(17 days)
Not Found
No
The summary focuses on hardware design for optimized ECG acquisition during MR, with no mention of AI/ML terms or data processing/analysis that would typically involve such technologies.
No
The description states the device is "designed to allow for an optimized ECG acquisition during MR examinations," indicating it's for diagnostic purposes (acquiring ECG data) rather than directly treating a condition.
No
The device is described as an "ECG acquisition option" designed to optimize ECG acquisition during MR examinations. Its intended use is to facilitate the collection of physiological data (ECG) for monitoring during MR procedures, not to interpret or diagnose medical conditions from that data.
No
The device description explicitly states "Active ECG Electrodes (AECGE)", which are hardware components used for ECG acquisition. The summary does not indicate that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is designed for "optimized ECG acquisition during MR examinations." ECG (Electrocardiogram) is a measurement of the electrical activity of the heart, which is a physiological measurement taken directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is to facilitate ECG acquisition during MR exams, not to analyze a biological sample.
Therefore, the Active ECG Electrodes are a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LNH
Device Description
The Active ECG Electrodes (AECGE) is an ECG acquisition option for the Magnetom Vision
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
directly above the patient's heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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 (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:
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