DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE

K961591 · Vision-Sciences, Inc. · EOB · Jul 2, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K961591
• Device Name: DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jul 2, 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 sleeve designed for the Vision-Sciences Model E-F100 Nasopharyngoscope. It covers the patient-contact portion of the scope during endoscopic procedures of the upper airway, vocal cords, and nasal passages. The sheath acts as a microbial barrier, preventing patient-to-patient cross-contamination. After each procedure, the sheath is removed and discarded, eliminating the need for high-level disinfection of the scope between uses. Used in clinical settings by physicians performing nasopharyngoscopy. Benefits include reduced risk of cross-contamination and improved workflow efficiency by minimizing scope reprocessing time.

Clinical Evidence

Bench testing only. No clinical data. Testing included functional and burst tests, scope angulation, outer diameter measurements, light transmittance, field of view, and resolution. Biocompatibility testing included irritation, sensitization, cytotoxicity, acute systemic toxicity, hemolysis, and implantation. Microbial barrier efficacy was validated using live polio virus and Phi X 174 bacteriophage.

Technological Characteristics

Sterile, disposable protective sheath. Designed for use with VSI Model E-F100 Nasopharyngoscope. Functions as a physical microbial barrier. Materials evaluated for biocompatibility (ISO/FDA standards implied). No electronic components, energy sources, or software.

Indications for Use

Indicated for use as a sterile, disposable protective covering for nasopharyngoscopes during endoscopic examination of the upper airway, vocal chords, and nasal passages in patients requiring such procedures.

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

Submission Summary (Full Text)

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Vision Sciences, Inc.
510(k) Premarket Notification
JUL - 2 1996
April 22, 1996
EndoSheath® for E-F100 Nasopharyngoscope
K961591

# 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:
Endosheath® for use with the Vision-Sciences
Model E-F100 Nasopharyngoscope

## 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:
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 VSI Model E-F100 Nasopharyngoscope 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.

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Vision Sciences, Inc.
510(k) Premarket Notification
April 22, 1996
EndoSheath® for E-F100 Nasopharyngoscope

## Safety and Performance:

The following in vitro functional tests were performed on the proposed Endosheath for use with the VSI Model E-F100 Nasopharyngoscope:

1. Functional and Burst Test
2. Scope Angulation (With and Without Sheath)
3. Scope OD (With and Without Sheath)
4. Sheath Longitudinal and Radial Strain when Loaded on Scope
5. Light Transmittance
6. Field of View
7. Scope Resolution (With and Without Sheath)

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 EndoSheath for use with the VSI Model E-F100 Nasopharyngoscope has been shown to be safe and effective for its intended use.

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