(137 days)
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.
Not Found
I'm sorry, but without further details about specific acceptance criteria and the study that proves the device meets them, I cannot provide the requested information. The provided text is a 510(k) clearance letter from the FDA for a Patient Ventilation Oxygen Concentrating System (PVOCS), which confirms its substantial equivalence to a predicate device. However, it does not include the details of acceptance criteria or performance study results.
To answer your request, I would need a document that outlines:
- Specific performance metrics for the PVOCS (e.g., oxygen concentration accuracy, flow rate stability, noise levels, reliability, safety parameters).
- Target thresholds or ranges for these metrics that define "acceptance."
- The details of a study conducted to evaluate the PVOCS against these criteria. This study description would typically include:
- Study design (e.g., bench testing, animal study, clinical trial)
- Methodology
- Results for each acceptance criterion
- Sample sizes (if applicable)
- Ground truth establishment and adjudication (if applicable, for clinical studies)
- Expert qualifications (if applicable)
- Details about training sets (if AI/ML components were involved, which is unlikely for this type of device from 2002).
The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, often relying on existing standards and predicate device performance, rather than requiring a detailed report of a new, comprehensive performance study with explicit acceptance criteria for this specific submission. While the manufacturer would have conducted internal testing to ensure the device met its own specifications and relevant standards, those detailed reports are typically not part of the FDA's public 510(k) clearance letter.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
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 (301) 594-1010. Tuchio. Italy, liance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 _________________________________________________________________________________________________________________________________________________________
§ 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).