(79 days)
The Prima III TotalSENSE Torso Coil is a receive-only 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 Intera 3.0T MRI system manufactured by Philips Medical Systems, 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 Philips Intera 3.0T MRI scanner manufactured by Philips Medical Systems, Inc.
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 yield information that can be useful in the determination of a diagnosis.
The Prima III TotalSENSE Torso Coil is a six channel receive only phased array coil. The coil is composed of a flexible top and a rigid bottom piece 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 and rigid plastic housings, which are fire rated.
The provided document describes a 510(k) premarket notification for a medical device, the Prima III TotalSENSE Torso Coil for Magnetic Resonance Imaging (MRI). It is a declaration of "substantial equivalence" to predicate devices, rather than a study demonstrating meeting specific acceptance criteria in the way a clinical trial for a novel drug or AI diagnostic would.
Therefore, many of the typical acceptance criteria and study design elements for an AI or diagnostic device are not applicable here. This document pertains to a hardware accessory for an existing medical imaging modality.
However, I will extract what can be inferred about the "acceptance criteria" for a 510(k) submission, which in this context means demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Description of Acceptance Criteria and Device Performance
The "acceptance criteria" for a 510(k) submission like this primarily revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, indications for use, technological characteristics, and safety/effectiveness. There are no explicit quantitative performance metrics like sensitivity/specificity/accuracy with specific thresholds in this type of submission for an MRI coil.
The "study" that proves the device meets these "acceptance criteria" is the 510(k) submission itself, where the manufacturer provides a comparison of their new device to existing predicate devices.
Here's the information structured as requested, with "N/A" where the requested information is not relevant to this type of regulatory submission (an MRI coil, not an AI diagnostic):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance / Comparison |
|---|---|
| Intended Use: Imaging of abdominal and pelvic anatomy, including liver, spleen, and renal arteries. | Similar to: Vision 5000 Torso Coil (K013594) and Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| Indications for Use: Identical to routine MRI imaging (diagnose based on distribution of protons, NMR parameters T1/T2, soft tissue structure). | Similar to: Vision 5000 Torso Coil (K013594) and Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). It is for use with the Philips Intera 3.0T MRI system, and the indications are the same as for that standard MRI system. |
| Technological Characteristics: | |
| * Coil Enclosure Material: Flame Retardant Polyurethane, Vinyl Coated EVA foam, Flame Retardant Polycarbonate. | Similar to: Mark 5000 Quadrature Shoulder Coil (K013854). |
| * Coil Design: Receive-only phased array coil. | Similar to: Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| * Decoupling: Switching diode decoupling. | Similar to: Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| * Prevention of RF Burns: Does not transmit RF power, decoupling isolates coil elements, elements/circuitry enclosed in non-conductive housing. | Similar to: Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| * Radio Frequency Absorption: Receive-only coil, does not transmit RF power. | Similar to: Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| * Formation of Resonant Loop: Decoupling isolates coil elements, cable length and stiffness prevents looping. | Similar to: Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209). |
| Safety and Effectiveness: No new questions of safety or effectiveness regarding the device or its intended use are raised compared to the predicate devices. (Implicit acceptance criterion for 510k). | The FDA's substantial equivalence determination implies that the device is considered as safe and effective as the predicate devices and does not raise new issues of safety or effectiveness. The comparison table directly addresses the technological characteristics related to safety (RF burns, RF absorption, resonant loops). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This is a hardware device (MRI coil) submission, not an AI or diagnostic algorithm requiring a test set of patient data for performance evaluation. The "test" is the comparison to predicate devices and the technical specifications provided.
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)
- N/A. Ground truth for patient data is not applicable to an MRI coil submission. The "ground truth" for the submission itself is the existing regulatory framework and the characteristics of predicate devices, assessed by the manufacturer and then reviewed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable, as there is no test set of patient data requiring expert 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
- N/A. Not applicable. No MRMC or AI component described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not applicable. This is a hardware component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. For this type of submission, the "ground truth" for demonstrating substantial equivalence relies on:
- Technical specifications and engineering data proving the coil's physical properties, safety features, and performance within the MRI system.
- Regulatory precedent (predicate devices cleared by the FDA).
- Established principles of MRI physics and safety.
8. The sample size for the training set
- N/A. Not applicable. There is no AI component or training set.
9. How the ground truth for the training set was established
- N/A. Not applicable. There is no AI component or training set.
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JUL 1 8 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Prima III TotalSENSE Torso 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 Prima III TotalSENSE Torso Coil is a receive-only phased array RF coil, used for obtainingdiagnostic images of the abdominal and pelvicanatomy, including the liver, spleen, and renalarteries in Magnetic Resonance Imaging Systems.The Prima III TotalSENSE Torso Coil is designed foruse with the Intera 3.0T MRI system manufacturedby Philips Medical Systems, Inc. The indications foruse are the same as for standard MR Imaging. |
| 8. Device Description: | The Prima III TotalSENSE Torso Coil is a sixchannel receive only phased array coil. The coil iscomposed of a flexible top and a rigid bottom piecewhich allow for imaging of patients of different sizes.The open, patient friendly design minimizesclaustrophobic effects and maximizes patientcomfort. The coil elements and accessoryelectronics are enclosed in flexible and rigid plastichousings, which are fire rated. |
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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 abdominaland pelvic 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 phased arraycoil. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K001209). |
| Decoupling: Switching diode decoupling. | -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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031365
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: April 28, 2003
Received: May 5, 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 t 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):__Ko_3 i 3 ك
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 Philips Intera 3.0T MRI scanner manufactured by Philips Medical Systems, 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 yield 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 OR (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 K031365
§ 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.