(137 days)
None
No
The description focuses on the hardware components and physical characteristics of the MRI coil, with no mention of AI or ML for image processing, analysis, or any other function. The image combination is described as a standard phased array technique.
No.
The device is described as a receive-only coil for MRI systems, designed to produce diagnostic images. It does not provide therapy or treatment.
No
Explanation: The device is a receive-only coil for MRI systems, designed to produce diagnostic images. It is a tool for image acquisition, not a diagnostic device itself that interprets images or provides a diagnosis. The diagnosis is made by a trained physician interpreting the images.
No
The device is a physical receive-only coil for an MRI system, not a software-only device. The description details hardware components and physical characteristics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The 1.5T 8ch Flex Suite is a receive-only coil for an MRI system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to produce diagnostic images. This process happens within the body (in vivo).
- Intended Use: The intended use is to produce diagnostic images of specific anatomical sites (upper and lower extremities, head, and spine) that are interpreted by a physician. This is a diagnostic imaging device, not a device that analyzes biological samples.
The description clearly indicates that this device is part of an MRI system used for imaging the human body directly, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
upper and lower extremities, head and spine
Indicated Patient Age Range
adult population
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)
Summary of Non-Clinical Tests:
Verification testing has been performed and is documented in the sections noted below of this submission. The following verification tests have been performed:
-
- Biocompatibility testing
-
- IEC 60601-1-2 testing
-
- IEC 60601-1 testing
-
- Maximum B1 Peak test
-
- Signal to Noise ratio and uniformity test according to NEMA standard
-
- Blocking Network analysis
-
- Surface temperature test normal condition
-
- Surface temperature test unplugged condition
Summary of Clinical Tests:
Analyses in axial, sagittal and coronal planes were run on the 8ch Flex Suite to show that anatomies of the submitted and predicate device have substantial equivalence.
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.
0
December 8, 2017
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Shenzhen RF Tech Co., Ltd. % Mr. Ke Xi CEO 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, Guangdong 518132 CHINA
Re: K172222
Trade/Device Name: 8ch Flex Suite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 20, 2017 Received: November 29, 2017
Dear Mr. Ke Xi:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K172222 |
|---|---|
| Device Name | 8ch Flex Suite |
| Indications for Use (Describe) | The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14) Page 1 of 1
n
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Image /page/3/Picture/0 description: The image shows the logo for RFT, which is a blue oval with the letters "RFT" in blue inside. There is a small orange diamond between the "R" and the "F". Below the logo, the text "510(k) Summary" is written in black.
In accordance with 21 CFR 807.92 the following summary of information is provided:
| I. | Submitter | Shenzhen RF Tech Co., Ltd |
|---|---|---|
| 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming | ||
| Shenzhen, 518132 China | ||
| Phone: (+86) 755-2664 1989 | ||
| Fax: (+86)755-2664 2989 | ||
| Contact Person: | Mr.Ke Xi | |
| CEO | ||
| Shenzhen RF Tech Co., Ltd | ||
| Email: xike@rft.cn | ||
| Date Prepared: | July 20, 2017 |
- II. Name of Device
| Name of Device: | 8ch Flex Suite |
|---|---|
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Classification Names: | Magnetic resonance diagnostic device (21 CFR 892.1000) |
| Regulation Class: | II |
| Product Code: | MOS |
- lll. Model numbers
| 10-F26000 | 8ch Flex Suite |
|---|---|
| 10-F24260 | 8ch Flex 70 Array |
| 10-F24261 | 8ch Flex 50 Array |
| 10-F24262 | 8ch Flex 40 Array |
IV. Predicate Device
Predicate device: K101632, 1.5T MetaFlexCoil;
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Image /page/4/Picture/0 description: The image shows a logo with the letters "RFT" in a bold, sans-serif font. The letters are a dark blue color. There is a small orange diamond between the "R" and the "T". The letters and the diamond are enclosed in a dark blue oval. The logo appears to be for a company or organization with the initials "RFT".
V. Device Description
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
VI. Intended Use
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.
VII. Compatibility
The 1.5T 8ch Flex Suite is compatible with GE 1.5T MRI systems (Such as: SIGNA Explorer system) where coil ID allows. The 1.5T 8ch Flex Suite is intended for use on 1.5T GE Magnetic Resonance Scanners with HD-Connectors (used on HD series scanners).
VIII. Technology
The 1.5T 8ch Flex Suite is flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.
The 1.5T 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers.
The 1.5T 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz.
IX. Determination of Substantial Equivalence
Summary of Non-Clinical Tests:
Verification testing has been performed and is documented in the sections noted below of this submission. The following verification tests have been performed:
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Image /page/5/Picture/0 description: The image shows the logo for RFT. The logo consists of the letters "RFT" in a bold, dark blue font, enclosed within a dark blue oval. A small orange diamond is positioned between the "R" and the "T", adding a touch of color to the design. The overall design is simple and clean.
-
- Biocompatibility testing
-
- IEC 60601-1-2 testing
-
- IEC 60601-1 testing
-
- Maximum B1 Peak test
-
- Signal to Noise ratio and uniformity test according to NEMA standard
-
- Blocking Network analysis
-
- Surface temperature test normal condition
-
- Surface temperature test unplugged condition
Summary of Clinical Tests:
Analyses in axial, sagittal and coronal planes were run on the 8ch Flex Suite to show that anatomies of the submitted and predicate device have substantial equivalence.
X. Conclusion
Shenzhen RF Tech Co., Ltd considers the 8ch Flex Suite does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.