(218 days)
Not Found
No
The description focuses on a quantitative analysis method based on a mathematical ratio calculation, not on AI/ML algorithms. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No
This device is for quantitative analysis and visualization of Magnetization Transfer in tissue, intended to improve lesion conspicuity. It processes images from an MR system and does not directly provide therapy or interact with the patient's body for treatment purposes.
Yes
The device is intended for quantifying magnetization transfer in tissue, enhancing image contrast to improve lesion conspicuity and visualize MT effects, which are diagnostic purposes.
Yes
The device is described as an "option" on an existing workstation (EasyVision), and its function is solely image processing and calculation based on images acquired from an MR system. There is no mention of any new or modified hardware being part of this specific submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves tests performed on blood, urine, tissue samples, etc., outside of the body.
- Device Function: This device processes images acquired from an MR system, which is an in vivo (within the living body) imaging modality. It analyzes the magnetization transfer within the tissue directly in the body.
- Intended Use: The intended use is to quantify magnetization transfer in tissue and enhance image contrast for visualization of MT effects. This is an image processing and analysis function, not a diagnostic test performed on a biological specimen.
The device is an image processing system that works with MR images, which are acquired in vivo. Therefore, it falls under the category of medical imaging software or a medical image processing device, not an IVD.
N/A
Intended Use / Indications for Use
The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.
Product codes
90 LLZ, 90 LNH
Device Description
The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR system
Anatomical Site
tissue, white matter, cartilage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Philips Easyvision Workstation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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SEP g lagg
Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of a shield shape with the word "PHILIPS" at the top. Inside the shield, there are wavy lines and star-like shapes. The logo is in black and white.
510 (k) Summary
Philips Medical Systems
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue |
| Shelton, CT 06484 | |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | January 27, 1999 |
| Device Name: | Philips Easy Vision Family Workstation Option |
| Quantitative MT Analysis Package | |
| Classification Name: | Image Processing System (90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Philips Easyvision Workstation |
System Description:
The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.
Intended Use:
The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.
Safety Information:
No new hazards are introduced by the addition of the Quantitative MT Analysis Option to the EasyVision Workstation.
Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-09 Tel: (203) 926-7674 Fax: (203) 929-6099
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Image /page/1/Picture/0 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1999 SEP
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917
Re:
K990335 Ouantitative NT Analysis Package for Easy Vision Workstation Dated: June 10, 1999 Received: June 11, 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 redassified 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 III (Premarket Aproval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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(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/cdrh/dsma/dsmamain.html".
Sincerely yours,
OART Daniel C. Schultz, M.D.
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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K
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Philips EasyVision Workstation Quantitative MT Analysis Option Device Name : Indications For Use:
The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spinspin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K990335 |
| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use | |
|---|---|---|---|
| -------------------------------------- | ---------------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)