(17 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the hardware components and standard performance metrics for MR coils. The "AI" in the device name appears to be part of the product branding rather than indicating the use of AI/ML technology within the device's function.
No
The device is described as a diagnostic imaging device accessory used to produce images and spectra for displaying the internal structure of the breast, not for therapeutic purposes.
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 "receive only MR coil," which is a hardware component used in Magnetic Resonance (MR) imaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast." This describes a device used for in vivo imaging, not for testing samples (like blood, urine, or tissue) outside the body.
- Device Description: The description details an "MR coil for imaging the human breast," which is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical imaging device accessory, not an IVD.
N/A
Intended Use / Indications for Use
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.
Product codes
MOS
Device Description
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are receive only MR coils for imaging the human breast. Both coils consist of 16 coil elements. Two housing halves each contain eight independent coil elements. Seven of each are arranged in a cylindrical geometry while one element is positioned in a horizontal plane at top of the cylinder faced outwards.
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 testing was 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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NOV 21 2008
Section 8 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
I. General Information
Date of summary preparation: October 08, 2008
Manufacturer Rapid Biomedical GmbH Technologiepark Wuerzburg-Rimpar Kettelerstrasse 3-11 D-97222 Rimpar, Germany Germany
Registration number: 3005049692
Importer/Distributor
Siemens AG Healthcare Sector Henkestrasse 127 D-91052 Erlangen, Germany Germany
Registration number: 8010024
Contact Person
Mr. Armin Purea Rapid Biomedical GmbH Kettelerstrasse 3-11 D-97222 Rimpar, Germany
Phone: +49 (9365) 8826-48 Fax: +49 (9365) 8826-99 e-mail: armin.purea@rapidbiomed.de
II. Classification and Device Name
| Classification Panel: | Radiology |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device Accessory |
| Device Class: | Class II [21 CFR § 892.1000] |
| Product Code: | MOS |
| Product Nomenclature: | Coil, Magnetic Resonance, Specialty |
| Common Name: | Special Purpose Coil |
| Trade Name: | 16 Ch AI Breast Coil 1.5 T |
| 16 Ch Al Breast Coil 3 T |
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III. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.
Device Description
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are receive only MR coils for imaging the human breast. Both coils consist of 16 coil elements. Two housing halves each contain eight independent coil elements. Seven of each are arranged in a cylindrical geometry while one element is positioned in a horizontal plane at top of the cylinder faced outwards.
Equivalency Information
Rapid Biomedical believes that the 16 Ch AJ Breast Coil 1.5 T and 3 T is substantially equivalent to the cleared CP Breast Array Coil for MAGNETOM Harmony and Symphony systems and the described in the following submission:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| CP BREAST ARRAY COIL | K973630 | 12/05/1997 |
Summary of Technological Characteristics of the Principal Device as compared with the Predicate Device
In contrast to the predicate device, the 16 Ch AI Breast Coils 1.5 T and 3 T consist of 16 coil elements as opposed to 4. Furthermore, the 16 Ch AI Breast Coil 3 T is designed for a field strength of 3 T. We believe, however, that both coils are substantially equivalent to the predicate device.
General Safety and Effectiveness Concerns
The following safety and performance parameters:
[Safety]
- Maximum Static Field
- Rate of Change of Magnetic Field
- RF Power Deposition
- Acoustic Noise Level
[Performance-Imaging]
- Geometric Distortion
- Slice Profile, Thickness and Gap
- High Contrast Spatial Resolution
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[Performance-Spectroscopy]
- Spatial Localization Accuracy
- Peak Assignment Accuracy
- Solvent Suppression
- Decoupling
specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
The following parameters were considered for the new 16 Ch AI Breast Coil Kit 1.5 T and 3 T:
[Safety] - Biocompatibility
[Performance-Imaging]
- Signal to Noise Ratio
- Image Uniformity
[Performance-Spectroscopy]
- Spectral Resolution
- Signal to Noise Ratio
No new materials were used for the new 16 Ch AI Breast Coil Kit 1.5 T and 3 T compared to the predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests according to IEC 62464-1 were performed for the new 16 Ch AI Breast Coil Kit 1.5 T and 3 T and the results presented in this submission show that they are equivalent with the predicate devices. Furthermore, spectroscopic tests on SNR and spectral resolution were carried out.
Conclusion as to Substantial Equivalence
Laboratory testing was 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.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2008
RAPID Biomedical GmbH % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K083255
Trade/Device Name: 16 Ch AI Breast Coil 1.5 T and 16 Ch AI Breast Coil 3 T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 31, 2008 Received: November 4, 2008
Dear Mr. Borsai:
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 iddictions 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 Found, or ug 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 1egally 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation mumber at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Development (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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) 633-241 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely vours.
hoque Mr. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2 Indications for Use Statement
Indications for Use
510(k) Number (if known)
Device Name: 16 Ch AI Breast Coil 1.5 T and 16 Ch AI Breast Coil 3 T
Indications for Use:
The 16 Ch AI Breast Coil 1.5 T and the 16 Ch AI Breast Coil 3 T are indicated for use as a diagnostic imaging device accessory to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that displays the internal structure of the breast.
Prescription Use X (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 Device Evaluation
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number