(49 days)
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.
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.
The provided text is a 510(k) Summary for the 8ch Wrist Coil, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of an AI algorithm's performance. Therefore, much of the requested information regarding AI algorithm performance (e.g., acceptance criteria for AI, training set details, multi-reader multi-case studies) is not present in this document.
However, based on the information provided, I can address the aspects related to the device's performance and validation, particularly in relation to its physical and imaging characteristics:
Acceptance Criteria and Device Performance for 8ch Wrist Coil
The document primarily focuses on demonstrating that the 8ch Wrist Coil performs "as well as" the predicate device and meets established industry standards for MRI coils.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functional Equivalence | Indicated Use (for wrists/fingers, diagnostic images, trained physician interpretation) | "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." (Matches predicate's broader wrist/hand indication, extended to 'fingers') |
| Anatomical Site | Wrist/Fingers (Predicate: Wrist/Hand) | |
| Transmit/Receive Type | RF coil (receive only) | |
| Number of Channels | 8CH | |
| Field Strength Compatibility | 1.5 T | |
| Preamplifier Noise | 0.5dB | |
| Energy Source | Scanner/DC 10V | |
| Compatible Systems | GE 1.5T MRI systems | |
| Coil Design | Phased array | |
| Tuning | Hydrogen (~64MHz) (Proton frequency of 63.86MHz stated elsewhere) | |
| Decoupling Method | Yes, active + passive | |
| Performance Metrics | Image Uniformity | "Bench testing was conducted to demonstrate that image uniformity...met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above." (Implies meeting NEMA MS 3-2008) |
| Signal-to-Noise Ratio (SNR) | "Bench testing was conducted to demonstrate that ...SNR...met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above." (Implies meeting NEMA MS-1-2008) | |
| Coil Surface Heating | "Bench testing was conducted to demonstrate that ...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." | |
| Safety & Biocompatibility | Biocompatibility of Patient-Contacting Materials | "Patient-contacting materials assessed for compliance with biocompatibility standards: Yes." "The biocompatibility of material used is both compliance with ISO 10993-5 and ISO 10993-10." |
| Electrical Safety (General Requirements) | "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;" | |
| Electromagnetic Compatibility (EMC) | "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;" | |
| MRI Equipment Specific Requirements | "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." |
The study proving the device meets these criteria is the "Summary of verification Tests," which states: "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."
Regarding AI-specific criteria, the document does not present information about an AI algorithm. This device is a passive MRI coil, not an AI software. Therefore, the following points are not applicable based on the provided text:
- 2. Sample size used for the test set and the data provenance: Not applicable for a hardware device validation based on bench testing. The "test set" here refers to the physical coil and its performance measurements.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by metrology and standard comparisons (e.g., NEMA, IEC).
- 4. Ground truth Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a hardware device, not an AI algorithm.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the hardware coil, the "ground truth" for its performance (SNR, uniformity) is established by adherence to recognized industry standards (NEMA MS-1, NEMA MS-3) and validated bench testing procedures.
- 8. The sample size for the training set: Not applicable (no AI component).
- 9. How the ground truth for the training set was established: Not applicable (no AI component).
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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:
| 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 | |
| Common Name of Device: | 8ch Wrist Coil |
| 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-F32119 |
| Device Trade Name: | 8ch Wrist Coil |
| IV. Predicate Device Information | |
| Sponsor: | MRI DEVICES CORPORATION |
| Device: | HRW-63-8 WRIST ARRAY COIL;HRW-127-8 WRIST ARRAY COIL |
| 510(K) Number: | K050622 |
| V. Device Description |
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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 DEVICESCORPORATION | Shenzhen RF Tech Co.,Ltd | |
| Indications for Use | To be used in conjunction witha magnetic resonancescanner to produce diagnosticimages of the wrist and handthat can be interpreted by atrained physician. | The 8ch Wrist Coilmanufactured by ShenzhenRF Tech Co.,Ltd isreceive-only coil and isdesigned for use as generalpurpose coil. The 8ch WristCoil is designed to be usewith GE 1.5T MRI systemsto produce diagnosticimages of the Wrists andfingers that can beinterpreted by a trainedphysician. | Equivalent |
| Anatomical site | Wrist/Hand | Wrist/Fingers | Same |
| Transmit/Receive | RF coil (receive only) | RF coil (receive only) | Same |
| Number ofchannels | 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 |
| Compatiblesystems | 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 |
| Decouplingmethod | Yes | Yes, active + passive | Same |
| Patient-contactingmaterials assessedfor compliance withbiocompatibilitystandards | 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.
§ 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.