(14 days)
The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
The MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
The provided text describes a 510(k) premarket notification for a medical device, the MC 3003G-32R Head Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria as might be seen for novel devices.
Therefore, the document does not contain information about specific "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, or image quality metrics with thresholds) or a "study that proves the device meets the acceptance criteria" in the way one might expect for a new diagnostic algorithm or AI product.
Instead, the submission for the MC 3003G-32R Head Coil demonstrates substantial equivalence primarily by comparing its design, intended use, and performance to a predicate device, focusing on safety and basic functional performance.
Here's a breakdown of the information that is available in the document, acknowledging that it doesn't directly address the structured questions about acceptance criteria for diagnostic performance:
1. A table of acceptance criteria and the reported device performance
- No specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are provided in the document.
- The document states that "Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met." However, the specific metrics and thresholds for these design specifications and customer requirements are not detailed.
- Reported Device Performance (as implied by the "Summary of Studies"):
- Electrical bench measurements
- Electrical/mechanical safety tests
- System safety and performance tests with phantoms
- Predicate device comparison tests
- Volunteer scans
- The primary functional difference highlighted is that the MC 3003G-32R Head Coil has a "32 element phased array RF structure as opposed to a 8 element phased array RF structure" of the predicate, which "may increase coil sensitivity and may reduce data acquisition time." This implies improved performance but doesn't quantify it against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "volunteer scans" as part of the testing activities, but does not specify the sample size of these volunteers.
- Data provenance is not specified. The studies were "conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. The "volunteer scans" are mentioned, and the intended use states that "when interpreted by a trained physician yield information that may assist in diagnosis." However, the document does not describe a study involving expert interpretation for establishing ground truth or performance metrics against such ground truth for the device itself. The focus is on safety and technical performance of the coil.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Since there's no mention of a diagnostic performance study with expert interpretation for ground truth, there's no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is an MR head coil, a hardware component for image acquisition, not an Artificial Intelligence (AI) diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; it is not an algorithm, so a standalone algorithm-only performance study would not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly described for diagnostic performance. For the "system safety and performance tests with phantoms," the ground truth would be the known properties and geometry of the phantoms. For "electrical bench measurements" and "electrical/mechanical safety tests," the ground truth would be engineering specifications and safety standards. For "volunteer scans," the purpose seems to be confirming image acquisition capability and safety, rather than a diagnostic performance study against a definitive clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is hardware and does not involve a training set as would an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI algorithm is involved.
Summary of the Study Mentioned (from "Summary of Studies"):
The study described is a design verification and validation process for a hardware device (an MR head coil). It included:
- Electrical bench measurements: Likely verifying electrical specifications.
- Electrical/mechanical safety tests: Ensuring the device meets safety standards.
- System safety and performance tests with phantoms: Using standardized objects with known properties to assess image quality, signal-to-noise ratio, uniformity, etc., under controlled conditions. This would be a technical performance evaluation, not a clinical diagnostic one.
- Predicate device comparison tests: Direct comparison of the new coil's performance (likely technical and imaging characteristics) against the predicate.
- Volunteer scans: Scans on human volunteers to confirm safe operation and the ability to acquire images, consistent with its intended use for generating images of the head.
The study's goal was to demonstrate that the MC 3003G-32R Head Coil is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness for its intended use, rather than to meet specific diagnostic performance metrics through a clinical trial.
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KC72931
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MC 3003G-32R Head C
Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1 : .
1. Contact Person
Mark Watson VP, Engineering Tel: (952) 229-8813 Fax: (952) 746-1437
MR Instruments, Inc., Inc. 5610 Rowland Road, Suite 145 Minnetonka, MN 55343
2. General Information
| Name: | MC 3003G-32R Head Coil |
|---|---|
| Trade Name: | MC 3003G-32R 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 MC 3003G-32R is a multi-channel receive only RF head coil. It has 32 RF elements that are tuned to 'H at 3T (127.8 MHz). Each element has active and passive blocking networks and integrated preamplifiers. The housing is constructed out of a rigid plastic with an opening for patient viewing and comfort. A head support/base is included.
The predicate device, manufactured for General Electric Company, Milwaukee, WI (USA) by MRI Devices Corp., HRH-127-8 Head Array for GE Signa 3T Excite MRI System (K024352), is also a multi-channel receive only RF head coil. The MC 3003G-R32'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 MC 3003G-32R Head Coil is to be used in conjunction with a Magnetic Resonance Scanner to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
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KC72931
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3G-32R Head Coil
MC 3003G-32R He
5. Substantial Equivalence Comparison
The MC 3003G-32R Head Coil is substantially equivalent to the following device with respect to intended use and design:
- t HRH-127-8 Head Array for GE Signa 3T Excite MRI System (K024352) manufactured for General Electric Company (Milwaukee, WI, USA) by MRI Devices, Waukesha WI, U.S.A.
The similarities between the two devices is that they are both multi-channel receive RF only head coils designed to work with the GE Signa 3.0T Excite MRI System. Both coils are similar in size, shape and construction.
The primary difference between the two devices is that the predicate utilizes an 8 element phased array RF structure as opposed to a 32 element phased array RF structure, which may increase coil sensitivity and may reduce data acquisition time.
6. Summary of Studies
Design verification and validation testing was performed to ensure that the coil design specifications and customer requirements were met. Testing activities included electrical bench measurements, electrical/mechanical safety tests, system safety and performance tests with phantoms, predicate device comparison tests and volunteer scans. System tests were conducted using the GE Healthcare Signa 3.0T MR System running standard clinical applications.
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 MC 3003G-32R Head Coil.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2008
MR Instruments, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072931
Trade Name: MR Instruments MC 3003G-32R Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class II Product Code: MOS Dated: October 15, 2007 Received: October 16, 2007
Dear Mr. Job:
This letter corrects our substantially equivalent letter of October 30, 2007.
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 (PMA), 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.
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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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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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MC 3003G-32R Head Coil
Indications for Use Statement
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The MR Instruments MC 3003G-32R Head Coil is to be used in conjunction with a GE Signa 3T Excite MR System to produce images and/or spectra of the head, that when interpreted by a trained physician yield information that may assist in diagnosis.
This device is for prescription use.
Lorn Whaz
(Division Sign Off)
(Division'Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MR Instruments, Inc.
:
§ 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.