The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

Device Description

The 1.5T HD T/R Knee Array is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 1.5T HD T/R Knee 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

Here is a summary of the acceptance criteria and study information for the 1.5T HD T/R Knee Array device, based on the provided text:

Device: 1.5T HD T/R Knee Array (10-F34127)
Predicate Device: Shenzhen RF Tech Co.,Ltd. 8ch T/R Knee Coil (K223225)

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological comparison and standard compliance, rather than providing specific quantitative acceptance criteria for device performance parameters like SNR and image uniformity. However, it states that the device "met specified requirements" for these tests.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Technological Equivalence	Same anatomical sites, transmit/receive, number of channels (8ch), field strength (1.5T), preamplifier noise (0.5dB), energy source, compatible systems (1.5T GE MRI), coil design (phased array), tuning (Hydrogen ~64MHz), decoupling method (active + passive), patient-contact (surface-contacting).	All technological characteristics listed in the criteria were found to be "Same" or "Equivalent" to the predicate device.
Biocompatibility	Compliance with ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization).	The device demonstrated compliance with ISO 10993-5 and ISO 10993-10.
Electrical Safety	Compliance with IEC 60601-1:2005+A1:2012 (General requirements for basic safety and essential performance).	Testing results "passed" according to IEC 60601-1.
EMC	Compliance with IEC 60601-1-2:2014 (Electromagnetic compatibility).	Testing results "passed" according to IEC 60601-1-2.
MRI Specific Safety/Performance	Compliance with IEC 60601-2-33:2010+A1:2013+A2:2015 (Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis).	Testing results "passed" according to IEC 60601-2-33.
Image Quality (SNR)	Compliance with NEMA MS-1-2008 (Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging). Meets specified requirements for SNR.	Bench testing demonstrated that SNR met specified requirements. (Specific values not provided)
Image Quality (Uniformity)	Compliance with NEMA MS 3-2008 (Determination of Image Uniformity in Diagnostic Magnetic Resonance Images). Meets specified requirements for image uniformity.	Bench testing demonstrated that image uniformity met specified requirements. (Specific values not provided)
Coil Surface Heating	Meets specified requirements for coil surface heating.	Bench testing demonstrated that coil surface heating met specified requirements. (Specific values not provided)

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

The document describes bench testing for image uniformity, SNR, and coil surface heating. It does not specify a "test set" in terms of subject or patient data. The data provenance is from laboratory bench testing. The country of origin for the testing is not explicitly stated, but the manufacturer is Shenzhen RF Tech Co., Ltd. from China. The study appears to be entirely retrospective in the sense that it relies on lab measurements and comparisons to established standards and a predicate device's specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided as the submission focuses on technical performance verification through bench testing against standards, not on clinical accuracy or diagnostic interpretation by experts.

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

This information is not applicable/none as the testing described is technical bench testing, not a clinical study requiring adjudication of expert interpretations.

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:

No MRMC comparative effectiveness study was done. This device is an MRI coil, a hardware component, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This information is not applicable/none. The device is an MRI coil and does not involve an algorithm for standalone performance evaluation in the context of diagnostic decision-making.

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

The "ground truth" for this submission is based on established engineering and medical device standards (e.g., NEMA MS-1, NEMA MS-3, IEC 60601 series, ISO 10993 series) and comparison to the specifications and performance of the legally marketed predicate device (K223225). For image quality parameters like SNR and uniformity, the ground truth is defined by the requirements outlined in the NEMA standards.

8. The sample size for the training set:

This information is not applicable/none as this is a hardware device (MRI coil) and does not involve a "training set" in the context of machine learning.

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

This information is not applicable/none for the reasons stated in point 8.

Summary

{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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 18, 2023

Shenzhen RF Tech Co., Ltd. % Gary Wang Quality & Regulation Director 2-F, BLD4 Juhui Industrial Park Tianliao, Guangming Shenzhen, GD 518132 CHINA

Re: K231085

Trade/Device Name: 1.5T HD T/R Knee Array (10-F34127) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: July 24, 2023 Received: July 24, 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-reporting-

combination-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.

FDA

Daniel M. Krainak, Ph.D. Assistant Director 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}------------------------------------------------

Indications for Use

Submission Number (if known)

K231085

Device Name

1.5T HD T/R Knee Array (10-F34127)

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)

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 PRAStaff(@fda.hhs.gov

"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 the logo for RFT, which is in blue and inside of a blue oval. The letters R, F, and T are in a bold, sans-serif font. There is a red diamond between the F and the T.

510(k) Summary

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:	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
Contact Person:	Mr. Gary WangE-mail: gary.wang@rft.cn
II. Device Regulation InformationDevice Trade Name:	1.5T HD T/R Knee Array
Classification panel:	Radiology
Classification Names:	Magnetic Resonance Diagnostic Device
Common 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-F34127
Device Trade Name:	1.5T HD T/R Knee Array
IV. Predicate Device Information

Sponsor: Device: 510(K) Number:

Shenzhen RF Tech Co.,Ltd. 8ch T/R Knee Coil K223225

V. Device Description

The 1.5T HD T/R Knee Array is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist.

The 1.5T HD T/R Knee Array is tuned to receive RF frequency corresponding to the proton

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

Image /page/4/Picture/0 description: The image shows a logo with the letters "RFT" in blue, enclosed in a blue oval. The letter "R" is on the left, followed by the letter "F" in the middle, and the letter "T" on the right. There is a red diamond shape between the letters "F" and "T".

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

VI. Indications for Use

VII. Compatibility

The 1.5T HD T/R Knee Array is intended for use on 1.5T GE MRI. The 1.5T HD T/R Knee Array is compatible with GEHC 1.5T SIGNA Explorer System where coil ID allows.

	Predicate Device	Subject	Result
K number	K223225
Manufacturer	Shenzhen RF TechCo.;Ltd.	Shenzhen RF TechCo.,Ltd.
Anatomical site	Knee, palm, sole, ankle,elbow, wrist	Knee, palm, sole, ankle,elbow, wrist	Same
Transmit/Receive	Transmit/Receive	Transmit/Receive	Same
Number of channels	8ch	8ch	Same
Field strength	1.5 T	1.5 T	Same
Preamplifier noise	0.5dB	0.5dB	Same
Energy Source	Scanner/DC 10V	Scanner/DC 10V	Same
Compatible systems	1.5T GE MRI	1.5T GE MRI	Equivalent
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 proposed 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:

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

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

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

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 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 HD T/R Knee Array achieved the expected results and satisfied the standards listed above.

X. Conclusion:

Shenzhen RF Tech Co., Ltd. considers the 1.5T HD T/R Knee 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.