(41 days)
The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
The provided text is a 510(k) Summary for the Flex Body SPEEDER and describes performance testing for substantial equivalence. However, it does not explicitly detail acceptance criteria and a study design in the format of an AI/human-in-the-loop diagnostic device study. The device is a receive-only, phased array coil for MRI, not an AI-powered diagnostic device that interprets images. Therefore, the questions related to AI performance metrics (e.g., standalone AI performance, MRMC studies, ground truth establishment for training/test sets, sample sizes for training/test sets, expert adjudication, effect size of AI assistance) are not directly applicable to this submission.
Instead, the performance data provided focuses on the physical and functional aspects of the MRI coil.
Here's an attempt to answer the relevant questions based on the provided text, while acknowledging the limitations for questions pertaining to AI diagnostic studies:
1. A table of acceptance criteria and the reported device performance
The document mentions that the SNR and uniformity were analyzed per NEMA MS-6 and NEMA MS-9 and found to conform to predetermined acceptance criteria, but it does not explicitly state the numerical acceptance criteria or the reported numerical performance values for SNR and uniformity.
| Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance |
|---|---|
| Electrocution (AAMI/ANSI ES60601-1) | Compliant |
| Heating (AAMI/ANSI ES60601-1) | Measured temperature of the surface of the coil never exceeded the maximum limit of 41°C. |
Electrostatic Discharge Immunity (IEC 60601-1-2 Ed 4.0 (2014)) | Compliant |
| SNR (NEMA MS-6) | Conformed to predetermined acceptance criteria |
| Uniformity (NEMA MS-9) | Conformed to predetermined acceptance criteria |
| Diagnostic Image Quality (Clinical Images) | Produces diagnostic quality images of the intended anatomies |
2. Sample size used for the test set and the data provenance
The document states, "clinical images from volunteer scanning of general human anatomy were obtained from the Flex Body SPEEDER."
- Sample size: Not explicitly stated, but implies a "volunteer scanning" was conducted, indicating a small clinical dataset for qualitative assessment.
- Data provenance: Not explicitly stated, but typically clinical image acquisition for such submissions is done in a controlled site, likely in the same country as the manufacturer (USA, given the FDA submission). It's a prospective data acquisition from "volunteer scanning."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This device does not involve expert interpretation to establish "ground truth" in the sense of a diagnostic finding (e.g., presence/absence of disease) for an AI algorithm. Instead, the "ground truth" here is the qualitative assessment of image quality for diagnostic use by a "trained physician."
- Number of experts: Not specified.
- Qualifications of experts: "Trained physician." Their specific experience (e.g., years, specialization) is not detailed.
4. Adjudication method for the test set
Not applicable in the context of adjudicating diagnostic labels, as this is an image acquisition device, not a diagnostic interpretation device. The "adjudication" implied is that the images "can be interpreted by a trained physician," implying they are deemed suitable for clinical diagnosis. No formal multi-reader adjudication process like 2+1 or 3+1 is described.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done, and it would not be applicable. This device is an MRI coil, not an AI diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" concept for this device relates to diagnostic image quality. The assessment was that the "Flex Body SPEEDER produces diagnostic quality images of the intended anatomies." This is based on qualitative assessment by a "trained physician" (implied "expert review") of the images' suitability for diagnostic interpretation, rather than a specific disease outcome or pathology.
8. The sample size for the training set
Not Applicable. The device does not involve an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not Applicable. The device does not involve an AI algorithm that requires a training set with established ground truth.
{0}------------------------------------------------
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Quality Electrodynamics, LLC % Mr. Eric Yeh Senior Regulatory Affairs Specialist 6655 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
April 8, 2020
Re: K200477
Trade/Device Name: Flex Body SPEEDER Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: February 26, 2020 Received: February 27, 2020
Dear Mr. Yeh:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
{1}------------------------------------------------
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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200477
Device Name Flex Body SPEEDER
Indications for Use (Describe)
The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy 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)
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 PRAStaff@fda.hhs.gov
"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."
{3}------------------------------------------------
510(k) Summary
1. Applicant
Quality Electrodynamics, LLC. (QED) 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143
2. Contact
Eric Yeh Senior Regulatory Affairs Specialist (440) 484-2940 eric.yeh@qualedyn.com
3. Date Prepared
26 February 2020
4. Tradenames
Flex Body SPEEDER
5. Common name
Coil, magnetic resonance, specialty
Model Numbers 6.
QED Model Number: Q7000198
7. Classification
Magnetic resonance diagnostic device (21 CFR 892.1000, Product Code MOS, Class II)
8. Predicate Device
Flex Body SPEEDER manufactured by Quality Electrodynamics, LLC., K193140
9. Device Description
The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities.
{4}------------------------------------------------
The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
10. Indications for Use
The Flex Body SPEEDER is intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
The Indications for Use statement for the Flex Body SPEEDER is not identical to that of the predicate device (Flex Body SPEEDER); however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety or effectiveness of the device relative to the predicate device. Both Indications for Use statements for the proposed Flex Body SPEEDER and predicate Flex Body SPEEDER indicate that the device is intended to be used in conjunction with a MR system to produce images of general human anatomy and that the images can be interpreted by a trained physician. The indications for use statements differ only in that the proposed Flex Body SPEEDER is intended to be used with 1.5T Canon MR systems instead of 3.0T Canon MR systems.
11. Predicate Device and Technological Characteristics
At a high level, the proposed device and predicate device are based on the following same technological elements:
- . Receive-only phased array RF coil
- Active PIN diode switching blocking circuitry. Passive blocking circuitry.
- . Flexible blanket-like enclosure
- . Materials used for flame retardancy and biocompatibility: Polycarbonate and aramid felt with a polyurethane coated nylon fabric
The following technological differences exist between the proposed and predicate device:
- Compatible with Canon 1.5T MR systems (proposed device) versus . compatible with Canon 3.0T MR systems (predicate device)
{5}------------------------------------------------
12. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
All surface materials on the Flex Body SPEEDER that are intended to come into direct or indirect contact with patient biological tissues, cells or body fluids have a history of safe use in previously-cleared devices. The material and processing methods used in the proposed device are identical to those used in previously-cleared devices. The medical device in its final finished form is identical to previously-cleared devices in formulation, processing, sterilization, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
Electrical Safety and Electromagnetic Compatibility
The Flex Body SPEEDER was tested to and found to be compliant with AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface heating was tested in accordance with AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41°C.
Electrostatic Discharge Immunity was tested in accordance with IEC 60601-1-2 Ed 4.0 (2014) utilizing IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques -Electrostatic discharge immunity test as the methodology. The Flex Body SPEEDER was found to be in compliance with IEC 60601-1-2 Ed 4.0 (2014) for electrostatic discharge immunity.
Performance Testing - Bench
The SNR and uniformity of the Flex Body SPEEDER was analyzed per NEMA MS-6 and NEMA MS-9 and was found to conform to predetermined acceptance criteria.
Performance Testing - Clinical
In accordance with the FDA Guidance for Industry: Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of general human anatomy were obtained from the Flex Body SPEEDER. These images
{6}------------------------------------------------
were used to demonstrate that the Flex Body SPEEDER produces diagnostic quality images of the intended anatomies.
13. Conclusion
electrical safety and a electromagnetic cocompatibility The and biocompatibility data support the safety of the Flex Body SPEEDER and the bench testing per the IEC standards and diagnostic quality sample clinical images demonstrates the performance and effectiveness of the device under the specified use conditions. This testing demonstrates that the Flex Body SPEEDER performs as well as or better than the 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.