INTERA-SENSATION FAMILY

K031815 · Philips Medical Systems · LNH · Sep 10, 2003 · Radiology

Device Facts

• Record ID: K031815
• Device Name: INTERA-SENSATION FAMILY
• Applicant: Philips Medical Systems
• Product Code: LNH · Radiology
• Decision Date: Sep 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that 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-SENSATION Release 1 family is a magnetic resonance imaging (MRI) system; successor to Gyroscan INTERA family. Inputs: magnetic resonance signals from 1H metabolites. System utilizes 1.0T, 1.5T, or 3.0T magnetic field strengths; supports 1, 4, 6, 8, 16, and 32-channel data acquisition; features advanced shimming and SUPER QUASAR gradients. Outputs: transverse, sagittal, coronal, and oblique cross-sectional images. Used in clinical settings by trained physicians to visualize internal body structures for diagnostic assistance. New functionality includes Examcards, MobiFlex, MobiView, O-flow, Real Time Bold Imaging, Re-scan, and CareTrak. Enhanced computer technology provides increased memory capacity. System operation remains consistent with predicate devices.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Magnetic resonance diagnostic device (MRDD). Field strengths: 1.0T, 1.5T, 3.0T. Data acquisition: 1, 4, 6, 8, 16, and 32 channels. Features: SUPER QUASAR gradient system, advanced shimming. Compliance: NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL and IEC 601 safety standards.

Indications for Use

Indicated for use as a magnetic resonance diagnostic device to produce cross-sectional images of the whole body based on 1H metabolites to assist trained physicians in 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 INTERA family release 10-series

Submission Summary (Full Text)

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Ko3 i 815

# SEP 1 0 2003

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 Nederland BV |
|-----------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | : | Veenpluis 4-6<br>Best, Netherlands, 5684 PC |
| Registration No. | : | 3003768277 |
| Contact person | : | Lynn Harmer.<br>Manager, regulatory Submissions<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Device (Trade) Name | : | INTERA-SENSATION¹ family. |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MR Diagnostic<br>Device Guidance, UL and IEC 601 appropriate safety<br>standards and/or draft standards are used |

#### Predicate Device(s):

The Philips Medical Systems INTERA-SENSATION Family Release 1-series is the successor of the already cleared (predicate device) Gyroscan INTERA family release 10-series with static magnetic field strengths of 1.0, 1.5 and 3.0 Tesla.

### Indications for use:

The INTERA-SENSATION Family Release 1-series magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

l This is not the final system name and will change. At the moment of this writing the system name is not known yet.

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#### Device description:

The INTERA-SENSATION Release 1 family is the successor of the current (Gyroscan) INTERA family Release 10-series. It consists of various configurations with magnetic field strengths (1.0T, 1.5T & 3.0T) and different optional gradient types.

The INTERA-SENSATION Release 1 family is based on the same platform with the same functionalities as its predecessor.

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

- new appearance (covers) .
- . data acquisition system supports 1,4,6,8 and 16 channels and is prepared for 32 channels
- Advanced shimming and SUPER QUASAR gradient. .
- Added new functionality: Examcards, MobiFlex, MobiView, O-flow, Real . Time Bold Imaging, Re-scan, and CareTrak
- 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 SENSATION Release 1-series 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 SENSATION Release 1-series family is substantially equivalent to its predecessor.

End

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Image /page/2/Picture/1 description: The image shows a circular logo with an abstract depiction of an eagle in the center. The eagle is composed of three curved lines that suggest its head, body, and tail feathers. Encircling the eagle is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a clockwise direction. The logo is rendered in black and white, giving it a simple and official appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2003

Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Highway BOTHELL WA 98021-8431

Re: K031815

Trade/Device Name: INTERA SENSATION' Release 1 Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 LNH Dated: June 5, 2003 Received: June 12, 2003

Dear Ms. Harmer:

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 adultcration.

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):

Device Name :

#### INTERA SENSATION Release 1 family.

Indication For Use :

The indication for use for the INTERA SENSATION Release 1-series remains the same as the previous released predicate device(s), i.e. the capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis

KO31815

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

, i

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David M. Syverson

(Division Sign-Off) Division of Reproductive, and Radiological Device 510(k) Number

¹ This is not the final system name and will change. At the moment of this writing the system name is not known yet.