reflected image data. Operation: light filtered via RGB color wheel; CCD captures color strobes; video processor compiles full color frames. Output: video signal to monitor. Used in clinical settings by physicians. Features: angulation controls, air/water delivery, suction, forward water jet, working channel for biopsy forceps. Benefits: enables diagnostic visualization and therapeutic intervention in lower GI tract.

Clinical Evidence

No clinical data; substantial equivalence based on bench testing and technical specifications.

Technological Characteristics

Flexible insertion tube; CCD image sensor; fiber optic light bundles; 300W xenon lamp source; RGB color wheel filtering; working channel for accessories; manual angulation controls; air/water/suction/jet channels.

Indications for Use

Indicated for visualization and therapeutic access to the lower gastrointestinal tract, including the rectum and sigmoid colon, in adult and pediatric patients requiring such 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

• EC-3800L, Video Colonoscope Pentax (K951574)
• EPM-3300, Video Processor Pentax (K934918)

Submission Summary (Full Text)

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JUN-24-96 MON 12:37 PENTAX SESC FAX NO. 305 430 8505 P. 05
K961567
510(K) SUMMARY JUN 24 1996
DEVICE: ES-3840, VIDEO SIGMOIDOSCOPE
PREPARED BY: PAUL SILVA DATE SUMMARY PREPARED: 06-14-96

1. SUBMITTER INFORMATION:
Pentax Precision Instrument Corporation
30 Ramland Road
Orangeburg, NY, 10962
TEL: [phone]

2. NAME OF DEVICE:
Trade Name: ES-3840, Video Sigmoidoscope
Classification Name: Sigmoidoscope, flexible (FAM), 876.1500

3. PREDICATED DEVICE(S) INFORMATION:
1. EC-3800L, Video Colonoscope Pentax K951574
2. EPM-3300, Video Processor Pentax K934918

4. DEVICE DESCRIPTION:
The ES-3840, Video Sigmoidoscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/down/left/right angulation, air/water delivery, suction, Forward Water Jet, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

5. INTENDED USE:
The ES-3840, Video Sigmoidoscope, is intended to provide visualization (via a video monitor) of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs, tissues, and subsystems: Rectum and Sigmoid Colon. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

6. COMPARISON TO PREDICATED DEVICE(S):
The submission for substantial equivalence included ES-3840 literature including specifications, the identification of standard set components, and identification of optional accessories, comparison tables were provided to illustrate the comparisons to the predicated devices. The submission for substantial equivalence was not based on an assessment of clinical performance data.