(196 days)
The Signa SP Crown Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of the head and extremities. These coils may also be used for dynamic (i.e., flexion of joints) magnetic resonance Imaging of the extremities.
The Signa SP Crown Coils are a group of solenoidal transmit/receive surface colls of varying dimensions that are contained in a flexible, blocompatible outer covering.
The provided text is a 510(k) summary for the GE Medical Systems Signa SP Crown Coils, submitted in 1996. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
It does not contain information about acceptance criteria or a study proving that the device meets those criteria because it is not a clinical study report or a performance validation report.
The 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on:
- Indications for Use: Facilitating magnetic resonance imaging of the head and extremities, including dynamic imaging of extremities.
- Device Description: A group of solenoidal transmit/receive surface coils of varying dimensions, contained in a flexible, biocompatible outer covering.
- Safety: Stating that it does not pose additional potential hazards compared to previously marketed flexible transmit/receive surface coils.
- Equivalence Claim: Stating substantial equivalence to the transmit/receive flexible surface coil in the Signa SP MR System (K942604) and similarity in utility and general coil type to the 0.2T Extremity Coil (K954353).
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) from this document. This document is used for regulatory clearance based on substantial equivalence, not for detailed performance validation against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The logo is black and white.
GE Medical Systems
General Electric Company
P () 803 414 Milwaukee W1 13201
Signa SP Crown Coils
December 10, 1996
JUN 26 1997
General Electric Medical Systems
SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- Larry A. Kroger, Ph.D. Contact: Phone: 414-544-3894 414-544-3863 FAX:
- Signa SP Crown Coils Product: Manufactured by General Electric Medical Systems Waukesha, Wisconsin, USA
-
- Indications for Use
The Signa SP Crown Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of the head and extremities. These coils may also be used for dynamic (i.e., flexion of joints) magnetic resonance Imaging of the extremities.
-
- Device Description
The Signa SP Crown Coils are a group of solenoidal transmit/receive surface colls of varying dimensions that are contained in a flexible, blocompatible outer covering.
- Device Description
-
- Marketing History
The Signa SP Crown Colls have not been previously marketed by GE Medical Systems.
- Marketing History
4) Potential Adverse Effects on Health
The use of the Signa SP Crown Coils does not result in any additional potential hazards compared to previously marketed flexible transmit/receive surface coils.
-
- Conclusions
It is the opinion of GE Medical Systems that the Signa SP Crown Coils are substantially equivalent with respect to materials and operation to the presently marketed transmit/receive flexible surface coll contained in the Signa SP MR System (K942604) and are similar in utility and general coil type (solenoid) to the 0.2T Extremity Coil (K954353).
- Conclusions
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Image /page/1/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized eagle head with three lines representing its feathers. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Larry Kroger, Ph.D. Manager, Safety and Regulatory Programs GE Medical Systems 3200 North Grandview Blvd. Waukesha, WI 53188
JUN 26 1997
Re: K964969 Signa SP Crown Coils MRI Accessory Dated: April 3, 1997 Received: April 4, 1997 Regulatory Class: II ................................ 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Kroger:
We have reviewed your Secuon 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Devices that have been realassified 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 misbranion.
If your device is classified (see above) into either class II (Prematket 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please aste: this response to your premarket notification does not affect any obligation you might have under sections 51 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 predication 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrh/dsmamain.html".
Sincerely yours,
William Y. PhD
Lilian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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: Signa SP Crown Coils
Indications For Use:
..............................................................................................................................................................................
The Signa SP Crown Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of the head and extremities and providing a mechanism for dynamic (i.e., fiexion of joints) magnetic resonance imaging of the extremities.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clined le. Séymon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
Prescription Use_ X (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.