(59 days)
Not Found
No
The summary describes a receive-only MRI coil and its performance characteristics (SNR, uniformity). There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) to produce diagnostic images. Its intended use is to aid in diagnosis, not to provide therapy.
No
The device is an MRI coil, which is an accessory used to produce diagnostic images, but it does not perform the diagnosis itself. The diagnostic interpretation is done by a trained physician.
No
The device description explicitly states that the device is a "receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI)". This describes a physical hardware component used in MRI systems, not a software-only device.
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 description clearly states that this device is a "receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI)". MRI is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is to "produce diagnostic images of general human anatomy". This aligns with the function of an MRI coil, which is to acquire signals from the body during an MRI scan.
Therefore, this device is a component of an MRI system, which is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 16CH Flex SPEEDER Medium 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 16ch Flex SPEEDER Large coil 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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
general human anatomy
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)
The signal-to-noise ratio (SNR) and image uniformity of the 16ch Flex Speeder Coils were measured on a 1.5T Canon MR System, manufactured by Canon Medical System. The SNR and uniformity of the 16ch Flex Speeder Coils were analyzed per NEMA MS-9 (using alternate method 2.5 from MS-6) and uniformity was analyzed using NEMA MS-9 (primary method from MS-6) using pre-determined acceptance criteria.
In accordance with the FDA Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of general human anatomy were obtained from a Canon 1.5T MR system. Clinical images were obtained for the 16CH Flex SPEDER Medium and Large 1.5T from upper and lower extremities, chest, abdomen, pelvis, head, neck and spine. These images were used to demonstrate that the 16ch Flex Speeder Coils produce diagnostic quality images of the intended anatomy. No adverse events were reported or recorded.
The electrical safety and electromagnetic compatibility data support the safety of the 16ch Flex Speeder Coils 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 16ch Flex Speeder Coils performs as well as or better than the predicate device.
Surface heating was tested in accordance with AAM/ANSI EN60601-1. The device was tested plugged. The measured temperature of the surface of the coil never exceeded the maximum limit of 41C.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 28, 2025
Quality Electrodynamics Jovanna Boudreaux Senior Quality/ Regulatory Engineer 6655 Beta Drive Ste 100 Mayfield Village, Ohio 44122
Re: K244054
Trade/Device Name: 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (07000247) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: December 30, 2024 Received: December 31, 2024
Dear Jovanna Boudreaux:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Signature
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Indications for Use (Describe)
The 16CH Flex SPEEDER Medium 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 16ch Flex SPEEDER Large coil 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| 510(k) #: | K244054 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2025-02-27 | |
| 21 CFR 807.92(a)(1) | |
| Contact Details | |
| Applicant Name | Quality Electrodynamics |
| Applicant Address | 6655 Beta Drive STE 100 Mayfield Village OH 44122 United States |
| Applicant Contact Telephone | 4404842340 |
| Applicant Contact | Mrs. JoVanna Boudreaux |
| Applicant Contact Email | jovanna.boudreaux@qualedyn.com |
| Device Name | |
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) |
| Common Name | Magnetic resonance diagnostic device |
| Classification Name | Coil, Magnetic Resonance, Specialty |
| Regulation Number | 892.1000 |
| Product Code(s) | MOS |
| Legally Marketed Predicate Devices | |
| 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) |
| K121362 | 1.5T 16ch Flex SPEEDER Coil Medium/Large |
| Product Code | |
| MOS | |
| Device Description Summary | |
| 21 CFR 807.92(a)(4) | |
| The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are a receive-only, 16-channel phased array coil designed for magnetic resonance imaging (MRI) using the Canon 1.5T MR systems. The 16ch Flex Speeder Medium and 16ch Flex Speeder Large coils are intended to be used for general anatomies. | |
| Intended Use/Indications for Use | |
| 21 CFR 807.92(a)(5) | |
| The 16CH Flex SPEEDER Medium 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 16ch Flex SPEEDER Large coil 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. | |
| Indications for Use Comparison | |
| 21 CFR 807.92(a)(5) | |
| The Indications for Use Statements for the 16ch Flex SPEEDER Medium and Large 1.5T are not identical to that of the predicate devices (1.5T 16ch Flex SPEEDER Medium and Large); however, the differences do not affect the safety or effectiveness of the device relative to the predicate device. Both Indications for Use statements for the proposed 16ch Flex SPEEDER Medium and Large 1.5Tand predicate 1.5T 16ch Flex SPEEDER Medium and Large indicate that the device is intended to be used in conjunction with a MR system to produce images of human anatomy and that the images can be interpreted by a trained physician. The indications for use statements for the proposed 16ch Flex SPEEDER Medium and Large 1.5T and predicate devices differ only in that the proposed devices are indicated for use |
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in general human anatomy whereas the predicate devices are indicated for use in various specific anatomies that comprise general human anatomy.
Technological Comparison
21 CFR 807.92(a)(6)
At a high level, the proposed 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.
- · Materials used for impact protection and biocompatibility: Polycarbonate with a polyurethane coated nylon fabric cover
No technological differences exist between the proposed and predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The signal-to-noise ratio (SNR) and image uniformity of the 16ch Flex Speeder Coils were measured on a 1.5T Canon MR System, manufactured by Canon Medical System. The SNR and uniformity of the 16ch Flex Speeder Coils were analyzed per NEMA MS-9 (using alternate method 2.5 from MS-6) and uniformity was analyzed using NEMA MS-9 (primary method from MS-6) using pre-determined acceptance criteria.
In accordance with the FDA Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, clinical images from volunteer scanning of general human anatomy were obtained from a Canon 1.5T MR system. Clinical images were obtained for the 16CH Flex SPEDER Medium and Large 1.5T from upper and lower extremities, chest, abdomen, pelvis, head, neck and spine. These images were used to demonstrate that the 16ch Flex Speeder Coils produce diagnostic quality images of the intended anatomy. No adverse events were reported or recorded.
The electrical safety and electromagnetic compatibility data support the safety of the 16ch Flex Speeder Coils 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 16ch Flex Speeder Coils performs as well as or better than the predicate device.
Surface heating was tested in accordance with AAM/ANSI EN60601-1. The device was tested plugged. The measured temperature of the surface of the coil never exceeded the maximum limit of 41C.