(13 days)
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is a receive-only phased array 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 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE 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 head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.
The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil 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 is a 510(k) summary for a Magnetic Resonance Imaging Accessory (3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil). It focuses on establishing substantial equivalence to predicate devices for safety and effectiveness and does not describe a study involving an algorithm or AI. Therefore, many of the requested categories related to algorithm performance, ground truth, and human reader studies are not applicable.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for an AI/algorithm. Instead, it demonstrates substantial equivalence by comparing product features and intended use to predicate devices. The "reported device performance" is essentially that its features and indications for use are similar to previously cleared devices, implying it performs equivalently in terms of safety and effectiveness.
| Acceptance Criteria (Demonstrated by Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use: Imaging of the spine | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Indications for Use: Identical to routine MRI imaging | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Coil Material: Flame Retardant Kydex, PVC, Polyurethane | Similar to predicate device (Premier 9000 8 Channel Phased Array CTL Spine Coil, K031366) |
| Coil Design: Receive-only phased array design | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Decoupling: RF Chokes with Switching Diodes | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Prevention of RF Burns: No RF transmission, decoupling, enclosed elements | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Radio Frequency Absorption: Receive-only coil | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
| Formation of Resonant Loops: Decoupling, cable length/stiffness | Similar to predicate device (Premier III Phased Array CTL Spine Coil, K013595) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device (MRI coil) submission, not an AI/algorithm-based device, so there is no "test set" in the context of data for an algorithm. The evaluation is based on engineering design, material properties, and comparison to existing 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. No "ground truth" in the context of expert consensus on image interpretation for an algorithm is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This device is an MRI coil, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an MRI coil, not an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for an MRI coil is its ability to produce diagnostic images safely and effectively, which is evaluated through engineering and clinical testing (not detailed here, but implied by the comparison to known safe and effective predicate devices), rather than by comparing algorithm output to a medical reference standard.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
AUG 2 5 2003
K032474
Page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory |
|---|---|
| 2. Proprietary Name : | 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil |
| 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 been issued under Section 514 of the Food, Drug and Cosmetic Act. |
| 7. Intended Use: | The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is a receive-only phased array 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 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner. |
| 8. Device Description: | The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil 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. |
{1}------------------------------------------------
K032474
Page 2 of 2
9. Safety and Effectiveness
| 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil ProductFeatures | Comparison to predicate device or other 510(k)cleared product |
|---|---|
| Intended Use: Imaging of the spine. | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Indications for Use: Identical to routineMRI imaging | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Coil Material:Flame Retardant KydexFlame Retardant PVCFlame Retardant Polyurethane | -Similar to the Premier 9000 8 Channel PhasedArray CTL Spine Coil manufactured by USAInstruments, Inc. (K031366) |
| Coil Design: Receive-only phased arraydesign | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| Decoupling: RF Chokes with SwitchingDiodes | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
| 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.(K013595) |
| 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.(K013595) |
| Formation of Resonant Loops:Decoupling isolates coil elements fromRF fields during RF transmission. Lengthof cable and stiffnessdoes not permit looping | -Similar to the Premier III Phased Array CTL SpineCoil manufactured by USA Instruments, Inc.(K013595) |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a black and white logo. The logo is circular and contains an abstract image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle. The bird image is composed of three curved lines that suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2003
Ms. Christie Shumaker Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K032474 Trade/Device Name: 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: August 8, 2003 Received: August 12, 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 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.
{3}------------------------------------------------
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
{4}------------------------------------------------
510(k) Number (if known): __(03 2 47 4
Device Name: 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil
Indications for Use: The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 4-Channel Cervico-Thoracic-Lumbar (CTL) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE 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 vield 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)
OR Prescription Use (Per 21 CFR 801.109
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive Abdominal and Radiological Dev 510(k) Number
§ 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.