(449 days)
Not Found
No
The description focuses on the physical characteristics and function of the MR coils, which are hardware components for signal acquisition. There is no mention of software algorithms, data processing beyond basic signal reception, or any terms related to AI/ML.
No
The 'Intended Use / Indications for Use' section explicitly states that the device is "indicated for use as diagnostic device extensions" and "yield information that may assist in diagnosis," without mentioning any therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the coils "are indicated for use as diagnostic device extensions" and "yield information that may assist in diagnosis."
No
The device description explicitly details physical hardware components, including coils, RF routing, a preamplifier, and a connector, which are integral to its function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). This device is a component of an MR system that directly interacts with the human body to produce images and spectra.
- The intended use is for producing images and spectra of internal structures. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (in glass/outside the body) analysis.
- The device description details its function as a transmit and receive coil for MR systems. This is consistent with imaging equipment, not laboratory diagnostic equipment.
Therefore, this device falls under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are single tuned surface type transmit and receive coils for usage in magnetic resonance systems, the operating frequency and interface being adapted for usage on Philips 3.0 T MR Systems. The coils are for transmit and receive (T/R) and provide the required magnetic RF field for excitation of the spins and receive the MR signal of 31P, 23Na or 13C spins. This is used for axial, sagittal, coronal and oblique imaging, spectroscopic imaging and/or spectroscopy, which display the internal structure and/or function of the human anatomy, e.g. of the calf, liver or heart.The coils are optimized for local examinations of human subjects. The housing is flexible for better adaption to the anatomical region of interest. The coils consist of a single loop (linear) with a diameter of 14 cm, RF routing (T/R switch), a low noise preamplifier and a connector to the Philips 3.0 T MR Systems. The coils are fixed tuned and matched to the typical load of human tissue at the Larmor frequency of 31P (51.7 MHz), 23Na (33.8 MHz) or 13C (32.1 MHz) at 3.0 T. There is no detuning or switching mechanism in the loops. The loops are tuned permanently to the working frequencies of 31P, 23Na or 13C while being decoupled from the 1H body coil at the 1H frequency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
whole body, e.g. of the calf, liver or heart.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Testing was performed to support this claim of substantial equivalence and to show that the modifications 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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2018
Rapid Biomedical Gmbh Christian Zimmermann Official Correspondent Kettelerstr. 3-11 Rimpar, 97222 DE
Re: K163661
Trade/Device Name: P-140-flex Coil, Na-140-flex Coil, C-140-flex Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: February 12, 2018 Received: February 12, 2018
Dear Christian Zimmermann:
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, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara
Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163661
Device Name
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce cross-sectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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3
Image /page/3/Picture/0 description: The image shows a logo for Rapid Biomedical. The text "RAPID" is in large, bold, black letters at the top. Below that, "Biomedical" is written in a smaller, bold, black font, underlined with a black line. At the bottom, in a smaller font, the text "MR Coils - Made to Measure" is present.
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.
General Information
Date of summary preparation: 2017-06-30
Manufacturer
RAPID Biomedical GmbH
Kettelerstrasse 3-11, 97222 Rimpar, Bavaria, Germany
FDA FEI: 3005049692
Designed and Manufactured for
Philips Medical Systems Nederland BV
Veenpluis 4-6, 5684 PC Best, Netherlands
FDA FEI: 3003768277
Contact Person
Mr. Christian Zimmermann RAPID Biomedical GmbH Kettelerstrasse 3-11, 97222 Rimpar, Bavaria, Germany Phone: +49 (9365) 8826-44, Fax: +49 (9365) 8826-99 e-mail: christian.zimmermann@rapidbiomed.de
Classification and Device Names
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 Names: P-140-Flex Coil, Na-140-Flex Coil or C-140-Flex Coil
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Image /page/4/Picture/0 description: The image shows the title of a document, which is a Traditional 510(k) Premarket Notification. The document number is K163661, supplement 001. The document is about P-140-Flex Coil, Na-140-Flex Coil, and C-140-Flex Coil.
Indications for Use
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are indicated for use as diagnostic device extensions for Philips 3.0 T MR Systems to produce crosssectional spectroscopy images and/or spectra in any orientation of the internal structure of the whole body, e.g. of the calf, liver or heart. These images when interpreted by a trained physician, yield information that may assist in diagnosis.
Device Description
The P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil are single tuned surface type transmit and receive coils for usage in magnetic resonance systems, the operating frequency and interface being adapted for usage on Philips 3.0 T MR Systems. The coils are for transmit and receive (T/R) and provide the required magnetic RF field for excitation of the spins and receive the MR signal of 31P, 23Na or 13C spins. This is used for axial, sagittal, coronal and oblique imaging, spectroscopic imaging and/or spectroscopy, which display the internal structure and/or function of the human anatomy, e.g. of the calf, liver or heart.The coils are optimized for local examinations of human subjects. The housing is flexible for better adaption to the anatomical region of interest. The coils consist of a single loop (linear) with a diameter of 14 cm, RF routing (T/R switch), a low noise preamplifier and a connector to the Philips 3.0 T MR Systems. The coils are fixed tuned and matched to the typical load of human tissue at the Larmor frequency of 31P (51.7 MHz), 23Na (33.8 MHz) or 13C (32.1 MHz) at 3.0 T. There is no detuning or switching mechanism in the loops. The loops are tuned permanently to the working frequencies of 31P, 23Na or 13C while being decoupled from the 1H body coil at the 1H frequency.
Equivalency Information
RAPID Biomedical believes that the subject devices are substantially equivalent to the Philips Phosphorous Spectroscopy Surface Coil P-140 which is an extension of the cleared Philips Magnetic Resonance Diagnostic Devices (MRDD) which are described in the submission:
| Predicate Device Name | Clearance Number | Date |
|---|---|---|
| ACHIEVA family | K043147 | 2005-02-15 |
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Image /page/5/Picture/0 description: The image shows the Rapid Biomedical logo on the left side. On the right side, the text reads, "Traditional 510(k) Premarket Notification K163661, supplement 001 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil". The Rapid Biomedical logo has the word "RAPID" in large blue letters above the word "Biomedical" in smaller blue letters. Below that, the text "MR Coils - Made to Measure" is written in small letters.
Summary of Characteristics of the Subject Device as compared with the Predicate Device
The subject device (P-140-Flex Coil, Na-140-Flex Coil and C-140-Flex Coil) and the predicate device (Philips P-140 Coil) are made for the usage on Philips 3.0T MR Systems as transmit/receive coils. The Philips 3.0 T MR Systems allow 31P, 23Na and 13C spectroscopy imaging and spectroscopy, including simultaneous 1H MR examinations and are capable of driving the subject device as described in the indications for use. Compared to the predicate device, the subject device yields flexible housing parts for better fitting the anatomy of the patient and offering better patient comfort. This gain in performance does not yield detrimental effects on the safety, reliability or other performance topics as compared to the predicate device. The active coil diameter of 14 cm of the subject device is exactly the same as the diameter of the predicate device. Subject device and predicate device do not offer a 1H channel for direct 1H MR examinations. These 1H examinations are provided by using the standard 1H body coil of the Philips 3.0 T MR System. The subject device is fixed tuned and matched while the predicate device has to be tuned and matched manually per patient.
Overall, the subject device and the predicate device share the substantial coil technology. Improvements in performance rectify the modifications in design while the intended use, the indication for use and safety stay substantially equivalent.
General Safety and Effectiveness
The safety and performance parameters specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this submission.
The subject devices are conforming to:
- · IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint)
- o with National Differences for United States (US), ANSI/AAMI ES60601-1: 2005 / A2:2010 and
- o Canada (CA), CAN/CSA-C22.2 No. 60601-1:08
- IEC 60601-2-33: 2010 (Third Edition) + A1: 2013 for use in conjunction ● with IEC 60601-1:2005 + A1: 2012.
This will assure that the performance is to be considered safe and effective when used with the Philips 3.0 T MR Systems.
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Image /page/6/Picture/0 description: The image shows the logo for Rapid Biomedical. The logo has the word "RAPID" in large, bold, black letters on the top line. Below that, the word "Biomedical" is in a smaller, bold, black font. Underneath that is the phrase "MR Coils - Made to Measure" in a smaller, regular font.
Substantial Equivalence
Testing was performed to support this claim of substantial equivalence and to show that the modifications do not raise any new questions pertaining to safety and effectiveness.
The modifications did not affect the Indications for Use and did not alter the Fundamental Scientific Technology.
RAPID Biomedical therefore believes the subject devices and the predicate device to be substantially equivalent (SE).
Rimpar, 2017-06-30
Signature:
Name:
Christian Zimmermann (Quality Management & Official Correspondent)