Search Results

• Defibrillation
• ECG Monitoring
• Cardioversion ●
• CPR Feedback ●

The CPR Dura-padz Reusable Defibrillation Electrode is used in conjunction with Dura-padz Gel, and for use with the following ZOLL Biphasic-only defibrillators with max. energy setting of 200 Joules:

• AED Pro
• M Series ●
• E Series ●
• R Series ●

The device will be used in pre-hospital, alternate care and hospital settings by trained personnel only, including:

• . Physicians
• Nurses
• Paramedics
• Emergency Medical Technicians ●
• Cardiovascular Laboratory Technicians
• First Responders

The CPR Dura-padz Reusable Defibrillation Electrodes are not for use with ZOLL AED Plus and/or any Public Access Defibrillators.

The CPR Dura-padz Reusable Defibrillation Electrodes are not indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).

As with the cleared predicate device (K100565), the CPR Dura-padz Reusable Defibrillation Electrode is intended for use with the following ZOLL biphasic-only defibrillators: AED Pro, E Series, R Series and M Series for ECG monitoring, defibrillation and cardioversion. The addition of a CPR sensor (cleared per K110742) to the subject device will enable CPR feedback. As with the currently marketed predicate device (K100565), the CPR Dura-padz electrode is intended for use in conjunction with Dura-padz Gel on adult patients, and the electrode is reusable up to 100 patient uses.

The provided text does not contain specific acceptance criteria for a device, nor does it describe a study detailing the device's performance against such criteria. The document is a 510(k) premarket notification for the "CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel," which is an FDA submission for substantial equivalence to legally marketed predicate devices.

Instead of acceptance criteria and device performance, the document states:

• "Substantial Equivalence - Non-Clinical Evidence:" "Safety, efficacy and substantial equivalence was shown through verification and validation testing." And earlier: "The existing features and functions (defibrillation, cardioversion and ECG monitoring) of the CPR Dura-padz Reusable Defibrillation Electrode have been cleared per K100565. ... The CPR Feedback monitoring function is the same technology used in the predicate device cleared per K110742."
• "Substantial Equivalence - Clinical Evidence: N/A - Clinical evidence was not necessary to show substantial equivalence."
• "Performance Testing:" "The CPR Dura-padz Reusable Defibrillation Electrode with Dura-padz Gel has been subjected to extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards. Performance testing is provided in Section 18 of this submission."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document refers to "Section 18 of this submission" for performance testing details, which is not included here. The core of this FDA submission is to demonstrate equivalence to existing devices (K100565 and K110742) rather than presenting a novel study against specific, new acceptance criteria.

Ask a specific question about this device