DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE

K963344 · Vision-Sciences, Inc. · FAM · Nov 21, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K963344
• Device Name: DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: FAM · Gastroenterology, Urology
• Decision Date: Nov 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

Device Story

Sterile, disposable protective sheath; covers patient-contact portion of VSI Model S-F100 Sigmoidoscope during clinical procedures. Sheath prevents direct patient contact with scope; removed and disposed of post-procedure. Used in clinical settings by physicians performing sigmoidoscopy. Benefits include maintaining sterile barrier between patient and reusable endoscope, reducing cross-contamination risk.

Clinical Evidence

Bench testing only. Functional and performance testing performed. Microbial barrier testing conducted using live polio virus and Phi X 174 bacteriophage to validate barrier integrity.

Technological Characteristics

Sterile, disposable protective sheath. Designed for use with VSI Model S-F100 Sigmoidoscope. Mechanical barrier function. No electronic or software components.

Indications for Use

Indicated for patients undergoing endoscopic examination of the sigmoid colon.

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

• SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690)
• EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591)
• EndoSheath for Use with the VSI C-F100 Colonoscope (K943895)
• EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809)

Submission Summary (Full Text)

{0}

Vision Sciences, Inc.
510(k) Premarket Notification
August 23, 1996
Modified EndoSheath® for VSI Fiberoptic Sigmoidoscope
NOV 21 1996
K963344
p1072

# Summary of Safety and Effectiveness

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:** SS-F32 EndoSheath® for use with the Vision-Sciences Model S-F100 Sigmoidoscope

**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

**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 874.4760).

**Predicate Devices:**

SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690)
EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591)
EndoSheath for Use with the VSI C-F100 Colonoscope (K943895)
EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809)

Manufactured and Distributed by:
Vision-Sciences, Inc.
6 Strathmore Rd.
Natick, MA 01760

**Product Description:**

The SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope consists of a sterile, disposable, protective sheath which covers the patient contact portion of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.

**Indications for Use:**

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

{1}

Vision Sciences, Inc.
510(k) Premarket Notification
August 23, 1996
Modified EndoSheath® for VSI Fiberoptic Sigmoidoscope
K963344
p 2 of 2

## Safety and Performance:

The following in vitro functional tests were performed on the proposed SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope:

1. Sheath Functional and Performance Test
2. Sheath Tensile Test

Microbial barrier testing using live polio virus as well as the Phi X 174 bacteriophage was also presented in support of the proposed label claims.

## Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the SS-F32 EndoSheath for use with the VSI Model S-F100 Sigmoidoscope has been shown to be safe and effective for its intended use.