The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.

Device Description

The dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T coils are designed for use with a Magnetic Resonance Imaging (MRI) system. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The coils are designed as receive only coil for high resolution diagnostic imaging and intervention of breast. The coil provides both unilateral and bilateral images (Left, Right and Both) of the anatomy of interest and permits MR-guided biopsy and localization of lesions.

AI/ML Overview

This K122646 submission for the dS Breast 16ch I/T MRI coils is a pivotal study concerning a Class II medical device. However, the provided documentation focuses on substantial equivalence to existing predicate devices rather than directly providing a detailed study with acceptance criteria and performance metrics in the format usually expected for AI/ML device evaluations.

Here's a breakdown of what can be extracted and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" and "reported device performance" are primarily framed within the context of demonstrating substantial equivalence to predicate devices rather than a direct quantitative clinical trial.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (from K122646)
Intended Use: Similar to predicate devices (aid to diagnosis, MR-guided biopsy/localization of breast lesions).	Coil indicated for use on order of a physician, with Philips 1.5T/3.0T MR scanners, to produce images of breast, chest wall, and axillary tissue as an aid to diagnosis. Permits MR-guided biopsy/localization.
Design Features: Similar to predicate devices (receive-only coil for high-resolution diagnostic imaging and intervention of breast, unilateral/bilateral imaging capability).	Designed to work with Body Coil of MRI system (transmitter), receive RF signals, receive-only coil for high resolution diagnostic imaging and intervention. Provides unilateral/bilateral images.
Technological Characteristics: Similar to predicate devices (receives RF signals from tissue of interest).	Fundamental scientific technology is receiving RF signals from tissue of interest.
Performance Metrics: Comparable Signal-to-Noise (SNR) ratio to predicate devices.	Supporting product evaluations included Signal-to-Noise (SNR) ratio assessment.
Performance Metrics: Comparable Image Uniformity to predicate devices.	Supporting product evaluations included Image Uniformity assessment.
Performance Metrics: Comparable clinical image quality to predicate devices.	Supporting product evaluations included assessment of clinical images.
Safety: Device passes electrical safety testing.	Device passed electrical safety testing in accordance with IEC standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" sample size in terms of patient numbers or images. The clinical image assessment mentioned is described generally.
Data Provenance: Not specified. It's listed as "clinical images," without details on country of origin, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only mentions "assessment of clinical images" without detailing who performed this assessment or their qualifications.

4. Adjudication Method for the Test Set

Not specified. There is no mention of a formal adjudication method (e.g., 2+1, 3+1, none) for the assessment of clinical images.

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

No, an MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI/ML diagnostic software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.

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

Not applicable. This device is an MRI coil, a hardware component, not an algorithm or AI software. Therefore, "standalone performance" in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

The ground truth for evaluating the coil's performance appears to be based on:
- Technical measurements: Signal-to-Noise (SNR) ratio and Image Uniformity.
- Qualitative assessment of clinical images: Comparing the images produced by the new coil against those of predicate devices in terms of diagnostic quality.
- Electrical safety standards: Verification against IEC standards.
- Design and technological similarity: Comparison of features and operating principles to predicate devices.

8. The Sample Size for the Training Set

Not applicable / Not specified. As this is an MRI coil and not an AI/ML model, there is no "training set" in the conventional sense for algorithm development. The device design and validation would rely on engineering principles, testing, and clinical evaluations rather than algorithm training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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K122646

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510(k) Summary of Safety and Effectiveness dS Breast 16ch I/T

Submitted By: Invivo Corporation 3545 SW 47th Avenue Gainesville, FL 32608 2 899 1 NOV August 29, 2012 Date: Contact Person: Lisa Simpson, Regulatory Affairs Engineer Tel: (352) 336-0010, ext. 164 Fax: (352) 336-1410 Proprietary Names: dS Breast 16ch I/T 1.5T dS Breast 16ch I/T 3.0T Common Name: Coil, Magnetic Resonance, Specialty Classification Name and Reference: 21 CFR 892.1000

A magnetic resonance diagnostic device, 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, class II.

Device Product Code and Panel Code: MOS / Radiology / 90

Device Description:

Indications for Use:

Technological Characteristics:

The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest.

Substantial Equivalence Information:

When compared to the predicate Breast Biopsy Coil (BBC) devices (K032576 and K041), substantial equivalence of the dS Breast 16ch (1.5 T & 3.0T) devices is based on similarities in intended use, design features, and technological characteristics. Supporting product evaluations includes Signal-to-Noise (SNR) ratio, Image Uniformity and assessment of clinical images. Additionally, the new devices passed electrical safety testing in accordance with IEC standards.

Section 005 Page 1 of 1

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Lisa Simpson Regulatory Engineer Invivo Corporation 3545 S.W. 47th Avenue GAINESVILLE FL 32608

NOV - 2 2012

Re: K122646

Trade/Device Name: dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 29, 2012 Received: August 30, 2012

Dear Ms. Simpson:

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 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 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 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 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 Parts 801 and 809), please contact the Office of In Vitro 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,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K122646

Device Name:

dS Breast 16ch I/T 1.5T dS Breast 16ch I/T 3.0T

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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 Devices (OIVD)

Murhus Dökken

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122646

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.