LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

K013421 · Lifeguard Medical Products, Inc. · BZD · Jan 8, 2002 · Anesthesiology

Device Facts

• Record ID: K013421
• Device Name: LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
• Applicant: Lifeguard Medical Products, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide When about with devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.

Device Story

Lifeguard Nasal CPAP mask; patient interface for CPAP therapy. Device functions as conduit for pressurized air delivery to nasal passages. Requires external CPAP device with exhalation port and headgear/support mechanism. Intended for single-patient re-use. Used in clinical or home settings under prescription. Provides airway pressure support to patients requiring CPAP therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nasal CPAP mask interface. Single-patient re-use design. Requires external exhalation port and support device for operation.

Indications for Use

Indicated for single-patient re-use to provide nasal CPAP therapy when used in conjunction with an exhalation port and a device providing support against the patient's face.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 8 2002

Mr. Craig Johnson Lifeguard Medical Products 120 Elm Street Plainfield, IN 46168

Re: K013421

Lifeguard Nasal CPAP Mask Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator, Accessory Regulatory Class: Class II (two) Product Code: BZD Dated: October 11, 2001 Received: October 16, 2001

Dear Mr. Johnson:

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.

{1}------------------------------------------------

## Page 2 - Mr. Craig Johnson

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

V. Seale Tiller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number K013421

Page 1 of 1

20 December 2001

Device Name: Lifeguard Nasal CPAP Mask

Indications for Use:

The Lifeguard Nasal CPAP mask is intended to be used to provide nasal CPAP, when used with devices that provided an exhalation port, devices that provide When about with devices that support the mask against the patient's face. The mask is intended for re-use by a single patient.

Prescription Use
(Per 21 CFR 801.109)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01542