The Philips Gyroscan NT Release 6 series have the same intended use as its predecessor and predicate device Gyroscan NT Release 5. The 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 'H and ''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

The predicate device Gyroscan NT Release 5 series with the additions mentioned hereafter is called Gyroscan NT Release 6 series.

The Synergy coils are based on the same principles of the existing Philips synergy coil but their physical design is as such for better matching with the ROI to be imaged.
Synergy Body coil: This coil consists of four coil elements to image the ROI in the abdomen and the pelvic or thoracic area.
Synergy Cardiac: This coil consists of 5 coil elements to image the heart and its coronary vessels
Contrast Enhanced Angiography (CE-MRA) Package - BolusTrak.
Contrast Enhanced Peripheral Angiography Package - MobiTrak.
Respiratory Navigators (MotionTrak) is an extension to the MR Cardiography package which offers the possibility to monitor the diaphragm position of the patient during scanning. Additional MR signals are acquired interleaved with the normal MR acquisition and evaluated in real-time. These navigator signals are used to determine the position of the imaging volume to enable gating and slice correction.
MR Neuro Imaging Package provide dedicated acquisition, reconstruction techniques resulting in functional rather than anatomical information. It contains:
o MR Perfusion Package. Enhanced 3D FFE and 3D FFE-EPI techniques , so-called PRESTO, which allows fast acquistion with large anatomical coverage. It provides high temporal information for evaluation of dynamic contrast agent studies.
o MR Bold Imaging Package. Extensions to the PRESTO technique with respect to motion correction, acquistion and recontruction, which offers the possibility of visualization of small susceptibility changes.
Introduction of Gyroscan CMR:
The dedicated cardiac version , based on the Gyroscan NT platform, will be marketed as Gyroscan CMR. The latter has the same performance as the NT version except for its appearance, i.e. the name and the color of the system covers.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Gyroscan NT Release 6 series, an MRI device. It describes the device's intended use and technological characteristics, comparing it to its predicate device (Gyroscan NT Release 5 series) to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria, device performance metrics, specific studies (like comparative effectiveness or standalone performance), sample sizes, data provenance, ground truth establishment, or expert qualifications and adjudication methods.

The summary focuses on:

Device Name: Philips Gyroscan NT Release 6 series
Classification: Magnetic Resonance Diagnostic Device, Class II
Intended Use: Diagnostic imaging of the head, body, or extremities, producing cross-sectional images, spectroscopic images, and/or spectra based on 1H and 31P metabolites. These images/spectra, when interpreted by a trained physician, assist in diagnosis. This is stated to be the same as the predicate device.
Description of Changes from Predicate:
- New Synergy coils (Body coil, Cardiac coil)
- Contrast Enhanced Angiography (CE-MRA) Package - BolusTrak
- Contrast Enhanced Peripheral Angiography Package - MobiTrak
- Respiratory Navigators (MotionTrak)
- MR Neuro Imaging Package (MR Perfusion Package with PRESTO and MR Bold Imaging Package)
- Introduction of Gyroscan CMR (a dedicated cardiac version with the same performance as the NT version).
Safety and Effectiveness: States that the extensions to Release 5 do not induce any other risks than those already known with MRI techniques.
Substantial Equivalence: Declares the device substantially equivalent to the predicate device (GYROSCAN NT Release 5 series).

Since this is a 510(k) summary for an MRI system and not an AI or diagnostic algorithm, the typical performance metrics (sensitivity, specificity, AUC) and study design elements (sample size, ground truth, experts, adjudication) asked for in the prompt are not applicable or reported in this type of submission. The 'performance' of such a device is generally established through engineering specifications, image quality assessments, and safety standards rather than clinical diagnostic accuracy studies in the way an AI algorithm would be.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details because the provided document does not contain this information. The document solely focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway that doesn't typically require de novo clinical performance studies for diagnostic accuracy in the way an AI medical device might.

Summary

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Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is the number "480645" written in black ink. The text is centered on a white background. The image appears to be a logo or brand name.

Philips Medical Systems

XJR-148-3145/bf2 1998-02-16

Page 1 of 2

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS.

This summary of 510(k) safety and effectiveness 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
		Shelton, CT 06484.
Registration No.	:	1217116
Contact person	:	Peter Altman
Telephone Number	:	203-926-7031
Prepared	:	Februrary 16, 1998.
Device Name	:	Philips Gyroscan NT Release 6 series.
Classification Name	:	Magnetic Resonance Diagnostic Device.
Classification	:	Class II.
Performance standards	:	NEMA voluntary standards, FDA MRI guidances, UL and IEC 601relevant safety standards and/or draft standards are used.
Common/Usual Name	:	Philips Gyroscan NT(*) Release 6 series.
Predicate Device(s)	:	Philips Gyroscan NT Release 5 series (FDA re.K963990).

Intended Use :

Description :

The predicate device Gyroscan NT Release 5 series with the additions mentioned hereafter is called Gyroscan NT Release 6 series.

The Synergy coils are based on the same principles of the existing Philips synergy coil but their physical design is as such for better matching with the ROI to be imaged.
Synergy Body coil: This coil consists of four coil elements to image the ROI in the abdomen and the pelvic or thoracic area.
Synergy Cardiac: This coil consists of 5 coil elements to image the heart and its coronary vessels

(*) By Gyroscan NT is meant all three versions. I e T5-NT (0.5T), T10-NT (1.0T) and ACS-NT (1.5T).

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Image /page/1/Picture/0 description: The image shows the text "Philips Medical Systems". The text is in a bold, sans-serif font. The text is black and is on a white background.

Image /page/1/Picture/1 description: The image shows the word "PHILIPS" in bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame. The background is plain white.

XJR-148-3145/bf2 1998-02-16 Page 2 of 2

- Contrast Enhanced Angiography (CE-MRA) Package - BolusTrak.

The BolusTrak package allows synchronization of a (3D FFE) Contrast Enhanced (CE) MRA scan with the arterial arrival of an intravenously injected contrast agent. After the administration of the contrast agent a rapid 2D FFE thick slice dynamic scan is started with real-time reconstruction, complex substraction and viewing. At the moment the bolus is observed in the volume of interest a slower 3D FFE scan is started..

- Contrast Enhanced Peripheral Angiography Package - MobiTrak.

The MobiTrak package allows rapid evaluation of the aorta and lower extremity vasculature. It is an extension of contrast enhanced MRA, combining the advantages of 3D FFE CE acquistion with table movement between successive coronal acquisitions to overcome the limitation of a single field-of-view in relation to the large region-of-interest.

Respiratory Navigators (MotionTrak) is an extension to the MR Cardiography package which offers the possibility to monitor the diaphragm position of the patient during scanning. Additional MR signals are acquired interleaved with the normal MR acquisition and evaluated in real-time. These navigator signals are used to determine the position of the imaging volume to enable gating and slice correction.
MR Neuro Imaging Package provide dedicated acquisition, reconstruction techniques resulting in functional rather than anatomical information. It contains:

o MR Perfusion Package. Enhanced 3D FFE and 3D FFE-EPI techniques , so-called PRESTO, which allows fast acquistion with large anatomical coverage. It provides high temporal information for evaluation of dynamic contrast agent studies.

o MR Bold Imaging Package. Extensions to the PRESTO technique with respect to motion correction, acquistion and recontruction, which offers the possibility of visualization of small susceptibility changes.

Introduction of Gyroscan CMR:

The dedicated cardiac version , based on the Gyroscan NT platform, will be marketed as Gyroscan CMR. The latter has the same performance as the NT version except for its appearance, i.e. the name and the color of the system covers.

Technological Characteristics:

The technological characteristics remain the same as those for other Gyroscan NT systems. New coils and sequences are available as the options are enabled.

General Safety and Effectiveness Concerns

The Philips GYROSCAN NT Release 6 series contains extensions to the Release 5 series which do not induce any other risks than the already known with MRI techniques.

Substantial Equivalence

The Philips GYROSCAN NT Release 6 series devices are substantially equivalent to the predicate devices of GYROSCAN NT Release 5 series.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/3 description: The image shows a partial view of a logo or emblem, featuring stylized, thick, black lines that appear to be abstract representations of waves or flowing elements. The lines are curved and stacked on top of each other, creating a sense of movement and depth. To the left of the abstract lines, there are partial letters, oriented vertically, which seem to be part of a word or phrase, possibly indicating the name of an organization or department.

। । MAY

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

Re:

K980645

Philips GYROSCAN NT Release 6 Series February 18, 1998 Dated: Received: February 19, 1998 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Unknown 180645 510(k) Number (if known): Philips GYROSCAN NT Release 6 series Device Name :

Indication For Use :

The Philips Gyroscan NT Release 6 series have the same intended use as its predecessor and predicate device Gyroscan NT Release 5. The 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 '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.

( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)

David A. Seymann
(Division Sign-Off)

Division of Reproductive, Abdominal, El and Radiological Devic

510(k) Number K980645

Prescription Use (Per 21 CFR 801.109) OR

ﺃﻧﻈﻤﺔ ﺍﻟﻤﺴﺎﺣﺔ

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.