(66 days)
Not Found
No
The summary describes a specific MR imaging package and pulse sequences, focusing on the physics of diffusion-weighted imaging. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is an imaging package for MR systems, designed to visualize the mobility of water molecules, particularly for identifying acute stroke. It is used for diagnostic purposes (imaging) and does not directly treat or prevent a disease.
Yes
The device is described as more accurate than conventional MRI in identifying the occurrence of acute stroke, which is a diagnostic purpose.
No
The device description explicitly states it is a "package" consisting of "echo-planar imaging (EPI) single-shot based sequences." While these sequences are software, the context of an "MR Imaging Package" and the mention of "Picker MR Systems" strongly suggest this software is an add-on or feature for existing MR hardware, not a standalone software device. The description focuses on the pulse sequences and their application within an MR system, not on a software application that processes or analyzes data independently of the MR scanner itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Picker Diffusion-Weighted MR Imaging Package is a software package for an MR imaging system. It works by applying specific pulse sequences to the patient's body to generate images based on the diffusion of water molecules within the body.
- No Specimen Analysis: This device does not analyze any specimens taken from the patient. It directly interacts with the patient's body to acquire imaging data.
Therefore, based on the provided information, the Picker Diffusion-Weighted MR Imaging Package falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.
Diffusion-weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
Product codes
90 LNH
Device Description
The Picker Diffusion-Weighted MR Imaging Package does not change the technological characteristics of the Picker MR Systems. This package consists of echo-planar imaging (EPI) single-shot based sequences which have selectable directionality and either fixed or selectable b-values. The sequences are basically spin-echo sequences which have large gradient pulses or lobes before and after the 180° RF refocusing pulse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR Imaging
Anatomical Site
Brain
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
6 1998 FEB
SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance (MR) Diagnostic Device |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance (MR) Device Option |
| Proprietary Name: | Diffusion-Weighted MR Imaging Package |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. |
Intended Uses 2.
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.
Diffusion-weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
Device Description 3.
The Picker Diffusion-Weighted MR Imaging Package does not change the technological characteristics of the Picker MR Systems. This package consists of echo-planar imaging (EPI) single-shot based sequences which have selectable directionality and either fixed or selectable b-values. The sequences are basically spin-echo sequences which have large gradient pulses or lobes before and after the 180° RF refocusing pulse.
1
Safety and Effectiveness 4.
The Picker Diffusion-Weighted Imaging Package is similar in technological characteristics and intended use to Picker MR systems with Echo-Planar Imaging Capability and the Siemens Diffusion-Weighted Imaging Package. The following table has been created to demonstrate their substantial equivalence.
| Parameter | Diffusion-Weighted MR
Imaging Package | Predicate Devices
Picker EPI-II Option - K954646
Siemens DWI - K971055 |
|-----------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Sequence Description | Same. | Echo-Planar Sequence with large
magnetic field gradient pulse
before and after the 180°
refocusing RF pulse. (K971055) |
| b-value | Fixed and variable sequences
available. | Siemens -- unknown. |
| Data Correction Calibration | Same. | Semi-automatic prescan process
(K954646) |
| Performance Specifications | Same. | (K954646) |
| Safety Parameters | Same. | (K954646) |
SUBSTANTIAL EQUIVALENCE TABLE
(
(DWI)
2
| Intended Use / Indications
for Use | Same. | The Siemens Diffusion-Weighted
MR Imaging Package has been
designed to image the diffusive
mobility of water or other proton-
containing molecules. One
important clinical application is to
visualize the apparent loss of
mobility by water molecules in
brain tissue affected by acute
stroke. Areas of decreased
diffusion, as is observed in acute
cerebral infarcts, appear as areas of
higher image intensity. |
|---------------------------------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Diffusion-weighted MR pulse
sequences are more accurate than
conventional MRI pulse sequences
in identifying the occurrence of
acute stroke during the first 24
hours after onset of symptoms.
(K971055) |
.
: 上一篇:
(
:
(DWI) 1 1/25/97 .
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 FEB
Elaine K. Keeler Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights. Ohio 44143 Re:
K974530 Diffusion Weighted MRI Package Dated: November 25, 1997 Received: December 2, 1997 Regulatory class: II 21 CFR 8921000/Procode: 90 LNH
Dear Ms. Keeler:
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 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 virgo diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.
h. Tiau Yu.
Lillian 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
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Diffusion Weighted Imaging Package
Indications for Use:
ﮐﻢ ﻣﯿﮟ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.
Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Ferguson
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 97453 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)