(18 days)
Not Found
Not Found
No
The summary describes a physical component (a breast array coil) for an MRI scanner and does not mention any software or processing capabilities that would typically involve AI/ML.
No
The device is described as being used with a Magnetic Resonance Scanner to produce diagnostic images, indicating a diagnostic rather than therapeutic purpose.
Yes
The device is used to produce "diagnostic images" that are "interpreted by a trained physician," explicitly stating its role in diagnosis.
No
The device description explicitly states "Model OBC-250-PAN Breast Array Coil," which is a hardware component used in conjunction with an MRI scanner.
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 of the breast and axillary tissue in conjunction with a Magnetic Resonance Scanner. This describes a device used in vivo (within the living body) to acquire images, not a device used in vitro (outside the living body) to examine specimens like blood, urine, or tissue samples.
- Device Description: The device is described as a "Breast Array Coil," which is a component of an MRI system used to receive the radiofrequency signals from the body. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, or controls, which are typical components and processes of IVD devices.
Therefore, the Model OBC-250-PAN Breast Array Coil is an accessory for an MRI scanner used for in vivo diagnostic imaging, 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 diagnostic images of the breast and axillary tissue, that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
Model OBC-250-PAN Breast 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
breast and axillary tissue
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 7 2003
Mr. Thomas Schubert President MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K024208
Trade/Device Name: Model OBC-250-PAN Breast Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance Diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: December 18, 2002 Received: December 20, 2002
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
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
proceed to the market.
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Section C - Statement of Indications for Use:
Applicant: MRI Devices Corporation 4208 KO2 510(k) number (if known): Model OBC-250-PAN Breast Array Coil Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissue, that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David h. Seymann
(Division Sign-Off) Division of Reproductive, and Radiological Device 12421 510(k) Number
Prescription Use
Over-The-Counter Use or (Per 21 CFR 801.109)
(Optional Format 1-2-96)