(57 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional MR imaging techniques and software features.
No
The device is described as an "MR Imaging System" that produces images for diagnosis, rather than providing therapy.
Yes
The document states that the images produced by the Infinion 1.5T MR Imaging System, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis," which is a direct indication of its diagnostic purpose.
No
The device description explicitly states "Philips's Infinion Software Features include... and other improvements to current imaging techniques." This indicates the software is an addition or improvement to an existing hardware system (the Infinion 1.5T MR Imaging System), not a standalone software device. The predicate devices also include hardware systems.
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 the Infinion 1.5T MR Imaging System is a NMR device that produces images of the head and whole body. It uses magnetic resonance technology to visualize internal structures.
- Input: The input is the patient's body within the MR scanner, not a sample taken from the body.
- Output: The output is an image, not a diagnostic result derived from analyzing a biological sample.
The device is an in vivo diagnostic imaging system, which is a different category of medical device than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Infinion Software Features do not change the existing indications for the Infinion 1.5T MR Imaging Systems as defined below.
The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.
Diffusion tensor imaging is indicated for use by producing magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion tensor imaging can be used to image the directional dependence of the diffusion coefficient in tissue with restricted diffusion from tissues with normal diffusion.
Product codes
90 LNH
Device Description
Philips's Infinion Software Features include rapid imaging SENSE, coil uniformity improvements of CLEAR, rapid imaging using the b-FFE technique, acoustic noise reduction of SofTone and other improvements to current imaging techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI) System
Anatomical Site
head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
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
K02 4066
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
FEB 0 4 2003
】-【
1. General Information
| Classification: | Class II
Magnetic Resonance Imaging (MRI) System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Infinion Software Features |
| Establishment Registration: | Philips Medical Systems
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane Praschan
Phone: (440) 483-5743 |
| | 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 Infinion Software Features do not change the existing indications for the Infinion 1.5T MR Imaging Systems as defined below.
The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.
Diffusion tensor imaging is indicated for use by producing magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion tensor imaging can be used to image the directional dependence of the diffusion coefficient in tissue with restricted diffusion from tissues with normal diffusion.
3. Device Description
Philips's Infinion Software Features include rapid imaging SENSE, coil uniformity
Philips Medical Systems (Infinion Software Features) 12/6/2002
1
improvements of CLEAR, rapid imaging using the b-FFE technique, acoustic noise reduction of SofTone and other improvements to current imaging techniques.
Safety and Effectiveness 4.
The functionality included in Philips' Infinion Software Features is similar in technology characteristics and intended used to the Philips (formerly Marconi's) Infinion 1.5T MR Imaging System, the Philips Intera (R7.5) Software Package, and the Diffusion Tensor offered by General Electric in K003573.
| Parameter | Infinion Software Features | Predicate Device – Infinion 1.5T Imaging
System (K003853), Philips Intera (R7.5)
Option (K001796) and General Electric
(K003573) |
|------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence Chart | | |
| TIME VARYING MAGNETIC FIELD | | |
| Method | Same | Based on IEC 601-2-33, 2nd ed. (K003853) |
| Normal Operating Mode | Same | R(t)≤ 0.8 (K003853) |
| First Controlled Operating
Mode | Same | 0.8>R(t)≤1.0 (K003853) |
| Gradient Performance
Levels | Same | All |
| Indications for Use for
System | Same | The Infinion 1.5T MR Imaging System is
indicated for use as a NMR device that
produces images that: (1) correspond to the
distribution of protons exhibiting NMR, (2)
depend upon the NMR parameters (proton
density, flow velocity, spin-lattice relaxation
time (T1), and spin-spin relaxation time (T2))
and (3) display the soft tissue structure of the
head and whole body. When interpreted by a
trained physician, these images yield
information that can be useful in the
determination of a diagnosis. |
| SENSE | | |
| Purpose | Same | To reduce scan time by speedup factors applied
in any PE direction (K001796) |
| Operator Choices | Same | - Acceleration factor greater than 1.0 in
primary phase encode direction
- Acceleration factor greater than 1.0 in
secondary phase encode direction
(K001796) |
| CLEAR | | |
| Purpose | Same | B1 receive field uniformity correction
(K001796) |
| Operator Choices | Same | Enable correction for an acquisition (K001796) |
Substantial Equivalence Chart
Philips Medical Systems
(Infinion Software Features)
2
| Parameter | Infinion Software Features | Predicate Device – Infinion 1.5T Imaging
System (K003853), Philips Intera (R7.5)
Option (K001796) and General Electric
(K003573) |
|---------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diffusion Tensor | | |
| Purpose | Same | Designed to create images that differentiate
tissues with restricted diffusion from tissues
with normal diffusion and image the directional
dependence of the diffusion coefficient in tissue
such as white matter. (K003573) |
| Method | Same | SS-DW-EPI(K003573) |
| Indications for use | Same | Diffusion tensor imaging produced magnetic
resonance (MR) images whose contrast is
dependent on the local diffusion coefficient of
water. Diffusion tensor imaging can be used to
image the directional dependence of the
diffusion coefficient in tissue with restricted
diffusion from tissues with normal diffusion.
(K003573) |
| SofTone | | |
| Purpose | Same | Reduce acoustic noise (K001796) |
| Method | Same | Reduce slew rates (K001796) |
.
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2003
Mr. Duane Praschan Manager, MR Regulatory Affairs Philips Medical Systems (Cleveland), Inc. 595 Miner Road CLEVELAND OH 44143
Re: K024066
Trade/Device Name: Infinion Software Features Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: December 6, 2002 Received: December 9, 2002
Dear Mr. Praschan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): Ko 2
Device Name: Infinion Software Features
Indications for Use:
Intended Use
The Infinion Software Features does not change the existing indications as defined below.
The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Indications for Use
Diffusion tensor imaging produced magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion tensor imaging can be used to image the directional dependence of the diffusion coefficient in tissue with restricted diffusion from tissues with normal diffusion.
(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,
and Radiological Devices
510(k) Number. K024066
Description Use ✓
OR
Over-The-Counter Use __
Prescription Use (Per 21 CFR 801.109)
OF
Over-The-Counter Use _ (Optional Format 1-2-96)