LIQUID OXYGEN SYSTEM

K032143 · Micro Technology Services, Inc. · BYJ · Mar 30, 2004 · Anesthesiology

Device Facts

• Record ID: K032143
• Device Name: LIQUID OXYGEN SYSTEM
• Applicant: Micro Technology Services, Inc.
• Product Code: BYJ · Anesthesiology
• Decision Date: Mar 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5655
• Device Class: Class 2

Intended Use

The LOX-Stat electronic contents gauge is intended for use with the Puritan Bennett companion 21/31/41 Liquid Oxygen Reservoirs to digitally display the liquid oxygen content remaining in the tank.

Device Story

LOX-Stat is an electronic contents gauge designed for integration with Puritan Bennett companion 21/31/41 liquid oxygen reservoirs. It measures the remaining liquid oxygen volume within the tank and provides a digital readout. The device assists users in monitoring oxygen supply levels, ensuring timely refills or replacements. It is intended for use in clinical or home environments where these specific reservoirs are utilized. By providing accurate, real-time content data, the device helps patients and caregivers manage oxygen therapy effectively and avoid unexpected depletion of the oxygen supply.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic contents gauge; digital display; designed for compatibility with Puritan Bennett companion 21/31/41 liquid oxygen reservoirs. No specific materials, energy sources, or software architecture details provided.

Indications for Use

Indicated for use with Puritan Bennett companion 21/31/41 Liquid Oxygen Reservoirs to provide a digital display of remaining liquid oxygen content.

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)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2004

Tommy Buie, P.E. V.P. Engineering Micro Technology Services, Incorporated 1819 Firman, Suite 137 Richardson. Texas 75081

Re: K032143

Trade/Device Name: LOX-Stat Liquid Oxygen Reservoir Content Gauge Regulation Number: 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: February 3, 2004 Received: February 4, 2004

Dear Mr. Buie:

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. In addition, if you wish to change or expand your current indications for use to include non-military environments, you will need to submit a new 510(k) premarket notification, and receive FDA clearance prior to marketing the device.

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. Tommy Buie, P.E.

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/dsma/dsmamain.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): K032143

Device Name: LOX-Stat Liquid Oxygen Reservoir Content Gauge

Indications For Use:

The LOX-Stat electronic contents gauge is intended for use with the Puritan Bennett companion 21/31/41 Liquid Oxygen Reservoirs to digitally display the liquid oxygen content remaining in the tank.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesia

of Anesthesiology, General Hospital, tion Control, De ಕ

510(k) Number.