(83 days)
Not Found
None
No
The summary describes a passive MRI coil set, which is a hardware component for image acquisition, not a software or processing device that would typically incorporate AI/ML. There are no mentions of AI, ML, or image processing capabilities.
No
The device is used to produce diagnostic images, not to treat a condition.
Yes
The intended use explicitly states that the device is used to produce "General Purpose diagnostic images".
No
The device description explicitly states "GPF-29 General Purpose Coil Set MRI RF Coil," which indicates a hardware component (an RF coil) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce diagnostic images in conjunction with a Magnetic Resonance Scanner. This indicates the device is used on the patient (in vivo) to acquire images, not to test samples from the patient (in vitro).
- Device Description: The description "MRI RF Coil" further confirms its role as a component used within an MRI system, which is an in vivo imaging modality.
- Input Imaging Modality: The input is a "Magnetic Resonance Scanner," which is an in vivo imaging technology.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an in vitro diagnostic test.
Therefore, the GPF-29 General Purpose Coil Set MRI RF Coil is a component of an in vivo diagnostic imaging system, 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 General Purpose diagnostic images, that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 6 2002
Dr. David A. Molyneux Vice President of Technology MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K020850 Trade/Device Name: GPF-29 General Purpose Coil Set MRI RF Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 4, 2002 Received: March 15, 2002
Dear Dr. Molyneux:
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. Snogdon
Nancy C. Progdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section C - Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known): KO20850 Device Name: Model GPF-29 General Purpose Coil Set
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce General Purpose diagnostic images, that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lippmann
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ KOZO950
/ Prescription Use Over-The-Counter Use or (Per 21 CFR 801.109)
(Optional Format 1-2-96)