(111 days)
The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in-home or ambulatory application.
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This document is a 510(k) premarket notification letter from the FDA regarding the Flo-Rite and Flo-Rite II devices. This type of letter generally does not contain acceptance criteria or study results because it is not a clinical study report.
The letter states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."
Therefore, based on the provided document:
- A table of acceptance criteria and the reported device performance: Not available in this document. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance acceptance criteria from a pre-defined study.
- Sample sized used for the test set and the data provenance: Not available in this document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
- Adjudication method for the test set: Not available in this document.
- 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: Not applicable. This document is for a noncontinuous ventilator, not an AI-assisted device, and does not describe comparative effectiveness studies of human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document is for a noncontinuous ventilator, not an algorithm.
- The type of ground truth used: Not available in this document. The 510(k) pathway for this device would typically rely on engineering testing and performance data to demonstrate equivalence, not ground truth established by expert consensus or pathology in the context of clinical interpretation.
- The sample size for the training set: Not applicable as this is not an AI/ML device. Information about training sets would not be present.
- How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.
Summary from the provided document:
The document is a 510(k) clearance letter for a noncontinuous ventilator, the Flo-Rite and Flo-Rite II. The FDA determined the device is substantially equivalent to legally marketed predicate devices. The letter does not detail specific acceptance criteria, study designs, sample sizes, expert involvement, or ground truth establishment, as these are typically part of the regulatory submission itself rather than the clearance letter. The regulatory pathway for this device (Class II for a noncontinuous ventilator) focuses on demonstrating equivalence to predicates through engineering and performance data, rather than clinical studies with "ground truth" as might be seen for diagnostic devices or AI applications.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Mr. Matthew Thie Engineer Ameriflo Corporation 478 Gradle Drive Carmel, Indiana 46032
Re: K041057
Trade/Device Name: Flo-Rite and Flo-Rite II Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: July 9, 2004 Received: July 13, 2004
Dear Mr. Thie:
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. Thie
Please be advised that FDA's issuance of a substantial equivalence determination does not r least 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. of the Act of ally I oderal states and engirements, including, but not limited to: registration I ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT at 807), abouting systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in are qt 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) I mis letter will anon yourse of substantial equivalence of your device to a premailed notification - I 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), If you desire specific at Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may 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 vours,
Ouls
Shih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for AMERIFLO CORPORATION. The word "AMERIFLO" is in large, bold, black letters. To the right of the word is a graphic of six horizontal lines that are parallel to each other and decrease in length from top to bottom. Below the word "AMERIFLO" is the word "CORPORATION" in smaller, black letters.
478 Gradle Dr. • Carmel Industrial Park • Carmel, IN 46032 • 800-976-2390 • 317-844-2019 • Fax 317-844-7164 www.ameriflo.com
Indications for Use
510 (k) Number (if known): K041057
Device Name: Flo-Rite and Flo-Rite II
Indications for Use: The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in-home or ambulatory application.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
2-1
AP
§ 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).