(400 days)
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No
The device description and performance studies indicate a simple magnetic field sensor with audio and visual alarms, not complex data processing or learning algorithms.
No.
The device is described as a 'Magno Alarm' that forewarns the presence of environmental magnetic fields through sound and light signals. Its purpose is to detect and alert individuals to potential hazards from magnetic fields, not to treat or alleviate a medical condition. The predicate device is a 'test magnet', reinforcing its role as a diagnostic/alerting tool rather than a therapeutic one.
No
Explanation: The device is described as a "Magno Alarm" that warns of environmental magnetic fields, not for diagnosing a medical condition in a patient. It is a warning device, not a diagnostic one.
No
The device description explicitly states it "produce sound and light signals," which implies hardware components are involved in generating these outputs. It also mentions testing for "electromagnetic compatibility," which is typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The described device detects environmental magnetic fields and provides audio and visual alerts. It does not analyze any biological samples from the user.
- Intended Use: The intended use is to warn individuals with implantable devices about potentially harmful magnetic fields in their environment, not to diagnose or monitor a medical condition through the analysis of biological specimens.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Magno Alarm is a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The Magno Alarm has been tested for electromagnetic compatibility and the test results is included in the supplement to our 510(k) (K960849) of 08-12-96.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Magno Alarm is presented to be substantially equivalent to the test magnets employed as an external and noncontacting auxiliary tool for pacemakers/ICD's.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.3690 Pacemaker test magnet.
(a)
Identification. A pacemaker test magnet is a device used to test an inhibited or triggered type of pacemaker pulse generator and cause an inhibited or triggered generator to revert to asynchronous operation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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510(k) Summary
MAR 2 7 1997
Background:
MAR 2 7 1997
Cardiac Assist Devices, Inc. has design, developed, and extensively tested a device that is useful, safe and effective for forewarning presence of environmental magnetic fields that might be potentially harmful for certain individuals with implanable devices such as pacemakers or ICD's.
Motivation for the development of the Masno Alarm:
The motivation for developing the Magno Alarm was the fact that the pacemakers/ICD's are equipped with a magnetic field sensory mechanism that is an integral part of the device. Trais magnetic field sensory mechanism, within the pacemaker/ICD's, is intended for a non-invasive and non-contact mode alteration of the implantable device via a test magnet by and under Although this magnetic field sensory mechanism within the supervision of a physician. implantable devices offers a useful remote, non-invasive and non-contact access for mode alteration of the implantable device, however, it does not have any safeguard against inadvertent exposure to environmental magnetic field. In other words, if an individual whose heart's function depends on a pacemaker or an ICD is inadvertently exposed to a magnetic field of, say the refrigerator door seal, then the mode of hisher implanted device may change; such occurrence may be extremely harmful to the individual. To protect the individual with implanted heart assisting devices such as pacemakers/ICD's against accidental exposure to environmental magnetic fields. Cardiac Assist Device, Inc. has device that has a lower activetion threshold from that of typical pacemakers and/ or ICD's. The lower activation threshold of the Magno Alarm provides a safety factor of at least two (2) for the patient to get a warning regarding the presence of magnetic field in hisher environment. The warning of the Masno Alarm enables the natient to retrace his/her steps to safety, before the environmental magnetic field can cause an undesirable of the implantable pacemaker/CD. The Masno Alarm has been designed so that it does not interfere with the function of pacemakers/ICD's. The Magno Alarm is a device that in presence of magnetic fields produce sound and light signals to be noticed by the hearing and sight senses of an individual who is using it. In coaclusion. the Magno Alarm is a safe, effective and useful device a person to sense presence of environmental magnetic fields by producing audio and visual signals. The Magno Alarm is presented to be substantially equivalent to the test magnets employed as an external and noncontacting auxiliary tool for pacemakers/ICD's. Next section of this supplement presents the bases of the substantial equivalence of the Magno Alarm and the predicate device.
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Bases of Substantial Equivalence:
- The Magno Alarm is used to ascerain and verify the proper magnetic field environments a) for pacemakers/ICD users. The test mannet interacts with pacemakers/ICD's via the magnetic field. While the test magnet employs magnetic field to make pacemakers/ICD's to operate in a particular mode (the mamet mode). the Magno Alarm detects the magnetic field(s) that prevents the pacemakers/ICD's from operating in a particular mode (the normal mode)
- b) Use of the test magnet generates information useful to the implantable pacemaker/ICD patients that is under the magnet mode. The pacemaker's pacing rate, under the test magnet, is an indication of the remained buttery life of the pacemaker. Similarly, use of Magno Alarm generates information useful to the implantable pacemaker/ICD patients. that is, when the device (Magno Alarming, the environmental mannetic field is safe for the implantable pacemaker/ICD.
- Both the test magnet and the Magno Alarm do not physically contact the implantable c) device while they perform their intended functions.
The Magno Alarm has been tested for electromagnetic compatibility and the test results is included in the supplement to our 510(k) (K960849) of 08-12-96.