LIV MEDICA CPR FACE MASK

K052458 · Liv Medica Products Pvt. , Ltd. · CBP · Jul 7, 2006 · Anesthesiology

Device Facts

• Record ID: K052458
• Device Name: LIV MEDICA CPR FACE MASK
• Applicant: Liv Medica Products Pvt. , Ltd.
• Product Code: CBP · Anesthesiology
• Decision Date: Jul 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.

Device Story

LIV Medica CPR Face Mask is a non-invasive, over-the-counter device used during cardiopulmonary resuscitation (CPR). It consists of a face shield with an integrated non-rebreathing valve. The device acts as a physical barrier between the rescuer and the patient to prevent direct mouth-to-mouth contact during rescue breathing. It is intended for use by laypersons or professionals in emergency situations to facilitate safe resuscitation while reducing the risk of cross-contamination.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-invasive face shield with integral non-rebreathing valve. Class II device under 21 CFR 868.5870. Mechanical barrier design.

Indications for Use

Indicated for use as a physical barrier during mouth-to-mouth resuscitation to prevent direct mouth contact with a patient's face. Suitable for non-prescription, over-the-counter use.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2006

LIV Medica Products Pvt. Ltd. C/O Mr. Michael Holstein Official Correspondent/President LIV Medica, Incorporated 458 Briarcreek Drive Hockessin, Delaware 19707

Re: K052458

Trade/Device Name: LIV Medica CPR Face Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: July 6, 2006 Received: July 6, 2006

Dear Mr. Holstein:

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.

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## Page 2 - Mr. Holstein

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.

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/industry/support/index.html.

Sincerely yours,

Sinette y. Michael Ems

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE FORM

Not Known at this time 510(k) Number (if Known):

LIV Medica CPR Face Mask Device Name:

Indications for Use:

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1< 052458 510(k) Number (if known): _

Device Name: LIV Medica CPR Face Mask

## Indications For Use:

The LIV MEDICA CPR Face Mask is a non-invasive, non-prescription face shield with an integral non-rebreathing valve. The face shield serves as a physical barrier, intended to prevent direct mouth contact with the patient's face when providing mouth-to-mouth resuscitation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X (Optional Format 1-2-96)

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