(28 days)
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
The 8 Channel Cardiac Phased Array Coil is a modification to the 8 Channel Cardiac Phased Array Coil (K022669), which features a flexible anterior half of the coil.
The provided text is a 510(k) summary for a medical device, specifically an 8 Channel Cardiac Phased Array Coil. It details the device's modification from a predicate device and states that testing was performed to demonstrate that the design modifications meet predetermined acceptance criteria. However, the document does not explicitly state what those acceptance criteria are, nor does it provide details of the study that proves the device meets them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Based on the provided text, the following information can be extracted:
- Device Name: 8 Channel Cardiac Phased Array Coil
- Purpose of the study: To demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
- Conclusion: GE states that the modified device is substantially equivalent to the predicate device (K022669) and does not result in any new potential hazards.
Missing Information:
All of the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size
- If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document focuses on regulatory approval based on demonstrating substantial equivalence, rather than a detailed scientific study report with specific performance metrics and validation methodologies.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters "GE" intertwined within a circle. The letters are stylized with curved lines, giving them a classic and recognizable appearance. The logo is presented in black and white, with the letters and the circle's outline in black against a white background. The overall design is simple yet iconic, representing the long-standing brand identity of General Electric.
K032045
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GE Medical Systems
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General Electric Company P.O. Box 414, Milwaukee, WI 53201
510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).
| Submitter: | GE Medical SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact Person: | Larry A. Kroger Ph.D.Manager, Regulatory Programs |
| Telephone: | 262- 544-3894 |
| Fax: | 262- 548-4768 |
| Date Prepared: | June 30, 2003 |
Device Name:
8 Channel Cardiac Phased Array Coil Magnetic Resonance Coil, 21 CFR 892.1000, 90-MOS
Marketed Device:
The 8 Channel Cardiac Phased Array Coil is substantially equivalent to the currently marketed GE 8 Channel Cardiac Phased Array Coil (K022669).
Device Description:
The 8 Channel Cardiac Phased Array Coil is a modification to the 8 Channel Cardiac Phased Array Coil (K022669), which features a flexible anterior half of the coil.
Indications for Use:
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
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Image /page/1/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 circular shape that resembles a globe. The globe has small, curved lines emanating from the letters, giving the impression of movement or energy. The logo is black and white.
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K032045
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GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Comparison with Predicate Device:
The 8 Channel Cardiac Phased Array Coil is a modification of the GE 8 Channel Cardiac Phased Array Coil (K022669) with the main difference being the flexibility of the anterior half of the coil.
Summary of Studies:
Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria.
Conclusion:
It is the opinion of GE that the 8 Channel Cardiac Phased Array Coil is substantially equivalent to the GE 8 Channel Cardiac Phased Array Coil (K022669). Usage of the 8 Channel Cardiac Phased Array Coil does not result in any new potential hazards.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with three horizontal lines above it, resembling the stripes of the American flag. The seal is black and white and appears to be of official government origin.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K032045
Trade/Device Name: 8 Channel Cardiac Phased Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: June 30, 2003 Received: July 7, 2003
Dear Dr. Kroger:
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 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) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
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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510(k) Number (if known):
Device Name: 8 Channel Cardiac Phased Array Coil
Indications For Use:
It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_ OR
David A. Sezmor
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
§ 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.