INTERA FAMILY

K030520 · Philips Medical Systems North America Co. · LNH · Mar 6, 2003 · Radiology

Device Facts

• Record ID: K030520
• Device Name: INTERA FAMILY
• Applicant: Philips Medical Systems North America Co.
• Product Code: LNH · Radiology
• Decision Date: Mar 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Story

INTERA Family is a magnetic resonance diagnostic device (MRDD) system; successor to Gyroscan/NT INTERA family. Operates at 0.5T, 1.0T, 1.5T, and 3.0T field strengths. Inputs: 1H metabolite signals. Outputs: cross-sectional images (transverse, sagittal, coronal, oblique). Used in clinical settings by trained physicians to assist in diagnosis. Key updates: Diffusion Tensor Imaging (DTI) functionality; migration from VMS to Microsoft Windows operating system; increased electronic data storage/memory capacity. System utilizes standard MR hardware configurations and gradient types.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological similarities and the established safety profile of the predicate device.

Technological Characteristics

Magnetic resonance diagnostic device; field strengths 0.5T, 1.0T, 1.5T, 3.0T. Compliance with NEMA standards, FDA MRDD guidances, UL, and IEC 601 safety standards. Features Diffusion Tensor Imaging (DTI) capability. Software platform: Microsoft Windows. Hardware includes upgraded electronic data storage and memory capacity.

Indications for Use

Indicated for whole-body diagnostic imaging in patients requiring transverse, sagittal, coronal, or oblique cross-sectional MR images based on 1H metabolites to assist in clinical diagnosis.

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

• Gyroscan / NT INTERA family

Submission Summary (Full Text)

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# K030520

Page 1 of 2

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

## General information

| Company Name | : | Philips Medical Systems North America Company |
|--------------------------|---|---------------------------------------------------------------------------------------------------------------------------------|
| Address | : | 22100 Bothell Everett Highway<br>P.O. Box 3003 |
| Registration No. | : | Bothell, WA 98041-3003 |
| Contact person | : | Lynn Harmer |
| Date Supplement Prepared | : | January 9, 2003 |
| Telephone | : | 425-481-7312 |
| Device (Trade) Name | : | INTERA family |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification | : | Class II |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MRDD guidances,<br>UL and IEC 601 appropriate safety standards and/or<br>draft standards are used |

#### Predicate Device(s):

The Philips Medical Systems INTERA Family is the successor of the already cleared (predicate device) Gyroscan / NT INTERA family with static magnetic field strengths of 0.5. 1.0, 1.5 and 3.0 Tesla.

#### Indications for use:

The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

### Device description:

The INTERA Family is the successor of the current (Gyroscan / NT INTERA family. It consists of various configurations with magnetic field strengths ( 0.5T, 1.0T, 1.5T & 3.0T) and different optional gradient types.

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The INTERA Family is based on the same platform with the same functionalities as its predecessor.

The main differences with the its predecessors (predicate devices) are:

- . Added new functionality: DIFFUSION TENSOR imaging differentiates tissues with restricted diffusion from tissues with normal diffusion.
- Operating software platform Microsoft Windows (instead of VMS) running . on the appropriate host-computer.
- Enhancements related to the use of up to date computer technology such as . larger electronic data storage (memory) capacity.

# General Safety and Effectiveness.

The INTERA Family does not induce any other risks than already indicated for the predicate devices. It has the same safety and effectiveness as its predecessor.

### Substantial Equivalence.

It is the opinion of Philips Medical Systems that the Philips INTERA Family is substantially equivalent to its predecessor.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of a human figure, with three stylized profiles overlapping each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the figure. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 6 2003

Philips Medical Systems North America Company % Mr. Marc M. Mouser Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709 Re: K030520

Trade/Device Name: INTERA Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Mouser:

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):

KU30520

Device Name :

INTERA Family.

Indication For Use :

The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

# ( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number

V Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________