SV DBS VRAIN ARRAY by MIDWEST RF, LLC

The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers.

Device Description

SV DBS Brain Array Model # 1500SV-GEMS64

AI/ML Overview

This section describes a 510(k) premarket notification for a medical device and, as such, typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with acceptance criteria and reported performance metrics in the format of a typical clinical trial report.

Therefore, the requested information elements related to specific acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment are not explicitly provided in the given text.

The document primarily states:

Device Name: SV DBS Brain Array Model # 1500SV-GEMS64 (also referred to as SV Brain Array, Model # 1500SV-GE64 in the Indications for Use)
Regulation Number/Name: 21 CFR 892.1000, Magnetic resonance diagnostic device
Indications For Use: "The 2D and 3D Magnetic Resonance Imaging of the anatomy of human head, brain and brain-stem. This device is used in conjunction with a GE Medical Signa HDx 1.5 T closed, horizontal bore MRI system capable of utilizing at least 8 channel Phased Array receive-only coils with integrated pre-amplifiers."

Summary of available information as per your request:

Table of acceptance criteria and the reported device performance:
- N/A. The document does not provide a table of acceptance criteria or specific performance metrics in terms of sensitivity, specificity, or other quantitative measures. The FDA's substantial equivalence determination implies that the device performs as safely and effectively as a legally marketed predicate device for its stated indications for use.
Sample size used for the test set and the data provenance:
- N/A. This information is not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not provided in the document.
Adjudication method for the test set:
- N/A. This information is not provided in the document.
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:
- N/A. This device is an MRI coil, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is hardware (an MRI coil), not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. As this is an MRI coil, a ground truth in the context of diagnostic accuracy is not typically established for the device itself in the same way as an AI algorithm. Its performance is evaluated through image quality, signal-to-noise ratio, uniformity, etc., which are compared to the predicate device.
The sample size for the training set:
- N/A. This information is not provided in the document, as it's not an AI/algorithm-based device.
How the ground truth for the training set was established:
- N/A. Not applicable, as this is an MRI coil, not an AI/algorithm-based device requiring a training set with established ground truth.

In summary, the provided document is an FDA 510(k) clearance letter for an MRI coil, which confirms substantial equivalence to a predicate device for specific imaging capabilities. It does not contain the detailed study results and performance metrics typically found in reports for AI-driven diagnostic software or clinical trials with specific acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features a stylized human figure and a circular border with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JUL - 5 2011

Mr. Helmut Keidl President Midwest RF, LLC P.O. Box 348 1015 Walnut Ridge Drive HARTLAND WI 53029

Re: K111259

Trade/Device Name: SV DBS Brain Array Model # 1500SV-GEMS64 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 26, 2011 Received: May 4. 2011

Dear Mr. Keidl:

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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish firther. 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 renarketed predicate device results in a classification for your device and thus, permits your dry ince to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment 3 Statement of Indication for Use

510(K) Number (if known): K 111259

Device Name: SV Brain Array, Model # 1500SV-GE64

Indications For Use:

Prescription Use (Per 21 CFR 801. Subpart D)

AND/OR

Over-the Counter Use (Per 21 CFR 801. Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation & Safety

Michael D'Orazio
(Division Sign Off)

Office of In Vitro Diagnostic Device Evaluation and Safety

510K K 111259

SV Brain Array

Attachment 3 Indication for Use Page 1 of 1

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.