The Leo III Tx/Rx Quadrature Knee Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the knee and surrounding anatomy in Magnetic Resonance Imaging Systems. The Leo III Tx/Rx Quadrature Knee Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.

The Alpha III Tx/Rx Quadrature Wrist Coil is a transmit-receive quadrature RF coil, used for obtaining diagnostic images of the wrist and hand in Magnetic Resonance Imaging Systems. The Alpha III T/R Quadrature Wrist Coil is designed for use with the Magnetom Trio 3.0T MRI system manufactured by Siemens Medical Solutions, Inc. The indications for use are the same as for standard MR Imaging.

The Leo III Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha III Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.0T scanner manufactured by Siemens Medical Solutions.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

Device Description

The Leo III Tx/Rx Quadrature Knee Coil is a multi-element quadrature transmit-receive coil. The coil has a split top design with a latching device and a large open viewing window on the top. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The Alpha III T/R Quadrature Wrist Coil is a multi-element quadrature transmit-receive coil. The coil has a rigid enclosure with windows on top to facilitate patient handling. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

AI/ML Overview

The provided document describes the safety and effectiveness of two medical devices: the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil. This document is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than conducting a de novo study with acceptance criteria and clinical performance data in the way a novel AI/software medical device would.

Therefore, many of the typical sections for AI/software medical device studies (like acceptance criteria, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) are not applicable or detailed in this type of submission.

Summary of Device Features and Comparison to Predicate Devices (serving as the basis for demonstrating safety and effectiveness):

Feature/Acceptance Criteria	Leo III Tx/Rx Quadrature Knee Coil Performance	Alpha III Tx/Rx Quadrature Wrist Coil Performance
Intended Use	Imaging of the knee and surrounding anatomy.	Imaging of the wrist and hand.
Indications for Use	Identical to routine MRI imaging.	Identical to routine MRI imaging.
Coil Enclosure Material	Flame Retardant Polyurethane, Polycarbonate, Kydex Acrylic/PVC, Delrin Acetal	Flame Retardant Polyurethane, Polycarbonate, Kydex Acrylic/PVC, Delrin Acetal
Coil Design	12 z-inductor transmit receive quadrature coil.	2 element saddle transmit receive quadrature coil.
Decoupling	Transmit/Receive Switch actively switched during transmit and receive modes.	Transmit/Receive Switch actively switched during transmit and receive modes.
Prevention of RF Burns	Uses pin diodes to isolate receive channel from transmit channel; elements/circuitry enclosed in non-conductive housing.	Uses pin diodes to isolate receive channel from transmit channel; elements/circuitry enclosed in non-conductive housing.
Radio Frequency Absorption	Power deposition limited by SAR algorithm.	Power deposition limited by SAR algorithm.
Formation of Resonant Loop	Active diodes and fast RF blowing fuses isolate coil elements; cable length and stiffness prevent looping.	Active diodes and fast RF blowing fuses isolate coil elements; cable length and stiffness prevent looping.

Study Information (Based on a 510(k) Substantial Equivalence Submission):

Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study of the device's diagnostic performance involving a test set, but rather a submission for substantial equivalence to predicate devices based on design and technical characteristics.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth established by experts is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This device is an MRI accessory (coil), not an AI/software medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an MRI accessory (coil), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The demonstration of safety and effectiveness relies on comparison to predicate devices, engineering documentation, and adherence to safety principles, not a ground truth for diagnostic accuracy.
The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Explanation of the Study and its findings:

The provided document is a 510(k) Premarket Notification to the FDA for the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil. This type of submission aims to demonstrate that the new device is "substantially equivalent" to one or more legally marketed predicate devices, meaning it has the same intended use and the same technological characteristics as the predicate devices, or has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

Key Findings from the Submission:

Substantial Equivalence: The FDA determined that both the Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are substantially equivalent to legally marketed predicate devices.
Predicate Devices:
- For the Leo III Tx/Rx Quadrature Knee Coil, predicate devices include the Allegra 3.0Tesla TxRx Head coil (K002179) and the Leo 7000 Knee Coil (K971246), both manufactured by USA Instruments, Inc. The Hi-Res 9000 Phased Array Carotid Coil (K001210) by USA Instruments, Inc. was also referenced for enclosure material.
- For the Alpha III Tx/Rx Quadrature Wrist Coil, predicate devices include the Alpha 7000 Wrist Coil (K972205) and the Allegra 3.0Tesla TxRx Head coil (K002179), both manufactured by USA Instruments, Inc. The Hi-Res 9000 Phased Array Carotid Coil (K001210) by USA Instruments, Inc. was also referenced for enclosure material.
Basis for Equivalence: The submission details various product features (Intended Use, Indications for Use, Coil Enclosure Material, Coil Design, Decoupling, Prevention of RF Burns, Radio Frequency Absorption, Formation of Resonant Loop) and explicitly compares them to the features of the identified predicate devices. The arguments for safety and effectiveness are based on these comparisons, asserting that the new coils share fundamental technology and safety features with already cleared devices.
No Clinical Trials for Diagnostic Accuracy: This type of submission, for an MRI accessory, typically does not involve a clinical study to assess diagnostic accuracy or create a "ground truth" test set for diagnostic performance. Instead, the focus is on engineering specifications, material safety, electrical safety, RF safety, and ensuring performance similar to existing coils for image acquisition. The indications for use are stated to be "the same as for standard MR Imaging," meaning the device is intended to enable the existing, established diagnostic capabilities of an MRI system for specific anatomies.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

K023982

1. Device Name:	Magnetic Resonance Imaging Accessory
2. Proprietary Name:	Leo III Tx/Rx Quadrature Knee Coil
3. Classification:	Class II
4. Establishment Registration #:	1529041
5. Manufacture Facility Location:	USA Instruments, Inc.,1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422.
6. Performance Standard:	No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act.
7. Intended Use:	The Leo III Tx/Rx Quadrature Knee Coil is atransmit-receive quadrature RF coil, used forobtaining diagnostic images of the knee andsurrounding anatomy in Magnetic ResonanceImaging Systems. The Leo III Tx/Rx QuadratureKnee Coil is designed for use with the MagnetomTrio 3.0T MRI system manufactured by SiemensMedical Solutions, Inc. The indications for use arethe same as for standard MR Imaging.
8. Device Description:	The Leo III Tx/Rx Quadrature Knee Coil is a multi-element quadrature transmit-receive coil. The coilhas a split top design with a latching device and alarge open viewing window on the top. The open,patient friendly design eases patient handling andpositioning and maximizes patient comfort. The coilelements and accessory electronics are enclosed ina rigid plastic housing, which is fire rated and has ahigh impact and tensile strength.

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9. Safety and Effectiveness

Leo III Tx/Rx Quadrature Knee CoilProduct Features	Comparison to predicate device or other 510(k)cleared products
Intended Use: Imaging of the knee andsurrounding anatomy.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)-Similar to the Leo 7000 Knee Coil manufacturedby USA Instruments, Inc. (K971246)
Indications for Use: Identical to routineMRI imaging.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)-Similar to the Leo 7000 Knee Coil manufacturedby USA Instruments, Inc. (K971246)
Coil Enclosure Material:Flame Retardant PolyurethaneFlame Retardant PolycarbonateKydex Acyrlic/PVCDelrin Acetal	- Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments, Inc.(K001210)
Coil Design: 12 z-inductor transmitreceive quadrature coil.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Decoupling: This is a transmit andreceive coil. There is no decoupling, theTransmit / Receive Switch is activelyswitched during transmit and receivemodes.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Prevention of RF Burns: The coil'stransmit /receive switch uses pin diodesto isolate the receive channel from thetransmit channel; coil elements andcircuitry are enclosed in a non-conductive housing.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Radio Frequency Absorption: Powerdeposition during imaging is limited bySAR algorithm	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Formation of Resonant Loop: Activediodes and fast RF blowing fusesisolate the coil elements from RF fields;length of cable and stiffness does notpermit looping	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)

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SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device Name:	Magnetic Resonance Imaging Accessory
2. Proprietary Name:	Alpha III Tx/Rx Quadrature Wrist Coil
3. Classification:	Class II
4. Establishment Registration #:	1529041
5. Manufacture Facility Location:	USA Instruments, Inc.1515 Danner DriveAurora, Ohio 44202, USATelephone: 330-562-1000; Fax: 330-562-1422.
6. Performance Standard:	No applicable performance standards have beenissued under Section 514 of the Food, Drug andCosmetic Act.
7. Intended Use:	The Alpha III Tx/Rx Quadrature Wrist Coil is atransmit-receive quadrature RF coil, used forobtaining diagnostic images of the wrist and hand inMagnetic Resonance Imaging Systems. The AlphaIII T/R Quadrature Wrist Coil is designed for usewith the Magnetom Trio 3.0T MRI systemmanufactured by Siemens Medical Solutions, Inc.The indications for use are the same as for standardMR Imaging.
8. Device Description:	The Alpha III T/R Quadrature Wrist Coil is a multi-element quadrature transmit-receive coil. The coilhas a rigid enclosure with windows on top tofacilitate patient handling. The open, patient friendlydesign eases patient handling and positioning andmaximizes patient comfort. The coil elements andaccessory electronics are enclosed in a rigid plastichousing, which is fire rated and has a high impactand tensile strength.

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9. Safety and Effectiveness

Alpha III Tx/Rx Quadrature Wrist CoilProduct Features	Comparison to predicate device or other 510(k)cleared products
Intended Use: Imaging of the wrist andhand	-Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205)
Indications for Use: Identical to routineMRI imaging.	-Similar to the Alpha 7000 Wrist Coil manufacturedby USA Instruments, Inc. (K972205)-Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Coil Enclosure Material:Flame Retardant PolyurethaneFlame Retardant PolycarbonateKydex Acrylic/PVCDelrin Acetal	- Similar to the Hi-Res 9000 Phased Array CarotidCoil manufactured by USA Instruments, Inc.(K001210)
Coil Design: 2 element saddle transmitreceive quadrature coil.Decoupling: This is a transmit andreceive coil. There is no decoupling, theTransmit / Receive Switch is activelyswitched during transmit and receivemodes.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Prevention of RF Burns: The coil'stransmit /receive switch uses pin diodesto isolate the receive channel from thetransmit channel; coil elements andcircuitry are enclosed in a non-conductive housing.	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Radio Frequency Absorption: Powerdeposition during imaging is limited bySAR algorithm	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)
Formation of Resonant Loop: Activediodes and fast RF blowing fusesisolate the coil elements from RF fields;length of cable and stiffness does notpermit looping	- Similar to the Allegra 3.0Tesla TxRx Head coilmanufactured by USA Instruments, Inc. (K002179)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Christie Shumaker Manager OA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

FEB 2 1 2003

Re: K023982 Trade/Device Name: Leo III Tx/Rx Quadrature Knee Coil and Alpha III Tx/Rx Quadrature Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 27, 2002 Received: December 2, 2002

Dear Ms. Shumaker:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):__ <○23982

Device Name: Leo III Tx/Rx Quadrature Knee Coil Alpha III Tx/Rx Quadrature Wrist Coil

Indications for Use: The Leo III Tx/Rx Quadrature Knee Coil is designed to provide Magnetic Resonance Images of the knee and surrounding anatomy. The Alpha III Tx/Rx Quadrature Wrist Coil is designed to provide Magnetic Resonance Images of the wrist and hand. The Leo III Tx/Rx Quadrature Knee Coil and the Alpha III Tx/Rx Quadrature Wrist Coil are designed for use with the Siemens Magnetom Trio 3.0T scanner manufactured by Siemens Medical Solutions.

Anatomic Regions: Leo III Tx/Rx Quadrature Knee Coil: Knee and surrounding Anatomy Alpha IIII Tx/Rx Quadrature Wrist Coil: Wrist and Hand Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
	OR
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K023982

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.