(29 days)
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No
The provided 510(k) summary contains no mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technologies in medical devices. The description focuses solely on measuring oxygen uptake.
No
Explanation: The device is intended to measure oxygen uptake, which is a diagnostic or research function, not a therapeutic intervention.
Yes
The MedGem measures oxygen uptake, which is a physiological parameter used to assess body functions, thereby supporting diagnosis or monitoring of health conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes measuring oxygen uptake, which typically involves hardware sensors.
Based on the provided information, it is unlikely that the MedGem is an IVD (In Vitro Diagnostic) device. Here's why:
- Intended Use: The intended use is to "measure oxygen uptake." This is a physiological measurement taken directly from a living organism (likely a human). IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Lack of Mention of Specimens: There is no mention of the device being used with any type of biological specimen.
- Focus on Oxygen Uptake: Measuring oxygen uptake is typically done through respiratory analysis, which involves breathing into or through a device. This is an in vivo measurement.
While the device is intended for "clinical and research applications," which can sometimes involve IVDs, the specific function described (measuring oxygen uptake) points away from it being an IVD.
In summary, the description strongly suggests the MedGem is a device for physiological measurement in vivo, not an IVD for analyzing specimens in vitro.
N/A
Intended Use / Indications for Use
The MedGem is intended for use in clinical and research applications to measure oxygen uptake.
Product codes
BZL
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1730 Oxygen uptake computer.
(a)
Identification. An oxygen uptake computer is a device intended to compute the amount of oxygen consumed by a patient and may include components for determining expired gas volume and composition.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 4 2002
HealtheTech, Inc. c/o Glenn M. Thibault 523 Park Point Dr. Golden, CO 80401
Re: K021605
MedGem Regulation Number: 21 CFR 868.1730 Regulation Name: Oxygen Uptake Computer Regulatory Class: Class II (two) Product Code: BZL Dated: May 15, 2002 Received: May 16, 2002
Dear Mr. Thibault:
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.
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
1
Page 2 - Mr. Glenn M. Thibault
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 vours.
Dakota Tuth
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section D - Statement of Indications for Use
| 510(k) Number: | K021605 |
|---|---|
| ---------------- | --------- |
MedGem Device Name:
Indications for Use: The MedGem is intended for use in clinical and research applications to measure oxygen uptake.
Prescription Use
(per 21 CFR 801.109)
or
Over-the -- Counter Use_______________________________________________________________________________________________________________________________________________________
Division of Cardiovascular & Respiratory Devices
510(k) Number K021165