(137 days)
Not Found
None
No
The summary describes a system for supplying medical gases and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device supplies medical-grade air and oxygen, but does not perform any therapeutic function itself. It acts as a utility or infrastructure device for other medical equipment.
No
Explanation: The device is described as supplying medical grade air and oxygen, which indicates it is a therapeutic or life-support device, not a diagnostic one used for identifying diseases or conditions.
No
The intended use describes a device that supplies medical grade air and oxygen, which inherently involves hardware components for gas handling and delivery. The summary does not mention any software-only functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply medical grade air and oxygen for clinical settings. This is a life support or medical gas delivery function, not a diagnostic test performed on samples taken from the human body.
- Device Description: While the description is "Not Found," the intended use clearly defines its function as providing gases, not analyzing biological samples.
- No Mention of IVD Activities: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is the core function of an IVD.
- No Mention of Diagnostic Results: The device provides gases, not diagnostic results or information about a patient's health status based on sample analysis.
Therefore, the PVOCS, as described, falls under the category of a medical device used for patient care and support, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
73 CAW
Device Description
Patient Ventilation Oxygen Concentrating System (PVOCS)
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
hospitals, surgical suites, and other clinical settings in military facilities only.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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.
1
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
2
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 _________________________________________________________________________________________________________________________________________________________