← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K102348
# 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T (K102348)
_Rapid Biomedical GmbH · MOS · Dec 22, 2010 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K102348
## Device Facts
- **Applicant:** Rapid Biomedical GmbH
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Dec 22, 2010
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Intended 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.
## Device Story
Dual Tuned Surface Coils 3T are transmit/receive RF coils for MRI systems; designed for 3T field strength. Coils consist of two concentric loops: one tuned to 1H (proton) frequency, one tuned to 31P, 23Na, or 13C frequency. Used in clinical settings by trained MRI technicians/physicians to acquire transverse, sagittal, coronal, and oblique images or spectra of head/extremities. Output is raw RF signal processed by the host Siemens MAGNETOM MRI system into diagnostic images/spectra. Physician interprets output to assist in clinical diagnosis. Benefits include non-invasive metabolic/structural assessment of tissues.
## Clinical Evidence
Bench testing only. No clinical data. Performance validated via NEMA MS 6-2008 (SNR, image uniformity) and NEMA MS 5-2003 (slice profile) standards. Spectroscopic performance (SNR, spectral resolution, decoupling) verified. Compliance with IEC 60601-1 and IEC 60601-2-33 confirmed.
## Technological Characteristics
Transmit/receive surface coils; dual-tuned (1H + 31P, 23Na, or 13C). 3T field strength. Interface housing box included. Conforms to IEC 60601-1 and IEC 60601-2-33. No new patient-contact materials. Standalone accessory for Siemens MAGNETOM 3T series.
## Regulatory 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).
## Special Controls
*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.
## Predicate Devices
- Siemens Medical Solutions 31P/IH heart/liver coil ([K020991](/device/K020991.md))
## Submission Summary (Full Text)
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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
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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 |
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#### 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:
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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
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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.
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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
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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,
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
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