The indication for use of the GYROSCAN NT and GYROSCAN CV systems remains the same, i.e. 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

RestGrid is a software option available for the Gyroscar-NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV.

RestGrid applies regional saturation of magnetization to the tissue. The saturation is spatially modulated resulting in a series of equally spaced saturation lines or bands. Deformation of the saturation pattern is used to evaluate regional cardiac motion or blood flow.

AI/ML Overview

Here's an analysis of the provided text regarding the RestGrid package, extracting information related to acceptance criteria and supporting studies:

This submission (K982834) describes the RestGrid package / GYROSCAN NT, a software option for Philips Gyroscan NT and Gyroscan CV Magnetic Resonance Imaging (MRI) systems. The core function of RestGrid is to apply regional saturation of magnetization to tissue, creating spatially modulated saturation lines or bands. The deformation of these patterns is then used to evaluate regional cardiac motion or blood flow.

It's important to note that this 510(k) summary does not detail specific performance studies with quantitative acceptance criteria against clinically defined ground truth. Instead, the demonstration of safety and effectiveness relies on substantial equivalence to previously cleared devices and adherence to established safety standards for MRI systems.

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are predominantly related to the device's functional equivalence to predicate devices and its compliance with general MRI safety standards, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) derived from a clinical study.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Intended Use	The device should be capable of evaluating regional heart wall motion and blood flow in a non-invasive study.	The RestGrid Option is stated to be "used to evaluate regional heart wall motion and blood flow in a non-invasive study." (This is a statement of capability rather than a measured performance against a clinical gold standard).
Technological Equivalence	The technological characteristics for creating spatially modulated saturation lines/bands should be consistent with predicate devices or established MRI principles.	"The technological characteristics remain identical to other Gyroscan NT systems. Spatially modulated saturation of the magnetization of the tissue is introduced for imposing the patterns of saturation lines." (Implies the underlying technology is not novel in a way that would introduce new risks or performance issues beyond existing systems).
Safety Parameters	The safety parameters of the MRI system with the RestGrid option should remain within the limits of FDA cleared Gyroscan NT systems and relevant FDA guidance documents for MRI. Specifically, adherence to:FDA cleared Gyroscan NT systems (ref.K963990)"Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application"Draft "MRI Guidance Update for dB/dt dd. 10-11-'95"NEMA voluntary standardsUL and IEC 601 relevant safety standards and/or draft standards	"The safety parameters of the MR systems remain the same as with the FDA cleared Gyroscan NT systems (re.K963990) and within the limits of the FDA documents: 'Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application' and draft 'MRI Guidance Update for dB/dt dd. 10-11-'95'." (This is a declaration of compliance based on the existing system's clearance and adherence to standards, not a new safety study specifically for RestGrid).
Substantial Equivalence	The device should be substantially equivalent to predicate devices for saturation techniques in MRI, specifically:RestSlab technique Gyroscan NT (ref.K.980645)Cardiac Tagging Techniques / Magnetom Vision (ref.K973799)	Philips "believes the RestGrid Software Package to be substantially equivalent to saturation techniques applied in commercially available RestSlabs (FDA re.K980645) and to Siemens Cardiac Tagging (FDA re.K973799)." (This is the primary argument for clearance, not a result of a direct comparative study within this submission).

Study Information (Based on Provided Text)

The provided 510(k) summary does not describe a specific clinical performance study with a test set, ground truth, or expert review process as typically understood for AI/CADe devices. Instead, the submission relies on the concept of substantial equivalence to existing, legally marketed predicate devices and compliance with established MRI safety and performance standards.

Therefore, many of the requested categories related to clinical study design cannot be answered from this document.

Sample size used for the test set and the data provenance: Not applicable, no specific clinical test set described. The submission relies on the established performance and safety of predicate devices and the underlying Gyroscan NT systems.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no described test set requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no test set described.
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. This device is a new software feature for an existing MRI system to enable a specific imaging technique (tagging), not an AI/CADe device designed to assist human readers in interpretation. There is no AI component or human-in-the-loop performance measurement described.
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 software option for an imaging system. The "performance" is the ability to generate the tagging patterns, which is inherent to the system's function rather than an interpretation task.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no dedicated clinical performance study with defined ground truth is presented in this document. The "truth" is implicitly aligned with the capabilities of the predicate devices.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, K982834 is a submission for a software option that introduces a new imaging technique (cardiac tagging via spatially modulated saturation) to an existing MRI platform. Its clearance is based on demonstrating that this new capability maintains the safety profile of the base MRI system and is substantially equivalent to other devices offering similar tagging functionalities, rather than proving diagnostic accuracy through a dedicated clinical study with defined acceptance criteria for diagnostic performance.

Summary

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K98 2834

OCT 2 9 1998

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 AvenueShelton, CT 06484.
Registration No.	:	1217116
Contact person	:	Peter Altman
Telephone Number	:	203-926-7031
Prepared	:	July 1998.
Device Name	:	RestGrid package / GYROSCAN NT.
Classification Name	:	Magnetic Resonance Diagnostic Device.
Classification	:	Class II.
Performance standards	:	NEMA voluntary standards, FDA MRI guidances, ULand IEC 601 relevant safety standards and/or draftstandards are used.
Common/Usual Name	:	RestGrid/ Tagging studies / SPAMM / CSPAMM
Predicate Device(s)	:	- RestSlab technique Gyroscan NT (ref.K.980645)- Cardiac Tagging Techniques / Magnetom Vision(ref.K973799).

Device Description :

RestGrid is a software option available for the Gyroscar-NT platforms: ACS-NT, T10-NT, T5-NT and the Gyroscan-CV.

Intended Use :

The RestGrid Option on the Gyroscan NT and Gyroscan CV is used to evaluate regional heart wall motion and blood flow in a non-invasive study..

Technological Characteristics:

The technological characteristics remain identical to other Gyroscan NT systems. Spatially modulated saturation of the magnetization of the tissue is introduced for imposing the patterns of saturation lines.

General Safety and Effectiveness Concerns

The safety parameters of the MR systems remain the same as with the FDA cleared Gyroscan NT systems (re.K963990) and within the limits of the FDA documents: "Attachment 1 of Guidance for content and review of a magnetic resonance device 510(k) application" and draft "MRI Guidance Update for dB/dt dd. 10-11-'95".

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Substantial Equivalence

Philips believes the RestGrid Software Package to be substantially equivalent to saturation techniques applied in commercially available RestSlabs (FDA re.K980645) and to Siemens Cardiac Tagging (FDA re.K973799).

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

OCT 2 9 1998

Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue Shelton, CT 06484

K982834

Re:

RestGrid Package for Philips Gyroscan NT and Gyroscan CV Dated: August 11, 1998 Received: August 12, 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 (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 ritro 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, piease 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/odri/dsmaldsmamain.html".

Sincerely yours,

William Yip

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

Image /page/2/Picture/14 description: The image shows a partial view of the Department of Health & Human Services logo. The logo features a stylized depiction of an eagle or bird-like figure, rendered in black. The words "DEPARTMENT OF HEALTH & H" are partially visible, arranged vertically along the left side of the logo.

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510(k) Number (if known):	Unknown
Device Name :	RestGrid package option for GYROSCAN NT and GYROSCAN CV.

Indication For Use :

The RestGrid is a software option to the Philips GYROSCAN NT and GYROSCAN CV systems.

This option is used to evaluate regional heart wall motion in both the left and right side of the heart and blood flow in a non-invasive study.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chrid C. Feguson

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological I

510(k) Number K982834

Prescription Use
(Per 21 CFR 801.109)

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.