(14 days)
The 3.0T 8-Channel CTL Spine Array is a receive-only phased arrav RF coil used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 8-Channel CTL Spine Array is designed for use with the Siemens Medical Systems 3.0T MRI scanner.
The 3.0T 8-Channel CTL Spine Array is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine when used with the Siemens 3.0T scanner manufactured by Siemens Medical Systems, Inc.
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 body. When interpreted by a trained physician, these images can be useful in the determination of a diagnosis.
The 3.0T 8-Channel CTL Spine Array is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. 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.
The provided document, K042186, is a 510(k) premarket notification for a medical device: the 3.0T 8-Channel CTL Spine Array. This application seeks to demonstrate substantial equivalence to a legally marketed predicate device rather than providing extensive independent performance studies with detailed acceptance criteria and clinical outcomes.
Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is not explicitly available in this type of regulatory submission. The focus here is on demonstrating similarity to an already approved device.
Here's how to interpret the provided information in the context of your request:
Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this context refers to demonstrating that the new device shares fundamental technological characteristics and intended use with a predicate device, thereby implicitly meeting the safety and effectiveness standards already established for the predicate.
| Acceptance Criteria Category (Implied by 510(k) Equivalence) | Reported Device Performance (Comparison from K042186) |
|---|---|
| Intended Use Equivalence | - Imaging of the spine.- Similar to the Premier III Phased Array CTL Spine Coil (K030042), which is also for imaging the spine. |
| Indications for Use Equivalence | - Identical to routine MRI imaging (diagnostic images of the spine in MRI systems).- Similar to the Premier III Phased Array CTL Spine Coil (K030042), with indications for use being the same as standard MR Imaging. |
| Material Composition Equivalence | - Coil Material: Flame Retardant PVC, Flame Retardant Polyurethane, Flame Retardant Polycarbonate (fire-rated plastic materials with high impact and tensile strength).- Similar to K030042. |
| Coil Design Equivalence | - Receive-only phased array design, shaped to conform to spine contours.- Similar to K030042. |
| Decoupling Mechanism Equivalence | - Decoupling: RF Chokes with Switching Diodes.- Similar to K030042. |
| RF Burn Prevention Equivalence | - Does not transmit RF Power, decoupling isolates elements during RF transmission, elements/circuitry enclosed in non-conductive housing.- Similar to K030042. |
| Radio Frequency Absorption Equivalence | - Receive-only coil, does not transmit RF power.- Similar to K030042. |
| Prevention of Resonant Loops Equivalence | - Decoupling isolates coil elements, cable length and stiffness prevent looping.- Similar to K030042. |
| Compatibility | - Designed for use with Siemens Medical Systems 3.0T MRI scanner.- (Not explicitly compared to predicate for compatibility in the provided text, but implied as part of the overall system for which it's intended). |
Study Information (Based on 510(k) Submission Type)
1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device through technical and functional comparisons, not through a new clinical performance study with a distinct test set of patient data. The safety and effectiveness are inferred from the predicate.
2. 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 / Not provided. Since there wasn't a new clinical performance study with a test set requiring new ground truth, this information is not part of this submission.
- Implicitly, the predicate device would have undergone such evaluations to establish its safety and effectiveness, which would have involved experts.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. As no new test set was used to establish ground truth for this device, no adjudication method is detailed.
4. 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:
- No. This device is a passive MRI accessory (a receive-only RF coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware component (an MRI coil), not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For this 510(k) submission, the "ground truth" for demonstrating safety and effectiveness relies on the established safety and performance of the predicate device (Premier III Phased Array CTL Spine Coil, K030042). The new device is shown to be technically similar and intended for the same uses, implying it performs equivalently to the predicate.
7. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.
8. How the ground truth for the training set was established:
- Not applicable / Not provided. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment for a training set.
In summary, for a 510(k) submission like K042186 for a hardware component such as an MRI coil, the "study" is primarily a comparative analysis of the device's technical specifications and intended use against a legally marketed predicate device. The acceptance criteria are essentially met by demonstrating substantial equivalence to the predicate in terms of safety and effectiveness, based on similar technology, materials, design, and intended use. New clinical studies with patient data, ground truth establishment, or multi-reader reviews are typically not part of such a submission unless there are significant technological differences or new indications for use.
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AUG 2 6 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | 3.0T 8-Channel CTL Spine Array |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc1515 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 3.0T 8-Channel CTL Spine Array is a receive-only phased arrav RF coil used for obtainingdiagnostic images of the spine (cervical, thoracicand lumbar regions) in Magnetic ResonanceImaging Systems. The indications for use are thesame as for standard MR Imaging. The 3.0T 8-Channel CTL Spine Array is designed for use withthe Siemens Medical Systems 3.0T MRI scanner. |
| 8. Device Description: | The 3.0T 8-Channel CTL Spine Array is a multi-element phased array receive-only coil. The coil isshaped to conform to the contours of the spine andhas been designed to maximize comfort and ease ofuse. The elements and associated circuitry areenclosed in a housing made of plastic materials,which are fire rated and have high impact and tensilestrength. |
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9. Safety and Effectiveness
| 3.0T 8-Channel CTL Spine ArrayProduct Features | Comparison to Predicate Device or other 510(k)Cleared Products |
|---|---|
| Intended Use: Imaging of the spine. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Coil Material:Flame Retardant PVCFlame Retardant PolyurethaneFlame Retardant Polycarbonate | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Coil Design: Receive-only phased arraydesign | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Decoupling: RF Chokes with SwitchingDiodes | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| 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 III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Radio Frequency Absorption: Coil is areceive-only coil and does not transmitRF power. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission. Lengthof cable and stiffness does not permitlooping. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K030042) |
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Food and Drug Administration 9200 Corporate Boulevard, Rockville MD 20850
AUG 2 6 2004
Mr. James Wrenn Manager, QA and Regulatory Affairs USA Instruments, Inc. . 1515 Danner Drive AURORA OH 44202
Re: K042186 Trade/Device Name: 3.0T 8-Channel CTL Spine Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 MOS Dated: August 11, 2004 Received: August 12, 2004
Dear Mr. Wrenn:
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 such 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) I mo lotel miration. 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. Ixxx | (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. Ogden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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510(k) Number (if known):__ K ما 18 ملا 2 18
Device Name: 3.0T 8-Channel CTL Spine Array
Indications for Use: The 3.0T 8-Channel CTL Spine Array is designed to manodations for of OResonance Images of the cervical, thoracic, and lumbar provide Magnotio Roconance They ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . with the Siemens 3.0T scanner manufactured by Siemens Medical Systems, Inc.
Anatomic Regions: Cervical, thoracic, and lumbar regions of the spine Hydrogen Nuclei Excited:
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, intages that. (1) on resparameters (proton density, spin lattice relaxation time (2) depend upon Ann (parant2) and (3) display the soft tissue structure of the r I, spin-spin rolaxation anno interpreted by a trained physician, these images nead and whole bout 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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdon
Division of Reproductive, Abdomi and Radiological Devices
510(k) Number K042186
§ 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.