VISION-SCIENCES ENT-3000 SCOPE

K050972 · Vision-Sciences, Inc. · EOB · Apr 29, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K050972
• Device Name: VISION-SCIENCES ENT-3000 SCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Apr 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The VSI Flexible ENT Scope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

Device Story

The Vision-Sciences ENT-3000 is a flexible fiberoptic nasopharyngoscope used for visualizing the upper airway, vocal cords, and nasal passages. This modification replaces the traditional integral light guide cable with a battery-powered LED light source (BLS-1000) and an accessory recharger. The device is used by clinicians in a clinical setting to perform endoscopic examinations. The physician inserts the scope into the patient's airway or nasal passages; the fiberoptic system transmits the image to the eyepiece for direct visualization. The LED light source provides illumination for the procedure. The device allows for diagnostic assessment of the upper airway, aiding in clinical decision-making regarding patient pathology. The primary benefit is improved portability and ease of use during endoscopic procedures.

Clinical Evidence

Bench testing only. Validation included light output, operating temperature, scope leak testing, reprocessing effects analysis, and electrical safety testing.

Technological Characteristics

Flexible fiberoptic nasopharyngoscope; battery-powered LED light source (BLS-1000); accessory recharger. Class II device (21 CFR 874.4760).

Indications for Use

Indicated for flexible endoscopic examination of the upper airway, vocal chords, and/or nasal passages in patients requiring visualization of these structures.

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

• Flexible ENT Scope (K942265)
• Modified EndoSheath for Flexible ENT Scope (K990354)

Submission Summary (Full Text)

{0}------------------------------------------------

050972

Vision-Sciences, Inc. April 15, 2005

Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scope

# 510(k) Summary

APR 2 9 2005

| Trade Name: | Vision-Sciences ENT-3000 Scope |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760<br>Registration #1223490 |
| Device Generic Name: | 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: | K942265 – Flexible ENT Scope<br>K990354 – Modified EndoSheath® for Flexible ENT Scope<br>Manufactured by:<br>Vision-Sciences, Inc.<br>9 Strathmore Road<br>Natick, MA 01760 |

Product Description: The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to replace the integral light guide cable with a battery-powered LED light source (with accessory recharger).

### Indications for Use:

The scope is indicated for use during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

## Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance 1 he varies titled "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 light output, operating temperature, scope leak testing, reprocessing effects analysis and electrical safety testing was included in Design Validation and Verification planning.

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate Davices, the modified VSI Flexible ENT Scope has been shown to be safe and effective for its intended use.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 symbol that resembles an eagle or bird in flight, with three stylized wing shapes and a curved body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2005

Vision Sciences, Inc. c/o Pamela Papineau Consultant to Vision Sciences Delphia Medical Device Consulting 5 Whitcomb Ave. Aver, MA 01432

Re: K050972

Trade/Device Name: Vision Sciences Model ENT-3000 Portable Flexible Nasopharyngoscope with BLS-1000 Battery Powered LED Light Source ﺒﻲ

Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Dated: April 15, 2005 Received: April 18, 2005

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 for about in the 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 If your device is elassince (toonal controls. Existing major regulations affecting your device can may or subject to back access 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any I 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 Of R Fart 6077, accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your of substantial equivalence of your device to a legally premated 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Vision-Sciences, Inc. April 15, 2005

Special 510(k) Premarket Notification: Device Modification Modified Flexible ENT Scope

Page

# 510(k) Number (if known):

Device Name: Vision-Sciences Flexible ENT Scope

Indications for Use:

The VSI Flexible ENT Scope is intended for 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 × (Part 21 CFR 801 Subpart D) AND/OR

Karin Bahr

1086

Number K05097

Over-the -Counter Use (21 CFR 807 Subpart D)

000010