(64 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description points to a mechanical or electronic regulator for oxygen flow.
No.
The device is a regulator for a portable oxygen tank, which is used for oxygen therapy. The regulator itself is not a therapeutic device but an accessory for delivering therapy.
No
Explanation: The device is described as an "oxygen tank for supplemental oxygen therapy," which is a treatment device, not a diagnostic one.
No
The device description explicitly refers to a "Conserving Device Regulator," which is a hardware component used with oxygen tanks. The summary does not mention any software-only aspects.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The device names (Flo-Rite, etc.) and the description of its function (regulating oxygen flow from a tank) are consistent with a medical device used for respiratory support, not for diagnostic testing of biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring biomarkers.
Therefore, the Flo-Rite Conserving Device Regulator is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.
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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three wavy lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2005
Mr. Matthew Thie Ameriflo Corporation 478 Gradle Drive Carmel Industrial Park Carmel, Indiana 46032
Re: K060382
Trade/Device Name: Flo-Rite, Flo-Rite II, Neumatix, Simpulse and Simpulse II Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: II Product Code: NFB Dated: March 16, 2006 Received: March 21, 2006
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. Matthew Thie
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,
Ynitta Y. Mcharlins.
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, sans-serif font, with the letters slightly slanted to the right. To the right of the word "AMERIFLO" are five horizontal lines of varying lengths, creating a sense of motion or speed. Below the word "AMERIFLO" is the word "CORPORATION" in a smaller, sans-serif font.
478 Gradle Dr. • Carmel Industrial Park • Carmel, IN 46032 • 800-976-2390 • Fax 317-844-7164 • www.ameriflo.com
Indications for Use
510(k) Number (if known): K060382 Device Name: _ Flo-Rite, Flo-Rite II, Nuematix, Simpulse and Simpulse II.
The Flo-Rite Conserving Device Regulator is intended for Indications for Use: 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 OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Vinu Abraham
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AMP
Manufacturers of quality gas flow control equipment and medical products