PRIMA III TOTALSENSE TORSO COIL

• K Number: K030371
• Device Name: PRIMA III TOTALSENSE TORSO COIL
• Manufacturer: USA INSTRUMENTS, INC.
• Date Cleared: 2003-05-05 ( 90 days)
• Product Code: MOS
• Regulation Number: 892.1000
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K013594 , K001209
• Predicate For: K103365

Intended Use

The Prima III TotalSENSE Torso Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems. The Prima III TotalSENSE Torso 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 Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Siemens Magnetom Trio 3,0T MRI scanner manufactured by Siemens Medical Solutions, Inc. Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries Nuclei Excited: Hydrogen 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 Prima III TotalSENSE Torso Coil is an eight element receive only phased array coil. The coil is composed of flexible top and bottom pieces which allow for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible plastic housings. which are fire rated.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a medical device, specifically an MRI coil (Prima III TotalSENSE Torso Coil). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data like one would find for a de novo device or a PMA.

Therefore, the document does not contain the acceptance criteria and the detailed study described in your request.

Here's why and what information can be inferred or is missing:

• Acceptance Criteria and Reported Device Performance: This information is not provided. 510(k) submissions typically demonstrate substantial equivalence through technical characteristics and, if necessary, non-clinical bench testing or phantom studies to show that the new device performs as intended and is as safe and effective as the predicate. Clinical performance data with specific acceptance criteria is generally not required for a device like an MRI coil in a 510(k) unless there's a significant change in intended use or technological characteristics that raises new safety or effectiveness questions.

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present because a formal clinical study with human subjects, requiring these elements, was not conducted or reported in this 510(k) summary. The "study" here is essentially a comparison to predicate devices and likely involved technical testing of the coil's performance (e.g., signal-to-noise ratio, image uniformity) which are not elaborated upon in a public summary.

In summary, based only on the provided text, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, types of ground truth, training set sample size, or how training set ground truth was established.

The document states:

• Device Name: Prima III TotalSENSE Torso Coil
• Intended Use: Obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems.
• Device Description: An eight-element receive-only phased array RF coil, composed of flexible top and bottom pieces for varied patient sizes, open design to minimize claustrophobia, and enclosed elements in flexible plastic housings. Designed for use with the Magnetom Trio 3.0T MRI system by Siemens Medical Solutions, Inc.
• Safety and Effectiveness: Demonstrated by "Similar to" comparisons with predicate devices (Vision 5000 Torso Coil K013594, Insight Plus 9000 Phased Array Torso and Pelvis Coil K001209, Mark 5000 Quadrature Shoulder coil K013854) across various features like intended use, indications for use, coil enclosure material, coil design, decoupling mechanisms, prevention of RF burns, radio frequency absorption, and formation of resonant loops.

This indicates that the device was cleared based on its equivalence in design and function to previously cleared devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Summary

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MAY 0 5 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

KO30371

1. Device Name:

2. Proprietary Name:

3. Classification:

Class II

4. Establishment Registration #:

5. Manufacture Facility Location:

6. Performance Standard:

7. Intended Use:

8. Device Description:

1529041 USA Instruments, Inc.,

Magnetic Resonance Imaging Accessory

Prima III TotalSENSE Torso Coil

1515 Danner Drive Aurora, Ohio 44202, USA Telephone: [phone]; Fax: [phone].

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

The Prima III TotalSENSE Torso Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries in Magnetic Resonance Imaging Systems. The Prima III TotalSENSE Torso 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 Prima III TotalSENSE Torso Coil is an eight element receive only phased array coil. The coil is composed of flexible top and bottom pieces which allow for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible plastic housings. which are fire rated.

Please turn over

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Prima III TotalSENSE Torso Coil ProductFeatures	Comparison to predicate device or other 510(k)cleared products
Intended Use: imaging of the abdominal andpelvic anatomy, including the liver, spleen,and renal arteries	-Similar to the Vision 5000 Torso Coil manufactured byUSA Instruments, Inc. (K013594).-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Indications for Use: Identical to routineMRI imaging.	-Similar to the Vision 5000 Torso Coil manufactured byUSA Instruments, Inc. (K013594).-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Coil Enclosure Material:Flame Retardant PolyurethaneVinyl Coated EVA foamFlame Retardant Polycarbonate	- Similar to the Mark 5000 Quadrature Shoulder coilmanufactured by USA Instruments, Inc. (K013854)
Coil Design: Receive-only phasedarraycoil.	-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Decoupling: Switching diode decoupling.Additional RF fuses incorporated.	-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Prevention of RF Burns: Does not transmitRF power; decoupling isolates the coilelements from RF fields during RFtransmission; coil elements and circuitry areenclosed in a non-conductive housing.	-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Radio Frequency Absorption: Coil is areceive only coil and does not transmit RFpower.	-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).
Formation of Resonant Loop: Decouplingisolates the coil elements from RF fieldsduring RF transmission; length of cable andstiffness does not permit looping.	-Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209).

9. Safety and Effectiveness

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 0 5 2003

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

Re: K030371

Trade/Device Name: Prima III TotalSENSE Torso Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: January 30, 2003 Received: February 4, 2003

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, 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 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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

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):_ ん ひ 3c>3 ア/

Device Name: Prima III TotalSENSE Torso Coil

Indications for Use: The Prima III TotalSENSE Torso Coil is designed to provide Magnetic Resonance Images of the abdominal and pelvic anatomies. The Prima III TotalSENSE Torso Coil is designed for use with the Siemens Magnetom Trio 3,0T MRI scanner manufactured by Siemens Medical Solutions, Inc.

Anatomic Regions: the abdominal and pelvic anatomy, including the liver, spleen, and renal arteries Nuclei Excited: Hydrogen

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.

(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)

David R. Lynn

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

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.