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

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (1.5T 24E Posterior Array, a receive-only MRI coil). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria for performance in the same way an AI-based diagnostic device might.

The document focuses on engineering and basic performance tests typical for an MRI coil, rather than on diagnostic accuracy metrics. Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of device and submission.

Here's an analysis of the provided information, addressing the relevant points and noting non-applicable ones:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Measured Performance)	Reported Device Performance
Image Uniformity (NEMA MS 3-2008): The device should meet specified requirements for image uniformity.	Bench testing was conducted to demonstrate that image uniformity met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards.
Signal-to-Noise Ratio (SNR) (NEMA MS-1-2008): The device should meet specified requirements for SNR.	Bench testing was conducted to demonstrate that SNR met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards.
Coil Surface Heating: The device should meet specified requirements for coil surface heating.	Bench testing was conducted to demonstrate that coil surface heating met specified requirements. The test results show that the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards.
Clinical Image Quality: Sample clinical images obtained with the device should be of sufficient quality for diagnostic use.	"The sample images obtained using the 1.5T 24E Posterior Array are of sufficient quality for diagnosis use." (This is a qualitative statement, without specific quantitative metrics or thresholds provided.)
Electrical Safety (IEC 60601-1:2005 + A1:2012): Compliance with general requirements for basic safety and essential performance.	"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"
Electromagnetic Compatibility (IEC 60601-1-2:2014): Compliance with requirements and tests for electromagnetic compatibility.	"All verification tests have been performed according to below standard, the testing results are passed... 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"
Biocompatibility - Cytotoxicity (ISO 10993-5:2009): Materials in contact with the patient must pass in vitro cytotoxicity tests.	"All verification tests have been performed according to below standard, the testing results are passed... 3. ISO 10993-5:2009: Biological evaluation of medical devices. Part 5-Tests for in vitro cytotoxicity."
Biocompatibility - Irritation & Sensitization (ISO 10993-10:2010): Materials in contact with the patient must pass irritation and skin sensitization tests.	"All verification tests have been performed according to below standard, the testing results are passed... 4. ISO 10993-10:2010 Biological evaluation of medical devices, Part 10-Tests for irritation and skin sensitization."
Particular Requirements for MR Equipment (IEC 60601-2-33:2010+A1:2013+A2:2015): Compliance with basic safety and essential performance for MR equipment.	"All verification tests have been performed according to below standard, the testing results are passed... 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."
Preamplifier Noise: 0.5dB (as stated for predicate device, implied acceptance criterion for subject device)	"0.5dB" (Subject device matches predicate device)

2. Sample size used for the test set and the data provenance

The document indicates "sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences" but does not specify the sample size (number of patients or images) for this clinical evaluation. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. This is typical for a 510(k) for an MRI coil, where the focus is on engineering metrics and general image quality rather than diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device submission. The clinical evaluation involves a qualitative assessment of image quality for diagnostic use, rather than a diagnostic accuracy study requiring ground truth established by multiple experts. The statement "can be interpreted by a trained physician" implies general medical expertise rather than a specific number or qualification of experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for this type of device submission, as it relates to diagnostic disagreement resolution, which is not described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an MRI receive coil, not an AI diagnostic device. No MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is hardware (an MRI coil), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "sufficient quality for diagnostic use" assessment in the clinical evaluation, the "ground truth" would implicitly be the opinion of "a trained physician" that the images are adequate for diagnosis, rather than a formal ground truth like pathology or outcomes data. This is a general judgment of image utility, not a specific diagnostic accuracy evaluation.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and does not have a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/algorithm-based device and does not have a training set.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

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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)

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)

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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.2-F,BLD4 Juhui Industrial Park,Tianliao,Guangming,Shenzhen,P.R.China 518132Phone: (+86) 755-2664 1989-113Fax: (+86)755-2664 2989
Submitter/Correspondent:	Bonnier Quality Supervision Consulting (JM) CenterHailunxinyuan No.3203, Jianghai District,Jiangmen City, China 529000Phone: (+86) 13600366215
Contact Person:	Mr. Gary WangQ&R ConsultantEmail: gary.wang@bonnier.net.cn
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 tuned to receive RF frequency corresponding to the proton

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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 MEDICALSYSTEMS CO., LTD.	Shenzhen RF Tech Co.,Ltd
Anatomical site	the entire body, including,but not limited to, head,neck, TMJ, spine, breast,heart, abdomen, pelvis,joints, prostate, bloodvessels, andmusculoskeletal regions ofthe body.	Spine, When used withother coils, it also includeabdomen, torso, pelvis,prostate, cardiac, hips, andlong 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:

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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.

Regulation Number and Section

§ 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.