(67 days)
Not Found
No
The summary describes standard MRI flow analysis techniques and does not mention AI or ML.
No
The device is used to obtain and map quantitative flow and velocity measurements from a vessel, which is a diagnostic function, not a therapeutic one. It provides information about the heart's function but doesn't treat any conditions directly.
No
The device is described as obtaining and mapping quantitative flow and velocity measurements. While these measurements may be used in diagnosis, the device itself is a measurement tool and does not state it provides a diagnosis or aids in diagnosis beyond providing these measurements. The "Intended Use / Indications for Use" section focuses on obtaining measurements, not on diagnostic interpretations.
No
The device description explicitly states "Picker's Quantitative Flow functionality includes the ability to create reference magnitude, phase velocity, phase contrast, phase contrast velocity and reference magnitude velocity images." This implies the device is part of or integrated with an MRI system, which is a hardware device. While the functionality described is software-based image processing and analysis, the device as a whole, as presented in the summary, is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device uses non-invasive techniques (NMR principles and MRI) to obtain measurements from a vessel within the body. It processes images acquired directly from the patient.
- Lack of Sample Analysis: There is no mention of analyzing biological samples taken from the patient.
Therefore, this device falls under the category of a medical imaging device used for diagnostic purposes, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.
Product codes
90 LNH
Device Description
Picker's Quantitative Flow functionality includes the ability to create reference magnitude, phase velocity, phase contrast, phase contrast velocity and reference magnitude velocity images. The operator can define up to eight regions of interest on the phase velocity images and perform several quantitative measurements. When combined with cardiac gating, the operator can observe changes in velocity and flow throughout the cardiac cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) System
Anatomical Site
vessel
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
In vivo testing demonstrated that flow could be measured to within 3.9% ± 0.8 for constant flow and 3.5% ± 2.2 for pulsatile flow.
Key Metrics
Accuracy of Flow Measurements: In vivo testing demonstrated that flow could be measured to within 3.9% ± 0.8 for constant flow and 3.5% ± 2.2 for pulsatile flow.
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
7 1999 SEP
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
| 1. | General Information
Classification: | Class II
Magnetic Resonance Imaging (MRI) System |
|----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option |
| | Proprietary Name: | Quantitative Flow |
| | Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
Contact: Elaine K. Keeler, Ph.D
Phone: (440) 473-3000
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. |
2. Intended Uses
The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.
3. Device Description
Picker's Quantitative Flow functionality includes the ability to create reference magnitude, phase velocity, phase contrast, phase contrast velocity and reference magnitude velocity images. The operator can define up to eight regions of interest on the phase velocity images and perform several quantitative measurements. When combined with cardiac gating, the operator can observe changes in velocity and flow throughout the cardiac cycle.
4. Safety and Effectiveness
The Quantitative Flow functionality included in Picker's Application Suite for Cardiovascular Assessment is similar in technological characteristics and intended use to the GE Flow Analysis Option. The following table has been created to demonstrate their substantial equivalence.
1
| Parameter | Quantitative Flow | Predicate Device - GE Flow Analysis Option (K924605) |
|---|---|---|
| System Compatibility | 1.5T Edge Eclipse and 1.0T Vista Polaris | 1.5T Signa Advantage |
| Sequences | 2D Phase Contrast, FAST | 2D and 3D Phase Contrast, Cine Phase Contrast |
| Acquisition Options | ECG-triggered cardiac gating, | |
| PPG-triggered cardiac gating and | ||
| phase encode grouping. | Flow compensation, respiratory | |
| compensation, ECG-triggered | ||
| cardiac gating, peripheral-triggered | ||
| cardiac gating, graphic prescription, | ||
| spatial presaturation, no phase | ||
| wrap, rectangular FOV. | ||
| Image Types | ||
| Produced | Reference Magnitude Image, Phase | |
| Velocity, Phase Contrast, Phase | ||
| Contrast Velocity, and Reference | ||
| Magnitude Velocity. | Magnitude, Flow and Speed Images | |
| Range of Velocities | 5-600 cm/sec | Approx. 20-400 cm/sec |
| Accuracy of Flow | ||
| Measurements | In vivo testing demonstrated that | |
| flow could be measured to within | ||
| $3.9% \pm 0.8$ for constant flow and | ||
| $3.5% \pm 2.2$ for pulsatile flow. | In vivo testing demonstrated that | |
| flow could be measured to within | ||
| $5.26% \pm 3.77$ for constant flow and | ||
| $5.73% \pm 3.0$ for pulsatile flow. | ||
| Parameter | ||
| Requirements | Cine images for quantitative | |
| analysis can only be sensitized in | ||
| one direction. | Images must be acquired in the | |
| CINE mode and the flow axis must | ||
| represent through-plane flow. The | ||
| slice thickness must be less than | ||
| 20mm. | ||
| ROI Drawing | User can manually draw up to | |
| eight ROIs for flow measurements. | User can manually draw up to four | |
| ROIs for flow measurements. | ||
| Data Output | Outputs include: |
- avg. velocity vs. time graph
- volume vs. time graph
- histogram of pixel velocities
- ROI statistics (mean, STD)
- Qp/Qs ratio calculations
- Regurgitate volumes | Outputs include:
- avg. velocity graph
- avg. flow graph
- ROI statistics (mean, max, min)
- Flow calculations (positive
volume, negative volume,
cardiac output, stroke volume) |
| Intended Use and
Indications for Use | The intended use of Quantitative
Flow is to non-invasively obtain
and map quantitative flow and
velocity measurements from a
vessel during a cardiac cycle using
the principles of NMR. | The Signa Advantage Flow Analysis
Option charts flow and velocity
changes during the cardiac cycle.
This post processing technique
provides flow information acquired
non-invasively during the cardiac
cycle. |
Substantial Equivalence Chart
PICKER INTERNATIONAL, INC.
(QFLOW)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP 7 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:
K992225 Quantitative Flow Dated: July 2, 1999 Received: July 2, 1999 Product Code: 90 LNH Requlatory Class: Il (two) 21.CFR 892.1000
Dear Dr. 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 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 II (Special Controls) or dass 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(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,
CAPT 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
3
510(k) Number (if known):
Quantitative Flow Device Name:
Indications for Use:
ﻠﻤ
The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.
(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 | K992225 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|