1.5T 24E Posterior Array

K223203 · Shenzhen RF Tech Co., Ltd. · LNH · Mar 2, 2023 · Radiology

Device Facts

• Record ID: K223203
• Device Name: 1.5T 24E Posterior Array
• Applicant: Shenzhen RF Tech Co., Ltd.
• Product Code: LNH · Radiology
• Decision Date: Mar 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.

Device Story

Receive-only phased array MRI coil; 24-channel design; tuned to proton precession frequency (~64MHz) in 1.5T magnetic field. Used with GE 1.5T MRI systems; operated by trained MRI technicians/radiologists in clinical settings. Device captures RF signals from patient anatomy; signals processed by host MRI scanner to generate diagnostic images. Output interpreted by physicians for clinical diagnosis. Benefits include high-quality diagnostic imaging of spine and other anatomical regions; facilitates clinical decision-making through improved visualization.

Clinical Evidence

Bench testing only. Verification performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA MS-1, and NEMA MS-3. Biocompatibility testing per ISO 10993-5 and ISO 10993-10. Sample clinical images obtained from various anatomical sites and pulse sequences demonstrate sufficient quality for diagnostic use.

Technological Characteristics

24-channel receive-only phased array coil; 1.5T field strength; hydrogen tuning (~64MHz); active/passive decoupling. Surface-contacting design. Biocompatibility per ISO 10993-5 and ISO 10993-10. Powered by host MRI scanner. Connectivity via proprietary coil interface for GE 1.5T systems.

Indications for Use

Indicated for patients requiring diagnostic MRI imaging of the spine, abdomen, torso, pelvis, prostate, cardiac, hips, and long bones 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

• GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355, OPTIMA MR360 (K123417)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 2, 2023

Shenzhen RF Tech Co., Ltd. % Gary Wang Q&R Consultant Bonnier Quality Supervision Consulting (JM) Center Hailunxinyuan No.3203, Jianghai District Jiangmen, Guangdong 529000 China

Re: K223203

Trade/Device Name: 1.5T 24E Posterior Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: February 1, 2023 Received: February 1, 2023

Dear Gary Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

D

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality 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) K223203

Device Name 1.5T 24E POSTERIOR ARRA Y

#### Indications for Use (Describe)

The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo with the letters "RFT" in blue, enclosed in a blue oval. There is a red diamond shape between the "R" and the "T". The letters are bold and stylized, giving the logo a clean and professional appearance. The oval shape provides a border around the letters, making the logo stand out.

# 510(k) Summary

Date:2023-03-02(YY-MM-DD)

In accordance with 21 CFR 807.92 the following summary of information is provided:

| I. Applicant/Manufacturer: | Shenzhen RF Tech Co., Ltd.<br>2-F,BLD4 Juhui Industrial Park,<br>Tianliao,Guangming,Shenzhen,<br>P.R.China 518132<br>Phone: [phone]-113<br>Fax: [phone] |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Correspondent: | Bonnier Quality Supervision Consulting (JM) Center<br>Hailunxinyuan No.3203, Jianghai District,<br>Jiangmen City, China 529000<br>Phone: [phone] |
| Contact Person: | Mr. Gary Wang<br>Q&R Consultant<br>Email: [e-mail] |
| II. Device Regulation Information | |
| Device Name: | 1.5T 24E Posterior Array |
| Classification panel: | Radiology |
| Classification Names: | Coil, Magnetic Resonance, Specialty |
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Class: | II |
| Product Code: | MOS |
| Type of 510(k) submission: | Traditional 510(k) |
| III. Device Information | |
| Product Number: | 10-F28808 |
| Device Trade Name: | 1.5T 24E Posterior Array |
| IV. Predicate Device Information | |
| Sponsor: | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |

Device: 510(K) Number:

GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355, OPTIMA MR360 K123417

V. Device Description

The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone.

The 1.5T 24E Posterior Array is tuned to receive RF frequency corresponding to the proton

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a blue oval with the letters "RFT" in blue inside. There is a red diamond between the "F" and the "T". The letters are bold and sans-serif.

precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

### VI. Indications for Use

The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be use with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.

### VII. Compatibility

The 1.5T 24E Posterior Array is compatible with GE 1.5T MRI systems where coil ID allows. The Compatibility with GE 1.5T MRI systems was verified.

| | Predicate Device | Subject | Result |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------|
| K number | K123417 | K223203 | |
| Manufacturer | GE HANGWEI MEDICAL<br>SYSTEMS CO., LTD. | Shenzhen RF Tech Co.,Ltd | |
| Anatomical site | the entire body, including,<br>but not limited to, head,<br>neck, TMJ, spine, breast,<br>heart, abdomen, pelvis,<br>joints, prostate, blood<br>vessels, and<br>musculoskeletal regions of<br>the body. | Spine, When used with<br>other coils, it also include<br>abdomen, torso, pelvis,<br>prostate, cardiac, hips, and<br>long bone. | Equivalent |
| Transmit/Receive | RF coil (receive only) | RF coil (receive only) | Same |
| Number of channels | 24 CH | 24 CH | Same |
| Field strength | 1.5T | 1.5T | Same |
| Preamplifier noise | 0.5dB | 0.5dB | Same |
| Energy Source | Scanner | Scanner | Same |
| Compatible systems | GE 1.5T MRI | GE 1.5T MRI | Same |
| Coil design | phased array | phased array | Same |
| Tuning | Hydrogen (~64MHz) | Hydrogen (~64MHz) | Same |
| Decoupling method | active + passive | active + passive | Same |
| Patient-Contact | Surface-contacting | Surface-contacting | Same |
| Bio-compatibility | ISO 10993-5 | ISO 10993-5 | Same |
| Compliance | ISO 10993-10 | ISO 10993-10 | Same |

#### VIII. Technological Comparison

The Subject device has the same technological characteristics on design, energy source and using environment as the predicate device. The biocompatibility of material used is both compliance with ISO 10993-5 and ISO 10993-10.

IX. Summary of Verification Tests:

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows a logo with the letters "RFT" in blue, enclosed in a blue oval. The "F" has a red diamond shape in the middle. The logo appears to be for a company or organization with the initials "RFT".

All verification tests have been performed according to below standard, the testing results are passed

1.IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +

A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;

2.IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;

3.ISO 10993-5:2009: Biological evaluation of medical devices. Part 5-Tests for in vitro cytotoxicity. 4.ISO 10993-10:2010 Biological evaluation of medical devices, Part 10-Tests for irritation and skin sensitization.

5.NEMA MS-1-2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging.

6.NEMA MS 3-2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images.

7.IEC 60601-2-33:2010+A1:2013+A2:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.

Bench testing was conducted to demonstrate that image uniformity, SNR and coil surface heating met specified requirements. The test results also show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards listed above.

X. Summary of Clinical Tests:

In accordance with the FDA guidance document Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway, sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences. The sample images obtained using the 1.5T 24E Posterior Array are of sufficient quality for diagnosis use.

XI. Conclusion:

Shenzhen RF Tech Co., Ltd. considers the 1.5T 24E Posterior Array does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.