(182 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, deep learning, or training/test sets for algorithms. The device description focuses on a mechanical oxygen conserving regulator.
Yes
The device is used for "supplemental oxygen therapy," which is a medical treatment.
No
Explanation: The device is an oxygen conserving regulator used for delivering supplemental oxygen, not for diagnosing medical conditions.
No
The device is described as a "Regulator" used in conjunction with a portable oxygen tank, implying a physical hardware component to control oxygen flow. 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 clearly states it's for delivering supplemental oxygen to patients. This is a therapeutic application, not a diagnostic one.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of Biological Samples: IVDs are used to examine biological samples (blood, urine, tissue, etc.) to diagnose or monitor conditions. There is no mention of this device interacting with biological samples.
- No Mention of Diagnostic Purpose: The purpose is to provide oxygen therapy, not to diagnose a disease or condition.
Therefore, the TheraFlow Oxygen Conserving Device Regulator is a medical device used for therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.
Product codes
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
adult patients
Intended User / Care Setting
prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility.
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
§ 868.5905 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, with three curved lines representing the wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 11. 2013
Medical Products, LLC Mr. David Mcgill President 7437 Oaklandon Road INDIANAPOLIS IN 46236
Re: K131023
Trade/Device Name: TheraFlow Single and Dual Lumen Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: September 11, 2013 Received: September 13, 2013
Dear Mr. Mcgill:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Mcgill
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.lda.gov/MedicalDevices/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID
Kwame Ulmer M.S.
Acting Division Director
FOR
Division of Anesthesiology, General Hospital,
Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): _ K131023 Device Name: TheraFlow
Indications for Use: The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
altally signed by Anva C. Harry -S
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1