PHILIPS GYROSCAN INTERA (*)

K992533 · Philips Medical Systems North America, Inc. · LNH · Oct 18, 1999 · Radiology

Device Facts

• Record ID: K992533
• Device Name: PHILIPS GYROSCAN INTERA (*)
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Gyroscan INTERA systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 3'P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Story

Magnetic Resonance Diagnostic Device (MRDD) producing cross-sectional images and spectroscopic data (1H, 31P) of head, body, and extremities; utilizes RF receive-only coils and magnet bore; operated by clinicians in radiology settings. Features include patient comfort enhancements (forced air, observation camera, laser positioning), ceiling-suspended console with LCD display, and Compaq Alpha processor for high-speed reconstruction (40 images/sec). Supports real-time interactive imaging, diffusion/perfusion mapping (ADC, TTP, MTT), and vector ECG gating. Physician interprets output to assist in clinical diagnosis; device provides structural and functional anatomical information.

Clinical Evidence

No clinical data provided; bench testing only. Safety and effectiveness are established through comparison to the predicate device and adherence to NEMA, UL, and IEC 601 standards.

Technological Characteristics

MRDD system (0.5T, 1.5T, 1.6T configurations). Uses RF receive-only coils (e.g., Synergy Pediatric Coil). Processing via Compaq Alpha processor. Connectivity includes ceiling-suspended console with 20-inch LCD. Safety standards: NEMA, FDA MRDD guidance, UL, IEC 601. Software-based reconstruction and analysis.

Indications for Use

Indicated for use as an MR diagnostic device to produce cross-sectional images and spectra (1H and 31P) of the head, body, or extremities to assist in diagnosis by a trained physician. No specific age or gender restrictions; contraindications not specified.

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

• Philips GYROSCAN NT Release 6 series (K980645)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" written above a circular emblem. The emblem features four stars arranged around two wavy lines. The logo is presented in black and white, with the word "PHILIPS" in bold, uppercase letters.

OCT 1 8 1999

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# 510(k) Summary

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

| Company Name | : | Philips Medical Systems North America Company. |
|-----------------------|---|--------------------------------------------------------------------------------------------------------------------------------|
| Address | : | 710 Bridgeport Avenue<br>Shelton, CT 06484. |
| Registration No. | : | 1217116 |
| Contact person | : | Peter Altman |
| Device (Trade) Name | : | Philips Gyroscan INTERA (*) |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH / LNI. |
| Performance standards | : | NEMA voluntary standards, FDA MRDD guidance's, UL and IEC 601<br>appropriate safety standards and/or draft standards are used. |
| Common/Usual Name | : | Philips Gyroscan INTERA (Release 7 series). |

### Predicate Device(s).

The Philips cleared MRDD Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.

## Intended use.

The Philips Gyroscan INTERA (Release 7) series have the same intended use as its predecessor and predicate device Gyroscan NT Release 6. The Gyroscan INTERA systems are indicated for use as diagnostic devices that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, based upon 'H and 3'P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

# Device Description and Technological Characteristics

The new Philips MRDD being the successor of Gyroscan NT (Rel.6), is the Release 7 series called the Gyroscan INTERA series. The Gyroscan INTERA is based on the same platform as its predicate device Gyroscan NT (re.K980645) with the same technological characteristics and intended use .

^(*)Gyroscan INTERA series are available in Gyroscan INTERA (0.5T), Gyroscan INTERA 1.6T (1.5T) and the CV version Gyroscan INTERA (1.5T)

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The main enhanced and new feature of the Gyroscan INTERA series are:

- The new look in its appearance to emphasis its compactness. .
- Hardware features to improve user friendliness such as the operator's console and the use of . LCD monitor displays.
- Patients comfort by forced air flow through the magnet bore and comfort zone with Patient . Observation provision. The patient can view the environment outside the bore and the built-in camera is used to observe the patient in the magnet bore.
- Save laser light cross beam is applied for reference for the patient positioning. .
- A ceiling suspended Examination Room Operator's console with tracker-ball control and 20 . inch LCD display.
- Enhanced and new functionality's : .
- * RF receive only Synergy Pediatric Coil
- * The use of the XP1000 Compaq (Alpha processor) allowing image reconstruction up to 40 images/second.
- * Real-time Interactive Imaging.
- * On-line calculation of the ADC maps (Diffusion package)
- * On-line calculation of TTP, Negative Integral, Index, and MTT maps (Perfusion package).
- * Three-points Plan scan ( enhancement Free Style Plan Scan).
- * Vector ECG signals for MR scan synchronization (triggering) and gating.

#### Safety parameters.

The safety parameters of the Gyroscan INTERA Release 7 remains the same as with its predecessor and predicate device Gyroscan NT Release 6 series ( re. K980645).

#### General Safety and effectiveness.

The safety and effectiveness of the Gyroscan INTERA a re the same as with its predicate device the GYROSCAN NT Release 6 systems (ref.K980645)

It does not induce other safety issues and warnings than already valid for its predecessor and predicate device.

#### Substantial Equivalence.

The Gyroscan INTERA (Release 7 series) is substantially equivalent to the predicate device Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 1999

Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917

Re:

K992533

Gyroscan Intera (Release 7 Series) Dated: July 28, 1999 Received: July 29, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Altman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in . regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | Unknown K992533 |
|---------------------------|--------------------------|
| Device Name : | Philips Gyroscan INTERA. |

#### Indication For Use :

The Philips Gyroscan INTERA (Release 7) series are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique crosssectional images, spectroscopic images and/or spectra, based upon 'H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremities. These images and/or spectra 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)

Prescription Use
(Per 21 CFR 801.109) ✓

OR Over-The-Counter Use

(Optional Format 1-2-96)

David h. Segears

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number