MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM

K024095 · Vision-Sciences, Inc. · EOB · Jan 9, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K024095
• Device Name: MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jan 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

Device Story

EndoSheath® System consists of sterile, disposable thermoplastic elastomer sheaths designed to fit over flexible fiberoptic ENT scopes. Sheath features integrated working channel (2.1 mm) allowing visual-only diagnostic scopes to function as multipurpose diagnostic/therapeutic devices. Used in clinical settings by physicians for upper airway, vocal cord, and nasal passage examinations. Eliminates need for high-level disinfection of scope between procedures. Sheath slides on/off scope without requiring vacuum/pressure sources. Provides microbial barrier protection for patient and scope.

Clinical Evidence

Bench testing only. Validation included microbial barrier testing, sheath tensile/elongation testing, and sheath leak/burst testing conducted under 21 CFR 820.30 Design Control requirements.

Technological Characteristics

Materials: Thermoplastic elastomer and thermoplastic polymer. Design: Disposable sheath with 2.1 mm working channel. Form factor: Slides over flexible fiberoptic ENT scopes. Sterilization: Sterile. Connectivity: None (mechanical accessory).

Indications for Use

Indicated for use as a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of the upper airway, vocal cords, 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

• Modified EndoSheath® for Flexible ENT Scopes (K990354)
• EndoSheath® System for Flexible ENT Scopes (K012543)
• EndoSheath® System for Flexible Fiberoptic Bronchoscope (K021344)

Submission Summary (Full Text)

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K024095

# JAN 0 9 2003

## 510(k) Summary

| Trade Name: | Vision-Sciences EndoSheath® System for use with Flexible ENT<br>Scopes |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Generic Name: | Disposable sheath for flexible ENT scopes |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. |
| Predicate Devices: | K990354 - Modified EndoSheath® for Flexible ENT Scopes<br>K012543 - EndoSheath® System for Flexible ENT Scopes<br>K021344 - EndoSheath® System for Flexible Fiberoptic Bronchoscope<br>Manufactured by:<br>Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760 |

Product Description: The device system described in this 510(k) consists of modified sterile, disposable sheaths designed to fit various models of flexible fiberoptic ENT scopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure. The disposable sheath features a specially designed working channel that allows a "visual-only" diagnostic flexible ENT scope to be utilized as a multipurpose diagnostic and therapeutic device

### Indications for Use:

The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

### 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 and sheath leak/burst testing 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 EndoSheath® System for use with Flexible ENT Scopes has been shown to be safe and effective for its intended use.

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| Proposed Modified VSI<br>Channel ENT EndoSheath® System<br>(Current Submission) | Currently Marketed, Unmodified<br>VSI ENT EndoSheath® System<br>(K990354, K012534) | Currently Marketed, Unmodified<br>VSI Bronchoscope EndoSheath®<br>System<br>(K021344) |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Same as VSI predicate devices | Thermoplastic elastomer | Thermoplastic elastomer |
| Same as VSI predicate devices | Thermoplastic polymer | Thermoplastic polymer |
| Same as VSI predicate devices | N/A - no luer connector | Thermoplastic polymer |
| Same as VSI predicate devices | N/A - no working channel | 2.1 mm |
| 2.1 mm | N/A - no working channel | Thermoplastic polymer |
| Same as VSI predicate devices | Thermoplastic polymer | Yes |
| Same family of adhesives as VSI<br>predicate devices | Yes | Thermoplastic polymer |
| Identical to VSI predicate devices | Thermoplastic polymer | Yes |
| Yes | Yes | VSI Bronchoscope |
| Vision-Sciences ENT-2000/E-F100<br>Olympus ENF-P4/P3/P2<br>Pentax VNL-1330 and FNL-<br>10S/10BS/10P2/10RP3/13S<br>Welch Allyn RL-150 | Vision-Sciences ENT-2000/E-F100<br>Olympus ENF-P4/P3/P2<br>Pentax VNL-1330 and FNL-<br>10S/10BS/10P2/10RP3/13S<br>Welch Allyn RL-150 | Vision-Sciences ENT-2000/E-F100 |
| Karl Storz 11101RP/11101RP1 | Karl Storz 11101RP/11101RP1 | |
| Slides on and off (no vacuum/pressure<br>source required) | Slides on and off (no vacuum/pressure<br>source required) | Slides on and off (no vacuum/pressure<br>source required) |
| .002" | .002" | .002" |
| For use in flexible, endoscopic<br>examination of the upper airway, vocal<br>cords and/or nasal passages. | For use in flexible, endoscopic<br>examination of the upper airway, vocal<br>cords and/or nasal passages. | Is used during flexible endoscopic<br>examination of the trachea and other<br>major passages of the lungs, to gather<br>specimens, and/or to find and<br>endoscopically remove foreign objects<br>from the lungs. |

# Figure D.2 Figure D.2
Design/Materials Comparison

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and sides. Inside the circle is a stylized symbol of three human profiles facing to the right, represented by curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 9 2003

Vision-Sciences, Inc. c/o Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

Re: K024095

Trade/Device Name: Endosheath System for use with Flexible ENT Scopes Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: December 6, 2002 Received: December 12, 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. Iisting 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

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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. 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), 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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Page 1

510(k) Number (if known): ¥02 ¥095

Device Name: EndoSheath® System for use with Flexible ENT Scopes

Indications for Use:

The EndoSheath® System provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Keun H. baker

Jivision Sig Division of Oph Nose and Throat

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number | Ko 24095 |