COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67

K964821 · Ventrex, Inc. · DQA · Jul 16, 1997 · Cardiovascular

Device Facts

• Record ID: K964821
• Device Name: COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
• Applicant: Ventrex, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Jul 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the “clothes pin” style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination. The COVERox Sheath is supplied non-sterile and is intended for single use only.

Device Story

COVERox Sheath is a single-use, non-sterile protective barrier designed for "clothes pin" style reusable pulse oximetry finger tip probes. Device acts as a physical shield to minimize probe exposure to gross contamination during routine clinical use. Operated by healthcare personnel in clinical settings; sheath is installed over the probe prior to patient application. By reducing direct contact between the probe and patient, the device simplifies cleaning and disinfection workflows between patients. Does not provide sterile or fluid-tight protection; not a substitute for required sterilization protocols.

Clinical Evidence

Bench testing only.

Technological Characteristics

Single-use, non-sterile protective sheath designed for "clothes pin" style pulse oximetry probes. Material acts as a physical barrier to gross contamination. No electronic components, energy sources, or software.

Indications for Use

Indicated for use as a protective barrier for reusable "clothes pin" style pulse oximetry finger tip probes to reduce gross contamination and cleaning effort between patient uses. Not for sterile or fluid-tight applications.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Robert Guthrie
President
Ventrex, Inc.
300J Bunsen Avenue
Unit K
Ventura, California 93003

JUL 16 1997

Re: K964821
Coverox Sheath Models Number PS65, PS67, EPS65 and EPS67
Regulatory Class: II (Two)
Product Code: 74 DQA
Dated: April 14, 1997
Received: April 17, 1997

Dear Mr. Guthrie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Robert Guthrie

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Premarket Submission Cover Sheet
## Supplemental

### INDICATIONS FOR USE

The COVERox Sheath is intended for use in conjunction with reusable pulse oximetry finger tip probes of the “clothes pin” style (these probes are generally placed onto finger tips only). It provides a gross contamination barrier when properly installed. It does not provide a sterile covering or a fluid tight covering and should not be used in lieu of sterilizing a reusable probe in situations where a sterile probe is indicated. It should be used to reduce the time and effort required to clean the reusable probe between uses by minimizing the probe exposure to gross contamination.

The COVERox Sheath is supplied non-sterile and is intended for single use only.

Prescription

Lark Madoo 2-28-97

(Division Sign Off)
Division of Card - Respiratory and Neurological Devices
510(k) Number K964821