(160 days)
Not Found
NONE
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest the use of AI/ML.
No
The device is an optional component of an oxygen delivery system used to conserve oxygen for patients with pulmonary disease, not to directly treat or diagnose a disease.
No
The device is described as an oxygen conserver for an oxygen delivery system used by patients with chronic obstructive pulmonary disease. Its function is to conserve oxygen by stopping flow during exhalation. This description clearly indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states "OXYGEN CONSERVER (VENTILATOR - NON CONTINUOUS)", which implies a hardware component for oxygen delivery and flow control, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an optional component of an oxygen delivery system for patients with chronic obstructive pulmonary disease. Its function is to conserve oxygen by controlling flow based on the patient's breathing. This is a therapeutic function, not a diagnostic one.
- Device Description: The description "OXYGEN CONSERVER (VENTILATOR - NON CONTINUOUS)" further reinforces its role in delivering oxygen, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment decisions based on in vitro analysis.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF.
THE DEVICE IS AN ORTIONAL COMPONENT OF THE OXYGEN DELI'VERY SYSTEM PRESCRIBED FOR USE USE PARTIENTS , SUFFERING FROM THE SOLE PURPOSE OF SYSTEM PRESCRIVED PULMONARY DISEASE. CHRONIC OBSTRUCTIVE PULMONARY DISENSE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN BY STOPPING THE FIOW WHEN THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN EXHALATION AND THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND . IS EXHALTIAC OK FRONING DEVICE SEMSES THE BECIMMING I NHAL ING. OF INHALATION BY THE USER.
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 (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
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 a stylized design featuring three curved lines that resemble a bird or a flame.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 2002
Mr. Gilbert Davidson Flotec, Inc. 8132 Woodland Drive Indianapolis, IN 46278
K970371 Re:
FLOTEC Oxysavrr™ Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II (two) Product Code: 73 NFB
Dear Mr. Davidson:
This letter corrects our substantially equivalent letter of July 10, 1997, regarding the FLOTEC Oxysavrr™. 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 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. Gilbert Davidson
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Dallas Tull
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
| 510(k) Number (if known): | K970371 |
|---|---|
| --------------------------- | --------- |
FLOTEC OXYGEN CONSERVER
| Device Name: | OXYGEN CONSERVER
(VENTILATOR - NON CONTINUOUS) |
|----------------------|---------------------------------------------------|
| Indications for Use: | |
Page one of one
THERE ARE NO INDICATIONS FOR USE OF THIS DEVICE BY ITSELF.
THE DEVICE IS AN ORTIONAL COMPONENT OF THE OXYGEN DELI'VERY SYSTEM PRESCRIBED FOR USE USE PARTIENTS , SUFFERING FROM THE SOLE PURPOSE OF SYSTEM PRESCRIVED PULMONARY DISEASE.
CHRONIC OBSTRUCTIVE PULMONARY DISENSE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN BY STOPPING THE FIOW WHEN
THIS DEVICE IS TO CONSERVE OXYGEN BY STOPEN EXHALATION AND THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND . IS EXHALTIAC OK FRONING DEVICE SEMSES THE BECIMMING I NHAL ING. OF INHALATION BY THE USER.
FLORTEC INC
Filbert Wilson
Chairman
EEDEDI NEEDED)
Concurrence of CORH, Office of Devise Evaluation (ODE)
Mr. Rugh
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K970371 |
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Over The-Counter Use
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