VISION SCIENCES ENDOSHEATH SYSTEM

K012543 · Vision-Sciences, Inc. · EOB · Jul 15, 2002 · Ear, Nose, Throat

Device Facts

• Record ID: K012543
• Device Name: VISION SCIENCES ENDOSHEATH SYSTEM
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Jul 15, 2002
• Decision: SESE
• Submission Type: Traditional
• 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 chords and/or nasal passages.

Device Story

EndoSheath System consists of sterile, disposable protective sheath covering patient-contact portion of flexible ENT scope. Used during endoscopic examination of upper airway, vocal cords, and nasal passages. Sheath acts as physical barrier between scope and patient; removed and disposed of after each procedure to prevent cross-contamination. Operated by clinicians in clinical settings. Device modification pertains specifically to updates in instruction manual.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Sterile, disposable protective sheath. Physical barrier design. No electronic components, energy sources, or software. Mechanical interface with flexible ENT scopes.

Indications for Use

Indicated for use as a sterile, disposable protective covering for flexible endoscopes during examination of the upper airway, vocal cords, and nasal passages in patients undergoing endoscopic 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

• EndoSheath® System for use with ENT Scopes (K990354)
• Thermometer Covers
• Transesophageal Ultrasound Probe Covers

Submission Summary (Full Text)

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K012543

# JUL 1 5 2002

Vision Sciences, Inc. 510(k) Premarket Notification

August 3, 2001 EndoSheath® for Flexible ENT Scopes

## 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Vision-Sciences, Inc. 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® System for use with ENT Scopes |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Operator: | Vision-Sciences, Inc.<br>9 Strathmore Rd.<br>Natick, MA 01760 |
| Manufacturing Site: | Vision-Sciences, Inc.<br>9 Strathmore Rd.<br>Natick, MA 01760<br>Reg. # 1223490 |
| Device Generic Name: | Nasopharyngo-laryngoscope and accessories |
| Classification: | According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the<br>device classification is Class II, Performance Standards 21 CFR 874.4760;<br>77EOB. |
| Predicate Devices: | EndoSheath® System for use with ENT Scopes (K990354)<br>Manufactured and distributed by:<br>Vision-Sciences, Inc.<br>9 Strathmore Rd.<br>Natick, MA 01760 |
| | Thermometer Covers<br>Marketed by:<br>Becton Dickinson, Stop & Shop |
| | Transesophageal Ultrasound Probe Covers<br>Marketed by:<br>Hewlett Packard |

#### Product Description:

The VSI ENT EndoSheath® System 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. This 510(k) addresses modifications to the EndoSheath® System Instruction Manual.

#### Indications for Use:

The Vision Sciences EndoSheath® Systems are indicated for use as a protective covering for the scope during endoscopic examination of the upper airway, vocal chords and/or nasal passages.

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Vision Sciences, Inc. 510(k) Premarket Notification

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the EndoSheath® Systems for use with Flexible ENT scopes have been shown to be safe and effective for their intended use.

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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 features a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUL 1 5 2002

Vision Sciences, Inc. c/o Pam Papineau, RAC Delphi Medical Device Consulting 5 Whitcomb Avenue Aver. MA 01432

Re: K012543

Trade/Device Name: Endosheath System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Dated: June 21, 2002 Received: June 26, 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 - Pam Papineau, RAC i

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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Vision Sciences, Inc. 510(k) Premarket Notification

July 20, 2001 EndoSheath® for Flexible ENT Scopes

Page 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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 chords 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 | <div> <span></span> </div> |
|----------------------|----------------------------|
| (Per 21 CFR 801.109) | |

OR

| on Sign-Off | |
|-------------------------------------------|--|
| ion of Ophthalmic Ear, and Throat D vises | |

K-01 259 Number _

Over-the -Counter Use ________________________________________________________________________________________________________________________________________________________

000005