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

Device Description

The INTERA Family is the successor of the current (Gyroscan / NT INTERA family. It consists of various configurations with magnetic field strengths ( 0.5T, 1.0T, 1.5T & 3.0T) and different optional gradient types. The INTERA Family is based on the same platform with the same functionalities as its predecessor. The main differences with the its predecessors (predicate devices) are: Added new functionality: DIFFUSION TENSOR imaging differentiates tissues with restricted diffusion from tissues with normal diffusion. Operating software platform Microsoft Windows (instead of VMS) running . on the appropriate host-computer. Enhancements related to the use of up to date computer technology such as . larger electronic data storage (memory) capacity.

AI/ML Overview

The provided text is a 510(k) summary for the Philips Medical Systems INTERA Family. It describes the device, its predicate, and its intended use. However, it does not include detailed information on acceptance criteria for a study, nor does it describe a study specifically designed to prove the device meets acceptance criteria as would be expected for a novel device.

The core of this submission is a claim of substantial equivalence to a previously cleared predicate device (Gyroscan / NT INTERA family). The document states:

"The INTERA Family does not induce any other risks than already indicated for the predicate devices. It has the same safety and effectiveness as its predecessor."
"It is the opinion of Philips Medical Systems that the Philips INTERA Family is substantially equivalent to its predecessor."

Therefore, the "acceptance criteria" and "study" described in the provided text are based on the premise of substantial equivalence, rather than a de novo study with specific performance metrics.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations regarding a formal "study":

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Implied by Substantial Equivalence Claim)
Safety: No new or increased risks compared to predicate device.	The INTERA Family does not induce any other risks than already indicated for the predicate devices.
Effectiveness: Same level of effectiveness as predicate device.	It has the same safety and effectiveness as its predecessor.
Indications for Use: Consistent with predicate device.	Produces transverse, sagittal, coronal, and oblique cross-sectional images based on 'H metabolites; displays internal body structure, to assist in diagnosis when interpreted by a trained physician. (Identical to predicate's indications).
Technological Characteristics: Substantially similar, or any differences do not raise new questions of safety/effectiveness.	Based on the same platform with same functionalities as predecessor. Main differences (DIFFUSION TENSOR imaging, Microsoft Windows OS, larger data storage) are presented as enhancements or modernizations that don't alter fundamental safety/effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional "test set" or a study involving patient data with a specific sample size. The claim of substantial equivalence relies on:

The INTERA Family being "based on the same platform with the same functionalities as its predecessor."
The new functionalities (like DIFFUSION TENSOR imaging) or software updates (Microsoft Windows) not introducing new safety or effectiveness concerns.

Therefore, there is no explicit 'sample size' or 'data provenance' for a test set mentioned, as the equivalence is based on engineering and functional comparison to the predicate, which would have undergone its own clearance process previously.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No "test set" and corresponding "ground truth" establishment by experts for this specific 510(k) submission is described. The reliance is on the general understanding and established safety/efficacy of the predicate device family.

4. Adjudication Method for the Test Set

Not applicable. As no test set analysis involving expert readers is described, no adjudication method is mentioned.

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

Not applicable. The INTERA Family is a Magnetic Resonance Diagnostic Device (MRDD), not an AI or CAD (Computer-Aided Detection/Diagnosis) device which would typically be assessed with MRMC studies comparing human readers with and without AI assistance. The submission describes hardware/software updates to an MR imager.

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

Not applicable. This is not an algorithm-only device. It's a medical imager.

7. The Type of Ground Truth Used

Not applicable. For a substantial equivalence claim based on an existing imaging platform with minor updates, a specific "ground truth" derived from patient outcomes or pathology for this new submission is not typically required or described. The assumption is that the imaging capability, like its predicate, provides images that "when interpreted by a trained physician, yield information that may assist in diagnosis."

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model that requires a "training set" in the conventional sense. The "training" for such an MR system would refer to its engineering development and calibration, not a dataset for machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. See point 8.

Summary

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K030520

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 North America Company
Address	:	22100 Bothell Everett HighwayP.O. Box 3003
Registration No.	:	Bothell, WA 98041-3003
Contact person	:	Lynn Harmer
Date Supplement Prepared	:	January 9, 2003
Telephone	:	425-481-7312
Device (Trade) Name	:	INTERA family
Classification Name	:	Magnetic Resonance Diagnostic Device (MRDD)
Classification	:	Class II
Product code	:	LNH
Performance standards	:	NEMA voluntary standards, FDA MRDD guidances,UL and IEC 601 appropriate safety standards and/ordraft standards are used

Predicate Device(s):

The Philips Medical Systems INTERA Family is the successor of the already cleared (predicate device) Gyroscan / NT INTERA family with static magnetic field strengths of 0.5. 1.0, 1.5 and 3.0 Tesla.

Indications for use:

Device description:

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The INTERA Family is based on the same platform with the same functionalities as its predecessor.

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

. Added new functionality: DIFFUSION TENSOR imaging differentiates tissues with restricted diffusion from tissues with normal diffusion.
Operating software platform Microsoft Windows (instead of VMS) running . on the appropriate host-computer.
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 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 Family is substantially equivalent to its predecessor.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of a human figure, with three stylized profiles overlapping each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the figure. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 6 2003

Philips Medical Systems North America Company % Mr. Marc M. Mouser Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709 Re: K030520

Trade/Device Name: INTERA Family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: February 14, 2003 Received: February 19, 2003

Dear Mr. Mouser:

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 adulteration.

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (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 (800) 638-2041 or (301) 443-6597 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):

KU30520

Device Name :

INTERA Family.

Indication For Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number

V Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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.