For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician.

Device Description

The 1.5T and 3T CP Head Coils are circularly polarized (CP) transmit and receive coils designed for magnetic resonance imaging of the head. The coils are designed for use with the Siemens MAGNETOM 1.5T Avanto/Espree and Siemens MAGNETOM 3T Trio a TIM/Verio systems respectively. The coil elements are enclosed in a rigid plastic housing (polycarbonate) which is fire-rated and has impact and tensile strength (material data provided). The coils have a split-top mechanical design with a system cable on the posterior half of the coil. The inner cross section is shaped to fit the head anatomy. The coils include the following accessories: a mirror to reduce patient anxiety/claustrophobia and foam pads also to aid positioning and enhance patient comfort.

AI/ML Overview

This submission (K091114) is for an MRI head coil, specifically the TxRx 1.5T CP Head Coil and TxRx 3T CP Head Coil, and not for an AI/ML device. Therefore, the provided document does not contain information regarding various aspects typically associated with AI/ML device evaluations. As such the questions are not applicable to the provided document.

Here's why and what information is available in the document:

Why the questions are not applicable (and the information is missing):

No AI/ML Device: The device is a magnetic resonance (MR) head coil, a hardware component for MRI scanners. It does not perform any Al/ML functions like image interpretation, anomaly detection, or diagnostic assistance.
No 'Performance' in the AI/ML Sense: The "performance" of an MR coil is typically evaluated based on signal-to-noise ratio, image uniformity, specific absorption rate (SAR), and other physical/electrical characteristics, not diagnostic accuracy metrics (like sensitivity, specificity, AUC) that would be established against a medical ground truth.
No Clinical Study for Diagnostic Efficacy: The 510(k) summary indicates substantial equivalence to predicate devices (other MR head coils). This usually means that the new device performs similarly in terms of image quality and safety, and does not require a new clinical study demonstrating diagnostic performance against a ground truth.

Information that is available from the document:

Device Description: The TxRx 1.5T and 3T CP Head Coils are circularly polarized transmit and receive coils designed for magnetic resonance imaging of the head. They are intended for use with specific Siemens MAGNETOM 1.5T Avanto/Espree and 3T Trio a TIM/Verio MRI systems, respectively.
Intended Use: "For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician."
Substantial Equivalence: The submission concludes that the new coils are substantially equivalent to legally marketed predicate devices (MAGNETOM Symphony Head Coil and MAGNETOM Trio Head Coil from USA Instruments) because they have similar designs, are constructed of similar materials, and their use does not result in any new potential hazards.

Therefore, I cannot provide answers to the questions because the provided document does not pertain to an AI/ML device or a study evaluating diagnostic performance against a ground truth.

Summary

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K09/114
Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Applicant

Quality Electrodynamics (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143 Phone (440) 484-2228

MAY - 1 2009

2. Contact

Christie Zydyk, MBA VP & GM, Regulatory Affairs, Quality Assurance, & Corporate Communications

Date prepared: April 8, 2009

4. Tradename

TxRx 1.5T CP Head Coil TxRx 3T CP Head Coil

Common name Coil, magnetic resonance, specialty
Classification

21 CFR 892.1000

7. Equivalent Device

MAGNETOM Symphony Head Coil and MAGNETOM Trio Head Coil manufactured by USA Instruments

8. Device Description

The coil elements are enclosed in a rigid plastic housing (polycarbonate) which is fire-rated and has impact and tensile strength (material data provided). The coils have a split-top mechanical design with a system cable on the posterior half of the coil. The inner cross section is shaped to fit the head anatomy. The coils include the following accessories: a mirror to reduce patient anxiety/claustrophobia and foam pads also to aid positioning and enhance patient comfort.

9. Intended Use

For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician.

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KC9114
Page 2 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

10. Comparison with Predicate Devices

510(k) #	Device	Manufacturer
K021262	MAGNETOM Symphony Head Coil	USA Instruments
K021330	MAGNETOM Trio Head Coil	USA Instruments

The 1.5T and 3T Siemens CP Head coils and predicate devices are designed for use in conjunction with magnetic resonance scanners to produce diagnostic images of the head that can be interpreted by a trained physician. The 1.5T and 3T Siemens CP Head Coils and the predicate devices have similar designs and are constructed of similar materials.

11. Conclusion

It is the opinion of Quality Electrodynamics that the 1.5T and 3T Siemens CP Head Coils are substantially equivalent to the above-listed legally marketed predicate devices. Use of the Quality Electrodynamics coils does not result in any new potential hazards

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 1 2009

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Quality ElectroDynamics % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K091114 ·

Trade/Device Name: TxRx 1.5T and 3T CP Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 16, 2009 Received: April 17, 2009

Dear Mr. Job:

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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx 21 CFR 884.xxx 21 CFR 892.xxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

(240) 276-0115 (240) 276-0115 (240) 276-0120 (240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely wours, NINARE

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

(09/1/4 510(k) Number (if known):

Device Name:

TxRx 1.5T CP Head Coil TxRx 3T CP Head Coil

Indications for Use:

For use with a 1.5T Siemens Avanto/Espree or 3T Siemens Trio a TIM/Verio magnetic resonance scanner to produce diagnostic images of the head that can be interpreted by a trained physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

long m. Whaley

ductive. Abdominal and Radiological L 510(k) Number

Page 1 of 1

Regulation Number and Section

§ 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.