(77 days)
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.
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.
This document describes the Patient Ventilation Oxygen Concentrating System, High Flow (PVOCS HF). However, it does not contain a study section with acceptance criteria and device performance in the format requested. The provided text is a 510(k) premarket notification for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing rather than detailed clinical trial results with specific acceptance criteria as might be found in a later-stage study.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions performance benchmarks but these are stated as capabilities rather than formal acceptance criteria. No explicit "acceptance criteria" are defined.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | High Flow OXY 93% mode: - Up to 30 lpm of USP 93% oxygen - Up to 30 lpm of medical grade air |
| Not explicitly stated in the document | Low Flow OXY 93% mode: - Up to 20 lpm of USP 93% oxygen - Up to 75 lpm of medical grade air |
| Not explicitly stated in the document | Oxygen concentration: 93 ± 3% oxygen |
| Not explicitly stated in the document | Oxygen port pressure: 6-psig (low-pressure) or 50-psig (moderate-pressure) |
| Not explicitly stated in the document | Medical-grade air port pressure: 50 psig |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. The "study" mentioned is "Non-clinical bench testing," which typically involves evaluating the physical device's output and specifications, not a patient-related test set.
- Data provenance: "Non-clinical bench testing by Carleton Life Support Systems, Inc." Implies internal company testing, likely in their facilities (Davenport, IA, USA would be the most likely location).
- Retrospective or prospective: Not applicable for bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was non-clinical bench testing assessing physical and chemical properties (oxygen concentration, flow rates, pressure), not a study requiring expert interpretation of medical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was non-clinical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is a medical device (oxygen concentrator), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for non-clinical bench testing would be established engineering specifications, chemical analysis standards, and measurement protocols for parameters like oxygen concentration, flow rate, and pressure. These are not derived from expert consensus, pathology, or outcomes data in the medical sense.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/machine learning algorithm.
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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: 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
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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 (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
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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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§ 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).