INFINION SOFTWARE FEATURES

K024066 · Philips Medical Systems (Cleveland), Inc. · LNH · Feb 4, 2003 · Radiology

Device Facts

• Record ID: K024066
• Device Name: INFINION SOFTWARE FEATURES
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

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 Story

Infinion Software Features are software enhancements for the Infinion 1.5T MR Imaging System. Features include SENSE (Sensitivity Encoding) for scan time reduction via acceleration factors; CLEAR (Constant Level Appearance) for B1 receive field uniformity correction; b-FFE (balanced Fast Field Echo) for rapid imaging; and SofTone for acoustic noise reduction via slew rate modification. Diffusion tensor imaging functionality enables visualization of water diffusion coefficients. Operated by trained clinicians in clinical settings. Output consists of MR images interpreted by physicians to aid diagnosis. Enhancements improve workflow efficiency, image quality, and patient comfort.

Clinical Evidence

Bench testing only. Substantial equivalence is based on technical comparison of imaging parameters, software functionality, and adherence to established safety standards (IEC 601-2-33) for MR systems.

Technological Characteristics

Software-based enhancements for 1.5T MRI system. Includes SENSE (parallel imaging), CLEAR (field uniformity correction), b-FFE (gradient echo sequence), and SofTone (acoustic noise reduction). Operates within existing MR hardware infrastructure. Complies with IEC 601-2-33 for time-varying magnetic fields.

Indications for Use

Indicated for patients requiring MR imaging of the head and whole body for diagnostic purposes. Diffusion tensor imaging indicated for imaging directional dependence of water diffusion coefficient in tissues (e.g., white matter) to differentiate restricted from normal diffusion.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Infinion 1.5T Imaging System (K003853)
• Philips Intera (R7.5) Software Package (K001796)
• General Electric Diffusion Tensor (K003573)

Submission Summary (Full Text)

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K02 4066

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

FEB 0 4 2003

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#### 1. General Information

| Classification: | Class II<br>Magnetic Resonance Imaging (MRI) System |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Infinion Software Features |
| Establishment Registration: | Philips Medical Systems<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>Contact: Duane Praschan<br>Phone: [phone] |
| | FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been<br>issued under section 514 of the Food, Drug and<br>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

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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<br>System (K003853), Philips Intera (R7.5)<br>Option (K001796) and General Electric<br>(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<br>Mode | Same | 0.8>R(t)≤1.0 (K003853) |
| Gradient Performance<br>Levels | Same | All |
| Indications for Use for<br>System | Same | The Infinion 1.5T MR Imaging System is<br>indicated for use as a NMR device that<br>produces images that: (1) correspond to the<br>distribution of protons exhibiting NMR, (2)<br>depend upon the NMR parameters (proton<br>density, flow velocity, spin-lattice relaxation<br>time (T1), and spin-spin relaxation time (T2))<br>and (3) display the soft tissue structure of the<br>head and whole body. When interpreted by a<br>trained physician, these images yield<br>information that can be useful in the<br>determination of a diagnosis. |
| SENSE | | |
| Purpose | Same | To reduce scan time by speedup factors applied<br>in any PE direction (K001796) |
| Operator Choices | Same | - Acceleration factor greater than 1.0 in<br>primary phase encode direction<br>- Acceleration factor greater than 1.0 in<br>secondary phase encode direction<br>(K001796) |
| CLEAR | | |
| Purpose | Same | B1 receive field uniformity correction<br>(K001796) |
| Operator Choices | Same | Enable correction for an acquisition (K001796) |

Substantial Equivalence Chart

Philips Medical Systems

(Infinion Software Features)

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| Parameter | Infinion Software Features | Predicate Device – Infinion 1.5T Imaging<br>System (K003853), Philips Intera (R7.5)<br>Option (K001796) and General Electric<br>(K003573) |
|---------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Diffusion Tensor | | |
| Purpose | Same | Designed to create images that differentiate<br>tissues with restricted diffusion from tissues<br>with normal diffusion and image the directional<br>dependence of the diffusion coefficient in tissue<br>such as white matter. (K003573) |
| Method | Same | SS-DW-EPI(K003573) |
| Indications for use | Same | Diffusion tensor imaging produced magnetic<br>resonance (MR) images whose contrast is<br>dependent on the local diffusion coefficient of<br>water. Diffusion tensor imaging can be used to<br>image the directional dependence of the<br>diffusion coefficient in tissue with restricted<br>diffusion from tissues with normal diffusion.<br>(K003573) |
| SofTone | | |
| Purpose | Same | Reduce acoustic noise (K001796) |
| Method | Same | Reduce slew rates (K001796) |

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## 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)