The Siemens Magnetom CP Breast Array Coil is indicated for use as a diagnostic imaging device accessory to produce transverse, saggital, coronal and oblique images of the internal structures of the breast.

Device Description

The CP Breast Array Coil is a receiver coil for the Magnetom Harmony and Symphony

AI/ML Overview

The provided text describes specific parameters that were evaluated for the Siemens CP Breast Array Coil to demonstrate substantial equivalence to a predicate device, rather than explicit acceptance criteria with numerical thresholds. Therefore, the table below reflects what was stated to be "unaffected" or had "additional measurements performed."

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Safety Parameters
Static Field Strength	Unaffected by the modifications described within this notification. (Implies meeting previous established safety levels for Magnetom Harmony and Symphony system)
RF Exposure	Unaffected by the modifications described within this notification. (Implies meeting previous established safety levels for Magnetom Harmony and Symphony system)
Performance Levels
High Contrast Spatial Resolution	Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system)
Slice Thickness	Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system)
Geometric Distortion	Unaffected by the modifications described within this notification. (Implies meeting previous established performance levels for Magnetom Harmony and Symphony system)
SNR (Signal-to-Noise Ratio)	Additional SNR measurements were performed for the new imaging coil & presented in this documentation. (Specific numeric results or thresholds are not provided in this summary.)
Image Uniformity	Additional image uniformity measurements were performed for the new imaging coil & presented in this documentation. (Specific numeric results or thresholds are not provided in this summary.)

Study Details

Sample size used for the test set and the data provenance:
The provided 510(k) summary does not specify the sample size for any clinical or laboratory test set. It broadly states that "Laboratory and clinical testing were performed to support this claim of substantial equivalence," but no details regarding the number of participants, images, or data provenance (e.g., country of origin, retrospective or prospective nature) are included. This is typical for older 510(k) summaries which focused more on technical equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish a ground truth for a test set. The focus is on technical performance metrics of the device as an accessory, not on diagnostic outcomes requiring expert interpretation.
Adjudication method for the test set:
Not applicable, as no expert review or diagnostic test set requiring adjudication is described.
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, and the device is a hardware component (a breast array coil) for an MRI system, not an AI-powered diagnostic tool. Therefore, questions regarding human reader improvement with AI assistance are not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a hardware component (an MRI coil), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As this device is a hardware accessory, the "ground truth" for its performance is based on physical and engineering measurements of parameters like static field strength, RF exposure, spatial resolution, slice thickness, geometric distortion, SNR, and image uniformity. No clinical diagnostic ground truth (like pathology or outcomes data) is mentioned as being used to assess the coil itself.
The sample size for the training set:
Not applicable, as the device is a hardware component (MRI coil), not a software algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable, for the same reason as above.

Summary

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510 (k) Summary

I. General Information.

K973630
Dec 5, 1997

This summary of 510(k) safety and effectiveness information is being such accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Establishment:	Siemens Medical Systems, Inc.
• Address:	186 Wood Avenue SouthIselin, N.J. 08830
Registration Number:	2240869
Contact Person:	Ms. Kathleen RutherfordManager, Regulatory Submissions(732) 321-4779(732) 321-4841
Date of Summary Preparation:	9/23/97
Device Name:
• Trade Name:	CP Breast Array Coil for the MagnetomHarmony and Symphony
• Classification Name:	Magnetic Resonance Diagnostic Device,CFR § 892.1000
• Classification:	Class II
• Performance Standards:	None established under Section 514 ofthe Food, Drug, and Cosmetic Act.

Page: 26

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II. Safety and Effectiveness Information Supporting Substantial Equivalence.

· Device Description:

The CP Breast Array Coil is a receiver coil for the Magnetom Harmony and Symphony

•Intended Use

• Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM Harmony and Symphony configured with the CP Breast Arrav Coil is substantially equivalent to the standard MAGNETOM Harmony and Symphony system.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Harmony and Symphony system with the new CP Breast Array Coil is substantially equivalent to standard operation of the MAGNETOM Harmony and Symphony system. The following safety parameter action levels:

static field strength, r
RF exposure, ।

and performance levels:

high contrast spatial resolution, ।
slice thickness, and -
geometric distortion -

specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. Additional SNR and image uniformity measurements were performed for the new imaging coil & presented in this documentation.

· Substantial Equivalence:

Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Kathleen Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions 9/23/97

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 5 1997

Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. Imaging Systems Group 186 Wood Avenue South Iselin, NJ 08830

Re: K973630 CP Breast Array Coil for 1.0T Harmony and 1.5T Symphony (MR Specialty Coil) Dated: September 23, 1997 Received: September 24, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Ms. Rutherford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in internate commerce prior to May 28, 1976, the ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Pederal Food, Drug, and Cometic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against mistoranion.

If your device is classified (see above) into class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Cade of Enderal Regulations. Title 21, Pars 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice r - wirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Polenal Register. Places note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This leter 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 predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions and advertising of your device, please castes: the Office of Compliance at (301) 594-4639. Also, please note the regulation 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/dsmamain.html".

Sincerely yours,

h.Jliau Yu
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: CP Breast Array Coil

Indications for Use:

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K973630

LLY.

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.