8ch Flex Suite

K172222 · Shenzhen RF Tech Co., Ltd. · MOS · Dec 8, 2017 · Radiology

Device Facts

• Record ID: K172222
• Device Name: 8ch Flex Suite
• Applicant: Shenzhen RF Tech Co., Ltd.
• Product Code: MOS · Radiology
• Decision Date: Dec 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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.

Device Story

Receive-only phased array MRI coil; 8-channel configuration; includes integrated preamplifiers. Designed for use with GE 1.5T MRI systems. Flexible, lightweight construction allows wrapping around various anatomical shapes (extremities, head, spine). Tuned to 63.86 MHz (proton frequency). Operates by receiving RF signals during MRI scanning; signals processed by host GE MRI system to produce diagnostic images. Used in clinical imaging environments by trained physicians/technicians. Provides high-quality diagnostic images for clinical decision-making; flexible design improves patient comfort and anatomical fit.

Clinical Evidence

No clinical trials performed. Substantial equivalence supported by bench testing and comparative imaging analysis. Bench testing included biocompatibility, IEC 60601-1/1-2 safety, B1 peak testing, NEMA-standard SNR and uniformity, blocking network analysis, and surface temperature testing. Comparative analysis of axial, sagittal, and coronal plane images confirmed performance equivalence to the predicate.

Technological Characteristics

Receive-only phased array coil; 8 elements; integrated preamplifiers. Tuned to 63.86 MHz. Flexible form factor. Compatible with GE 1.5T MRI systems via HD-Connectors. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), NEMA (SNR/uniformity).

Indications for Use

Indicated for adult patients requiring diagnostic MRI imaging of upper and lower extremities, head, and spine using GE 1.5T MRI systems.

Regulatory Classification

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

• 1.5T MetaFlexCoil (K101632)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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| 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) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <div> <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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FORM FDA 3881 (8/14) Page 1 of 1

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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: [phone] |
| | | Fax: [phone] |
| | Contact Person: | Mr.Ke Xi |
| | | CEO |
| | | Shenzhen RF Tech Co., Ltd |
| | | Email: [e-mail] |
| | 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.

- 1. Biocompatibility testing
- 2. IEC 60601-1-2 testing
- 3. IEC 60601-1 testing
- 4. Maximum B1 Peak test
- 5. Signal to Noise ratio and uniformity test according to NEMA standard
- 6. Blocking Network analysis
- 7. Surface temperature test normal condition
- 8. 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.