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.

Device Description

The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the Mayo Clinic BC-10 3.0T MR coil. This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a diagnostic algorithm.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable in this context. The document primarily details the device's technical specifications and intended use, comparing it to existing, legally marketed devices.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The provided summary does not explicitly state quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm with sensitivity, specificity, etc. Instead, the "acceptance criteria" are implied to be that the device performs "in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." The reported device performance is that it is "substantially equivalent to already approved extremity coils" and is a "proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic."

Acceptance Criteria (Implied)	Reported Device Performance
Performs in accordance with predetermined acceptance criteria	Substantially equivalent to already approved extremity coils
Safety and reliability meets/exceeds standards	Proven design with well documented clinical, safety, and reliability data
Accurately image maladies associated with hand, wrist, forearm, elbow	High SNR for small extremity imaging with 10cm FOV (compared to predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document for a formal test set in the context of proving diagnostic performance. The submission refers to "clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN," which suggests retrospective data from a U.S. institution, but specific sample sizes for particular tests are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as this is not a study evaluating a diagnostic image interpretation algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as this is not a study evaluating a diagnostic image interpretation algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided nor is it applicable, as the device is an MR coil, not an AI-powered diagnostic tool requiring human reader evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided nor is it applicable, as the device is an MR coil, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the context of a formal study with ground truth for a diagnostic outcome. The "clinical, safety, and reliability data" would likely refer to a combination of clinical observations, imaging characteristics, and potentially patient outcomes over time, but no specific method for establishing "ground truth" for a test set is described.

8. The sample size for the training set

This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.

9. How the ground truth for the training set was established

This information is not provided as this refers to an MR coil, not an algorithm that undergoes a training phase.

In summary: The provided document is a 510(k) summary for an MR coil, focusing on demonstrating substantial equivalence to existing devices. It does not contain the detailed information about clinical study design, performance metrics, ground truth establishment, or reader studies that would be expected for a diagnostic algorithm. The "study" mentioned generally refers to engineering tests and the accumulated clinical use data at Mayo Clinic, rather than a specific clinical trial designed to prove diagnostic performance through a test set.

Summary

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K040122

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 Ventures200 First St. SWRochester, MN 55905
Contact Person:	Jade SadostyProgram 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:

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 < 10cm	Hand and wrist
Compatibility	All Signa 1.5T MR systems	Signa 1.5T with PA option only
Tuning	No external tuning necessary.Coil is optimized for smallextremity anatomy.	No external tuning necessary.

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Patient Positioning	Overhead or at patient's side	Overhead or at patient's side
Imaging Configuration	High SNR for small extremityimaging with 10cm FOV.	High SNR for hand and wristimaging with 6cm FOV.

Summary of 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)

Conclusions:

The results of the testing and evaluations referenced above show that the Mayo Clinic BC-10 is substantially equivalent to already approved extremity coils. It is a proven design with well documented clinical, safety, and reliability data from years of use at the Mayo Clinic in Rochester, MN.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2004

Ms. Jade Sadosty Program Manager Mayo Medical Ventures 200 First St. SW ROCHESTER MN 55902

Re: K040122

Trade/Device Name: Mayo Clinic BC-10 3.0T MR coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 15, 2004 Reccived: January 30, 2004

Dear Ms. Sadosty:

We have reviewed your Scction 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 cither 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 dctermination 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 practicc 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ras lotter will and your your e FDA finding of substantial equivalence of your device to a legally prematicated predicated. " 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 It you dock be proceed in 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

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 1: Indications For Use

Page 1 of 1

510(k) Number (if known):

K040122

Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Ingram
(Division Sign-Off)

ision of Reproductive, Abdominal, ... Radiological Devices

:10(k) Number

Prescription Use __________	سما
(Per 21 CFR 801.109)	Company of the control of the control control controller of the contraction of the contraction of the contribution of the contribution of the contribution of the contributionSTATUTE AND CONSULTIVE OF CHEARTH AND

Regulation Number and Section

§ 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.