(125 days)
Not Found
No
The summary describes a passive hardware component (surface coils) for an MRI system. There is no mention of software processing, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on hardware characteristics like SNR and uniformity.
No
The device is described as a diagnostic imaging device accessory used to produce images and spectra that assist in diagnosis, not directly treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the coils are "indicated for use as a diagnostic imaging device accessory" and produce images and/or spectra that "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states it is a "transmit/receive surface coil" and includes "additional components housed in a separate interface housing box," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that this device is a surface coil accessory for Magnetic Resonance (MR) diagnostic devices. It is used to produce images and/or spectra of the internal structure and/or function of the head or extremities. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use describes the device as a diagnostic imaging device accessory to produce images and spectra for interpretation by a trained physician to assist in diagnosis. This aligns with the function of an MR imaging component, not an IVD.
Therefore, the Dual Tuned Surface Coils 3T are a component of an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on l H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
MOS
Device Description
The Dual Tuned Surface Coils 3 T are transmit/receive surface coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single concentric loops, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus-31P, carbon-13C or sodium-23Na frequency. Additional components are housed in a separate interface housing box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
Anatomical Site
head or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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.
Safety parameters considered: Biocompatibility, RF Power Deposition. Performance-Imaging parameters considered: Signal to Noise Ratio, Image Uniformity, Slice Profile, Thickness and Gap. Performance-Spectroscopy parameters considered: Spectral Resolution, Signal to Noise Ratio, Decoupling.
The new devices conform to IEC 60601-1 and IEC 60601-2-33, 2nd edition. All safety tests are performed on the Siemens MAGNETOM Trio a Tim System. This is the most critical engine for safety and performance of the Siemens MAGNETOM 3T series. Passing these tests gives the Siemens approval for the complete MAGNETOM 3T series.
No new materials coming in contact with patients were used for the new Dual Tuned Surface Coils 3 T compared to the predicate device. Therefore no biocompatibility tests were performed.
Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA MS 6-2008 as well as slice profile tests according to NEMA MS 5-2003 were performed for the new Dual Tuned Surface Coils 3 T and the results presented in this submission show that they are equivalent with the predicate devices.
Furthermore, spectroscopic tests on SNR, spectral resolution and decoupling were carried out.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal to Noise Ratio, Image Uniformity, Slice Profile, Thickness and Gap, Spectral Resolution, Decoupling.
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.
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.
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K102348
p'/5
Section 8 510(k) Summary
DEC 2 2 2010
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: December 22, 2010
Manufacturer
Rapid Biomedical GmbH Technologiepark Wuerzburg-Rimpar Kettelerstrasse 3-11 D-97222 Rimpar, Germany Germany
Registration number: 3005049692
Importer/Distributor
RAPID MR International, LLC 2236 CityGate Drive Columbus, Ohio 43219-3565 USA
Owner/operator number: 10033421
Contact Person
Mr. Armin Purea Rapid Biomedical GmbH Kettelerstrasse 3-11 D-97222 Rimpar, Germany
1
K102348
$\rho^{2/5}$
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(s): | 31P/1H Dual Tuned Surface Coil 3 T |
| 23Na/1H Dual Tuned Surface Coil 3 T | |
| 13C/1H Dual Tuned Surface Coil 3 T |
2
III. Safety and Effectiveness Information Supporting Substantial Equivalence Intended Use
The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on l H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The Dual Tuned Surface Coils 3 T are transmit/receive surface coils to detect radiofrequency (RF) signals of hydrogen (1H) nuclei in combination with either phosphorus (31P), carbon (13C) or sodium (23Na) nuclei. Each coil consists of two single concentric loops, one of which is always tuned to the proton frequency, the other being tuned to either phosphorus-31P, carbon-13C or sodium-23Na frequency. Additional components are housed in a separate interface housing box.
Equivalency Information
Rapid Biomedical believes that the Dual Tuned Surface Coils 3 T are substantially equivalent to the cleared 31P/IH heart/liver coil by Siemens Healthcare (formerly Siemens Medical Solutions) which is described in the following submission:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens Medical Solutions 31P/IH | ||
| heart/liver coil included in syngo MR | ||
| 2002B | K020991 | Jun 13th, 2002 |
Summary of Technological Characteristics of the Principal Device as compared with the Predicate Device
In contrast to the predicate device, the Dual Tuned Surface Coils 3 T are designed for a field strength of 3 T. While the predicate device was only available as 31P//H coil, the new devices are also available as 23Na/1H and 13C/1H coils. Although the predicate coil is designed for non-invasive in vivo detection of 31P-metabolites instead of the additional 13C and 23Na metabolites detectable with the coils described in this submission, we believe that they are substantially equivalent Magnetic Resonance Specialty Coils for spectroscopy of nuclei other than protons. Numerous publications by researchers worldwide support the usefulness of 13C and 23Na spectroscopy. No risks different to standard MR occur for the patient during these investigations.
General Safety and Effectiveness Concerns
The following safety and performance parameters:
3
KID2348 p4/5
[Safety]
- Maximum Static Field
- Rate of Change of Magnetic Field
- Acoustic Noise Level
[Performance-Imaging]
- Geometric Distortion
- High Contrast Spatial Resolution
[Performance-Spectroscopy]
- Spatial Localization Accuracy
- Peak Assignment Accuracy
- Solvent Suppression
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 Dual Tuned Surface Coils 3 T:
[Safety]
- Biocompatibility
- RF Power Deposition
[Performance-Imaging]
- Signal to Noise Ratio
- Image Uniformity
- Slice Profile, Thickness and Gap
[Performance-Spectroscopy]
- Spectral Resolution
- Signal to Noise Ratio
- Decoupling
The new devices conform to IEC 60601-1 and IEC 60601-2-33, 2nd edition. All safety tests are performed on the Siemens MAGNETOM Trio a Tim System. This is the
4
most critical engine for safety and performance of the Siemens MAGNETOM 3T series. Passing these tests gives the Siemens approval for the complete MAGNETOM 3T series.
No new materials coming in contact with patients were used for the new Dual Tuned Surface Coils 3 T compared to the predicate device. Therefore no biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests according to NEMA MS 6-2008 as well as slice profile tests according to NEMA MS 5-2003 were performed for the new Dual Tuned Surface Coils 3 T and the results presented in this submission show that they are equivalent with the predicate devices.
Furthermore, spectroscopic tests on SNR, spectral resolution and decoupling 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.
5
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Armin Purea Rapid Biomedical GmBH Kettelerstr 3-11 Rimpar. Bavario GERMANY 97222
DEC 2 2 2019
Re: K102348
Trade Name: 31P/1H Dual Tuned Surface Coil: 13C/1H Dual Tuned Surface Coil 3T; 23Na/1H Dual Tuned Surface Coil 3T Regulation Number: 21 CFR § 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 29, 2010 Received: December 1, 2010
Dear Mr. Purea:
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. Iisting 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
6
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,
signature
David G. Brown, Ph.D. Acting 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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Section 3
Indications for Use Statement
Indications for Use
DEC 2 2 2010
510(k) Number: K102348
Device Name: Dual Tuned Surface Coils 3T
Indications for Use:
The Dual Tuned Surface Coils 3T are surface type transmit/receive coils dual tuned on 1H (proton) and either 31P (phosphorus), 23Na (sodium) or 13C (carbon) nuclei. The coils are indicated for use as a diagnostic imaging device accessory to Siemens MAGNETOM Trio, A Tim System 3T and MAGNETOM Verio 3T magnetic resonance diagnostic devices to produce transverse, sagittal, coronal and oblique images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
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 In Vitro Diagnostic Devices (OIVD)
Signature
(Difision Sign=Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K162348