PLIX

K050414 · Respironics, Inc. · BYJ · Apr 11, 2005 · Anesthesiology

Device Facts

• Record ID: K050414
• Device Name: PLIX
• Applicant: Respironics, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The PLOX is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Device Story

PLOX is a double-walled, vacuum-insulated cryogenic vessel; stores ~1 lb liquid oxygen at 22 psig. Operates via heat exchange tubing, relief valves, and pneumatic conserving device within a plastic enclosure. Liquid oxygen converts to near-ambient temperature gaseous oxygen via warming coils; delivered to patient via single lumen nasal cannula. Designed for ambulatory use; refilled from industry-standard stationary liquid oxygen units. Provides three modes: conserve, continuous, and off. Mechanical device; no electronics or software. Benefits patients by providing portable supplemental oxygen for ambulatory activities.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Double-walled vacuum-insulated cryogenic vessel; plastic enclosure. Mechanical operation; no electronics or software. Energy source: stored cryogenic pressure (22 psig). Dimensions/form factor: portable vessel. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients requiring supplemental oxygen due to difficulty extracting oxygen from air; typically administered via nasal cannula. Intended for ambulatory use inside and outside the home. Not for life support or life sustaining use. No contraindications.

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.

Predicate Devices

• Puritan-Bennett Helios Portable Liquid Oxygen System (K993220)

Submission Summary (Full Text)

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PLOX

Official Contact Zita Yurko Manager, Regulatory Affairs Respironics Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Phone: [phone] Fax: [phone] [e-mail] PLOX Proprietary Name Portable Liquid Oxygen System Common/Usual Name Portable liquid oxygen unit. (BYJ). Classification Name Puritan-Bennett Helios Portable Liquid Oxygen System Predicate Devices (K993220)

## Device Description

The PLOX is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The PLOX is a mechanical device and does not contain any electronics or software. The PLOX is designed to be refiled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

The PLOX provides three modes of operation: conserve mode, continuous mode, and off mode.

## Indications for Use

The PLOX is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a snake winding around a staff.

Public Health Service

APR 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Intertek ETL SEMKO 3033 Madison Avenue SE Grand Rapids, Michigan 49548

Re: K050414

Trade/Device Name: Respironics PLOX Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: March 25, 2005 Received: March 28, 2005

Dear Mr. Devine:

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 (1111), it may of be abyed 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. Devine

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 moun that I Dri may 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 and inoments 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) rms retet notification. The FDA finding of substantial equivalence of your device to a promation is the motion on 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), nlease 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 vours,

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

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The PLOX is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ques

ision of Anesthesiciogy, General Hospital, Intection Control, Dental De

510(k) Number K05044