(45 days)
The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III Total SENSE Cardiac 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 Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cardiovascular system 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.
The Spirit III TotalSENSE Cardiac Coil is a six element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows 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. All rigid plastic housing parts have a high impact and tensile strength.
Here's an analysis of the provided text regarding the Spirit III TotalsENSE Cardiac Coil, structured to address your requested information.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation is primarily a 510(k) submission summary for a Magnetic Resonance Imaging Accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated for device) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Imaging of the cardiovascular system. | Similar to predicate device (K024187). |
| Indications for Use | Identical to routine MRI imaging (soft tissue structure of head and whole body, etc.). | Similar to predicate device (K024187). |
| Coil Enclosure Material | Flame Retardant Polyurethane, Vinyl Coated EVA foam, Flame Retardant Polycarbonate. | Similar to predicate device (K024187). |
| Coil Design | Receive-only phased array coil. | Similar to predicate device (K024187). |
| Decoupling | Switching diode decoupling. | Similar to predicate device (K023650). |
| Prevention of RF Burns | Does not transmit RF power, decoupling isolates coil elements, enclosed in non-conductive housing. | Similar to predicate device (K024187). |
| Radio Frequency Absorption | Coil is receive-only, does not transmit RF power. | Similar to predicate device (K024187). |
| Formation of Resonant Loop | Decoupling isolates coil elements, cable length and stiffness prevent looping. | Similar to predicate device (K024187). |
Note: The acceptance criteria are largely implied by the comparison to predicate devices, where the "acceptance" is that the new device performs identically or similarly in these functional and safety aspects. This document does not provide quantitative performance metrics (e.g., signal-to-noise ratio, image resolution benchmarks) that would typically be associated with a detailed performance study. The safety aspects (RF burns, RF absorption) are critical for MR coils and are addressed by design features.
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not describe a specific clinical or technical test set with a defined sample size. The submission focuses on a comparison to predicate devices based on design features, intended use, and indications for use. There is no mention of a study involving real patient data or a specific "test set" that was evaluated. Therefore, no information on data provenance (country, retrospective/prospective) is available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no specific test set or clinical study is described, there is no information provided regarding experts establishing ground truth. The assessment is primarily technical and regulatory, comparing the new device's specifications to existing, cleared devices.
4. Adjudication Method for the Test Set
As there is no described test set or clinical data evaluation, there is no adjudication method mentioned.
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
The document describes an MRI accessory (a cardiac coil), not an AI-powered device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant in this context. The study is not comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This device is an MRI coil, a hardware component. It is not an algorithm or software that would have a standalone performance evaluated. Therefore, no standalone performance study was done in the context of an algorithm.
7. The Type of Ground Truth Used
Given that this is a 510(k) for an MRI coil, the "ground truth" for demonstrating safety and effectiveness relies on engineering specifications, design comparisons to predicate devices, and adherence to established safety principles for MRI equipment. It does not involve medical ground truth like pathology, expert consensus on disease diagnosis, or outcomes data from a clinical trial in the way an AI diagnostic device would. The ground truth here is predominantly technical conformance and substantial equivalence.
8. The Sample Size for the Training Set
The device is a hardware component (an MRI coil), not a software algorithm that requires a training set. Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this device.
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Ko 3 1172
MAY 2 9 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Spirit III TotalSENSE Cardiac 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 Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtainingdiagnostic images of the cardiovascular system inMagnetic Resonance Imaging Systems. The Spirit IIITotal SENSE Cardiac Coil is designed for use withthe Intera 3.0T MRI system manufactured by PhilipsMedical Systems, Inc. The indications for use arethe same as for standard MR Imaging. |
| 8. Device Description: | The Spirit III TotalSENSE Cardiac Coil is a sixelement receive only phased array coil. The coil iscomposed of a flexible top piece and a rigid bottompiece. The flexible top piece allows for imaging ofpatients of different sizes. The open, patient friendlydesign minimizes claustrophobic effects andmaximizes patient comfort. The coil elements andaccessory electronics are enclosed in flexible andrigid plastic housings, which are fire rated. All rigidplastic housing parts have a high impact and tensilestrength. |
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| 9. Safety and Effectiveness | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------- |
| Spirit III TotalSENSE Cardiac Coil ProductFeatures | Comparison to predicate device or other 510(k)cleared products |
|---|---|
| Intended Use: imaging of thecardiovascular system | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Indications for Use: Identical to routineMRI imaging. | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Coil Enclosure Material:Flame Retardant PolyurethaneVinyl Coated EVA foamFlame Retardant Polycarbonate | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Coil Design: Receive-only phased arraycoil. | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Decoupling:Switching diode decoupling. | -Similar to the Insight Plus 9000 Phased Array Torsoand Pelvis Coil manufactured by USA Instruments, Inc.(K023650) |
| 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 Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Radio Frequency Absorption: Coil is areceive only coil and does not transmit RFpower. | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
| Formation of Resonant Loop: Decouplingisolates the coil elements from RF fieldsduring RF transmission; length of cable andstiffness does not permit looping. | -Similar to the Spirit III TotalSENSE Cardiac Coilmanufactured by USA Instruments, Inc. (K024187). |
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three horizontal lines extending from its head, representing feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Ms. Christie Shumaker Manager, QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K031172
Trade/Device Name: Spirit III TotalSENSE Cardiac Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 11, 2003 Received: April 22, 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. 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 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) 594-4610 |
| 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 vours.
Nancy 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: Spirit III TotalSENSE Cardiac Coil
Indications for Use: The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cardiovascular system 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)
§ 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.