The Active ECG Electrodes (AECGE) are designed to allow for an optimized ECG acquisition during MR examinations. The small dimensions and the method of placing the AECGE directly above the patient's heart are means of minimizing the interference with the MR system.

Device Description

The Active ECG Electrodes (AECGE) is an ECG acquisition option for the Magnetom Vision

AI/ML Overview

Unfortunately, no information is provided in the document regarding acceptance criteria or a specific study that proves the device meets those criteria.

The document is a 510(k) summary and the FDA's clearance letter for the "Active ECG Electrodes MAGNETOM VISION Systems." It focuses on demonstrating substantial equivalence to a previously cleared device (Siemens Magnetom Impact, 42 SP and 63 SP with Disposable ECG Electrodes, K915112), rather than providing detailed performance data against specific acceptance criteria.

Here's a breakdown of what is and is not in the provided text, related to your request:

What is present:

Device Description and Intended Use: The Active ECG Electrodes (AECGE) are an ECG acquisition option for the Magnetom Vision, designed for optimized ECG acquisition during MR examinations by minimizing interference.
Technological Characteristics: States that the magnet, RF system, and gradient system are substantially equivalent to the standard MAGNETOM Vision system.
General Safety and Effectiveness Concerns: Lists MR safety and performance parameters that are unaffected by the modification (e.g., Maximum Static Field, RF Power Deposition, Signal to Noise, Image Uniformity). This implies these parameters already meet established safety and performance levels for MRI systems, and the new electrodes do not degrade them.
Substantial Equivalence Claim: The core of the 510(k) is the assertion that the device is substantially equivalent to a predicate device.

What is NOT present (and therefore cannot be extracted from this document):

A table of acceptance criteria and reported device performance: This document does not present specific quantitative performance metrics for the Active ECG Electrodes, nor does it list acceptance criteria that these metrics would be measured against. The focus is on not affecting the performance of the core MR system.
Sample sized used for the test set and data provenance: No information is given about any specific studies conducted solely on these active ECG electrodes to measure performance.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as a dedicated performance study with a test set and ground truth is not described.
Adjudication method: Not applicable.
Multi reader multi case (MRMC) comparative effectiveness study: No mention of such a study.
Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable as this is hardware (electrodes), not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable as this is hardware.
How the ground truth for the training set was established: Not applicable.

In essence, this document is a regulatory submission demonstrating that a new component (Active ECG Electrodes) does not negatively impact the safety and effectiveness of an existing, cleared medical device (MAGNETOM VISION MR system) and thus is substantially equivalent to another existing component (Disposable ECG Electrodes). It does not provide the kind of detailed performance study and acceptance criteria often seen for new diagnostic algorithms or devices with novel performance claims.

Summary

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510 (k) Summary

This summary of 510(k), safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

I. General Information.

Establishment:

Siemens Medical Systems, Inc. Address: . 186 Wood Avenue South Iselin, N.J. 08830
2240869 Registration Number:

Contact Person: Ms. Durkhani Roshan Technical Specialist, Regulatory Submissions Telephone: (732) 321-4625 FAX: (732) 321-4841

Date of Summary Preparation: 9/18/98

Device Name:

· Trade Name: Active ECG Electrodes / MAGNETOM VISION
· Systems Classification Name: Magnetic Resonance Diagnostic Device, CFR $892.1000
· Classification : Class II
· Performance Standards : None established under Section 514 of the Food, Drug, and Cosmetic Act.

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II. Safety and Effectiveness Information Supporting Substantial Equivalence. · Device Description:

The Active ECG Electrodes (AECGE) is an ECG acquisition option for the Magnetom Vision

• Intended Use

· Technological Characteristics

The magnet, RF system, and gradient system, of the MAGNETOM Vision configured with the Active ECG Electrodes (AECGE) is substantially equivalent to the standard MAGNETOM Vision system.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Vision with the Active ECG Electrodes (AECGE) is substantially equivalent to standard operation of the MAGNETOM Vision system. The following MR safety and performance parameters are unaffected by the modification:

[Safety]

Maximum Static Field .
. Rate of Change of Magnetic Field
RF Power Deposition
Acoustic Noise Levels
Specification Volume .

[Performance]

Signal to Noise ●
Image Uniformity .
. Geometric Distortion
. Slice Profile, Thickness and Gap
. High Contrast Spatial Resolution

· Substantial Equivalence:

Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the Magnetom Vision with the Active ECG Electrodes is substantially equivalent to the Siemens Magnetom Impact, 42 SP and 63 SP with the Disposable ECG Electrodes which were originally described in premarket notification K915112 which received FDA clearance on 12/27/91.

Kathleen Rutherford
Kathleen M. Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions

9/21/98
Date

Active ECG Electrodes MAGNETOM VISION

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Image /page/2/Picture/16 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle's head and neck, with the head facing to the right. The eagle is composed of thick, black lines that create a sense of movement and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, with the words separated by dots.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1998

Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Woods Avenue South Iselin, NJ 08830

Re: K983327

Active ECG Electrodes MAGNETOM VISION Systems September 18, 1998 Dated: Received: September 22, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Rutherford:

We have reviewed your Section 510(k) notification of intent to market the device referenced 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 Devices that have been reclassified in accordance with the provisions of the Federal Food Drug, and Cosmetic Act (Act). You may, therefore, narket the device, subject to the general controls of the Act. The generalsontrols 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 equivalian assumes-compliance.with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices of Central regulation (2) 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 additions 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 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 Ervision 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/odrh/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, P Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) _ K 9 8 3,3 x 2 _

Device Name: Active ECG Electrodes

Indications for Use:

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use ✓

Over-The-Counter Use

Stinil A. Seym

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Regulation Number and Section

N/A