(72 days)
Not Found
Not Found
No
The summary describes a passive receiver coil for MRI, with no mention of AI/ML terms, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a diagnostic imaging device accessory used to produce images of the breast, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device accessory".
No
The device description explicitly states it is a "receiver coil," which is a hardware component used in MRI systems.
Based on the provided information, the Siemens Magnetom CP Breast Array Coil is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce images of the internal structures of the breast using Magnetic Resonance. This is an in vivo (within a living organism) diagnostic imaging process, not an in vitro (outside of a living organism) test performed on biological samples.
- Device Description: It's described as a receiver coil for an MRI system, which is consistent with an in vivo imaging device accessory.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing chemical or biological tests, or providing information about a patient's health status based on the analysis of such samples.
Therefore, the Siemens Magnetom CP Breast Array Coil is a medical device used for diagnostic imaging in vivo, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The CP Breast Array Coil is a receiver coil for the Magnetom Harmony and Symphony
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Breast
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 South |
| Iselin, N.J. 08830 | |
| Registration Number: | 2240869 |
| Contact Person: | Ms. Kathleen Rutherford |
| Manager, 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 Magnetom |
| Harmony and Symphony | |
| • Classification Name: | Magnetic Resonance Diagnostic Device, |
| CFR § 892.1000 | |
| • Classification: | Class II |
| • Performance Standards: | None established under Section 514 of |
| the Food, Drug, and Cosmetic Act. |
Page: 26
N
1
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
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.
• 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
2
Image /page/2/Picture/0 description: The image is a black and white drawing. The drawing appears to be a partial image of a person's face. The person has a partial hairline and a few lines that could be part of their hair.
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
3
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name: CP Breast Array Coil
Indications for Use:
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.
(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.