(49 days)
The Premier III Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier III Phased Array CTL Spine 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 Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. 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 Premier III Phased Array CTL Spine Coil is a twelve element receive only phased array 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 coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
The provided text is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Premier III Phased Array CTL Spine Coil. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial for a novel AI device or a device requiring new clinical evidence.
Therefore, many of the requested sections (2-9), which are typical for studies proving meeting acceptance criteria for AI/diagnostic devices, cannot be directly answered from the provided text. The device described is a hardware component (an MRI coil), and its "performance" is primarily assessed by comparing its features and intended use to existing, legally marketed predicate devices, ensuring it doesn't raise new questions of safety or effectiveness.
Here’s what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a study. Instead, it presents a comparison of the new device's features and safety aspects against predicate devices to establish substantial equivalence. The "performance" is inferred from these comparisons being "similar."
| Acceptance Criteria (Inferred / Stated implicitly as "Similar to predicate") | Reported Device Performance |
|---|---|
| Intended Use: Imaging of the spine. | Similar to predicate device (K030042) |
| Indications for Use: Identical to routine MRI imaging. | Similar to predicate device (K030042) |
| Coil Material: Polycarbonate Plastic, Flame Retardant Polyurethane | Similar to predicate device (K030042) |
| Coil Design: Receive-only phased array design. | Similar to predicate device (K030042) |
| Decoupling: Switching diode decoupling. | Similar to predicate device (K980157) |
| Prevention of RF Burns: Does not transmit RF Power, Decoupling isolates coil elements from RF fields during RF transmission, Coil elements and circuitry are enclosed in a non-conductive housing. | Similar to predicate device (K030042) |
| Radio Frequency Absorption: Coil is a receive-only coil and does not transmit RF power. | Similar to predicate device (K030042) |
| Formation of Resonant Loops: Decoupling isolates coil elements from RF fields during RF transmission. Length of cable and stiffness does not permit looping. | Similar to predicate device (K030042) |
Regarding the study proving the device meets acceptance criteria:
The provided document describes a 510(k) Premarket Notification process, which is a regulatory pathway to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing design, materials, intended use, and safety features rather than extensive clinical studies with specified acceptance criteria as might be seen for novel diagnostic algorithms or drugs.
The "study" described here is essentially a comparison to predicate devices to prove substantial equivalence.
2. 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. The document does not describe a test set, clinical trial, or data of patients. The evaluation is based on design and technical specifications compared to predicate devices.
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)
- Not applicable / Not provided. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method for a test set is described.
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
- No, not done. This device is an MRI hardware component (a coil), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No specific ground truth type is mentioned as this is a device for substantial equivalence, not a diagnostic accuracy study.
8. The sample size for the training set
- Not applicable / Not provided. The concept of a "training set" is not relevant to the evaluation of this hardware device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. The concept of "ground truth for the training set" is not relevant here.
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K031139
MAY 2 9 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name: | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name: | Premier III Phased Array CTL Spine 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 Premier III Phased Array CTL Spine Coil is areceive- only phased array RF coil, used forobtaining diagnostic images of the cervical, thoracic,and lumbar regions of the spine in MagneticResonance Imaging Systems. The Premier IIIPhased Array CTL Spine Coil is designed for usewith the Intera 3.0T MRI system manufactured byPhilips Medical Systems, Inc. The indications for useare the same as for standard MR Imaging. |
| 8. Device Description: | The Premier III Phased Array CTL Spine Coil is atwelve element receive only phased array coil. Thecoil is shaped to conform to the contours of thespine and has been designed to maximize comfortand ease of use. The coil elements and accessoryelectronics are enclosed in a rigid plastic housing,which is fire rated and has a high impact and tensilestrength. |
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9. Safety and Effectiveness
| Premier III Phased Array CTL SpineCoil Product Features | Comparison to predicate device or other510(k) cleared product |
|---|---|
| Intended Use:Imaging of the spine. | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Indications for Use:Identical to routine MRI imaging | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Coil Material:Polycarbonate PlasticFlame Retardant Polyurethane | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Coil Design:Receive-only phased array design | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Decoupling:Switching diode decoupling. | -Similar to the Premier 7000 Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K980157) |
| Prevention of RF Burns:Does not transmit RF Power,Decoupling isolates the coil elementsfrom RF fields during RF transmission,Coil elements and circuitry are enclosedin a non-conductive housing. | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Radio Frequency Absorption:Coil is a receive only coil and does nottransmit RF power | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission.Length of cable and stiffnessdoes not permit looping | -Similar to the Premier III Phased Array CTLSpine Coil manufactured by USA Instruments,Inc. (K030042) |
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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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three heads or faces in profile, with flowing lines beneath them.
Public Health Service
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: K031139
Trade/Device Name: Premier III Phased Array CTL Spine Coil Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 9, 2003 Received: April 15, 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 nay, 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) 594-4616 |
| 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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KO31139 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Premier III Phased Array CTL Spine Coil
Indications for Use: The Premier III Phased Array CTL Spine Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The Premier III Phased Array CTL Spine Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cervical, thoracic, and lumbar regions of the spine. 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
(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 K031139
§ 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.