PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)

K013223 · Litton Systems, Inc. · CAW · Feb 11, 2002 · Anesthesiology

Device Facts

• Record ID: K013223
• Device Name: PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
• Applicant: Litton Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Feb 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PVOCS is intended to supply medical grade air and oxygen (USP oxygen 99%) at 50 psig nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only.

Device Story

Patient Ventilation Oxygen Concentrating System (PVOCS) supplies medical grade air and USP 99% oxygen at 50 psig nominal and lower output pressures. Used in military hospitals, surgical suites, and clinical settings. Operated by clinical staff. Provides oxygen/air supply for patient ventilation. Benefits patients by ensuring consistent medical-grade gas delivery in military clinical environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen concentrating system providing USP 99% oxygen and medical grade air at 50 psig nominal output. Designed for military clinical use.

Indications for Use

Indicated for patients in military hospitals, surgical suites, and clinical settings requiring medical grade air and USP 99% oxygen at 50 psig nominal or lower output pressures.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. Gary Byrd Litton Systems, Inc. Life Support Division 2734 Hickory Grove Road Davenport, IA 52804

Re: K013223

Patient Ventilation Oxygen Concentrating System (PVOCS) Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II (two) Product Code: 73 CAW Dated: January 14, 2002 Received: January 14, 2002

Dear Mr. Byrd:

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. Gary Byrd

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a backed complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must in and listing and listing and listing or any Federal statutes and regulations daminding, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mortains, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFRT art 820); and if applicable, the electronic forth in the quality systems (QS) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wilf anow you to obgin manisang of substantial equivalence of your device to a legally premarket nother in the r DA miding of backand 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 If you desire specific advice to: your acvitoo diagnostic devices), please contact the Office of additionally 21 CFN Fart 807.10 101 m 11:10 cm. 10 cm. 11:00 promotion and advertising of Compliance at [phone]. Tuchio. Italy, liance at [phone]. Also, pease note the your device, prease oomavena a a by reference to premarket notification" (21CFR Part 807.97). It guilation chittied, "Misoranang of responsibilities under the Act may be obtained from the Other general information on your responsionation 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,

Dele Telle

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

Enclosure

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## SECTION 5: INDICATIONS FOR USE STATEMENT

510(k) Number (if known)__K013223

Device Name: Patient Ventilation Oxygen Concentrating System (PVOCS)

The PVOCS is intended to supply medical grade air and oxygen (USP oxygen 99%) at 50 psig nominal and lower output pressures in hospitals, surgical suites, and other clinical settings in military facilities only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Division of Cardiovascular & Respiratory Devices**
510(k) Number K013223

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________