(71 days)
Magnetic resonance imaging (MRI) of the hand and wrist.
Model 445PH-64 Quadrature Wrist Coil. Compatible with Philips Gyroscan ACS-NT 1.5T MRI system.
This document describes the 510(k) summary for the Medical Advances, Inc. Model 445PH-64 Quadrature Wrist Coil, submitted on April 21, 1999 (K991434). This device is a Magnetic Resonance Imaging (MRI) coil intended for diagnostic imaging of the hand and wrist.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this submission are framed around demonstrating substantial equivalence to the predicate device (the Philips Gyroscan ACS-NT 1.5T MRI system operated without the Medical Advances Quadrature Wrist Coil). The key performance parameters are assessed by showing "No change" compared to the predicate device, indicating that the addition of the new coil does not adversely affect these fundamental MRI system capabilities. No specific quantitative numerical acceptance thresholds are provided in this summary.
| Acceptance Criteria Category | Specific Parameter | Reported Device Performance (with Medical Advances Quadrature Wrist Coil) |
|---|---|---|
| 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 | |
| Imaging Performance | 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 | Instructions for Use (Indications, Precautions, Cautions, Contraindications, Warnings, QA Testing) | Device includes these to assure safe and effective use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify a separate "test set" in the context of clinical studies with human subjects or detailed performance evaluations for the Quadrature Wrist Coil. The submission relies on demonstrating that the new coil, when integrated with an existing, legally marketed MRI system (Philips Gyroscan ACS-NT 1.5T), does not alter the system's safety and imaging performance parameters.
The data provenance is implied to be from engineering and technical testing of the coil's compatibility and performance characteristics within the specified MRI system, rather than a clinical study with patient data. No information on country of origin or whether it's retrospective/prospective is given, as it's not a clinical data-driven submission in the modern sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given the nature of the submission, which focuses on demonstrating substantial equivalence through technical specifications rather than clinical diagnostic accuracy, no information is provided regarding experts used to establish ground truth for a test set. This type of submission does not involve a diagnostic accuracy study where ground truth would be established by medical experts for a set of cases.
4. Adjudication Method for the Test Set
As there is no specified test set involving human subject data or diagnostic interpretations, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed by the device manufacturer, as this submission is for an MRI coil and focuses on technical equivalence rather than comparing diagnostic efficacy with and without AI assistance. The device itself is an accessory to an MRI system, not an AI-enabled diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study was done as the device is a passive MRI coil and does not incorporate an algorithm that operates independently.
7. Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety specifications of the predicate Philips Gyroscan ACS-NT 1.5T MRI system when operating without the Medical Advances Quadrature Wrist Coil. The new coil is demonstrated to not alter these established parameters. This is based on technical specifications and engineering measurements rather than expert consensus, pathology, or outcomes data from a diagnostic study.
8. Sample Size for the Training Set
There is no mention of a training set as this device is a passive MRI coil and does not employ machine learning or AI algorithms requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this question is not applicable.
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JUL - 6 1999
10991434
510(k) Summary of Safety and Effectiveness
| Device Name | Model 445PH-64Quadrature Wrist Coil |
|---|---|
| Applicability | Compatible with Philips Gyroscan ACS-NT 1.5TMRI system |
| 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 445PH-64Quadrature Wrist Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | 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 | Hand and Wrist. |
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Standards
| Performance Standards | None Established under Section 514 | |
|---|---|---|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part I: General Requirements for Safety |
| UL 94 | Tests for Flammability of Plastic Materials | |
| IEC 601-1 | General Safety Requirements for Medical 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 Philips Gyroscan ACS-NT 1.5T MRI system operated with the Medical Advances Quadrature Wrist Coil is substantially equivalent to the same system operated without the Medical Advances Quadrature Wrist Coil within the Class II definition of MR diagnostic systems.
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 Philips Gyroscan ACS-NT 1.5T MRI system operated with the Medical Advances Quadrature Wrist Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated without the Medical Advances Quadrature Wrist Coil within the Class II definition of MR diagnostic systems. The use of this coil does not affect the Philips Gyroscan ACS-NT 1.5T system safety parameter specifications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 1999
Thomas E. Tynes Vice President. Operations Medical Advances, Inc 10437 Innovation Drive Milwaukee, Wisconsin 53226 RE:
K991434 Quadrature Wrist Coil Model 445PH-64 Dated: April 21, 1999 Received: April 26, 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 (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 (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 requlatory 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 yitro 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/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 ______ of _______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Model 445 Series: Quadrature Wrist Coil Device Name:
Indications for Use:
Magnetic resonance imaging (MRI) of the hand and wrist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Szymm
(Division Sign-Off) (Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number
Prescription Use 3 (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.