PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)

K051887 · Carleton Life Support Systems, Inc. · CAW · Sep 27, 2005 · Anesthesiology

Device Facts

• Record ID: K051887
• Device Name: PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF)
• Applicant: Carleton Life Support Systems, Inc.
• Product Code: CAW · Anesthesiology
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PVOCS HF system is intended to provide respiratory gases to include pre and post operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used in military field hospitals and other applications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use. It is appropriate for use by military personnel only.

Device Story

Dual-mode medical gas system; supplies 93% oxygen and medical-grade air. Inputs: separate compressed air supply. Transformation: pressure swing adsorption (PSA) using synthetic zeolite to concentrate oxygen; filtration and drying for medical air. Outputs: oxygen at 6-psig (nasal cannula) and 50-psig (ventilators); medical air at 50-psig. Includes storage plenum (purge tank) to maintain flow during high demand. Used in military field hospitals; operated by military personnel. Provides respiratory support and pneumatic power for ventilators/anesthesia machines; benefits patients by ensuring oxygen availability in austere environments where traditional cylinders/liquid oxygen are impractical.

Clinical Evidence

Bench testing only. Testing verified system capability to produce 30 lpm of USP 93% oxygen and 30 lpm of medical-grade air in High Flow mode, and 20 lpm of USP 93% oxygen and 75 lpm of medical-grade air in Low Flow mode.

Technological Characteristics

Dual-mode medical gas system; pressure swing adsorption (PSA) technology using synthetic zeolite; 6-psig and 50-psig output ports; storage plenum (purge tank) for flow stability; requires external compressed air source.

Indications for Use

Indicated for military personnel requiring respiratory gases, including pre/post-operative oxygen, pneumatic drive gas for ventilators/anesthesia machines, and oxygen enrichment for ventilators/anesthesia machines in settings where traditional high-pressure or liquid oxygen is unavailable or unsafe.

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).

Predicate Devices

• Patient Ventilation Oxygen Concentrating System (PVOCS) (K013223)

Submission Summary (Full Text)

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# SECTION 11: PREMARKET NOTIFICATION [510(K)

February 21, 2005 Date:

Carleton Life Support Systems, Inc. Applicant: 2734 Hickory Grove Road Davenport, IA 52804

563-383-6299 Phone: [phone] FAX:

Gary Byrd, Medical Oxygen Engineering Manager Contact:

Trade Name: Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF)

Common Name: Oxygen Concentrator

Classification Name: Generator, Oxygen , Portable

Establishment Registration Number: 3002840531

Legally Marketed Device to which Substantial Equivalence is claimed: Patient Ventilation Oxygen Concentrating System (PVOCS) K013223

## Description

The PVOCS HF is a dual-mode medical gas system which supplies both oxygen-enriched gas at 93 ± 3% oxygen (hereafter referred to as OXY 93% or USP Oxygen 93%) and medical-grade air (MED AIR). In the High Flow OXY 93% mode, the PVOCS HF can supply up to 30 lpm of oxygen and 30 lpm of medical-grade air, and in the Low Flow OXY 93% mode oxygen mode, up to 20 lpm of oxygen and 75 lpm of medical-grade air. The system requires a separate compressed air supply from which oxygen is concentrated using pressure swing adsorption (PSA) techniques with synthetic zeolite. The oxygen is supplied at two low-pressure (6-psig) ports for patient respiration via nasal cannula and four moderate-pressure (50-psig) ports for patient ventilators. A storage plenum (purge tank) is included in the product line to ensure that short-term, high-demand flows do not cause a drop in oxygen concentration or pressure drops below rated output pressure in the product gas. The medical-grade air is provided to four ports at 50 psig by filtering the compressed air supply and drying it using PSA techniques.

#### Indications for Use

The PVOCS HF system is intended to provide respiratory gases to include pre and post operative respiratory oxygen, pneumatic drive gas for ventilators and anesthesia machines, and oxygen enrichment for ventilators and anesthesia machines. It may be used

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in military field hospitals and other upplications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use. It is appropriate for use by military personnel only.

# Technological Summary

The PVOCS HF uses the same technology, the pressure swing adsorption process, as the predicate device to produce USP 93% oxygen and medical grade air.

## Performance

Non-clinical bench testing by Carleton Life Support Systems, Inc. verified that the system is capable of producing up to 30 lpm of of USP 93% oxygen and 30 lpm of medical grade air in the High Flow mode and 20 lpm of USP93% oxygen and 75 lpm of medical grade air in the Low Flow mode.

#### Conclusions

Based upon the nonclinical bench testing and analysis provided, the PVOCS HF is substantially equivalent to the predicate device PVOCS.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services in the USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are written around the edge of the circle.

Public Health Service

SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Byrd Carleton Life Support Systems Inc. 2734 Hickory Grove Road Davenport, Iowa 52804-1203

Re: K051887

Trade/Device Name: Patient Ventilation Oxygen Concentrating System, High Flow Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: July 7, 2005 Received: July 12, 2005

Dear Mr. Byrd:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 conimered provises 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). and Cosmetic Free (110) and the device, subject to the general controls provisions of the Act. The I ou may, ateres, and servisions 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 may or sations to ouch as a suese al 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. Byrd

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat 1 Dri 3 issuance or a cadesice complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cach statutes and regarations and limited to: registration and listing (21 Colliply with an the Free STequirements)01); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro histors (seting your device as described in your Section 510(k) This icture will anow you to begin mationing of substantial equivalence of your device to a legally premarket notification: "The PDF intaing of the more 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 If you ucsire specific advice for your as 0) 276-0120. Also, please note the regulation entitled, Comaci the Office of Comparket notification" (21CFR Part 807.97). You may obtain Missuranting Uy reference to premaintentibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Clre

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): K051887

Device Name: Patient Ventilation Cxygen Concentrating System, Hi Flow (PVOCS HF)

Indications For Use: The PVOCS HF system is intended to provide respiratory gases to midleations For USe. The F VOSO fir System on, pneumatic drive gas for ventilators, Include ple and post operator. Toopiratory onlygon for ventilators and anesthesia
and anesthesia machines, and oxygen enrichment for ventilators and innounbest and anesthesia machines, and oxygoff of hospitals and other applications when oxygen machines. It may be used in military not available, practical, or safe to use. It is appropriate for use by military personnel only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qun Suliom
(Division Sign-Off)

( Civision Oigh-Old)
Division of Anesthesionogy, General Hospital, Infection Control, Dental Devi

510(k) Number: K051887

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