The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Device Description

The Fukuda Denshi ECG Monitor Model DS-3130/3140 is being added to increase the clinical utility of the AIRIS and STRATIS in the stationary configuration. The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS. The Model DS-3140 ECG Monitor has a stripchart recorder, the Model DS-3130 does not. As with the previous version of the ECG Monitor, the Model DS-3130/3140 supports ECG, peripheral pulse and respiratory gating; respiratory gating is not supported on the AIRIS. The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems.

AI/ML Overview

This document describes a 510(k) submission for an ECG Monitor (Model DS-3130/3140) to be added as an accessory to existing Hitachi MRI systems (AIRIS and STRATIS). The submission essentially states that the new ECG Monitor is "Identical to the Predicate Device" (Hitachi AIRIS with ECG Monitor and Hitachi STRATIS with ECG Monitor).

Therefore, the acceptance criteria and study information provided in this document are minimal, as the submission relies on the substantial equivalence of the new accessory to previously cleared devices.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria or performance metrics for the ECG monitor itself beyond it being "UL-listed" and meeting "UL/ETL listing requirements." The core of the submission is that the device's technological characteristics are "Identical to the Predicate Device."

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functionality: Support ECG, peripheral pulse, and respiratory gating (respiratory gating not supported on AIRIS).	The Fukuda Denshi ECG Monitor Model DS-3130/3140 supports ECG, peripheral pulse, and respiratory gating (respiratory gating is not supported on the AIRIS).
Safety: UL-listed and meets UL/ETL listing requirements.	The new ECG Monitor is UL-listed, and is being added to meet UL/ETL listing requirements for the AIRIS and STRATIS.
Technological Characteristics: Identical to the Predicate Device.	Identical to the Predicate Device (Hitachi AIRIS with ECG Monitor and Hitachi STRATIS with ECG Monitor).
Intended Use: Function as an accessory to Hitachi MRI systems to increase clinical utility.	The Fukuda Denshi ECG Monitor Model DS-3130/3140 is only intended for distribution in the US as an accessory to the Hitachi MRI systems. It is being added to increase the clinical utility of the AIRIS and STRATIS.

Where the document falls short on providing the requested information:

Sample size used for the test set and the data provenance: Not mentioned. Since the device is considered "identical," it's likely no new clinical testing data was deemed necessary for this specific 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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 relevant. This is an ECG monitor accessory for an MRI, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant. This is a monitoring device, not a standalone AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not relevant. This is not an AI/machine learning model.
How the ground truth for the training set was established: Not relevant. This is not an AI/machine learning model.

In summary, this 510(k) submission is for an accessory (ECG Monitor) which is claimed to be technologically identical to devices already on the market. Therefore, it focuses on demonstrating safety (UL-listing) and functional equivalence rather than presenting new clinical study data with specific performance metrics or ground truth validation as would be expected for a novel diagnostic device or AI algorithm.

Summary

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K96 1174

JUN 21 1996

Attachment 1 510(k) Summary of Safety and

Effectiveness

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SUBMITTER INFORMATION:

1.1 Hitachi Medical Systems America Submitter: 1963 Case Parkway Twinsburg, OH 44087 PH: 216 425 1313 FX: 216 425 1410
1.2 Contact: James Jochen Rogers
1.3 Date: March 21, 1996

2.0 DEVICE NAME

Classification Panel: 2.1 Radiology 2.2 Classification Number: 892.1000 Magnetic Resonance Diagnostic Device 2.3 Product Number: 90LNH 2.4 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging 2.5 Trade/Proprietary Name: ECG Monitor Model DS-3130/3140 2.6 Predicate Device: Hitachi AIRIS with ECG Monitor

Hitachi STRATIS with ECG Monitor.

3.0 DEVICE DESCRIPTION:

FUNCTION 3.1

3.2 SCIENTIFIC CONCEPTS

Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in magnetic resonance. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radiofrequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation.

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The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by two exponential relaxation times called T1 and T2 which can be measured.

These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emissions on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by appropriately applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT.

For magnetic fields up to 1.5T, the RF frequencies commonly used range up to 65MHz. The RF fields have pulse powers from several watts to greater than 10 kilowatts, and repeat at rates from once every few seconds to greater than fifty per second. The time-varying magnetic gradient fields have a typical duration of submillisecond to several milliseconds.

3.3 PHYSICAL AND PERFORMANCE CHARACTERISTICS

MR is currently of great interest because it is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation times T1 and T2 all may contribute to image contrast. In addition, by varying the duration and spacing of the RF pulses, images may be produced in which the contrast is primarily dependent on T1 relaxation. T2 relaxation, proton density, or a combination of all three.

4.0 DEVICE INTENDED USE:

Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:

2D T1- / T2-weighted imaging T1, T2, proton density measurements MR Angiography image processing

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Imaging capabilities: ●

ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤ

2D, 3D Spin Echo (SE) 2D Fast Spin Echo (FSE)

2D Inversion Recovery (IR)

2D, 3D Gradient Echo (GE)

2D, 3D Gradient Echo with Rephasing (GR)

2D, 3D Steady state acquisition with rewinded GE (SARGE)

2D Dual Slice acquisition (DS)

MR Angiography (2D TOF, 3D TOF, half echo,

high resolution/high definition)

5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS:

Identical to the Predicate Device.

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.