Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware (coil design, phased array, frequency tuning) and its function in receiving RF signals for MRI imaging. There is no mention of software processing, algorithms, or any terms related to AI/ML.

Therapeutic

No
The device is a receive-only coil for MRI systems, designed to produce diagnostic images, not to provide therapy.

Diagnostic

No
The device is a receive-only coil for an MRI system, designed to produce diagnostic images, not directly perform diagnosis itself. The images are then interpreted by a trained physician.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "receive-only phased array coil" and mentions hardware components like "intergraded preamplifiers" and being "tuned to the proton frequency," indicating it is a physical hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
Device Function: The 8ch Wrist Coil is a component of an MRI system. It's a receive-only coil used to capture radiofrequency signals emitted by the body during an MRI scan. This process happens inside the body.
Intended Use: The intended use is to produce diagnostic images of the wrists and fingers, which are then interpreted by a physician. This is an imaging modality, not a laboratory test performed on a sample.

The information provided clearly describes a medical imaging device used for diagnostic purposes in vivo (within the living body), not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The 8ch Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

Product codes (comma separated list FDA assigned to the subject device)

MOS

Device Description

The 8ch Wrist Coil is receive only phased array coil to produce diagnostic images of the wrists and fingers in adult population.

The 8ch Wrist 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.

The 8ch Wrist Coil is based on phased array technique to produce the images from 8 different channels with intergraded preamplifiers. The 8ch Wrist Coil is tuned to the proton frequency of 63.86MHz.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance Imaging (MRI)

Anatomical Site

wrists and fingers

Indicated Patient Age Range

Adult population

Intended User / Care Setting

Trained physician / Not Specified

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was conducted to demonstrate that image uniformity, SNR and coil surface heating met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050622

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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.

December 8, 2022

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

Re: K223239

Trade/Device Name: 8ch Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: October 19, 2022 Received: October 20, 2022

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,

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) K223239

Device Name 8ch Wrist Coil

Indications for Use (Describe)

The 8ch Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

Type of Use (Select one or both, as applicable)

|X 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 letters "RFT" in blue, with a red diamond in place of the dot on the "i". The letters are inside of a blue oval. The letters are large and bold, and the diamond is small and centered above the "T". The oval is thin and surrounds the letters closely.

K223239 510(k) Summary

Date:2022-12-08(YY-MM-DD)

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

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Image /page/4/Picture/0 description: The image shows a blue oval with the letters "RFT" in blue inside. The letter "F" has a red diamond in the middle. The letters are in a bold, sans-serif font. The oval appears to be a logo or emblem.

The 8ch Wrist Coil is receive only phased array coil to produce diagnostic images of the wrists and fingers in adult population.

The 8ch Wrist 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.

The 8ch Wrist Coil is based on phased array technique to produce the images from 8 different channels with intergraded preamplifiers. The 8ch Wrist Coil is tuned to the proton frequency of 63.86MHz.

VI. Indications for Use

The 8ch Wrist Coil by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

VII. Compatibility

The connector of 8ch Wrist Coil is P-Port type. The 8ch Wrist Coil is compatible with GE1.5T MRI systems where coil ID allows.

Specification	Predicate Device	Subject	Result
K number	K050622	K223239
Manufacturer	MRI DEVICES
CORPORATION	Shenzhen RF Tech Co.,Ltd
Indications for Use	To be used in conjunction with
a magnetic resonance
scanner to produce diagnostic
images of the wrist and hand
that can be interpreted by a
trained physician.	The 8ch Wrist Coil
manufactured by Shenzhen
RF Tech Co.,Ltd is
receive-only coil and is
designed for use as general
purpose coil. The 8ch Wrist
Coil is designed to be use
with GE 1.5T MRI systems
to produce diagnostic
images of the Wrists and
fingers that can be
interpreted by a trained
physician.	Equivalent
Anatomical site	Wrist/Hand	Wrist/Fingers	Same
Transmit/Receive	RF coil (receive only)	RF coil (receive only)	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	GE 1.5T MRI systems	GE 1.5T MRI systems	Same

VIII Technological Comparison

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Image /page/5/Picture/0 description: The image shows a logo with the letters "RFT" in blue, with a red diamond shape in the middle. The letters are inside a blue oval shape. The letters are bold and easy to read. The logo is simple and clean.

Coil design	phased array	phased array	Same
Tuning	Hydrogen (~64MHz)	Hydrogen (~64MHz)	Same
Decoupling
method	Yes	Yes, active + passive	Same
Patient-contacting
materials assessed
for compliance with
biocompatibility
standards	Yes	Yes	Same

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. ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl.

AMD2:2021] 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 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 8ch Wrist Coil achieved the expected results and satisfied the standards listed above.

X. Conclusion:

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