(85 days)
No
The summary describes a passive MRI coil and does not mention any software or processing capabilities, let alone AI/ML.
No
Explanation: The device is described as a magnetic resonance coil used for imaging and diagnosing maladies rather than treating them.
No
The device is a magnetic resonance coil used to image maladies. Imaging devices are not considered diagnostic.
No
The device description explicitly states it is a "magnetic resonance coil," which is a hardware component used in MRI systems.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Mayo Clinic BC-10 3.0T wrist coil is an accessory for an MRI system. It is used to image the body directly, not to analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow." This is an imaging function, not an in vitro diagnostic test.
The device is a component of an imaging system used for diagnosis, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.
Product codes
90 MOS
Device Description
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
hand, wrist, forearm, and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards. Details of this testing are included in the abbreviated 510(k) submission for the referenced device (K031119)
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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
Attachment 3: 510(k) Summary of Safety and Effectiveness
This special 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | Mayo Medical Ventures
200 First St. SW
Rochester, MN 55905 |
|-----------------|------------------------------------------------------------------|
| Contact Person: | Jade Sadosty
Program Manager |
| Telephone: | (507) 538-1352 |
| Fax: | (507) 284-5410 |
| Date Prepared: | November 17, 2003 |
Device Name:
Mayo Clinic BC-10 3.0T MR coil
Device Description:
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
Indications for Use:
The Mayo Clinic BC-10 3.0T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body, which can be imaged.
Predicate Device:
The predicate devices for this coil include both the MRI Devices 1.5T phased array wrist coil and the GE Signa 1.5T birdcage, high-pass, quadrature T/R head coil.
| Feature | Mayo Clinic BC-10 | MRI Devices Signa 1.5T |
|---|---|---|
| Coil Type | High-pass, quadrature, T/R | Phased array, receive only |
| Region of Interest | Small extremities |