ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE

K071903 · Vision-Sciences, Inc. · EOX · Aug 2, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K071903
• Device Name: ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE
• Applicant: Vision-Sciences, Inc.
• Product Code: EOX · Ear, Nose, Throat
• Decision Date: Aug 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4710
• Device Class: Class 2

Intended Use

The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.

Device Story

EndoSheath® Systems are sterile, single-use protective sheaths for flexible trans-nasal esophagoscopes; cover entire insertion tube of endoscope. Used in clinical settings for endoscopic access/examination of larynx, esophagus, gastro-esophageal junction; assists intubation. Physician operates endoscope with sheath to provide barrier protection. Device modification submission; supports safe/effective use via design controls and verification/validation testing.

Clinical Evidence

Bench testing only. Verification and validation activities, including sheath functional and performance testing, were conducted per design control requirements.

Technological Characteristics

Sterile, single-use protective sheath system for flexible endoscopes. Includes versions with or without a working channel. Designed to cover the entire insertion tube of the flexible endoscope.

Indications for Use

Indicated for endoscopic access and examination of the larynx, esophagus, and gastro-esophageal junction, and to assist intubation in patients requiring such procedures.

Regulatory Classification

Identification

An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. 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 flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• EndoSheath® Systems for use with VSI Flexible TNE Scope (K031786)

Submission Summary (Full Text)

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Vision-Sciences, Inc. July 6, 2007

Special 510(k) Premarket Notification: Device Modification lodified EndoSheath® Systems for Use with VSI Flexible TNE Scopes

# 510(k) Summary

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

Subject Device Name: Common/Usual Name: Product Codes: FDA Regulations: Device Classification:

Predicate Device Name:

Common/Usual Name: Product Codes:

Device Classification:

Premarket Notification:

FDA Regulations:

Vision-Sciences, Inc. 9 Strathmore Road Natick, MA 01760 [phone] [phone] Charles Iannaccone; QA/RA Manager

AUG - 2 2007

EndoSheath® Systems for use with VSI Flexible TNE Scope Protective sheath for use with flexible endoscope EOX 21 CFR 874.4710 Class II

EndoSheath® Systems for use with VSI Flexible TNE Scope Protective sheath for use with flexible endoscope EOX 21 CFR 874.4710 Class II K031786

## Device Description

The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.

#### Intended Use

The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.

## Performance Testing

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. V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning.

#### Conclusion

Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the modified VSI EndoSheath® Systems for use with the VSI flexible TNE scope have been shown to be safe and effective for their intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG - 2 2007

Vision-Sciences, Inc. c/o Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave. Aver, MA 01432

Re: K071903

Trade/Device Name: EndoSheath® Systems for use with VSI Flexible TNE Scope Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOX Dated: July 6, 2007 Received: July 10, 2007

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 association 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will you to organizal equivalence of your device of your device to a legally prematics in the month 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 rryou desire specific an reices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to (210) 210 01161 ation" (21CFR Part 807.97). For questions regarding postmarket surveillance, premarket nonnoulon (210-101 Surveillance and Biometric's (OSB's) Division of Postmarket prease connect ODICT 8 3474. For questions regarding the reporting of device adverse events Burveillance at 210 210 b 1 10 b 1 10 b 1 contact the Division of Surveillance Systems at 240-(Mcdical DV100 reporting (the 1999) progral information on your responsibilities under the Act from 270 - 101: Tou may 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/industry/support/index.html.

Sincerely yours,

M.B. Egeland, MD

Malvina B. Eydelman, 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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Vision-Sciences, Inc. July 6, 2007

Special 510(k) Premarket Notification: Device Modification Modified EndoSheath® Systems for Use with VSI Flexible TNE Scopes

K071903

510(k) Number (if known):

EndoSheath® Systems for use with VSI Flexible TNE Scope Device Name:

Indications for Use:

The flexible trans-nasal esophagoscope with EndoSheath® System is intended for use in The liextble trans-nasal esophagosopo with Enastronomis and gastro-esophageal endoscopic access and exalso be used to assist intubation.

Prescription Use _ X (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use _ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amabolel

(Division Sign-Off)
Division of Ophthalmic Ear,
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**510(k) Number**

010016