(308 days)
The BOLD Analysis option for the EasyVision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.
The BOLD Analysis package supports the visualization and analysis of dynamic MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs over dynamic scans as a result of the variation of blood oxygenation through task performance by the subject (e.g. finger tapping). BOLD data can be processed with the BOLD Analysis package to provide data analysis based on standard statistical methods.
The provided text is a 510(k) Summary for the Philips Easy Vision Family Workstation Option BOLD Analysis Package. It describes the device's intended use and safety information, as well as the FDA's clearance letter. However, this document does not contain any information about acceptance criteria, device performance metrics, or any studies proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device rather than detailed performance studies.
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203 926 7933 TO 91 301 48047
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510 (k) Summary
1990329
Philips Medical Systems
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport AvenueShelton, CT 06484 |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | January 21, 1999 |
| Device Name: | Philips Easy Vision Family Workstation OptionBOLD Analysis Package |
| Classification Name: | Image Processing System (90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Philips Easyvision Workstation,GE Advantage Windows (Functool) Workstation |
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System Description:
The BOLD Analysis package supports the visualization and analysis of dynamic MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs over dynamic scans as a result of the variation of blood oxygenation through task performance by the subject (e.g. finger tapping). BOLD data can be processed with the BOLD Analysis package to provide data analysis based on standard statistical methods.
Intended Use:
The BOLD Analysis option for the Easy Vision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.
Safety Information:
No new hazards are introduced by the addition of the BOLD Analysis Option to the Easy Vision Workstation.
hilios Modical Systems th America Commans (203) 926-7674
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 1999
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917
Re:
BOLD Analysis Package for EasyVision Workstation Dated: September 30, 1999 Received: October 1, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Altman:
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 (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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drup 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 requlation 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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510(k) Number (if known): K990329
Philips EasyVision Workstation BOLD Analysis Option Device Name :
Indications For Use :
The BOLD Analysis option for the EasyVision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elinid G. Glynn
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K990329
Prescription Use
(Per 21 CFR 801.109
✓
OR
Over-The-Counter Use
(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.