(545 days)
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No
The summary describes a system for generating oxygen using molecular sieve technology and does not mention any AI or ML components.
Yes
The device is described as providing "supplemental product oxygen" and "supplemental delivery for oxygen therapy," directly indicating its use for therapeutic purposes.
No
Explanation: The device is described as an "Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen... for oxygen therapy." This indicates it is a therapeutic device that provides oxygen, not a device used to diagnose a medical condition.
No
The device description and intended use clearly describe a system that produces and delivers oxygen, which involves physical hardware (molecular sieve technology, cylinders, distribution system). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen for oxygen therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an "Oxygen concentration system" that produces oxygen. This aligns with a therapeutic device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not 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 information for diagnosis, monitoring, or screening
Therefore, the FreshAir System, as described, is a medical device used for oxygen therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.
Note: The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)
Product codes
73 CAW
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three lines representing the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP | 6 1999
Mr. John Kortgardner Colorado MEDtech, Inc. 6175 Longbow Drive Boulder, CO 80301
K981047 Re: Fresh Air Project Regulatory Class: II (two) Product Code: 73 CAW Dated: Auqust 13, 1999 Received: August 23, 1999
Dear Mr. Kortgardner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. John Kortgardner
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION E
Product Information
Revised: 7/19/99
K981047 510 (k) number:_______________________________________________________________________________________________________________________________________________________________
Device Name: FreshAir System
Indications for Use:
Prescription Use
(Per 21 CFR 801.109)
Oxygen concentration by means of molecular sieve technology, yielding supplemental product oxygen in conformance with official USP designation "Oxygen 93 Percent", and supplemental delivery for oxygen therapy.
Note:
The intended use of this system is as a secondary oxygen source. The primary oxygen source for the facility is normally provided by liquid oxygen and distributed in a gaseous state via (typically) 'H' or 'K' supply cylinders in a conventional configuration. (reference: NFPA 99C,1996, fig. 4-3.1.1.6)
Please do not write below this line - Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Over-the-Counter-Use__________________________________________________________________________________________________________________________________________________________
| (Division Sign-Off) |
|---|
| Division of Cardiovascular, Respiratory, |
| and Neurological Devices |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
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