(80 days)
Not Found
Not Found
No
The summary describes a mechanical device for oxygen delivery and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device delivers oxygen, which can be a therapeutic intervention, but the description solely identifies it as a "demand oxygen delivery system" that "extends and offers cost savings." It appears to be an accessory for oxygen delivery, not a standalone therapeutic device itself.
No
The device description states it is a "demand oxygen delivery system that delivers oxygen only during inspiration," which describes a therapeutic function, not a diagnostic one.
No
The device description clearly identifies the device as an "Oxygen Conserving Pressure Regulator," which is a hardware component used in oxygen delivery systems. 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 describes a system that delivers oxygen during inspiration. This is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "Oxygen Conserving Pressure Regulator" further reinforces that this is a device for managing oxygen delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Oxygen Conserving Pressure Regulator, as described, is a medical device used for oxygen therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
INDICATIONS FOR USE: The Oxygen Conserving Pressure Regulator (OCPR) is a demand oxygen delivery system that delivers oxygen only during Inspiration. The OCPR extends and cost savings.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. R. Clark Sherwin, P.E. Victor Equipment Company P.O. Drawer 1007 Denton, TX 76202
K963247 Re: Oxygen Conserving Pressure Regulator Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Sherwin:
This letter corrects our substantially equivalent letter of November 7, 1996, regarding Oxygen This letter corrects our substantially equivalent ictier of Norther May 19, 2017 - 11:40
Conserving Pressure Regulator. Our letter identified the product code as 73 BZD. Thi Conservilly I ressure regulared 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 > IV(x) prematics is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed previce Amendments, for use stated in the enclosire) to legally market treated nedices Device Amendments, or to
commerce prior to May 28, 1976, the enactment with the provision of the Federal Fo commerce prior to May 28, 1976, the enactnent usel of the Federal Food, Drug, devices that have been reclassified in accordance while proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject on the general ocamal registration, listing of
general controls provisions of the Act Indians and mobibitions and general controls provisions of the Act Include requirements see in the county misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in the can If your device is classified (see above) into entire) class if topedial one affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Exismig major regarder on and comments of the may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In add be found in the Code of Federal Regulations, Frid Box 1, 2017, 1977, 1997, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 1991, 199
1
Page 2 - Mr. R. Clark Sherwin, P.E.
r age."
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's lissuance of a substantial with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a determination that your dover Federal agencies. You must
or any Federal statutes and regulations administered by other Federal on and listin or any Federal statutes and regulations administered to: registration and listing (21
comply with all the Act's requirements, including, but not limited to set comply with all the Act's requirements, including, our ive requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacture; prist are electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (QS) regulation (21 CFR Part obs) and 11 Trial (11
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the may of a This Calinn of exhatential equivalence of your device t This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inude of substantial equir device and th premarket notification. The FDA finding of substantal equivalence of 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 tor your device on on rabeting regulates contact the Office of
additionally 21 CFR Part 809.10 for in a cuestions on the promotion and advertisi additionally 21 CFR Part 809.10 for my to ruestions on the promotion and advertising of
Compliance at (301) 594-4648. Additionally, for questions on the promotion and adverti Compliance at (301) 594-4648. Additionshy, tor quested. on also . Also, please note the your device, please contact the Office of Complanses on premarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket and may be o regulation entitled, "Misbranding by relective a pronder the Act may be obtained from the Other general information on your responsibilities international and its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-f Division of Sinan Manazalian (301) 443-6597 or at its Internet address (800) 038-2041 of (501) ++0 0397 or and on http://www.fda.gov/cdrch/dsmamain.html
Sincerely yours,
for
Da Th
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
UC (BROWN).
510(k) Number (if known): _
Oxygen Conserving Pressure Regulator
K96 32 47
Page 1 of 1
Device Name: _
Indications For Use:
Indications Por Georgen Conserving Pressure Regulator (OCPR) is a
INDICA TIONS FOR USE: The Oxygen Conserving Pressure Regulator the Personal States the Beats willes INDICATIONS FOR USE: The Oxygen Conserving Pressure Regulator (OO Alle
demand oxygen delivery system that delivers oxygen only during instructures the stransation the learne INDICATIONS FOR USE: The Oxygen Only during Inspiration on
demand oxygen delivery system that delivers oxygen only during and ost saving and ost saving and cost saving and co INDICATIONS Stephens system that delivery only . The OCPK extends and one
demand oxygen delivery system that delivery steady flow. The OCPK extends and cost savings.
useful
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
E FELE NEEDED) PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard M. Phillips
nvision Sign-Off)
Division of Cardiovascular, Respiratory, Division of Canaly
Ind Neurological Devices Devices 63247 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use Over-The-Counter 1-2-96)
(Optional Format 1-2-96) (Optional Format OR