GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES

K963990 · Philips Medical Systems, Inc. · LNH · May 29, 1997 · Radiology

Device Facts

• Record ID: K963990
• Device Name: GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
• Applicant: Philips Medical Systems, Inc.
• Product Code: LNH · Radiology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Philips Gyroscan NT 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 1H 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.

Device Story

Magnetic Resonance Imaging (MRI) system; produces transverse, sagittal, coronal, oblique cross-sectional images; performs spectroscopy based on 1H and 31P metabolites. Input: magnetic resonance signals from patient anatomy. Output: diagnostic images and spectra. Used in clinical settings by trained physicians to visualize internal structures/functions; assists in clinical diagnosis. System includes RF-limit protection, gradient rate control, and coil decoupling circuitry. Operates as a diagnostic tool for head, body, and extremities.

Clinical Evidence

No clinical data provided; bench testing and compliance with safety standards cited.

Technological Characteristics

Magnetic Resonance Imaging system; field strengths 0.5T (T5-NT), 1.0T (T10-NT), 1.5T (ACS-NT). Features RF-limit protection, gradient rate control, and coil decoupling. Supports 1H and 31P metabolite spectroscopy. Software-controlled imaging system.

Indications for Use

Indicated for diagnostic imaging and spectroscopy of head, body, or extremities in patients requiring internal structure or functional assessment via 1H and 31P metabolites.

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.

Submission Summary (Full Text)

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MAY 29 1997
K963990

# Summary of Safety and Effectiveness

## Philips GYROSCAN NT Systems

1. The GYROSCAN T5-NT (0.5T), GYROSCAN T10-NT (1.0T), GYROSCAN ACS-NT (1.5T) Release 5 series are designed and manufactured to comply with the relevant safety standards. Adequate safety precautions include RF-limit protection, rate of gradient change, and selection/decoupling circuitry for the applicable coils.

2. The systems, as their predecessors, are indicated for use as diagnostic devices producing transverse, sagittal, coronal, and oblique cross-sectional images and displaying the internal structure of the head, body, or extremities. These images, when interpreted by a trained physician, yield information useful in the determination of diagnosis.

3. MR Imaging utilizes mature technology to visualize images with which the industry and users have many years of experience. A Comprehensive Operator’s Manual contains adequate instructions and provides sufficient cautions and warnings to ensure safe operation.

4. The software used in Release 5 is equivalent to the software used in the predicate device. The hardware used in Release 5 is identical to the predicate device.

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 29 1997

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

Re: K963990
GYROSCAN T5-NT, T10-NT and ACS-NT Release 5 Series
Dated: March 6, 1997
Received: March 7, 1997
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 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). 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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] for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html".

Sincerely yours,


Lillian Yin, Ph.D.
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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To: FDA ODE
Page 1 of 1

510(k) Number (if known): Unknown

Device Name: Philips Gyroscan T5-NT, T10-NT, and ACS NT

Indications For Use:

The Philips Gyroscan NT 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 $^{1}\mathrm{H}$ and $^{31}\mathrm{P}$ 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segura
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K963440

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)