(30 days)
Not Found
Not Found
No
The summary describes a passive hardware component (a coil) for an MRI scanner and contains no mention of software, algorithms, or AI/ML terms.
No
Explanation: The device is intended to produce diagnostic images, not to provide therapy.
Yes
The device is described as producing "diagnostic images," indicating its role in the diagnostic process.
No
The device description explicitly states "Model HRK-63-8 Knee Array Coil," which is a hardware component used in MRI. The summary does not mention any software-only aspects.
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 knee using a Magnetic Resonance Scanner. This is a medical imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis.
- Device Description: It's described as a "Knee Array Coil," which is a component used in an MRI system to acquire imaging data.
- Input Imaging Modality: The input is Magnetic Resonance, which is a physical imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The device is used on the knee, which is a part of the patient's body, not a specimen taken from the body.
IVD devices are specifically designed to perform tests on biological samples outside of the body to aid in diagnosis. This device is used on the body to generate images.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
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
Magnetic Resonance Scanner
Anatomical Site
knee
Indicated Patient Age Range
Not Found
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
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): 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.
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 is a black and white logo. The logo is circular and contains an abstract image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the top half of the circle. The text is written in a small, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2003
MRI Devices Corporation Thomas Schubert, President 1515 Paramount Drive Waukesha, WI 53186.
Re: K032633 Trade/Device Name: HRK-63-8 Knee Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: RF Coil for Magnetic Resonance Imaging System Regulatory Class: II Product Code: 90 MOS Dated: August 4, 2003 Received: August 26, 2003
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 adultcration.
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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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
Nancv C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
Section C - Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known): no 32633 Device Name: Model HRK-63-8 Knee Array Coil
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Sypniewski
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K032633 510(k) Number
Prescription Use
Over-The-Counter Use_ Or (Per 21 CFR 801.109)
(Optional Format 1-2-96)