(111 days)
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No
The summary provides no information suggesting the use of AI or ML. It describes a mechanical device for oxygen delivery.
Yes
The device is described as being used for "supplemental oxygen therapy," which is a therapeutic intervention.
No
Explanation: The device, the Flo-Rite Conserving Device Regulator, is described as being used "in conjunction with a portable oxygen tank for supplemental oxygen therapy." Its function is to regulate, or conserve, the oxygen from the tank, which is a therapeutic function rather than a diagnostic one. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The description explicitly states the device is a "Conserving Device Regulator" used in conjunction with a "portable oxygen tank," implying a physical hardware component that regulates oxygen flow. There is no mention of software as the primary or sole component.
Based on the provided information, the Flo-Rite Conserving Device Regulator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "supplemental oxygen therapy for in-home or ambulatory application," used in conjunction with a portable oxygen tank. This describes a device used on a patient to deliver a therapeutic gas, not a device used to examine specimens outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic or monitoring information based on sample analysis
The device described is a medical device used for delivering oxygen, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Product codes
NFB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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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 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.
1
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
2
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