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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Philips Gyroscan INTERA (Release 7 series) MRI system. It asserts substantial equivalence to a predicate device, the Philips GYROSCAN NT Release 6 series. However, it does not contain a study that proves the device meets specific acceptance criteria.

Instead, the document focuses on demonstrating that the new device has "the same intended use" and "the same technological characteristics" as its cleared predicate device, and that its "safety parameters" and "General Safety and effectiveness" remain the same. This is typical for a 510(k) submission seeking substantial equivalence, rather than a de novo approval requiring a full clinical performance study against specific acceptance criteria.

Therefore, many of the requested information points, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth information for a new study, are not present in this document.

Here's what can be extracted based on the provided text, with a clear indication of what is not available:

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in this document. The document asserts that the safety and effectiveness of the Gyroscan INTERA Release 7 are implicitly proven by its substantial equivalence to the predicate device, the GYROSCAN NT Release 6, which was previously cleared. There are no explicit acceptance criteria or comparative performance measures presented for the Philips Gyroscan INTERA (Release 7 series) itself beyond the statement of equivalent safety and effectiveness.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. No separate "test set" for performance evaluation is described for the Gyroscan INTERA (Release 7 series) in the context of specific performance metrics. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No new ground truth establishment process for a performance study is described.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a Magnetic Resonance Diagnostic Device (MRDD), not an AI-based diagnostic aid that would typically involve a "human readers improve with AI vs without AI assistance" study. The submission focuses on hardware and software updates to an existing MRI platform.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent in its image generation capabilities for a trained physician to interpret.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided for a new study. The intended use statement mentions that "These images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis." This implies that the 'ground truth' for an MRI system's utility is diagnostic information derived by a physician. However, no specific ground truth for a new performance evaluation is detailed here.

8. The sample size for the training set

Not applicable/N/A. This document describes a medical device (MRI scanner), not a machine learning algorithm that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable/N/A.

Summary of Device and Regulatory Context (Based on the document):

Device Name: Philips Gyroscan INTERA (Release 7 series)
Predicate Device: Philips GYROSCAN NT Release 6 series (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 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."
Basis for Approval: Substantial Equivalence to the predicate device. The document explicitly states: "The Gyroscan INTERA (Release 7 series) is substantially equivalent to the predicate device Philips GYROSCAN NT Release 6 series systems with FDA ref.K980645." This means the new device is considered as safe and effective as the predicate device without needing new, extensive clinical studies demonstrating performance against novel acceptance criteria. The enhancements are primarily focused on user-friendliness, patient comfort, and faster image reconstruction/processing, without altering the fundamental diagnostic capability or safety profile compared to the predicate.

Summary

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Image /page/0/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be 'K99 25 33'. The handwriting is somewhat stylized, with the numbers being slightly more rounded.

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

Page 1 of 2

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 AvenueShelton, 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 601appropriate 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

(*)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 (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/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 :

( 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

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.