(87 days)
The Premier 7000 Phased Array CTL Spine Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier 7000 Phased Array CTL Spine Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems.
The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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 7000 Phased Array CTL Spine Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has an removable anterior section for imaging the anterior cervical region. The elements and associated circuitry are enclosed in a housing made of plastic materials which are fire rate and have high impact and tensile strength.
The provided documentation for the K980157 Premier 7000 Phased Array CTL Spine Coil is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove novel performance criteria.
Therefore, the submission does not include a study that proves the device meets specific acceptance criteria in the way a traditional clinical trial or performance study would. Instead, the "acceptance criteria" here are aligned with demonstrating substantial equivalence in terms of intended use, indications for use, materials, design, and safety mechanisms compared to predicate devices.
Here's an analysis based on the provided text, addressing your questions where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "Reported Device Performance" for the Premier 7000 Phased Array Spine Coil is its ability to match or be similar in these characteristics.
| Parameter | Acceptance Criteria (Based on Predicate Devices) | Premier 7000 Phased Array Spine Coil Performance (as reported) |
|---|---|---|
| Intended Use | Imaging of the spine (as in K932693, K911806) | Imaging of the spine. |
| Indications for Use | Identical to routine MRI imaging (as in K932693, K911806) | Identical to routine MRI imaging: produces images corresponding to proton distribution, dependent on NMR parameters, displaying soft tissue structure, useful for diagnosis by a trained physician. Anatomic Regions: Spine, Nuclei Excited: Hydrogen. |
| Coil Material | Use of materials comparable to those in legally marketed devices (e.g., K964531, K971246, K962677, K972826, K944469) | ABS/PVC Plastic alloy, Polyurethane Plastic, Glass fiber reinforced polyester (Flame retardant Fiberglass), Naughahyde (fabric material) |
| Coil Design | Receive-only phased array design (as in K972340, K932693) | Receive-only phased array design |
| Decoupling | RF chokes with switching diodes (as in K972340) | RF Chokes with Switching Diodes |
| Prevention of RF Burms | Mechanisms to prevent RF burns (as in K972340) | Does not transmit RF Power, Decoupling isolates coil elements from RF fields during RF transmission, Coil elements and circuitry enclosed in non-conductive housing. |
| Radio Frequency Absorption | Limited or no RF power transmission for receive-only coils (as in K972340) | Coil is a receive only coil and does not transmit RF power |
| Formation of Resonant Loops | Mechanisms to prevent formation of resonant loops (as in K972340) | Decoupling isolates coil elements from RF fields during RF transmission, Length of cable and stiffness does not permit looping. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. A clinical "test set" with patient data to evaluate performance metrics directly is not described. The evaluation is based on comparing device specifications and technical characteristics to predicates.
- Data Provenance: Not applicable. The submission is a comparison of technical specifications and intended use against existing, cleared devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on image quality or diagnostic accuracy, is not part of this 510(k) submission.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
- Adjudication Method: Not applicable. No test set involving human interpretation and adjudication 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
- MRMC Study: No. This device is an MRI accessory (a coil), not an AI-powered diagnostic system.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is a hardware component with its performance intrinsically linked to the MRI scanner it integrates with, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices. The applicant asserts that their new device shares the same fundamental scientific technology and intended use, and does not raise new questions of safety or effectiveness compared to these predicates. This is a regulatory "ground truth" rather than a clinical one.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable.
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APR 1 3 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Magnetic Resonance Imaging Accessory 1. Device Name : Premier 7000 Phased Array CTL Spine Coil 2. Proprietary Name : Class II 3. Classification : 1529041 4. Establishment Registration #: USA Instruments, Inc., 675-B Alpha Drive, 5. Manufacture Facility Location: Highland Heights, Ohio 44143, USA Telephone: 216-442-5920; Fax: 216-442-5919. No applicable performance standards have been issued 6. Performance Standard: under Section 514 of the Food, Drug and Cosmetic Act. 7. Intended Use: The Premier Phased Array CTL Spine Coil is a receiveonly phased array RF coil, used for obtaining diagnostic images of the spine region (cervical, thoracic and lumbar anatomy) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The Premier 7000 Phased Array CTL Spine Coil is designed for use with the 1.5T Signa MRI scanner manufactured by GE Medical Systems. 8. Device Description: The Premier 7000 Phased Array CTL Spine Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has an removable anterior section for imaging the anterior cervical region. The elements and associated circuitry are enclosed in a housing made of plastic materials which are fire rate and have high impact and tensile strength.
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9. Safety and Effectiveness
| Parameter | Premier 7000 Phased ArraySpine Coil | Same as Predicate Device |
|---|---|---|
| Intended Use | Imaging of the spine. | Phased Array C/T/L Spine Coil, Edge MRI SystemPicker International(K932693) |
| Magnetic Resonance Diagnostic Accessory (CTL Phased ArraySpine Coil)GE (General Electric)(K911806) | ||
| Indications for Use | Identical to routine MRIimaging | Phased Array C/T/L Spine Coil, Edge MRI SystemPicker International(K932693) |
| Magnetic Resonance Diagnostic Accessory (CTL Phased ArraySpine Coil)GE (General Electric)(K911806) | ||
| Coil Material | ABS/PVC Plastic alloy, | Profile 7000 Volume Neck Coil, USA Instruments(K964531) |
| Polyurethane Plastic | Leo 7000 Quadrature Knee Coil, USA Instruments(K971246) | |
| Glass fiber reinforced polyester(Flame retardant Fiberglass) | Head Coil for 1.5T Esteem MRI system, Elscint MR(K962677 and K972826) | |
| Naughahyde (fabric material) | General Purpose Flex Coil, Picker International(K944469) | |
| Coil Design | Receive-only phased array design | Insight 7000 Phased Array Torso Coil, USA Instruments(K972340) |
| Phased Array C/T/L Spine Coil, Edge MRI SystemPicker International(K932693) | ||
| Decoupling | RF Chokes with Switching Diodes | Insight 7000 Phased Array Torso Coil, USA Instruments(K972340) |
| Prevention of RF Burns | Does not transmit RF PowerDecoupling isolates the coilelements from RF fields during RFtransmissionCoil elements and circuitryare enclosed in a non-conductivehousing. | Insight 7000 Phased Array Torso Coil, USA Instruments(K972340) |
| Radio FrequencyAbsorption | Coil is a receive only coil and doesnot transmit RF power | Insight 7000 Phased Array Torso Coil, USA Instruments(K972340) |
| Formation of ResonantLoops | Decoupling isolates coil elementsfrom RF fields during RFtransmission.Length of cable and stiffnessdoes not permit looping | Insight 7000 Phased Array Torso Coil, USA Instruments(K972340) |
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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three abstract human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 1998
Rony Thomas Regulatory Affairs Manager USA Instruments, Inc. 675-B Alpha Dr. Highland Heights, Ohio 44143 Re:
Premier 7000 Phased Array CTL Spine Coil Dated: December 30, 1997 Received: January 16, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Thomas:
We have reviewed your Section 510%) notification of intent to market the device referenced above and we have desembled the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Resulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510ks) 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 80) and additionally 809.10 for in vitro diagnostic devices); please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Magnifacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Premier 7000 Phased Array Spine Coil
Indications for Use: The Premier 7000 Phased Array Spine Coil is designed to provide Magnetic Resonance Images of the spine anatomy. The Premier 7000 Phased Array Spine Coil is designed for use with the GE MR's Signa 1.5T scanner.
Anatomic Regions: Spine Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Signa 1.5T 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) | |||
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of | Digestive, Gastrointestinal, ENT, and Radiological Devices | ||
| 510(k) Number | K980157 | ||
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
§ 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.