(56 days)
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are surface coils used for Magnetic Resonance Imaging. They are tuned to image Proton nuclei in a receive-only configuration. They are comprised of 32 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques. The 16 Ch version uses multiplexers to allow a 32 channel design to be used on 16 Channel systems.
The GE Healthcare 510(k) Premarket Notification Submission (K103365) describes the Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil. The submission asserts that these devices are substantially equivalent to their predicate device, the USA Instruments Prima III TotalSENSE Torso Coil (K030371).
The study provided to demonstrate substantial equivalence and meet acceptance criteria is based on non-clinical voluntary standards, focusing on safety and performance, rather than clinical efficacy.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards and Performance Metrics) | Reported Device Performance |
|---|---|
| Safety Standards: | Comply with all applicable sections. |
| IEC 60601-1: Electrical Safety | Comply with all applicable sections. |
| IEC 60601-1-2: Electromagnetic Compatibility (e.g., electrostatic discharge) | Comply with all applicable sections. |
| IEC 60601-2-33: Electrical Safety (e.g., documentation requirements) | Determinded to be post market acceptable. |
| ISO 10993-1: Biocompatibility (determination of post market acceptability of materials) | Improved upon the predicate device. |
| Performance Standards: | |
| SNR testing method identified in Section 18 | Increased channel and larger coverage area compared to the predicate. Shares similar high-level phased array, receive-only design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a specific "test set" in terms of patient data. The evaluation appears to be based on testing of the device hardware against engineering and safety standards. Therefore, information regarding "country of origin of the data" or "retrospective or prospective" is not applicable as it's not a clinical study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluation is against engineering standards rather than expert-derived ground truth on clinical images.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication for a test set, as the study relies on compliance with technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence based on technical specifications and safety standards, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Not applicable. This device is a receive-only RF coil for an MRI system, not an algorithm. Its performance is evaluated in terms of its ability to acquire high-quality MR signals.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through compliance with recognized electrical, electromagnetic, and biocompatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1), and performance characteristics like Signal-to-Noise Ratio (SNR) as per a specified method. This is a technical and engineering-based ground truth, not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This is a hardware device (MRI coil), not an AI algorithm, so there is no training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
JAN 1 2 2011
In accordance with 21 CFR 807.92 the following summary of information is provided:
ト
| Date: | November 16, 2010 |
|---|---|
| Submitter: | GE Healthcare Coils (USA Instruments, Inc.)Establishment Registration Number: 15290411515 Danner Dr.Aurora, OH 44202, USA |
| Primary Contact Person: | Mr. Michael S. PretoRegulatory Affairs Leader, MRGE Healthcare Coils (USA Instruments, Inc.)Phone: +1 330 995-8333Fax: +1 330 562-1422Email: michael.preto@ge.com |
| Secondary Contact Person: | Mr. Glen SabinRegulatory Affairs Director, MRGE Healthcare (GE Medical Systems, LLC)Establishment Registration Number: 21835533200 N Grandview Blvd., Mail Code - W-827Waukesha, WI 53188, USAPhone: +1 262 521 6848Fax: +1 262 521 6439Email: glen.sabin@ge.com |
| Device: Trade Name: | Discovery 3T 16 Ch Body Array Coil andDiscovery 3T 32 Ch Body Array Coil |
| Common/Usual Name: | Coil, magnetic resonance, specialty |
| Classification Names: | 21 CFR 892.1000, Magnetic resonance diagnostic device |
| Product Code: | 90MOS |
| Predicate Device(s): | K030371, USA Instruments Prima III TotalSENSE Torso Coil |
| Device Description: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch BodyArray Coil are surface coils used for Magnetic Resonance Imaging.They are tuned to image Proton nuclei in a receive-only configuration.They are comprised of 32 individual Phased Array coil elements eachutilizing an integrated preamplifier to improve image quality. Thegeometry is optimized for use with parallel imaging techniques. The 16Ch version uses multiplexers to allow a 32 channel design to be used on16 Channel systems. |
| Intended Use: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch BodyArray Coil are receive-only RF Coils designed for use with 3.0T MRIsystems manufactured by GE Healthcare. The indications for use includechest, cardiac, abdomen, torso, pelvis, prostate, hips, and long boneimaging. The nucleus detected is hydrogen. |
| Technology: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch BodyArray Coil are 32-element phased array RF receive only coils withintegrated preamplifiers. The coil designs consist of RF chokes with fastswitching PIN diodes to provide decoupling which isolates the coilelements from RF fields during RF transmission. This coil is designedbased on the same technology as the predicate device. The 16 Ch versionuses multiplexers to allow a 32 channel design to be used on 16 Channelsystems |
| Determination of SubstantialEquivalence: | The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch BodyArray Coil have comparable indications for use as their predicate deviceand the same or similar non-clinical voluntary standards are used todemonstrate substantial equivalence of safety and performance:IEC 60601-1: Electrical Safety - compliant with all applicable sectionsIEC 60601-1-2: Electromagnetic Compatibility - compliant with allapplicable sections (i.e. electrostatic discharge)IEC 60601-2-33: Electrical Safety - compliant with all applicablesections (i.e. documentation requirements)ISO 10993-1: Biocompatibility - determination of post marketacceptability of materialsSNR testing according to the method identified in Section 18.The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch BodyArray Coil have increased channel and larger coverage area than theTotalSENSE Torso Coil. They share a similar high-level phased array,receive-only design. |
| Conclusion: | GE Healthcare considers the Discovery 3T 16 Ch Body Array Coil andDiscovery 3T 32 Ch Body Array Coil to be as safe, as effective, andperformance is substantially equivalent to the predicate device. |
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GE Healthcare GE Healthcare
510(k) Premarket Notification Submission
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael S. Preto Regulatory Affairs Leader-MR GE Healthcare Coils (USA Instruments, Inc.) ' 1515 Danner Drive AURORA OH 44202
JAN 1 2 201
Re: K103365
Trade/Device Name: Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 16, 2010 Received: November 18, 2010
Dear Mr. Preto:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dan
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K103365
510(k) Number (if known):
Device Name:
Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil
JAN. 1.2 2011
Indications for Use:
The Discovery 3T 16 Ch Body Array Coil and Discovery 3T 32 Ch Body Array Coil are receive-only RF Coils designed for use with 3.0T MRI systems manufactured by GE Healthcare. The indications for use include chest, cardiac, abdomen, torso, pelvis, prostate, hips, and long bone imaging. The nucleus detected is hydrogen.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
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n of Radiologic Office of In Vitro Dia 510K.
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§ 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.