The Extremity Coil is a specialty receive-only RF coil, used to obtain diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Extremity Coil is designed for use with the Rhapsody 1.0T MRI Scanners manufactured by Siemens Medical Systems, Inc.

The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.

The Siemens Rhapsody 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 yield information that can be useful in the determination of a diagnosis.

Device Description

The Extremity Coil package consists of a knee coil (two sizes: small and large ) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane , fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called "Extremity Coil." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as one might find for novel or high-risk devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, and ground truth establishment is not applicable or available within this type of regulatory submission document. The device is an accessory (MRI coil) and its safety and effectiveness are established by demonstrating similarity to previously cleared devices.

Here's a breakdown of why each point is not relevant or present in this context:

1. A table of acceptance criteria and the reported device performance

Not Applicable. For a 510(k) submission of an MRI accessory, specific "acceptance criteria" related to diagnostic performance (like sensitivity/specificity for a disease detection algorithm) are not typically defined or reported. The performance is assessed by demonstrating that the new device functions similarly to predicate devices in terms of image quality and safety characteristics common to MRI coils.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. There is no mention of a "test set" in the context of clinical images or diagnostic data. The focus is on technical specifications and comparison to predicate devices, not on a study evaluating diagnostic accuracy on a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As there is no test set in the diagnostic sense, there is no need for experts to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or diagnostic performance adjudication.

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. This is an MRI accessory, not an AI-powered diagnostic tool. MRMC studies or AI assistance effect sizes are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. The device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. No ground truth for diagnostic accuracy is established as this is not a diagnostic device in the sense that it interprets images or detects disease.

8. The sample size for the training set

Not Applicable. This is an MRI coil, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. No training set for an AI model.

Summary of Safety and Effectiveness (as per the provided document):

The safety and effectiveness of the Extremity Coil are established through comparison to legally marketed predicate devices, specifically the Legend 5000 Knee and Foot Coil (K994040) and the Leo 7000 Quadrature Knee coil (K971246), both manufactured by USA Instruments, Inc.

The document highlights the following features of the Extremity Coil and states their similarity to the predicate devices:

Intended Use: Knee and Foot Imaging Applications
Indications for Use: Identical to routine MRI imaging
Coil Material: Flame retardant Polyurethane, ABS plastic alloy, Fiberglass
Coil Design: Two-channel receive-only Phased Array Design
Decoupling: RF Chokes with Switching Diodes
Prevention of RF Burns: Does not transmit RF Power, Decoupling isolates coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing.
Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power.
Formation of Resonant Loops: Decoupling isolates coil elements from RF fields during RF transmission, Length of cable and stiffness does not allow permit looping.

The FDA's review concluded that the device is substantially equivalent to the predicate devices for the stated indications for use, thereby permitting its marketing. This determination is based on the technical and functional similarities, implying that the safety and performance characteristics are consistent with existing, cleared devices.

Summary

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Jan 8 2002

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SUMMARY OF SAFETY AND EFFECTIVENESS

K013592

1. Device Name :	Magnetic Resonance Imaging Accessory
2. Proprietary Name :	Extremity Coil
3. Classification :	Class II
4. Establishment Registration #:	1529041
5. Manufacture Facility Location:	USA Instruments, Inc., 1515 Danner Drive,Aurora, 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 Extremity Coil is a specialty receive-only RFcoil, used to obtain diagnostic images of the kneeand foot anatomy in Magnetic Resonance Imagingsystems. The indications for use are the same asfor standard MR Imaging. The Extremity Coil isdesigned for use with the Rhapsody 1.0T MRISiemens MedicalScanners manufactured bySystems, Inc.
8. Device Description:	The Extremity Coil package consists of a knee coil(two sizes: small and large ) and an attachable footcoil. The electrical circuitry is enclosed in a durablehousing assembly made of polyurethane , fiberglass,and ABS/PVC plastic alloy, which are fire rated andhave high impact and tensile strength. The KneeCoil is mechanically split into two halves for easiercoil handling and more accurate positioning of thepatient's knee in the coil. The foot Coil is contouredto accommodate the foot and is mechanicallyattached to the knee coil.

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9. Safety and Effectiveness

. ..........

12/11/2017

Extremity CoilProduct Features	Comparison to predicate device or other 510(k)cleared product
Intended Use:Knee and Foot Imaging Applications	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)
Indications for UseIdentical to routine MRI imaging	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)
Coil Material•Flame retardant PolyurethaneABS plastic alloyFiberglass	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)
Coil DesignTwo channel receive only PhasedArray Design	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)
DecouplingRF Chokes with Switching Diodes	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)
Prevention of RF BurnsDoes not transmit RF Power,Decoupling isolates the coil elementsfrom RF fields during RFtransmission, Coil elements andcircuitry are enclosed in a non-conductive housing.	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)
Radio Frequency AbsorptionCoil is a receive only coil and does nottransmit RF power	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)
Formation of Resonant LoopsDecoupling isolates coil elementsfrom RF fields during RFtransmission, Length of cable andstiffness does not allow permit looping	-Similar to the Legend 5000 Knee and Foot Coilmanufactured by USA Instruments, Inc. (K994040)-Similar to the Leo 7000 Quadrature Knee coilmanufactured by USA Instruments, Inc. (K971246)

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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern around the edge. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 JAN

Mr. Rony Thomas Vice President Marketing and Programs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202

Re: K013592

Trade/Device Name: Extremity Coil MRI specially coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: October 24, 2001 Received: October 30, 2001

Dear Mr. Thomas:

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.

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 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 this 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" (21 CFR Part 807.97). 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): __ イ o / 35 タク

Device Name: Extremity Coil

Indications for Use: The Extremity Coil is a receive-only specialty RF coil, used for obtaining diagnostic images of the knee and foot in Magnetic Resonance Imaging systems. The Extremity Coil is designed for use with the Siemens Rhapsody 1.0Tesla MRI scanner manufactured by Siemens Medical Systems, Inc.

Anatomic Regions: Shoulder and surrounding regions. 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)

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

Over-The-Counter Use
(Optional Format 1-2-96)

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.