(7 days)
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
The provided text describes a 510(k) premarket notification for the TEM 3000G Head Coil. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study proving specific performance metrics against those criteria.
However, based on the information provided, we can infer some aspects and construct a response:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it states that "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the user-ability of the GE based Head Coil." This implies the acceptance criteria were related to the coil's ability to produce Magnetic Resonance Images (MRIs) of the brain, soft tissues, and vasculature of the head when used with the specified GE MR system, and that these images should be comparable in quality to those produced by the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to provide Magnetic Resonance Images of the brain, soft tissues, and vasculature of the head. | "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the user-ability of the GE based Head Coil. Test results modified.com and performance of the TEM 3000G Head Coil for its intended use." (This implies successful imaging of the specified anatomical regions.) |
| Compatibility and functional performance with the GE Signa 3.0T Excite MR System. | "The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE." and "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System..." (This indicates successful integration and operation with the specified MR system.) |
| Similar imaging quality and utility to the predicate device (GE Signa 3.0T Excite MR System Split Head Coil Assembly for G3). | "The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the TEM 300G Head Coil." and "The similarities between the two devices is that they are both quadrature transmit and receive RF coils designed to work with the GE Signa 3.0T Excite transmit and the similar in size, shape and construction." (This implies performance is comparable enough to be considered substantially equivalent.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the performance testing. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts to establish ground truth or their qualifications. The testing appears to be focused on technical performance and compatibility rather than diagnostic accuracy requiring expert interpretation of images.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on technical performance rather than diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or mentioned. This device is an MRI head coil, a hardware component for image acquisition, not an AI-powered diagnostic tool requiring human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is hardware (an MRI coil), not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this type of device would likely be the technical specifications and image quality metrics (e.g., signal-to-noise ratio, image homogeneity, artifact levels) achieved with the coil, compared to the expected performance characteristics of a head coil for the specified MR system and the performance of the predicate device. It is inferred that these technical specifications and image quality were assessed, although the specific metrics and results are not detailed in this summary.
8. The Sample Size for the Training Set
This question is not applicable as the TEM 3000G Head Coil is a hardware device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for a hardware device.
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AUG 1 9 2005
TEM 3000G Head Coil
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Contact Person
Mark Watson VP, Engineering Tel: (952) 746-1435 Fax: (952) 746-1437
MR Instruments, Inc., Inc. 4802 Park Glen Road Minneapolis, MN 55416
2. General Information
| Name: | TEM 3000G Head Coil |
|---|---|
| Trade Name: | TEM 3000 Head Coil |
| Common Name: | Head Coil |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification: | This device is classified by the RadiologyPanel into Class II, (21 CFR 892.1000) |
3. Device Description
The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
The predicate device, manufactured for General Electric Company, Milwaukee, WI (USA) by GE Medical Systems (India) Private LTD, Split Head Coil Assembly for G3 (K040444), is also quadrature transmit/receive coil. The TEM 3000G's fundamental construction and use of materials (as defined above) is similar to the predicate device. (See Attachment B for device drawings.)
4. Intended Use
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM
CONFIDENTIAL
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NNSTASMENTS
3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
5. Substantial Equivalence Comparison
antial Equivalient o coil is substantially equivalent to the following device i with respect to intended use and design:
- GE Signa 3.0T Excite MR System (Split Head Coil Assembly for G3) . GE Signa 0.0 + Exection for General Electric Company (Milwaukee, WI, (114044) manufal Systems (India) Private LTD, Banagalore, India
The similarities between the two devices is that they are both quadrature transmit and receive RF coils designed to work with the GE Signa 3.0T Excite transmit and the similar in size, shape and construction.
The primary difference between the two devices is that the predicate utilizes The philary anterence as a transverse electromagnetic (TEM) technology, which requires less RF power to achieve high-resolution imaging.
6. Summary of Studies
Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the usershility of the GE based Head Coil. Test results modified.com and performance of the TEM 3000G Head Coil for its intended use.
7. Conclusion (statement of equivalence)
The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the TEM 300G Head Coil.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2005
MR Instruments, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K052200
Trade/Device Name: TEM 3000G Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: August 10, 2005 Received: August 12, 2005
Dear Mr. Job:
. .
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 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the support of all and of also and securedaries to Jegal This letter will allow you to begin marketing your entress of your device to a legally premarket notification. The FDA Inding of Sabstantial of 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), please If you desire specific advice for your device on our laboring numbers, based. on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, firstitution on your responsibilities under the Act from the 807.97). You may obtain other general miormation on Jour September Assistance at its toll-free number (800) DIVIsion of Billion (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic
t the MR Instruments TEM 3000 is and vasculature of the head. Th The MR Instruments TEM 3000C Head Coll is designed to processor to the head. The TEM
Resonance Images of the brain, soft tissues and vasculature of the MR System Resonance Images of the brain, son tissues and Vasualaria
3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and Radiological Devices
510(k) Number July 29, 2005
Nancy C. Bropon
(Division Sign-Off)
Division of Reproductive, Abdominal,
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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.