(68 days)
Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.
Model 414GE-09 Linear Shoulder Coil. Compatible with GE Signa Profile 0.2 T MRI systems.
The provided text describes a 510(k) premarket notification for a new MRI coil, the Model 414GE-09 Linear Shoulder Coil. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a new type of AI/algorithmic device.
Therefore, many of the requested elements for an AI/algorithmic device study are not applicable or cannot be extracted from this document, as this is a physical medical device (an MRI coil).
However, I can extract information related to the device's technical specifications and how its "performance" (in terms of safety and imaging parameters) is compared to the predicate device to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For this device, "acceptance criteria" are implicitly defined by the safety and imaging performance parameters of the predicate device. The new device is considered acceptable if it performs "no change" or equivalently to the predicate device in these parameters. There are no numerical performance metrics or thresholds explicitly stated as acceptance criteria in the document for the new device itself, but rather a qualitative comparison to the predicate.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (vs. Predicate) |
|---|---|
| Maximum Static Magnetic Field: No change from predicate | No change |
| Rate of Magnetic Field Strength Change: No change from predicate | No change |
| RF Power Deposition: No change from predicate | No change |
| Acoustic Noise Levels: No change from predicate | No change |
| Specification Volume: No change from predicate | No change |
| Signal-to-Noise Ratio: No change from predicate | No change |
| Image Uniformity: No change from predicate | No change |
| Geometric Distortion: No change from predicate | No change |
| Slice Thickness and Gap: No change from predicate | No change |
| High Contrast Spatial Resolution: No change from predicate | No change |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission focuses on demonstrating that the new coil, when used with the GE Signa Profile 0.2T MRI system, operates equivalently in terms of safety and imaging parameters to the predicate device. It doesn't describe a clinical study with a specific test set of patients or images.
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)
This information is not applicable and not provided. This device is an MRI coil, not an AI or algorithmic diagnostic tool requiring expert ground truth for interpretation. The "ground truth" here would relate to the physical and electrical performance of the coil itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
An MRMC study is not applicable and not mentioned. This is a physical device (MRI coil), not an AI algorithm for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study as described for AI algorithms is not applicable. This is a physical MRI coil. Its "performance" refers to its ability to generate MRI signals and images with specific physical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context would be based on physical measurements and engineering tests of the coil's performance against established specifications and comparison to the predicate device. It would involve objective measurements of magnetic field properties, RF power, signal-to-noise ratio, image uniformity, etc., using phantoms or controlled environments, not clinical ground truth like pathology for diagnostic algorithms. The document does not detail the specific method for establishing this "ground truth" beyond stating "no change" from the predicate.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
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JUN = 8 1999
510(k) Summary of Safety and Effectiveness
| Device Name | Model 414GE-09 Linear Shoulder Coil |
|---|---|
| Applicability | Compatible with GE Signa Profile 0.2 T MRIsystems |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90LNH |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 414GE-09 Linear Shoulder Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | IGC Medical Advances Inc.10437 Innovation DriveMilwaukee, WI 53226 |
| Point of Contact | Thomas E. TynesVice President - Operations(414) 258-3808 Ext. 407 |
| 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 | Shoulder and other related joint structures. |
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Standards
| Performance Standards | None Established under Section 514 | ||
|---|---|---|---|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment,Part 1: General Requirements forSafety | |
| UL 94 | Tests for Flammability of PlasticMaterials | ||
| IEC 601-1 | General Safety Requirements forMedical Electrical Equipment |
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 Signa Profile 0.2T MRI system operated with the Medical Advances Linear Shoulder 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 Signa Profile 0.2T MRI system operated with the Medical Advances Linear Shoulder Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated with the identified legally marketed predicate device. The use of this coil does not affect the GE Signa Profile 0.2T system safety parameter specifications.
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Public Health Service
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
DEPARTMENT OF HEALTH & HUM
JUN
Medical Advances, Inc.
10437 Innovation Drive
Milwaukee, Wisconsin 53226
Thomas E. Tynes Vice President, Operations
RE:
K991115 Model 414GE-09 Linear Shoulder Coil Dated: March 25, 1999 Received: April 1, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Tynes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 531 through 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 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 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 Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting 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 ______________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Model 414GE Series: Linear Shoulder Coil
Indications for Use:
Magnetic resonance imaging (MRI) of the shoulder joint and surrounding tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | ||
| 510(k) Number | K991115 | |
| 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.