(25 days)
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to infer such technology.
Yes
The device is described as an "oxygen conserving pressure regulator for ambulatory patients," which directly relates to providing a medical therapy (oxygen delivery).
No
The "Intended Use" states it is an "oxygen conserving pressure regulator for ambulatory patients," which describes a therapeutic or life-support function, not a diagnostic one.
No
The device is described as an "oxygen conserving pressure regulator," which is a hardware device. The summary does not mention any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an oxygen conserving pressure regulator for ambulatory patients." This describes a device used to deliver oxygen to a patient, which is a therapeutic or life-support function, not a diagnostic test performed on samples taken from the body.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample, which is a core characteristic of IVDs.
- No mention of diagnostic testing: The intended use is about delivering oxygen, not diagnosing a condition or disease.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The O2n Demand-II does not fit this description.
N/A
Intended Use / Indications for Use
The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).
Product codes
73 NFB
Device Description
Not Found
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of flowing lines. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. Dick Langford Victor Equipment Company P.O. Drawer 1007 Denton, TX 76202
K992659 Re:
K992659
O2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II)
Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Langford:
This letter corrects our substantially equivalent letter of September 3 1999, regarding the This letter corrects our substantially equivalent news of onserving Pressure Regulator-II (OCPRO2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving correct product co O2n Demand-II, Victor Model OCF X-II, and Oxygon Geller Ally
II). Our letter identified the product code as 73 BZD. This is in error; the correct product code is 73 NFB as indicated above.
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) prematice is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) it regally nianced tecalcal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance was as archives and over of the Act. The and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general construction f You may, therefore, market the device, subject to the gentlation, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act mender requirement.
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 If your device is classified (see above) nito crain to as if ependations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controls. Existing mays of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 500 to 898. In addition be found in the Code of Federal Regalations, in the Federal Register.
1
Page 2 -- Mr. Dick Langford
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualice of a succession with other requirements of the Act
that FDA has made a determination that your device complies with opension . You must that FDA has made a decemmanon that your arres by other Federal agencies. You must or any Federal statutes and regulations administer of registration and listing (21
comply with all the Act's requirements, including, but not mastice requirements as set comply with all the Act S requirements, monamas comments or crice requirements as set
CFR Part 807); labeling (21 CFR Part 801); and if explicable, the electronic CFR Part 807); iabeling (21 CFR Pat 801); good analities (21); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) regulation (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)
10 legally This letter will allow you to begin makemig your artial equivalence of your device to a legally premarket notification. The FDA inding of substantial of are 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 for your devices), please contact the Office of additionally 21 CFK Part 809.10 for miro attends on the promotion and advertising of
Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertisi Compliance at (301) 594-4046. Additionally, 18. queen (301) 594-4639. Also, please note the your device, prease contact the Offee of eet career to premarket notification's and 807.97).
regulation entitled, "Misbranding by reference to premarket many be obtained from regulation entitled, "Misoraliung of reference to printer the Act may be obtained from the Other general miorination on your responsionated and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 2011 fda gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Der Tulli
-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
Page
510(K) Number (if known): x992659 (Special 510 (k): Device Modification)
02N-Demand-II Device Name:
Indications For Use: The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
USD
Concultrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
W. Roff
- on Sign-Off) of Cardiovascular, Respiratory, ಿದ ಅಂದಾlegical Devices
510(k) Number _