(77 days)
Not Found
No
The description focuses on the physical and functional aspects of a gas supply system using pressure swing adsorption, with no mention of AI or ML technologies.
Yes
The device is intended to provide respiratory gases, including oxygen enrichment, directly to patients through ventilators or nasal cannulas, which is a therapeutic function.
No
The device is described as supplying respiratory gases (oxygen-enriched gas and medical-grade air), which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a hardware system that generates and supplies medical gases using pressure swing adsorption techniques, filters, and storage tanks. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide respiratory gases (oxygen and medical-grade air) for patient respiration and to power ventilators and anesthesia machines. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The device description details the process of generating and supplying gases, not analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly designed to provide a medical gas supply for patient care, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
CAW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
military personnel / military field hospitals and other applications where oxygen stored in high pressure cylinders or liquid oxygen is not available, practical or safe to use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
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).(b)
Classification. Class II (performance standards).
0
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: 563-383-6107 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
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
4
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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