CTL BODY / SPINE ARRAY COIL by USA INSTRUMENTS, INC.

The CTL Body / Spine Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The CTL Body / Spine Coil is designed for use with Array the Rhapsody™1.0T MRI scanner manufactured by Siemens Medical Systems.

The CTL Body / Spine Array Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The CTL Body / Spine Array Coil is designed for use with the Siemens Rhapsody™ 1.0Tesla scanner.

Anatomic Regions: Spine Nuclei Excited: Hydrogen

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

The Siemens Rhapsody™ 1.0Tesla 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 CTL Body Spine Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the CTL Body / Spine Array Coil, which is an accessory for Magnetic Resonance Imaging (MRI) systems. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about specific acceptance criteria, a study proving device performance against those criteria, or quantitative performance data (like sensitivity, specificity, accuracy, etc.).

Below is a template for the requested information, with sections filled out based on the available text where possible, and explicitly stating when information is "Not Available in Text".

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device must ensure no RF burns and prevent the formation of resonant loops.	Safety: The device is a receive-only coil and does not transmit RF power, thereby preventing RF burns. Decoupling isolates coil elements from RF fields during RF transmission. The length and stiffness of cables do not permit looping.
Intended Use: Imaging of the spine.	Intended Use: Similar to predicate devices (Premier 7000 C/T/L Spine Coil K980157 and Magna 5000 CTL Spine Coil K994345) for imaging of the spine.
Indications for Use: Identical to routine MRI imaging, specifically for the Siemens Rhapsody™ 1.0T MRI scanner to produce images of spine anatomy based on proton distribution, NMR parameters (T1, T2), and soft tissue structure, useful for diagnosis by a trained physician.	Indications for Use: Identical to predicate devices (Premier 7000 C/T/L Spine Coil K980157 and Magna 5000 CTL Spine Coil K994345) and routine MRI imaging. Designed for use with the Siemens Rhapsody™ 1.0T MRI scanner.
Material Composition: Use of MRI-compatible materials.	Material Composition: Polyurethane Plastic, Polycarbonate Plastic. Similar to Magna 5000 CTL Spine Coil (K994345).
Design: Receive-only phased array design with decoupling.	Design: Receive-only phased array design with RF Chokes with Switching Diodes for decoupling. Similar to predicate devices.
Image Quality / Diagnostic Efficacy: (Quantitative metrics like SNR, spatial resolution, contrast-to-noise ratio, diagnostic accuracy, etc.)	Not Available in Text. The submission focuses on substantial equivalence based on device features and intended use rather than presenting a performance study with quantitative acceptance criteria for image quality or diagnostic efficacy.

Study Information

The provided document is a 510(k) summary for a medical device accessory and does not describe a specific clinical performance study with acceptance criteria, a test set, ground truth, or statistical analysis in the way a clinical trial for a diagnostic device algorithm might. Instead, it demonstrates substantial equivalence to legally marketed predicate devices through a comparison of product features, intended use, and safety aspects.

Therefore, the following information is Not Available in Text as it pertains to a performance study that was not described in this 510(k) summary.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Available in Text (No specific performance study described.)
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 Available in Text
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Available in Text
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 Available in Text (This device is an MRI coil accessory, not an AI-based diagnostic algorithm. This question is not applicable.)
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Available in Text (This is an MRI coil, not a standalone algorithm. This question is not applicable.)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not Available in Text
The sample size for the training set: Not Available in Text
How the ground truth for the training set was established: Not Available in Text

Summary

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FEB 0 5 2002

SUMMARY OF SAFETY AND EFFECTIVENESS

Kol4086

1. Device Name :

Classification :

Magnetic Resonance Imaging Accessory

CTL Body / Spine Array Coil

Proprietary Name :

Class II

Establishment Registration #:
Manufacture Facility Location:

1. Performance Standard:

Intended Use:

1529041 USA Instruments, Inc 1515 Danner Drive
Aurora, Ohio 44202, USA Telephone: 330-562-1000; Fax: 330-562-1422.

No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.

1. Device Description: The CTL Body Spine Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has a removable anterior section for imaging the anterior cervical region. The coil also has three bridges consisting of coil elements for enhanced imaging of the thoracic and lumbar spine. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

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9. Safety and Effectiveness

.....

CTL Body / Spine Array Coil ProductFeatures	Comparison to predicate device or other 510(k)cleared product
Intended Use: Imaging of the spine.	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Indications for Use: Identical to routineMRI imaging	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Coil Material:Polyurethane PlasticPolycarbonate Plastic	-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Coil Design: Receive-only phased arraydesign	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Decoupling: RF Chokes with SwitchingDiodes	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Prevention of RF Burns: Does nottransmit RF Power, Decoupling isolatesthe coil elements from RF fields duringRF transmission, Coil elements andcircuitry are enclosed in a non-conductive housing.	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Radio Frequency Absorption: Coil is areceive only coil and does not transmitRF power	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)
Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission. Lengthof cable and stiffnessdoes not permit looping	-Similar to the Premier 7000 C/T/L Spine Coilmanufacture by USA Instruments, Inc. (K980157)-Similar to the Magna 5000 CTL Spine Coilmanufactured by USA Instruments, Inc. (K994345)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2002

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

Re: K014086

Trade/Device Name: CTL Body/Spine Array Coil MRI Specialty Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: December 7, 2001 Received: December 11, 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):____________________________________________________________________________________________________________________________________________________

Device Name: CTL Body / Spine Array Coil

Indications for Use: The CTL Body / Spine Array Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The CTL Body / Spine Array Coil is designed for use with the Siemens Rhapsody™ 1.0Tesla scanner.

Anatomic Regions: Spine 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)

	(Division Sign-Off)
	Division of Reproductive, Abdominal, and Radiological Devices
	510(k) Number	K014086

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
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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.