(164 days)
The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended to operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to improve the signal-to-noise performance of the MR system in specific anatomical areas.
The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended for general diagnostic use to present magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance of phosphorus (31P) spectra.
The coil consists of two 5 inch by 6.5 inch surface coils that are electronically summed to create a corotating "saddle-coil" pair. The two coils are contained in a flexible material, covered with fabric. This allows the flex coil to bend in one direction, making it easy to wrap around the anatomy of interest. The unit is 21" long (not including straps) by 8" wide.
The Signa® 1.5T Phosphorus (3) Transmit/Receive Flex Coil consists of two overlapped loop coils . with an octogonal shape. The two coils are contained in a flexible foam material with a cleanable coated surface.
The flexibility of the coil makes it easy to wrap the coil around the anatomy of interest.
The 31P Flex Coil performs best when closest to a circular shape, and less well when in flatter configuration.
The coils are 13cm by 16.5cm surface coils that are electronically summed to create co-rotating "saddle" coil pair. When the coil pair is aligned properly, this saddle design provides good uniformity across the senstive volume of the coil.
The 1.5T Phosphorous (31P) Transmit/Receive Flex Coil is available in configurations for fixed sites and relocatable units.
The subject magnetic resonance surface coil has the same technological characteristics as the legally marketed predicate magnetic resonance surface coils. Specifications, specifications, materials, and mode of action are equivalent.
The provided text does not contain information about acceptance criteria and a study to prove a device meets those criteria. The document is primarily a 510(k) premarket notification for a medical device: the "Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil."
This notification focuses on demonstrating substantial equivalence to previously marketed devices, rather than presenting a performance study against specific acceptance criteria. The key aspects of the document are:
- Device Identification: Naming the device and manufacturer.
- Predicate Devices: Identifying similar devices already on the market to establish substantial equivalence.
- Indications for Use: Defining how the device is intended to be used.
- Device Description: Explaining the physical characteristics and function of the coil.
- Clinical Benefits & Features: Highlighting the design and expected performance improvements (e.g., improved signal-to-noise ratio).
- FDA Clearance: The letter from the FDA stating that the device is substantially equivalent to predicate devices and can be marketed.
Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
The document's purpose is a regulatory submission for market clearance based on substantial equivalence, not a detailed report of a clinical or performance study with defined acceptance criteria.
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2/19/99
K98 3139
Image /page/0/Picture/2 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 frame. The letters are white against a black background, and the frame has a decorative, swirling pattern around the edge.
GE Medical Systems
Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21CFR Part 807.7(h).
| Identification of Submitter | Larry A Kroger, Ph.D.(414) 544-3894Summary prepared 4 September 1998 |
|---|---|
| Product Identification | |
| Name: | Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Cor |
| Manufacturer: | General Electric Medical Systems |
Predicate Marketed Devices
The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is substantially equivalent to the currently marketed products:
- Signa® 1.5T Magnetic Resonance System; 510(k) Number K962061 ● This submission cleared the MR system for imaging.
- Hydrogen Spectroscopy Accessory Probe; 510(k) Number K930265 . This submission cleared the option for the MR system to produce localized spectra that display the internal biochemical characteristics of the human body.
- . General Purpose Flex Coil: 510(k) Number K923264 This submission cleared the use of the flex coil within the MR system as an option for the purpose of improving the signal-to-noise performance of the MR system in specific anatomical areas.
Statement of Indications for Use
The Signa® 1.5T Phosphorus (1) Transmit/Receive Flex Coil is designed to operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to improve the signal-to-noise performance of the MR system in specific anatomical areas.
The Signa® 1.5T Phosphorus (3) Transmit/Receive Flex Coil is intended for general diagnostic use to present magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance of phosphorus ("P) spectra.
Device Description
The coil consists of two 5 inch by 6.5 inch surface coils that are electronically summed to create a corotating "saddle-coil" pair. The two coils are contained in a flexible material, covered with fabric. This allows the flex coil to bend in one direction, making it easy to wrap around the anatomy of interest. The unit is 21" long (not including straps) by 8" wide.
Clinical benefits
When the coil pair is aligned properly, this "saddle" design provides uniformity in SNR across the sensitive volume of the coil.
Features
- The Signa® 1.5T Phosphorus (3) Transmit/Receive Flex Coil consists of two overlapped loop coils . with an octogonal shape. The two coils are contained in a flexible foam material with a cleanable coated surface.
- · The flexibility of the coil makes it easy to wrap the coil around the anatomy of interest.
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- · The 31P Flex Coil performs best when closest to a circular shape, and less well when in flatter configuration.
- · The coils are 13cm by 16.5cm surface coils that are electronically summed to create co-rotating "saddle" coil pair. When the coil pair is aligned properly, this saddle design provides good uniformity across the senstive volume of the coil.
- · The 1.5T Phosphorous (31P) Transmit/Receive Flex Coil is available in configurations for fixed sites and relocatable units.
The subject magnetic resonance surface coil has the same technological characteristics as the legally marketed predicate magnetic resonance surface coils. Specifications, specifications, materials, and mode of action are equivalent.
The above statements are accurate representations of this 510(k) premarket notification and of the device this firm intends to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted (21CFR 807.87).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1999
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414. W-709 Milwaukee, WI 53201
Re:
K983139 Phosphorus (P-31) Transmit/Receive Flex Coil for 1.5T Signa MRI System Dated: December 28, 1998 Received: December 29, 1998 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Dr. Kroger:
We have reviewed your Section 510(k) 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 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). 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 (QS) 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(t) 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D. Acting 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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Indications for Use Statement
510(k) Number (if known):
Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil Device Name:
Indications for Use:
The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended to operate with the Signa® 1.5T Magnetic Resonance System. The coil is simply to improve the signal-to-noise performance of the MR system in specific anatomical areas.
The Signa® 1.5T Phosphorus (31P) Transmit/Receive Flex Coil is intended for general diagnostic use to present magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance of phosphorus (31P) spectra.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| DRAERD | |
| 510(k) Number: | K983139 |
| Prescription Use | or | Over-The-Counter Use | |
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| (Per 21CFR801.109) | (Optional Format 1-2-96) |
§ 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.