(123 days)
Not Found
No
The summary describes a passive MRI coil and its performance characteristics, with no mention of AI or ML for image processing or interpretation.
No
The device is a transmit/receive coil for MRI systems, designed to produce diagnostic images. It does not treat or cure any medical condition.
Yes
The device is described as producing "diagnostic images" that "can be interpreted by a trained physician," directly indicating its role in diagnosis.
No
The device description explicitly states it is a "transmit/receive phased array coil," which is a hardware component used in MRI systems. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states this device is a "transmit/receive coil" for use with MRI systems to produce "diagnostic images" of anatomical sites like the knee, palm, etc. This is an imaging device that works on the body, not with specimens taken from the body.
The information provided describes a medical imaging accessory, specifically an MRI coil, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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 (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 1.5T HD T/R Knee Array 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.
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
§ 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.
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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.
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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
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Indications for Use
Submission Number (if known)
Device Name
1.5T HD T/R Knee Array (10-F34127)
Indications for Use (Describe)
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.
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)
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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 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 518132
Phone: (+86) 755-2664 1989-113
Fax: (+86)755-2664 2989 |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Correspondent: | Shenzhen RF Tech Co., Ltd.
2-F,BLD4 Juhui Industrial Park,
Tianliao,Guangming,Shenzhen,
P.R.China 518132
Phone: (+86) 755-2664 1989-113
Fax: (+86)755-2664 2989 |
| Contact Person: | Mr. Gary Wang
E-mail: gary.wang@rft.cn |
| II. Device Regulation Information
Device 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
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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
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.
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 Tech | ||
| Co.;Ltd. | Shenzhen RF Tech | ||
| Co.,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
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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" 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.