VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH

K963795 · Vision-Sciences, Inc. · EOQ · Dec 23, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963795
• Device Name: VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH
• Applicant: Vision-Sciences, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Dec 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.

Device Story

System comprises reusable fiberoptic bronchoscope (Model B-F100) and sterile, disposable protective sheath (Model BS-F21). Bronchoscope features D-shaped cross-section with fiberoptic illumination and imaging bundles. Disposable sheath integrates suction/biopsy channel; sheath removed and discarded post-procedure to prevent cross-contamination. Used by clinicians for diagnostic bronchoscopy, specimen collection, and foreign body retrieval. Device provides direct visualization of airway anatomy via fiberoptic bundles. Benefits include reduced risk of patient-to-patient contamination compared to traditional reusable scopes by isolating the scope from patient contact via the disposable barrier.

Clinical Evidence

Bench testing only. Testing included system functional testing, system cycle testing, sheath burst testing, and microbial barrier testing. Biocompatibility testing included irritation, sensitization, cytotoxicity, and acute systemic toxicity.

Technological Characteristics

Fiberoptic bronchoscope with D-shaped cross-section; includes illumination and imaging bundles. Disposable sterile sheath provides suction/biopsy channel. Biocompatible materials used for sheath. No electronic or software-based processing components described.

Indications for Use

Indicated for diagnostic examination of the trachea and major lung air passages, specimen collection, and foreign object removal in patients requiring bronchoscopy.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Model BF-3C20 Bronchoscope (Olympus Corp.)
• Model FB-10X Bronchoscope (Pentax Precision Instrument Corp.)
• Model FB-18RX Bronchoscope (Pentax Precision Instrument Corp.)
• Model FI-10P Intubation Scope (Pentax Precision Instrument Corp.)
• Model SF-100 Flexible Fiberoptic Sigmoidoscope and Disposable EndoSheath (K921690)
• Model SV-100 Flexible Video Sigmoidoscope and Disposable EndoSheath (K932843)
• Protective Sheath for use with the VSI Model E-F100 ENT endoscope (K961591)
• Protective Sheath for use with the Machida Models ENT-3L and ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K950809)

Submission Summary (Full Text)

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K963795

DEC 23 1996

Vision Sciences Inc.
510(k) Premarket Notification

Flexible Fiberoptic Bronchoscope with Disposable EndoSheath®
September 20, 1996

# 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 B-F100 Bronchoscope with Model BS-F21 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:
Bronchoscope and accessories

## Classification:
According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II, Performance Standards (CFR 874.4680).

{1}

Vision Sciences Inc.
510(k) Premarket Notification
Flexible Fiberoptic Bronchoscope with Disposable EndoSheath®
September 20, 1996

## Predicate Devices:

1. Model BF-3C20 Bronchoscope

Manufactured and Distributed by:
Olympus Corp.
4 Nevada Dr.
Lake Success, NY 11042

2. Model FB-10X Bronchoscope, Model FB-18RX Bronchoscope and Model FI-10P Intubation Scope

Manufactured and Distributed by:
Pentax Precision Instrument Corp.
30 Ramland Road.
Orangeburg, NY 10962

3. Model SF-100 Flexible Fiberoptic Sigmoidoscope and Disposable EndoSheath (K921690)

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

4. Model SV-100 Flexible Video Sigmoidoscope and Disposable EndoSheath (K932843)

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

{2}

Vision Sciences Inc.
510(k) Premarket Notification
Flexible Fiberoptic Bronchoscope with Disposable EndoSheath®
September 20, 1996

5. Protective Sheath for use with the VSI Model E-F100 ENT endoscope (K961591)

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

6. Protective Sheath for use with the Machida Models ENT-3L and ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes (K950809)

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

## Product Description:

The VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath consists of a reusable bronchoscope with a D-shaped cross section containing fiberoptic illumination and imaging bundles and a sterile, disposable, protective sheath containing the suction/biopsy channel. The sheath is removed and disposed of following each procedure.

## Indications for Use:

The Vision Sciences (VSI) Bronchoscope and Disposable Sheath System will be used for diagnostic examination of the inside of the trachea or windpipe and other major air passages of the lungs. It may also be used to gather specimens and to find and remove foreign objects in the lungs.

{3}

Vision Sciences Inc.
510(k) Premarket Notification
Flexible Fiberoptic Bronchoscope with Disposable EndoSheath®
September 20, 1996

## Safety and Performance:

The following in vitro functional tests were performed on the proposed VSI Model B-F100 Bronchoscope with BS-F21 Disposable EndoSheath:

1. System Functional Testing
2. System Cycle Testing
3. Sheath Burst Testing

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

1. Irritation
2. Sensitization
3. Cytotoxicity
4. Acute Systemic Toxicity

Microbial barrier testing was also included.

## Conclusion:

Based on the indications for use, technological characteristics, and safety and performance testing, the VSI Model B-F100 Bronchoscope with Model BS-F21 Disposable EndoSheath has been shown to be safe and effective for its intended use.

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