(70 days)
Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints.
Model 414GE-09 Linear Wrist Coil. Compatible with GE Signa Profile 0.2 T MRI Systems. Magnetic Resonance Imaging Coil.
The provided text describes a 510(k) submission for a medical device, a linear wrist coil for MRI. The submission focuses on establishing substantial equivalence to a predicate device, rather than proving a new device's independent performance against defined acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or available in this document.
However, I can extract and infer some information based on the document's content. The "acceptance criteria" here are essentially the demonstration of "no change" in key safety and imaging performance parameters when the new coil is used with the specified MRI system, compared to the predicate device.
Here's a breakdown of the requested information, addressing what's present and what's not:
1. Table of acceptance criteria and the reported device performance
| Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Safety Parameters | ||
| 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 |
| Imaging Performance Parameters | ||
| Specification Volume | No change from predicate | No change |
| Signal-to-Noise Ratio (SNR) | 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 |
| General Safety and Effectiveness Concerns | Instructions for use, indications, precautions, cautions, contraindications, warnings, and quality assurance testing | Device includes these elements to assure safe and effective use. |
Study that proves the device meets the acceptance criteria:
The document describes the basis for proving substantial equivalence, which is the "study" in this context. The study is a comparison of the new device (Medical Advances Linear Wrist Coil) with a legally marketed predicate device when both are operated with the GE Signa Profile 0.2 T MRI system.
The core of the study is to demonstrate that the new coil "has the same intended use and technological characteristics" as the predicate and "does not affect the GE Signa Profile 0.2T system safety parameter specifications." This implies that testing was conducted to verify that the performance of the system with the new coil remained consistent with its performance with the predicate coil in terms of the listed safety and imaging parameters.
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: Not explicitly stated. The document indicates a comparison with a predicate device, but doesn't specify how many instances or types of images were used for comparison. This is a 510(k) summary, which typically focuses on demonstrating equivalence rather than providing detailed clinical trial methodologies.
- Data provenance: Not explicitly stated, but it would have been collected from testing the GE Signa Profile 0.2 T MRI system with both the new coil and the predicate coil. The origin of the data would likely be from an engineering/testing environment rather than patient data, given the nature of the parameters being assessed (e.g., SNR, uniformity, geometric distortion are often measured using phantoms). It is a "new device" submission and not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is not established by human experts in a clinical context (e.g., radiologists diagnosing a condition). Instead, it's based on quantitative measurements of physical and performance characteristics, likely against established engineering specifications or the performance of the predicate device.
4. Adjudication method for the test set
Not applicable. There's no human-based adjudication described as the evaluation criteria are objective physical and performance measures.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of a component (the coil) to a predicate, not on the comparative clinical effectiveness of the entire system (MRI + coil) or the improvement of human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "study" described is entirely standalone in that it assesses the physical and functional performance of the device itself (the coil) and its interaction with the MRI system, without involving human interpretation of images for diagnostic purposes. This is an engineering/performance assessment, not a clinical trial of diagnostic accuracy.
7. The type of ground truth used
The "ground truth" is the established safety and imaging performance specifications of the GE Signa Profile 0.2 T MRI system when operated with its original or a legally marketed predicate coil. The new coil's performance is compared against these established technical benchmarks. It's based on objective measurements of physical parameters rather than pathology, outcomes data, or expert consensus.
8. The sample size for the training set
Not applicable. This device is an MRI coil, a hardware component. There is no "training set" in the context of machine learning, as this is not an AI/algorithm-driven device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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JUN 1 0 1999
510(k) Summary of Safety and Effectiveness
| Device Name | Model 414GE-09 Linear Wrist 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 440GE-09 Linear Wrist 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 |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2weighted imaging. 2D, 3D time of flight, phasecontrast imaging. |
| Anatomic Regions | Wrist 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 0.2 T MRI system operated with the Medical Advances Linear Wrist 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 0.2 T MRI system operated with the Medical Advances Linear Wrist 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1999
Thomas E. Tynes Vice President, Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, Wisconsin 53226 Re:
K991113 Linear Wrist Coil Model: 440GE 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 redassified 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 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 vitto 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.qov/cdrh/dsma/dsmamain.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 ___ 1___ of ___ 1________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _ _ _ _ Model 440GE Series: Linear Wrist Coil
Indications for Use:
Magnetic resonance imaging (MRI) of the musculoskeletal structures and soft tissue of the Wrist and surrounding joints.
(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 | K991113 | |
| 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.