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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Infinion Software Features:

Note: This 510(k) summary is for a software update to an existing Magnetic Resonance Imaging (MRI) system. The acceptance criteria and "study" described are primarily based on the principle of substantial equivalence to predicate devices, rather than a traditional clinical study with novel performance metrics. The software features aim to improve existing functionalities (rapid imaging, uniformity, noise reduction, and diffusion tensor imaging) without changing the fundamental indications for use of the MRI system. Therefore, the "acceptance criteria" revolve around demonstrating that these new features perform equivalently or better than the predicate technology, without introducing new safety or effectiveness concerns.

Description of Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infinion Software Features are detailed by demonstrating substantial equivalence to predicate devices (Philips Infinion 1.5T MR Imaging System (K003853), Philips Intera (R7.5) Software Package (K001796), and General Electric (K003573)). The "reported device performance" is implicitly that the Infinion Software Features achieve the same functional performance characteristics as the predicate devices for specific parameters.

Parameter	Acceptance Criteria (Demonstrated by Substantial Equivalence to Predicate)	Reported Device Performance (as stated in the document)
TIME VARYING MAGNETIC FIELD
Method	Same as IEC 601-2-33, 2nd ed. compliance (K003853)	Same
Normal Operating Mode	R(t) ≤ 0.8 (K003853)	Same
First Controlled Operating Mode	0.8 > R(t) ≤ 1.0 (K003853)	Same
Gradient Performance Levels	All levels consistent with predicate (K003853)	Same
Indications for Use for System	Same as predicate MRI system (K003853)	Same (No change to existing indications)
SENSE (Rapid Imaging)
Purpose	To reduce scan time by speedup factors (K001796)	Same
Operator Choices	Acceleration factor > 1.0 in primary/secondary phase encode directions (K001796)	Same
CLEAR (Coil Uniformity)
Purpose	B1 receive field uniformity correction (K001796)	Same
Operator Choices	Enable correction for an acquisition (K001796)	Same
Diffusion Tensor Imaging
Purpose	Create images to differentiate restricted/normal diffusion, image directional dependence (K003573)	Same
Method	SS-DW-EPI (K003573)	Same
Indications for Use	Image contrast dependent on local diffusion coefficient of water, image directional dependence (K003573)	Same
SofTone (Acoustic Noise Reduction)
Purpose	Reduce acoustic noise (K001796)	Same
Method	Reduce slew rates (K001796)	Same

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly describe a "test set" in the context of a prospective clinical study with a specific sample size. The evidence for "acceptance criteria" and "device performance" is primarily based on the comparison of technical specifications and intended use with previously cleared predicate devices. The phrase "similar in technology characteristics and intended used" indicates the evaluation was against established performance of marketed devices rather than a new data set generated for the Infinion Software Features alone.

Therefore, there is no specified sample size for a test set or data provenance in the sense of patient data in this 510(k) summary. The "data provenance" for the predicate devices would be derived from their original clearance documents (K003853, K001796, K003573).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish ground truth for a test set for the Infinion Software Features. The "ground truth" for demonstrating substantial equivalence relies on the established and accepted performance of the predicate devices, which were cleared based on their own prior documentation. The interpretation of MR images for diagnosis is explicitly stated to be done by a "trained physician," but this pertains to the general use of the MRI system, not the evaluation of these specific software features for 510(k) clearance.

4. Adjudication Method

There is no adjudication method described for a test set. The review process is based on comparing the new device's specifications and performance claims against those of the predicate devices.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or mentioned in this document. This 510(k) summary predates the widespread regulatory focus on AI/ML-driven devices and reader performance studies. The improvements described, such as reduced scan time and improved uniformity, are inherent technical enhancements to the imaging process, not direct AI-driven assistance to human readers for diagnostic tasks.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This document does not describe a "standalone" algorithm-only performance study. The Infinion Software Features are enhancements to a human-operated MRI system. The performance is assessed in the context of the overall MRI system, with a trained physician interpreting the resulting images.

7. The Type of Ground Truth Used

The "ground truth" for the clearance of the Infinion Software Features is based on the established performance and safety characteristics of the predicate devices as previously cleared by the FDA. This is a regulatory "ground truth" of substantial equivalence rather than a clinical ground truth like pathology, expert consensus, or outcomes data specifically generated for these software features. The technical specifications and intended use of the Infinion Software Features were found to be "same" as the predicate devices.

8. The Sample Size for the Training Set

There is no mention of a training set sample size. The Infinion Software Features are described as technical improvements and new imaging techniques integrated into an existing MRI platform. They are not described as machine learning or AI algorithms that require a specific training data set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this document.

Summary

{0}------------------------------------------------

K02 4066

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

FEB 0 4 2003

】-【

1. General Information

Classification:	Class IIMagnetic Resonance Imaging (MRI) System
Common/Usual Name:	Magnetic Resonance Imaging (MRI) System
Proprietary Name:	Infinion Software Features
Establishment Registration:	Philips Medical Systems595 Miner RoadHighland Heights, Ohio 44143Contact: Duane PraschanPhone: (440) 483-5743
	FDA Owner Number: #1580240FDA Registration Number: #1525965
Performance Standards:	No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic 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.

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 ImagingSystem (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 OperatingMode	Same	0.8>R(t)≤1.0 (K003853)
Gradient PerformanceLevels	Same	All
Indications for Use forSystem	Same	The Infinion 1.5T MR Imaging System isindicated for use as a NMR device thatproduces images that: (1) correspond to thedistribution of protons exhibiting NMR, (2)depend upon the NMR parameters (protondensity, flow velocity, spin-lattice relaxationtime (T1), and spin-spin relaxation time (T2))and (3) display the soft tissue structure of thehead and whole body. When interpreted by atrained physician, these images yieldinformation that can be useful in thedetermination of a diagnosis.
SENSE
Purpose	Same	To reduce scan time by speedup factors appliedin any PE direction (K001796)
Operator Choices	Same	- Acceleration factor greater than 1.0 inprimary phase encode direction- Acceleration factor greater than 1.0 insecondary 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 ImagingSystem (K003853), Philips Intera (R7.5)Option (K001796) and General Electric(K003573)
Diffusion Tensor
Purpose	Same	Designed to create images that differentiatetissues with restricted diffusion from tissueswith normal diffusion and image the directionaldependence of the diffusion coefficient in tissuesuch as white matter. (K003573)
Method	Same	SS-DW-EPI(K003573)
Indications for use	Same	Diffusion tensor imaging produced magneticresonance (MR) images whose contrast isdependent on the local diffusion coefficient ofwater. Diffusion tensor imaging can be used toimage the directional dependence of thediffusion coefficient in tissue with restricteddiffusion 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)

Over-The-Counter Use _ (Optional Format 1-2-96)

Regulation Number and Section

§ 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.