(23 days)
Not Found
Not Found
No
The summary describes a passive hardware component (a coil) for an MRI scanner and lacks any mention of software, algorithms, image processing, AI, or ML.
No
The device is intended to produce diagnostic images, not to treat a condition.
Yes
The "Intended Use" states the device is used to "produce diagnostic images...that can be interpreted by a trained physician," indicating its role in diagnosis.
No
The device description explicitly states "Model KAC-300 Knee Array Coil," which is a hardware component used in conjunction with an MRI scanner. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
- This device is a Magnetic Resonance (MR) coil used in vivo (inside the body) in conjunction with an MR scanner to produce images of anatomical structures. The diagnostic information comes from the interpretation of these images by a physician, not from analyzing a biological specimen.
The intended use clearly states it's used with an MR scanner to produce images of the knee, foot, and ankle. This is a core function of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee , foot, and ankle that can be interpreted by a trained physician.
Product codes
90 MOS
Device Description
Model KAC-300 Knee Array Coil
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
knee , foot, and ankle
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): 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.
Not Found
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 shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three overlapping, abstract shapes that resemble birds in flight or flowing ribbons.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1999
Thomas Schubert President MRI Devices Corporation N8 W22520-K Johnson Drive Waukesha. WI 53186
Re:
K993719 Model KAC-300 Knee Array Coil Dated: October 30, 1999 Received: November 3, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Schubert:
We have reviewed vour Section 510/k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Capt. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Section C - Statement of Indications for Use:
Applicant: MRI Devices Corporation 510(k) number (if known): K 99 37/9 Device Name: Model KAC-300 Knee Array Coil
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee , foot, and ankle that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seppanen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 29937 510(k) Number
Prescription Use or (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)