CLEARVIEW ENDOSCOPE COVER

K080740 · Invotec International, Inc. · EOB · Dec 31, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K080740
• Device Name: CLEARVIEW ENDOSCOPE COVER
• Applicant: Invotec International, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Dec 31, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.

Device Story

ClearView Endoscope Cover System functions as a single-use sterile protective jacket for Otolaryngology or Rhinological endoscopes. Device is placed over the endoscope prior to clinical examination procedures to provide a barrier between the instrument and the patient. Operated by trained medical professionals in clinical settings. Primary benefit is the reduction of cross-contamination risk during endoscopic procedures by providing a disposable sheath that is discarded after a single use. Does not alter the optical or mechanical function of the underlying endoscope.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, single-use polymer jacket/sheath. Designed for specific endoscope geometries. Non-powered, passive accessory. No electronic or software components.

Indications for Use

Indicated for use by trained medical professionals during Otolaryngology or Rhinological endoscopic examination procedures. Designed as a single-use sterile barrier for specific endoscope models.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol. The logo is presented in black and white.

Public Health Service

DEC 3 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Invotec International, Inc. c/o Jeffrey Aull 6833 Phillips Industrial Blvd. Jacksonville, Florida 32256-3029

Rc: K080740

Trade/Device Name: Clearview Endoscope Cover Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class, II Product Code: EOB Dated: December 16, 2008 Received: December 18, 2008

Dear Mr. Aull:

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 – Mr. Jeffrey Aull

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Malvina B. Eggleston, us

Malvina B. Evdelman, M.I 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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K080740

## Indications for Use

510(k) Number (if known): K K080740

Device Name:____Flexible Endoscope Barrier Sheath.

Indications For Use: The ClearView™ Endoscope Cover System is indicated as a one time use sterile jacket, placed over a medical Otolaryngology or Rhinological endoscope, during examination procedures, conducted by trained medical professional. It is designed and sized to fit on to specific manufactures' endoscope models.

Prescription Use ×

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Karen H. Baker

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

510(k) Number K080740