(119 days)
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.
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.
The provided text describes the 510(k) premarket notification for the "8ch T/R Knee Coil" by Shenzhen RF Tech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and performance through bench testing, rather than an AI/ML-based device requiring extensive clinical study for performance metrics like sensitivity and specificity.
Therefore, the following information is extracted from the provided text according to the specific questions:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative performance table (e.g., specific SNR thresholds for passing). Instead, it states that the device "met specified requirements" for various tests as demonstrated through bench testing. The criteria are implied to be conformance to the listed standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to IEC 60601-1 (Basic safety & essential performance) | Demonstrated conformance; tests passed |
| Conformance to IEC 60601-1-2 (EMC) | Demonstrated conformance; tests passed |
| Conformance to ISO 10993-5 (In vitro cytotoxicity) | Demonstrated conformance; tests passed |
| Conformance to ISO 10993-10 (Irritation & skin sensitization) | Demonstrated conformance; tests passed |
| Conformance to NEMA MS-1 (SNR determination) | Met specified requirements for SNR; tests passed |
| Conformance to NEMA MS-3 (Image uniformity determination) | Met specified requirements for image uniformity; tests passed |
| Conformance to IEC 60601-2-33 (MR equipment safety/performance) | Demonstrated conformance; tests passed |
| Coil surface heating within specified requirements | Met specified requirements for coil surface heating; tests passed |
| Performance as well as the legally marketed predicate device | Considered to perform as well as the predicate device |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes "bench testing" of the device. There is no mention of a "test set" in the context of patient data or clinical images. The testing involved physical tests of the device itself. Therefore, sample size and data provenance in this context are not applicable in the way they would be for an AI/ML diagnostic algorithm.
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)
Not applicable. This device is an MRI coil, not an AI diagnostic algorithm requiring expert "ground truth" for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" in the context of clinical images requiring adjudication.
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 coil, not an AI solution intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI coil, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's testing relates to established engineering and safety standards (e.g., material biocompatibility, electrical safety, signal-to-noise ratio measurements, image uniformity).
8. The sample size for the training set
Not applicable. This device is an MRI coil and does not involve AI/ML modeling that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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) |
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
"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."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
{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 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:
| 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 529000 |
| Contact Person: | Mr. Gary WangQ&R ConsultantEmail: gary.wang@bonnier.net.cn |
| II. Device Regulation Information | |
| Device Trade Name: | 8ch T/R Knee Coil |
| 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-F31896 |
| Device Trade Name: | 8ch T/R Knee Coil |
| IV. Predicate Device Information | |
| Sponsor: | MRI DEVICES CORP. |
| Device: | HRK-63-8 KNEE ARRAY COIL |
| 510(K) Number: | K032633 |
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.
{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 "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:
{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" 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.
§ 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.