PROTEGE LIQUID OXYGEN SYSTEM

K971545 · Healthdyne Technologies, Inc. · BYJ · Jul 25, 1997 · Anesthesiology

Device Facts

• Record ID: K971545
• Device Name: PROTEGE LIQUID OXYGEN SYSTEM
• Applicant: Healthdyne Technologies, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.

Device Story

The Protégé Liquid Oxygen System is a portable device designed to store and deliver supplemental oxygen to patients. It functions by holding liquid oxygen in a portable container, which is then converted to a gaseous state for inhalation by the patient at a flow rate determined by a physician. The device is intended for use by patients with respiratory conditions such as COPD to improve oxygenation. It is operated by the patient or caregiver in home or ambulatory settings. The system provides a continuous supply of oxygen, assisting in the management of chronic respiratory insufficiency.

Clinical Evidence

No clinical data provided; substantial equivalence is based on device design and intended use.

Technological Characteristics

Portable liquid oxygen storage and delivery system. Operates via physical conversion of liquid oxygen to gas for patient inhalation. Class II device, product code BYJ.

Indications for Use

Indicated for patients with lung disorders, including COPD, requiring supplemental oxygen at a physician-prescribed flow rate.

Regulatory Classification

Identification

A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.

Submission Summary (Full Text)

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

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 with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

JUL 2 5 1997

Mr. Jay Hayes Healthdyne Technologies 933 Western Drive Indianapolis, Indiana 46241

Re : K971545 Protégé Liquid Oxygen System Regulatory Class: II (two) Product Code: 73 BYJ Dated: April 25, 1997 Received: April 28, 1997

Dear Mr. Hayes:

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 requirements, 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 obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. Jay Hayes

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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

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

Enclosure

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

510(k) Number: K971545

Device Name: Portable Liquid Oxygen System BYJ

Indications For Use:

The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.

hyra

(Division Sign-On Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

- Prescription Use