B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM

K021344 · Vision-Sciences, Inc. · EOQ · May 24, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K021344
• Device Name: B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: May 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Indications for Use

The VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is used for flexible endoscopic examination of the trachea and other major passages of the lungs, to gather specimens, and/or to find and endoscopically remove foreign objects from the lungs. The EndoSheath® is a protective covering for the bronchoscope.

Device Story

System consists of modified flexible fiberoptic bronchoscope and sterile, disposable EndoSheath®. Sheath provides protective barrier, eliminating need for high-level disinfection of scope between procedures. Modification introduces 'slide-on' installation technique for sheath, replacing vacuum-based method. Suction valve relocated from sheath to scope. Used by clinicians for visualization of trachea and lung passages, specimen collection, and foreign object retrieval. Fiberoptic technology transmits images to eyepiece/monitor for physician guidance. Benefits include reduced scope reprocessing requirements and maintained sterility via microbial barrier.

Clinical Evidence

Bench testing only. Validation included microbial barrier testing, sheath tensile/elongation testing, sheath leak testing, sheathed scope articulation testing, and sheathed scope image quality evaluation. No clinical data provided.

Technological Characteristics

Flexible fiberoptic bronchoscope with disposable protective sheath. Features: 170°/120° down articulation, 90° field of view, 6.0 mm working channel ID. Slide-on installation mechanism. Microbial barrier protection. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for patients requiring flexible endoscopic examination of the trachea and major lung passages, specimen collection, or foreign object removal. Contraindications not specified.

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

• Bronchoscope with Disposable EndoSheath® (K963795)
• Modified EndoSheath® for Flexible ENT Scopes (K990354)

Submission Summary (Full Text)

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**MAY 24 2002**

K021344

Vision-Sciences, Inc. April 24, 2002

pecial 510(k) Premarket Notification: Modified Flexible Fiberoptic Bronchoscope and EndoSheath® System

# 510(k) Summary

| Trade Name: | Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath®<br>System |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Generic Name: | Flexible, fiberoptic bronchoscope with protective sheath system |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K963795 – Bronchoscope with Disposable EndoSheath®<br>K990354 – Modified EndoSheath® for Flexible ENT Scopes |
| Manufactured by: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760 |

Product Description: The device system described in this 510(k) consists of a modified sterile, disposable sheath designed to fit the modified VSI flexible fiberoptic bronchoscope. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The sheath and scope have been modified to accommodate the "slide-on" sheath installation technique.

#### Indications for Use:

The Bronchoscope with EndoSheath® System is used for flexible endoscopic examination of the trachea and other major passages of the lungs, to gather specimens, and/or to find and endoscopically remove foreign objects from the lungs.

### Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Validation testing including microbial barrier testing, sheath tensile/elongation testing, sheath leak testing, sheathed scope articulation testing and sheathed scope image quality evaluation is included in Design Validation and Verification planning.

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified VSI Flexible Fiberoptic Bronchoscope and EndoSheath® System has been shown to be safe and effective for its intended use.

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Special 510(k) Premarket Notification.

Design Compariso Table D.1

| Characteristic | Proposed Modified<br>Bronchoscope with<br>Slide-on<br>EndoSheath® System<br>(Current Submission) | Currently Marketed,<br>Unmodified<br>Bronchoscope with<br>EndoSheath® System<br>(K963795) | Currently<br>Marketed Slide-on<br>EndoSheath®<br>System for use with<br>ENT Scopes<br>(K990354) | Currently Marketed<br>VSI Flexible GI<br>Scope/EndoSheath®<br>Systems* | Substantial Equivalence<br>Comparison:<br>Proposed Modified<br>Bronchoscope with Slide-on<br>EndoSheath® System |
|---------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Down Articulation<br>(sheathed scope) | 170°/120° | 170°/120° | | | Equivalent to unmodified<br>VSI Bronchoscope/sheath<br>system |
| Field of View<br>(apter) | 90° | 90° | | | |
| Depth of Field | +2/-8 | +2/-8 | | | |
| Insertion Tube OD | 3 - 50 mm | 3 - 50 mm | | | |
| Working Channel ID | 6.0 mm | 6.0 mm | | | |
| Working Length | 2.1 mm | 2.1 mm | | | |
| Submersible scope | 550 mm | 550 mm | | | |
| Microbial barrier claim | Yes | Yes | Yes | Yes | Identical to unmodified VSI<br>Bronchoscope/sheath system |
| Listing scope models | VSI Bronchoscope | VSI Bronchoscope | Various | VSI GI Scopes | Identical to VSI ENT<br>Scope/sheath system |
| Sheath installation method | Slide-on | Vacuum | Slide-on | Pressure | Identical to VSI ENT<br>Scope/sheath system |
| Sheath wall thickness | .0020 - .0045" | .010 ± .002" | .0020 - .0045" | No S.E. comparison required - different<br>sheath material | |

Currenty marketed Vision-Sciences G1 Endoscope with EndoSheath System (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Sigrem (Signem (Signem (Sig

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| Change Description | Where/How Evaluated (V&V Tests) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sheath material changed | • Sheath burst/leak test<br>• Sheath tensile/elongation test<br>• Sheath installation/system functional test<br>• Microbial barrier test |
| Sheath working channel<br>construction changed | • Sheath burst/leak test<br>• Sheath tensile/elongation test<br>• Sheath installation/system functional test<br>• Microbial barrier test |
| Suction valve moved from<br>sheath to scope | • Sheath installation/system functional test<br>• Pinch valve cycle test |

Table D.3 Product Changes/Testing Summary

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

MAY 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vision Sciences. Inc. C/O Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, MA 01432 Attn: Ms. Pam Papineau

Re: K021344

Trade/Device Name: B-F200 Bronchoscope with BSS-F21 Endosheath System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: April 24, 2002 Received: April 29, 2002

Dear Ms. Papineau:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Pam Papineau

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Special 510(k) Premarket Notification: Device Modification Modified Flexible Fiberoptic Bronchoscope and EndoSheath® System

Page

510(k) Number (if known): DJ2 13 44

Device Name: Flexible Fiberoptic Bronchoscope with EndoSheath® System

Indications for Use:

The VSI Flexible, Fiberoptic Bronchoscope with EndoSheath® System is THE VST rexible, I lochopic Eronomooootic examination of the trachea and other major assages of the lungs, to gather specimens, and/or to find and passagos of the fange, to gign objects from the lungs. The EndoSheath® endoscopioally romove role protective covering for the bronchoscope.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use √

21 CFR 801.109)

(Divisio Division of Ophthalmic Ear, Nose and

510(k) Number K02 1344

Over-the -Counter Use

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