(23 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.
Model 125GE-64 Phased Array Cervical Spine Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
The provided 510(k) summary for the Model 125GE-64 Phased Array Cervical Spine Coil does not contain a study that demonstrates the device meets specific acceptance criteria in the manner typically found for AI/ML-enabled devices or those requiring performance validation against numerical targets. Instead, the submission focuses on substantial equivalence to predicate devices.
The acceptance criteria here are implicitly met by demonstrating that the new device does not negatively alter the performance of the integrated MRI system compared to the predicate devices. The "study" in this context is the submission of data demonstrating that various safety and imaging performance parameters remain unchanged when the new coil is used.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated as "No Change" from predicate) | Reported Device Performance (with Model 125GE-64) |
|---|---|
| Safety Parameters: | |
| Maximum Static Magnetic Field: No change | No change |
| Rate of Magnetic Field Strength Change: No change | No change |
| RF Power Deposition: No change | No change |
| Acoustic Noise Levels: No change | No change |
| Imaging Performance Parameters: | |
| Specification Volume: No change | No change |
| Signal-to-Noise Ratio: No change | No change |
| Image Uniformity: No change | No change |
| Geometric Distortion: No change | No change |
| Slice Thickness and Gap: No change | No change |
| High Contrast Spatial Resolution: No change | No change |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical performance study with a defined sample size. The evaluation relies on demonstrating "no change" in performance and safety parameters, which typically involves engineering measurements and comparisons rather than a clinical dataset. Therefore, sample size for a test set is not applicable or provided in this type of submission.
Data Provenance: Not explicitly stated as a separate clinical study. The data provenance would be from the engineering and safety testing performed by the manufacturer, Medical Advances, Inc., likely on their integrated MRI system (GE 1.5T Signa MRI system with the coil).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This submission focuses on engineering and safety equivalence, not a clinical study requiring expert ground truth establishment for diagnostic accuracy or similar clinical performance.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC comparative effectiveness study is mentioned. This type of study is more common for AI/ML devices or those claiming improved diagnostic performance over human readers, which is not the case for this MRI coil submission focused on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is an MRI coil, a hardware component, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The coil's performance is demonstrated within the context of the overall MRI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by the engineering specifications and performance characteristics of the predicate devices and the GE 1.5T Signa MRI system. The manufacturer demonstrated that the new coil, when integrated, maintained these established characteristics. Thus, it's essentially an engineering and safety specifications comparison.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device; there is no "training set" in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
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182222
510(k) Summary of Safety and Effectiveness
Device Name
Applicability
Reason for 510(k)
Classification Name
Device Classification Panel
Device Classification Number
Product Code
Common Name
Proprietary Name
Establishment Registration Number
Address of MFG Facility
Point of Contact
Classification
Intended Uses
Diagnostic Uses
Anatomic Regions _____________________________________________________________________________________________________________________________________________________________
Model 125GE-64 Phased Array Cervical Spine Coil
Compatible with GE Signa 1.5T MRI systems with Phased Array option
New device
Magnetic Resonance Diagnostic Device
Radiology
892.1000
90LNH
Magnetic Resonance Imaging Coil
Model 125GE-64 Phased Array Cervical Spine Coil
2183683
Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226
Thomas E. Tynes Vice President - Operations (414) 258-3808 Ext. 407
Class II
2D, 3D imaging, proton density, T1 and T2 weighted imaging. 2D, 3D time of flight, phase contrast imaging.
Cervical spine, soft tissue and vascular structures of the neck.
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Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 544 | Medical and Dental Equipment |
| UL 94 | Tests for Flammability of PlasticMaterials | |
| IEC 601-1 | General Safety Requirements forMedical Electrical Equipment | |
| CPAI-84 | Specification for Flame ResistantMaterial Used in Camping Tentage |
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 Medical Advances Phased Array Cervical Spine Coil is substantially equivalent to the same system with the legally marketed predicate devices 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 Medical Advances Phased Array Cervical Spine 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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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1098 OCT
Thomas E. Tynes Vice President-Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, WI 53226
Re: K983222
Phased Array Cervical Spine Coil (Model 125GE-64) Dated: September 14, 1998 Received: September 15, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Tynes:
We have reviewed your Section 510/12 notification of intent to market the device referenced above and we have deiermined 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 II (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drag 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/odri/dsmaldsmamain.html".
Sincerely yours,
William Yin
Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page ___ 1___ of ___ 1 ___ 1
510(k) Number (if known): _ 《98 3 2 2 2 2 - --------
Device Name:___________ Model 125 Series: Phased Array Cervical Spine Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the cervical spine, soft tissue and vascular structures of the neck.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David C. Symm
(Division Sign-Off) 4 Division of Reproductive, Abdominal, ENT, and Radiological Devis 510(k) Number
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.