ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS

K983327 · Siemens Medical Solutions USA, Inc. · LNH · Oct 9, 1998 · Radiology

Device Facts

• Record ID: K983327
• Device Name: ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

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 Story

Active ECG Electrodes (AECGE) function as an ECG acquisition option for the MAGNETOM Vision MR system. Electrodes are placed directly above the patient's heart to capture cardiac electrical signals during MR imaging. Small dimensions minimize electromagnetic interference with the MR system. Used in clinical MR environments by trained personnel. Output provides ECG data to the MR system to facilitate cardiac-gated imaging. Benefits include optimized signal acquisition and reduced interference, enabling clearer cardiac MR images.

Clinical Evidence

No clinical data provided; bench testing only. Safety and performance parameters were evaluated to ensure no degradation of MR system function or image quality compared to the predicate.

Technological Characteristics

ECG electrodes designed for MR compatibility. Small form factor for placement over the heart. Integrates with MAGNETOM Vision MR system. No changes to magnet, RF, or gradient systems. No specific materials or software algorithms described.

Indications for Use

Indicated for patients undergoing MR examinations requiring ECG acquisition. No specific age or gender restrictions provided.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Siemens Magnetom Impact, 42 SP and 63 SP with the Disposable ECG Electrodes (K915112)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

#### 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

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.

# · 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use ✓

OR

Over-The-Counter Use

Stinil A. Seym

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

8