(87 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).
Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
The provided document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) coil, not a medical device algorithm or AI-powered diagnostic tool. Therefore, many of the requested categories related to algorithm performance, training data, ground truth, and expert evaluation are not applicable.
The document describes the device's technical specifications and asserts its substantial equivalence to a predicate device based on safety and imaging performance parameters. The "acceptance criteria" here refer to meeting the established safety and imaging performance benchmarks of a legally marketed predicate device, rather than a diagnostic performance threshold for an AI model.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Parameter | Acceptance Criteria (based on predicate device) | Reported Device Performance |
|---|---|---|---|
| Safety Parameters | Maximum Static Magnetic Field | No change (compared to predicate device) | No change |
| Rate of Magnetic Field Strength Change | No change (compared to predicate device) | No change | |
| RF Power Deposition | No change (compared to predicate device) | No change | |
| Acoustic Noise Levels | No change (compared to predicate device) | No change | |
| Imaging Performance | Specification Volume | No change (compared to predicate device) | No change |
| Signal-to-Noise Ratio | No change (compared to predicate device) | No change | |
| Image Uniformity | No change (compared to predicate device) | No change | |
| Geometric Distortion | No change (compared to predicate device) | No change | |
| Slice Thickness and Gap | No change (compared to predicate device) | No change | |
| High Contrast Spatial Resolution | No change (compared to predicate device) | No change |
Study Proving Device Meets Acceptance Criteria:
The document states that the GE 1.5T Signa MRI system operated with the IGC-Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device. This statement implies that testing was conducted to verify that the new coil, when used with the specified MRI system, performs identically or equivalently to the predicate device with respect to the listed safety and imaging parameters. However, details of the specific "study" (e.g., experimental design, number of subjects, quantitative results) are not provided in this summary, as is typical for a 510(k) summary for a physical component like an MRI coil. The "study" here refers to the technical evaluation and comparison performed by the manufacturer to demonstrate substantial equivalence.
Regarding the unapplicable requested information (due to the device being an MRI coil, not an AI/algorithm):
- 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data in the context of an algorithm. Evaluation would involve technical measurements on phantoms and potentially studies on human volunteers/patients to confirm imaging quality, but the specifics are not detailed in this summary.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance of an algorithm is not relevant here.
- 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 is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be the direct physical measurements of its output (e.g., SNR, uniformity) and its adherence to safety limits.
- 8. The sample size for the training set: Not applicable. This device does not use a training set as it is not an algorithm.
- 9. How the ground truth for the training set was established: Not applicable.
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FEB 1 4 2003
510(k) Summary of Safety and Effectiveness
| Device Name | Model 675GE-64 Peripheral Vascular Coil consistingof Model 665GE-64 Lower Extremity Flexible Arrayand Model 538GE-64 Medium General Purpose FlexCoil |
|---|---|
| Applicability | Compatible with GE Signa 1.5T MRI systems withPhased Array option |
| Reason for 510(k) | New indication for use |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90MOS |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 675GE-64 Peripheral Vascular Coil consistingof Model 665GE-64 Lower Extremity Flexible Arrayand Model 538GE-64 Medium General Purpose FlexCoil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC-Medical Advances Inc.10437 Innovation DriveMilwaukee, WI 53226 |
| Point of Contact | Anthony DietzlerQuality Assurance Engineering and RegulatoryAffairs(414) 258-3808 Ext. 255 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2weighted imaging. 2D, 3D time of flight, phasecontrast imaging. |
| Anatomic Regions | Vascular structures, soft tissue and musculo-skeletal structures in the lower extremities (mid-abdomen to mid-foot).Pediatric applications. |
| Standards | |
| Performance Standards | None Established under Section 514 |
| Voluntary Safety Standards | UL 544 Medical and Dental Equipment |
| UL 94 Tests for Flammability of Plastic Materials | |
| IEC 601-1 General Safety Requirements for Medical Electrical Equipment | |
| CPAI-84 Specification for Flame Resistant Material Used in Camping Tentage |
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Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The GE 1.5T Signa MRI system operated with the IGC-Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device listed in section 4.0, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
Safety Parameters
| Maximum Static Magnetic Field: | No change |
|---|---|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
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Imaging Performance Parameters
| Specification Volume: | No change |
|---|---|
| Signal-to-Noise Ratio: | No change |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.
Substantial Equivalence Summary
The GE 1.5T Signa MRI system operated with the IGC-Medical Advances Peripheral Vascular Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate devices. The use of this coil does not affect the GE Signa system safety parameter specifications.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Mr. R. Jerry Frohlich Manager, QA/RA IGC Medical Advances, Inc. 10437 Innovation Drive MILWAUKEE WI 53226
Re: K023848 Trade/Device Name: Model 675GE-64 Peripheral Vascular Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: November 15, 2002 Received: November 19, 2002
Dear Mr. Frohlich:
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 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 vours.
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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Page 1 of 1
510(k) Number (if known):
Device Name: Model 675GE-64: Peripheral Vascular Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).
(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)
Daniel A. Seymour
§ 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.