VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE

K040984 · Vision-Sciences, Inc. · EOB · Apr 27, 2004 · Ear, Nose, Throat

Device Facts

• Record ID: K040984
• Device Name: VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.

Device Story

The Vision Sciences Model ENT-2000V is a modified flexible fiberoptic nasopharyngo-laryngoscope. It incorporates an integral camera module and a camera control unit to facilitate visualization. The device is used by clinicians for endoscopic examination of the upper airway, vocal cords, and nasal passages. The camera module captures visual data, which is processed by the control unit and displayed for the clinician. This visualization assists the physician in performing diagnostic or procedural examinations, potentially improving clinical decision-making by providing direct observation of anatomical structures.

Clinical Evidence

Bench testing only. Validation included scope image quality evaluation, focal length, resolution, distortion, reprocessing effects, and electrical safety testing.

Technological Characteristics

Flexible fiberoptic nasopharyngo-laryngoscope with integrated camera module and camera control unit. Device is Class II. Compliance with 21 CFR 820.30 design controls. Electrical safety testing performed.

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 Scopes (K990354)

Submission Summary (Full Text)

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Ko40984

# 510(k) Summary

| Trade Name: | Vision Sciences Model ENT-2000V Flexible Nasopharyngo-<br>Laryngoscope |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Scopes<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 include an integral camera module and camera control unit.

#### 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 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 scope image quality evaluation, focal length, resolution, distortion, reprocessing effects and electrical safety 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 Flexible ENT Scope has been shown to be safe and effective for its intended use.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

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

Re: K040984

Trade/Device Name: Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Layngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: EOB Dated: April 8, 2004

Received: April 15, 2004

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 - Pamela Papineau, RAC

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]. 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 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,

Ahelyl 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

Enclosure

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Page 1 of 1

510(k) Number (if known): _K040984

Device Name: Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Laryngoscope

Indications for Use:

The VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope 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 | X | AND/OR |
|-----------------------------|---|--------|
| (Part 21 CFR 801 Subpart D) | | |
| | | |
| | | |

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

510{k) Number

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