(113 days)
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite 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 a 510(k) premarket notification for a medical device, the "8ch Flex Suite," an MRI receive-only coil. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to a different type of device clearance (an MRI coil, not an AI diagnostic algorithm) and a different regulatory pathway (substantial equivalence, not a de novo or PMA requiring detailed performance studies against defined criteria for an algorithm).
The document mentions "Clinical images evaluation testing for the proposed device was evaluated by connected to compatible MRI system," and that "Based on above testing, the proposed 8ch Flex Suite was found to have a safety and effectiveness profile that is similar to the predicate device." This suggests image quality and clinical utility were assessed, but the specifics of how this was done, what metrics were used, or any quantitative "acceptance criteria" for image performance are not provided. The comparison focuses on technical specifications and intended use matching a predicate device.
To directly answer your request based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: Not applicable/provided. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use, not on specific performance metrics for an AI/ML algorithm against predefined acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not applicable/provided. There is no mention of a "test set" in the context of an AI/ML algorithm's performance. The clinical evaluation refers to the performance of the coil itself.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No ground truth establishment for an AI/ML algorithm is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
- 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/provided. This device is an MRI coil, not an AI assistance tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided.
- 8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable/provided.
In summary, the provided document is a 510(k) summary for an MRI coil, not an AI/ML diagnostic device. Therefore, the information requested about AI/ML acceptance criteria and performance studies is not contained within this text.
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July 22, 2020
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shenzhen RF Tech Co., Ltd. % Mr. Gary Wang Q&R Director 2-F, Bld4, Juhui Industrial Park, Tianliao, Guangming Shenzhen, Guangdong 518132 CHINA
Re: K200836
Trade/Device Name: 8ch Flex Suite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: June 18, 2020 Received: June 22, 2020
Dear Mr. 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 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
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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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200836
Device Name 8ch Flex Suite
Indications for Use (Describe)
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac 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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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 | 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 |
| Contact Person: | Mr. Gary WangQ&R DirectorShenzhen RF Tech Co., Ltd.Email: gary.wang@rft.cn |
| II. Name of DeviceCommon Name of Device: | 8ch Flex Suite |
| Common/Usual Name: | Coil, Magnetic Resonance, Specialty |
| Classification panel: | Radiology |
| Classification Names: | Magnetic Resonance Diagnostic Device |
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Class: | II |
| Product Code: | MOS |
| Type of 510(k) submission: | Traditional 510(k) |
| III. Device InformationProduct Number: | Device Trade Name |
| 10-F25061 | 8ch Flex 70 Array |
| 10-F25062 | 8ch Flex 50 Array |
| 10-F25063 | 8ch Flex 40 Array |
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V. Device Description
The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite 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.
Image /page/4/Picture/3 description: The image shows three different versions of what appears to be a white, flexible keyboard-like device with a cable and connector attached. The text labels below each device, "10-F25061", "10-F25062", and "10-F25063", likely represent different model or part numbers. Each device has a similar rectangular shape with segmented sections, resembling keys or pressure-sensitive areas. The cable and connector suggest that the device is electronic and requires a wired connection.
VI. Intended Use
The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.
VII. Comparison of Technological Characteristics with the Predicated Device
| Specification | Predicate Device | Proposed | DiscussionDifference |
|---|---|---|---|
| K number | K172222 | ||
| Device name | 8ch Flex Suite | 8ch Flex Suite | |
| Manufacturer | Shenzhen RF Tech Co.,Ltd | Shenzhen RF Tech Co.,Ltd | |
| Intended Use | The 1.5T 8ch Flex Suite manufactured by ShenzhenRF Tech Co.,Ltd is receive-only coil and is designedfor use as general purpose coil. The 1.5T 8ch FlexSuite is designed to be use with GE 1.5T MRI systemsto produce diagnostic images of upper and lowerextremities, head and spine that can be interpreted bya trained physician. | The 1.5T 8ch Flex Suite manufactured by ShenzhenRF Tech Co.,Ltd is receive-only coil and is designedfor use as general purpose coil. The 1.5T 8ch FlexSuite is designed to be use with GE 1.5T MRI systemsto produce diagnostic images of upper and lowerextremities, head, spine and cardiac that can beinterpreted by a trained physician. | Similar |
| Anatomical site | The upper and lower extremities, head and spine inadult populations that can be interpreted by a trainedphysician. | The upper and lower extremities, head, spine andcardiac in adult populations that can be interpreted bya trained physician. | Similar |
| Coil type | RF coil (receive only) | RF coil (receive only) | Same |
| Channel | 8 CH | 8 CH | Same |
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| Field strength | 1.5 T | 1.5 T | Same |
|---|---|---|---|
| RF power | 16kw | 16kw | Same |
| amplitude | B1 max =25UT | B1 max =25UT | Same |
| rise time | 330usec | 330usec | Same |
| slew rate | 100 T/m/s | 100 T/m/s | Same |
| shielding | 80dB | 80dB | Same |
| cooling | 12kw(water cooling) | 12kw(water cooling) | Same |
| preamplifier noise | 0.5dB | 0.5dB | Same |
| Storagetemperature | -30°C to +55°C | -30°C to +55°C | Same |
| Storage humidity | 5% to 95% | 5% to 95% | Same |
| Operationtemperature | 15° C to 21°C | 15° C to 21°C | Same |
| Operatinghumidity | 30% to 75% | 30% to 75% | Same |
| Power source | +10V | +10V | Same |
|---|---|---|---|
| Biocompatibility | Comply with ISO 10993-5 and ISO 10993-10 | Comply with ISO 10993-5 and ISO 10993-10 | Same |
| Electrical Safety | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same |
| Other: DeviceSpecific GuidanceRequirements forComparison | Guidance for the Submission of PremarketNotifications for Magnetic Resonance DiagnosticDevices; Final | Guidance for the Submission of PremarketNotifications for Magnetic Resonance DiagnosticDevices; Final | Same |
The proposed 8ch Flex Suite can be wrapped around the anatomy of interest and have same design and same technology character with same manufacturing process and material with predicate device. The proposed 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers. It is same with predicate device
The proposed 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz. It is same with predicate device
The proposed 8ch Flex Suite has similar intended purpose with predicate device.
The difference between proposed 8ch Flex Suite and predicate device is the plug type. The proposed 8ch Flex Suite is P port and predicate device is A port, which is connected to MRI system with different port. The proposed 8ch Flex Suite extended its image scope by adding cardiac image compared to predicate device.
VIII Standard List for Performance 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 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
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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 Resonance Images.
7.IEC60601-2-33:2010+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.
IX. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
The biocompatibility evaluation was conducted in accordance with ISO International Standard and included cytotoxicity test, sensitization test and irritation test to raw material which will contact with surface skin.
The test for safety and electromagnetic compatibility (EMC), basic safety and performance test were conducted in accordance with IEC and NEMA Standard.
Shelf Life testing and mechanical reliability testing were conducted.
Clinical images evaluation testing for the proposed device was evaluated by connected to compatible MRI system.
Summary: Based on above testing, the proposed 8ch Flex Suite was found to have a safety and effectiveness profile that is similar to the predicate device.
X. Conclusion:
Shenzhen RF Tech Co., Ltd. considers the proposed 8ch Flex Suite 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.