Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hardware component (an MRI coil) and its performance characteristics related to image quality and safety. There is no mention of software processing, algorithms, or any terms associated with AI/ML.

Therapeutic

No
The device is an MRI coil used to produce diagnostic images, not to treat a condition or disease.

Diagnostic

Yes
The device is described as producing "diagnostic images" that "can be interpreted by a trained physician," indicating its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device is described as a "transmit/receive phased array coil" and undergoes bench testing for physical properties like "image uniformity, SNR and coil surface heating," indicating it is a hardware component used in MRI systems, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The 8ch T/R Knee Coil is an accessory for an MRI system. Its function is to transmit and receive radiofrequency signals to produce diagnostic images of the body. It does not analyze samples taken from the body.
Intended Use: The intended use is to produce diagnostic images of specific anatomical sites (knee, palm, sole, ankle, elbow, wrist) for interpretation by a trained physician. This is a function of an imaging device, not an IVD.

Therefore, based on the provided information, the 8ch T/R Knee Coil is a medical device used in conjunction with an MRI system for diagnostic imaging, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

Product codes

MOS

Device Description

The 8ch T/R Knee Coil is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist.
The 8ch T/R Knee Coil 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

Magnetic Resonance Imaging (MRI)

Anatomical Site

knee, palm, sole, ankle, elbow, wrist

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained physician / Not Found

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

Bench testing was conducted to demonstrate that image uniformity, SNR and coil surface heating met specified requirements. The test results also show that the8ch T/R Knee Coil achieved the expected results and satisfied the standards listed above.

Key Metrics

Not Found

Predicate Device(s)

K032633

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 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: K223225

Trade/Device Name: 8ch T/R Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: January 16, 2023 Received: January 17, 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.

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

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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,

D. K.

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 Ouality 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) K223225

Device Name 8ch T/R Knee Coil

Indications for Use (Describe)

The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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 the logo for RFT, which is in blue and inside of a blue oval. The letters R, F, and T are in bold, and there is a red diamond between the F and the T. The logo is simple and easy to recognize.

510(k) Summary

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

V. Device Description

The 8ch T/R Knee Coil is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist.

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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 "R" and the "T". The letters are in a bold, sans-serif font. The oval is outlined in a slightly darker shade of blue.

The 8ch T/R Knee Coil 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. Indications for Use

The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

VII. Compatibility

The 8ch T/R Knee Coil is compatible with GE 1.5T SIGNA Victor &SIGNA Prime systems where coil ID allows. The 8ch T/R Knee Coil is intended for use on 1.5T GE Magnetic Resonance Scanners.

	Predicate Device	Subject	Result
K number	K032633
Manufacturer	MRI DEVICES CORP.	Shenzhen RF Tech Co.,Ltd
Anatomical site	knee	Knee, palm, sole, ankle,
elbow, wrist	Equivalent
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	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 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:

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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" has a red diamond shape in the middle. The logo appears to be for an organization or company with the initials "RFT".

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 the8ch T/R Knee Coil achieved the expected results and satisfied the standards listed above.

X. Conclusion:

Shenzhen RF Tech Co., Ltd. considers the 8ch T/R Knee Coil does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.