(139 days)
Not Found
No
The summary describes a receive-only MRI coil and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "receive-only coil" designed to "produce diagnostic images" and for "diagnosis use," which indicates its purpose is for obtaining information to help in diagnosis, not for treating a condition.
Yes
The device is described as producing "diagnostic images of spine" and other anatomical sites "that can be interpreted by a trained physician," indicating its role in diagnosis.
No
The device is described as a "receive-only phased array coil," which is a physical hardware component used in MRI systems.
Based on the provided information, 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 1.5T 24E Posterior Array is an MRI coil. Its function is to receive radiofrequency signals from the body during an MRI scan to produce diagnostic images. It does not analyze samples taken from the body.
- Intended Use: The intended use is to produce diagnostic images of various anatomical sites within the body. This is a function of an imaging device, not an in vitro diagnostic device.
Therefore, the 1.5T 24E Posterior Array is an imaging device, specifically an MRI coil, and not an IVD.
N/A
Intended Use / Indications for Use
The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone.
The 1.5T 24E Posterior 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 systems
Anatomical Site
spine, abdomen, torso, pelvis, prostate, cardiac, hips, and long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 24E Posterior Array achieved the expected results and satisfied the standards listed above.
In accordance with the FDA guidance document Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway, sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences. The sample images obtained using the 1.5T 24E Posterior Array are of sufficient quality for diagnosis use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 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: K223203
Trade/Device Name: 1.5T 24E Posterior Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: February 1, 2023 Received: February 1, 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.
1
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-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
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 Quality 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) K223203
Device Name 1.5T 24E POSTERIOR ARRA Y
Indications for Use (Describe)
The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging 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 a logo with the letters "RFT" in blue, enclosed in a blue oval. There is a red diamond shape between the "R" and the "T". The letters are bold and stylized, giving the logo a clean and professional appearance. The oval shape provides a border around the letters, making the logo stand out.
510(k) Summary
Date:2023-03-02(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 518132
Phone: (+86) 755-2664 1989-113
Fax: (+86)755-2664 2989 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Correspondent: | Bonnier Quality Supervision Consulting (JM) Center
Hailunxinyuan No.3203, Jianghai District,
Jiangmen City, China 529000
Phone: (+86) 13600366215 |
| Contact Person: | Mr. Gary Wang
Q&R Consultant
Email: gary.wang@bonnier.net.cn |
| II. Device Regulation Information | |
| Device Name: | 1.5T 24E Posterior Array |
| 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-F28808 |
| Device Trade Name: | 1.5T 24E Posterior Array |
| IV. Predicate Device Information | |
| Sponsor: | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
Device: 510(K) Number:
GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355, OPTIMA MR360 K123417
V. Device Description
The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone.
The 1.5T 24E Posterior Array is tuned to receive RF frequency corresponding to the proton
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 "F" and the "T". The letters are bold and sans-serif.
precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
VI. Indications for Use
The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be use with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.
VII. Compatibility
The 1.5T 24E Posterior Array is compatible with GE 1.5T MRI systems where coil ID allows. The Compatibility with GE 1.5T MRI systems was verified.
| Predicate Device | Subject | Result | |
|---|---|---|---|
| K number | K123417 | K223203 | |
| Manufacturer | GE HANGWEI MEDICAL | ||
| SYSTEMS CO., LTD. | Shenzhen RF Tech Co.,Ltd | ||
| Anatomical site | the entire body, including, | ||
| but not limited to, head, | |||
| neck, TMJ, spine, breast, | |||
| heart, abdomen, pelvis, | |||
| joints, prostate, blood | |||
| vessels, and | |||
| musculoskeletal regions of | |||
| the body. | Spine, When used with | ||
| other coils, it also include | |||
| abdomen, torso, pelvis, | |||
| prostate, cardiac, hips, and | |||
| long bone. | Equivalent | ||
| Transmit/Receive | RF coil (receive only) | RF coil (receive only) | Same |
| Number of channels | 24 CH | 24 CH | Same |
| Field strength | 1.5T | 1.5T | Same |
| Preamplifier noise | 0.5dB | 0.5dB | Same |
| Energy Source | Scanner | Scanner | Same |
| Compatible systems | GE 1.5T MRI | GE 1.5T 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 Subject 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:
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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 "F" has a red diamond shape in the middle. The logo appears to be for a company or organization with the initials "RFT".
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 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 the 1.5T 24E Posterior Array achieved the expected results and satisfied the standards listed above.
X. Summary of Clinical Tests:
In accordance with the FDA guidance document Magnetic Resonance (MR) Receive-only Coil -Performance Criteria for Safety and Performance Based Pathway, sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences. The sample images obtained using the 1.5T 24E Posterior Array are of sufficient quality for diagnosis use.
XI. Conclusion:
Shenzhen RF Tech Co., Ltd. considers the 1.5T 24E Posterior Array does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device.