(29 days)
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No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered image analysis.
No
The device is described as producing images for interpretation by a physician, which indicates a diagnostic rather than a therapeutic purpose.
Yes
The device is used to produce images that can be interpreted by a trained physician, implying it aids in the diagnostic process by providing visual information for medical analysis.
No
The summary describes a device used "in conjunction with a Magnetic Resonance Scanner" to produce images. This strongly implies a hardware component (the scanner itself) is integral to the device's function, even if the summary doesn't explicitly detail the device's hardware. A software-only device would typically process data from an existing source without being directly integrated with a hardware imaging system in this manner.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The intended use of this device is to produce images of the head using a Magnetic Resonance Scanner. This is an in vivo imaging process, meaning it is performed on a living organism, not on a sample taken from the body.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples. The device's function is solely related to image acquisition.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce 16 be about images of the head, that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
HRH-127 Allegra Head Array Coil
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
Head
Indicated Patient Age Range
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Intended User / Care Setting
Trained physician
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)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K013508
Trade/Device Name: HRH-127 Allegra Head Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 12, 2001 Received: October 22, 2001
Dear Mr. Schubert:
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 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 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.
1
This letter will allow you to begin 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 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,
Nancy C. Snyder
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
NOV 2 0 2001
Section C – Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known):_____________________________________________________________________________________________________________________________________________________ Model HRH-127-Allegra Head Array Coil Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce 16 be about images of the head, that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013508
Prescription Use (Per 21 CFR 801.109) or
Over-The-Counter Use_
(Optional Format 1-2-96)