VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM

K964326 · Vision-Sciences, Inc. · FAM · Jan 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964326
• Device Name: VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: FAM · Gastroenterology, Urology
• Decision Date: Jan 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Reusable video sigmoidoscope with D-shaped cross-section; incorporates fiberoptic illumination and imaging bundles. Utilizes sterile, disposable EndoSheath covering containing air, water, and suction/biopsy channels. Sheath disposed after each procedure. Used by clinicians in clinical settings for lower bowel tract visualization and intervention. Output is real-time video feed for physician observation; facilitates diagnostic/therapeutic decision-making. Disposable sheath design eliminates need for high-level disinfection of scope between patients, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Performance testing included scope angulation/cycle testing and scope resolution testing, both performed with and without the EndoSheath. No clinical data or biocompatibility data presented.

Technological Characteristics

Reusable video sigmoidoscope; D-shaped cross-section; fiberoptic illumination and imaging bundles. Sterile, disposable protective EndoSheath provides air, water, and suction/biopsy channels. No software or electronic processing described.

Indications for Use

Indicated for examination of the lower bowel tract and performance of diagnostic and therapeutic procedures in patients requiring sigmoidoscopy.

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

• Vision-Sciences Model S-V100 Video Sigmoidoscope with SS-V32 EndoSheath System (K932843)
• Model VS-200 Video Sigmoidoscope (K954704)

Submission Summary (Full Text)

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Vision Sciences, Inc.
510(k) Premarket Notification
October 29, 1996
Color Video Sigmoidoscope with EndoSheath® System
K964326
Jan 3, 1997

# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." VSI chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name: VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath

Owner/Operator: Vision-Sciences, Inc.
6 Strathmore Rd.
Natick, MA 01760

Manufacturing Site: EndoSheath:
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick, MA 01760
Reg. # 1223490

Endoscope:
Vision-Sciences, Inc.
40 Ramland Rd. South
Orangeburg, NY 10962
Reg. #2242464

Device Generic Name: Sigmoidoscope and accessories

Classification: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Performance Standards (CFR 876.1500).

# Predicate Devices:

1. Vision-Sciences Model S-V100 Video Sigmoidoscope with SS-V32 EndoSheath System (K932843)
Manufactured and Distributed by:
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick, MA 01760

2. Model VS-200 Video Sigmoidoscope (K954704)
Manufactured and Distributed by:
Welch Allyn Inc.
4341 State Street Road
Skaneateles Falls, NY 13153

000226
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{1}

Vision Sciences, Inc.
510(k) Premarket Notification
October 29, 1996
Color Video Sigmoidoscope with EndoSheath® System

## Product Description:

The VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath consists of a reusable video sigmoidoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the air, water and suction/biopsy channels. The sheath is removed and disposed of following each procedure. The EndoSheath intended for use with the proposed sigmoidoscope is currently under FDA review in K964100.

## Indications for Use:

The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

## Safety and Performance:

The following performance testing was presented in support of this submission:

1. Scope Angulation/Cycle Testing (with and without EndoSheath)
2. Scope Resolution (with and without EndoSheath)

Performance testing for the EndoSheath is contained in K964100.

No biocompatibility data was presented in support of this Premarket Notification.

## Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model S-V200 Color Video Sigmoidoscope with Disposable EndoSheath has been shown to be safe and effective for its intended use.

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