(83 days)
The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System. The small head coil is intended for imaging of the head anatomy and extremities.
The Signa Profile Small Head Coil is a receive only coil with a birdcage RF design. It is designed for use with a vertical magnetic field MR imaging system.
The provided text describes a 510(k) premarket notification for the GE Signa Profile Small Head Coil, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and performance metrics for a new AI algorithm.
Therefore, many of the requested categories for AI algorithm evaluation are not applicable to this document. The document describes a hardware device, a new MRI coil, and its performance is assessed against established safety and NEMA standards rather than clinical endpoints related to diagnostic accuracy of an AI.
Here's an analysis based on the provided text, highlighting what information is available and what is not:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with appropriate NEMA performance standards. | "The Profile Small Head Coil was evaluated to the appropriate NEMA performance standards." |
| Compliance with International safety standards IEC 601-1 and IEC 601-2-33. | "The coil was evaluated to the International safety standards IEC 601-1 and IEC 601-2-33 and performed to stated specifications." |
| Substantial equivalence to the currently marketed Signa Profile Head Coil. | "It is the opinion of GE that the Signa Profile System with the Small Head Coil is substantially equivalent to the presently marketed Signa Profile Head Coil." |
| Does not result in any new potential hazards. | "This coil does not result in any new potential hazards." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this is a hardware device (MRI coil) and not an AI algorithm, a "test set" in the context of diagnostic accuracy is not applicable. The evaluation focused on physical and electrical performance standards.
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)
This information is not provided and is not applicable. Ground truth, in the AI diagnostic sense, is not relevant for the evaluation of an MRI coil's performance against NEMA and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable.
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
This information is not provided and is not applicable. This study type is specific to evaluating AI's impact on human diagnostic performance, which is not relevant for an MRI coil.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided and is not applicable. This document describes a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided and is not applicable. The "ground truth" for this device would be its physical and electrical characteristics conforming to specified engineering and safety standards, rather than a clinical diagnostic truth.
8. The sample size for the training set
This information is not provided and is not applicable. There is no "training set" for a hardware device like an MRI coil.
9. How the ground truth for the training set was established
This information is not provided and is not applicable.
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are decorative swirls or flourishes around the outer edge of the circle, adding a touch of elegance to the design. The logo is presented in black and white.
GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
SUMMARY OF SAFETY AND EFFECTIVENESS
- o This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- ் Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, August 21, 1998
- o Identification of the Product Signa Profile Small Head Coil
Manufacturer Address: GE Yokogawa Medical Systems, Ltd. 4-7-127, Asahigaoka, Hino-Shi Tokyo, 191 Japan
- া Marketed Devices The Signa Profile MR System with the Small Head Coil is substantially equivalent to the currently marketed Signa Profile Head Coil.
- ୍ ୦ Device Description The Signa Profile Small Head Coil is a receive only coil with a birdcage RF design. It is designed for use with a vertical magnetic field MR imaging system.
- o Indications for Use The Indications for Use for the Small Head Coil expands the imaging capability of the Signa Profile System. It can be used to image the head anatomy and extremities.
- o Comparison with Predicate
The Signa Profile Small Head Coil is similar Signa Profile Head Coil except that the Small Head Coil is smaller and uses a helmholtz RF design.
-
0 Summary of Studies
The Profile Small Head Coil was evaluated to the appropriate NEMA performance standards. The coil was evaluated to the International safety standards IEC 601-1 and IEC 601-2-33 and performed to stated specifications. -
o Conclusions
It is the opinion of GE that the Signa Profile System with the Small Head Coil is substantially equivalent to the presently marketed Signa Profile Head Coil. This coil does not result in any new potential hazards.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 1008
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 . W-709 Milwaukee, WI 53201
Re:
Signa Profile Small Head Coil Dated: August 21, 1998 Received: August 25, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Kroger:
We have reviewed your Section 510%) 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 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 (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 (OS) 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 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/cdr/dsmardsmamain.html".
Sincerely yours,
William Yih, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K982972
510(k) Number (if known):_
Device Name: Signa Profile Small Head Coil
Indications For Use:
The Indications for Use for the Signa Profile Small Head coil expands the imaging capability of the Signa Profile System
The small head coil is intended for imaging of the head anatomy and extremities .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eric K. Seymour
(Division Sign-Off)
of Reproductive, Abdominal, EN 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 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.