VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES

K950809 · Vision-Sciences, Inc. · EOB · Aug 5, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K950809
• Device Name: VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• 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 upper airway, vocal chords, and/or nasal passages.

Device Story

EndoSheath is a sterile, disposable protective covering for flexible nasopharyngoscopes (Machida ENT-4L, Olympus ENF Type 3P, Pentax FNL-10S, Pentax FNL-13S). Device covers patient-contact portion of scope during clinical procedures; removed and discarded after each use. Provides microbial barrier to prevent cross-contamination between patients. Used in clinical settings by physicians performing endoscopic examinations. Benefits include reduced risk of patient-to-patient contamination and elimination of need for high-level disinfection between procedures.

Clinical Evidence

Bench testing only. Includes in vitro functional tests (sheath expansion/installation, image quality, pressure/burst) and biocompatibility testing (irritation, sensitization, cytotoxicity, acute systemic toxicity, hemolysis, implantation). Microbial barrier efficacy validated using live polio virus and Phi X 174 bacteriophage.

Technological Characteristics

Sterile, disposable protective sheath. Materials biocompatible per standard testing. Designed for specific compatibility with Machida ENT-4L, Olympus ENF Type 3P, Pentax FNL-10S, and Pentax FNL-13S nasopharyngoscopes. Mechanical barrier function.

Indications for Use

Indicated for patients undergoing endoscopic examination of the upper airway, vocal chords, and/or nasal passages.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247)

Submission Summary (Full Text)

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K950809

Vision Sciences, Inc.
510(k) Premarket Notification
AUG - 5 1996
AUG - 5 1996
May 24, 1996
K950809/A1

# 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:** EndoSheath® for use with Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S Nasopharyngoscopes

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

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

**Device Generic Name:** Nasopharyngoscope 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:**

EndoSheaths for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K921244, K925421, K933247)

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

**Product Description:**

The VSI EndoSheath for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes 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 upper airway, vocal chords, and/or nasal passages.

C0020

{1}

Vision Sciences, Inc.
510(k) Premarket Notification
May 24, 1996
K950809/A1

## Safety and Performance:

The following in vitro functional tests were performed on the proposed Endosheath:

1. Sheath Expansion and Installation Test
2. Sheathed Scope Image Quality Test
3. Sheath Pressure/Burst Test

The following biocompatibility data was presented in support of this Premarket Notification:

1. Irritation
2. Sensitization
3. Cytotoxicity
4. Acute Systemic Toxicity
5. Hemolysis
6. Implantation

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 EndoSheaths for use with Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes have been shown to be safe and effective for their intended use.