(160 days)
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.
OXYGEN CONSERVER (VENTILATOR - NON CONTINUOUS)
This document is a 510(k) cleared letter from the FDA for the FLOTEC Oxysavrr™, a noncontinuous ventilator. It primarily focuses on the regulatory clearance and a correction to a product code.
Based on the provided text, the following information regarding acceptance criteria and a study is available:
-
A table of acceptance criteria and the reported device performance:
The document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a study report. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not mention any test set sample size or data provenance. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The document does not mention any experts used to establish ground truth or their qualifications. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not mention any adjudication method. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The document does not mention an MRMC comparative effectiveness study, nor does the device appear to be an AI-assisted device. The device is described as an "Oxygen Conserver" that stops oxygen flow during exhalation. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document does not mention any standalone performance study. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not describe the type of ground truth used. -
The sample size for the training set:
The document does not mention a training set sample size. This device is a medical device, not an AI or machine learning algorithm, and thus the concept of a "training set" in this context is not applicable. -
How the ground truth for the training set was established:
The document does not mention how ground truth for a training set was established.
Summary of what is present in the document:
- Device Name: FLOTEC Oxysavrr™ (also referred to as FLOTEC OXYGEN CONSERVER)
- Regulation Number: 868.5905
- Regulation Name: Noncontinuous Ventilator
- Regulatory Class: II (two)
- Product Code: 73 NFB
- Indications for Use: "THE DEVICE IS AN OPTIONAL COMPONENT OF THE OXYGEN DELIVERY SYSTEM PRESCRIBED FOR PATIENTS, SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THIS DEVICE IS TO CONSERVE OXYGEN BY STOPPING THE FLOW WHEN THE PATIENT IS EXHALING OR PAUSING BETWEEN EXHALATION AND INHALATION. THE DEVICE SENSES THE BEGINNING OF INHALATION BY THE USER."
- Regulatory Status: Substantially Equivalent (510(k) clearance) to legally marketed predicate devices.
Conclusion:
This document is a regulatory approval letter and does not contain the detailed technical study information requested regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, or comparative effectiveness. The device described is a mechanical oxygen conserver, not an AI or diagnostics device that would typically involve many of the requested study elements.
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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.
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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
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| 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 |
: } : {
Over The-Counter Use
(Optional Formai 1-2-96)
iri cooripuon lise ﺳﮯ (Per 2: Oria 80) 109:
§ 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).