(27 days)
Intended Use:
- Defibrillation .
- Cardioversion ●
- Noninvasive Pacing
- . ECG Monitoring
- CPR Sensor .
For use with ZOLL @ Defibrillators:
- R Series ◆
- M Series ●
By Trained Personnel only, Including:
- Physicians .
- Nurses ◆
- Paramedics .
- Emergency Medical Technicians .
- Cardiovascular Laboratory Technicians .
The OneStep Adult Electrodes are not indicated for use on a patient less than 8 years of age or weighs less than 55 Lbs. (25Kg).
The OneStep Electrode System is intended for use with ZOLL R Series and M Series for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Sensor of adult patients in either the hospital or pre-hospital environment.
Through part number selection you can choose the full featured Complete model down to the Basic version which offers fewer therapy options. The OneStep Adult Electrodes consist of 5 versions related to the combination of features included with the electrodes.
The system is comprised of a single use, disposable electrode made of solid hydrogel with a pure tin electrical conductive element having a polyethylene terephtalate (PET) backing with an adhesive perimeter suitable for coupling to patient skin during rescue and/or treatment. By product selection it is determined whether all therapy providing options are available or a reduced choice is made as applicable to caregiver needs.
This submission describes a Special 510(k) for the OneStep Adult Multi-Function Electrode, primarily to address a change in the self-test continuity circuit. The device is determined to be substantially equivalent to previously cleared ZOLL electrodes. The provided document does not contain acceptance criteria or a study that directly proves the device meets specific performance acceptance criteria in the context of typical AI/software device evaluation.
Instead, the document focuses on:
- Demonstrating substantial equivalence to predicate devices (ZOLL ready-padz OneStep Electrodes K060559 and ZOLL stat: padz MWP K051076).
- Describing a change in the self-test continuity circuit to enhance its effectiveness and reliability.
- Stating that the device has undergone "extensive performance testing to ensure the device meets all of its functional requirements and performance specifications as defined in applicable National/International recognized standards."
- Mentioning Validation Project Number (VPN) 0730 which "addresses design validation to ensure the safety and effectiveness considerations have been successful in integrating the OneStep electrode with previously stated ZOLL defibrillators and performs as well and/or better than the legally marketed predicate devices."
Therefore, the following information cannot be extracted from the provided text for the reasons stated below:
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A table of acceptance criteria and the reported device performance: The document does not explicitly state numerical acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) nor does it provide a table of reported device performance against such criteria. It generally states that the device 'meets/exceeds National and International Standards ANSI/AAMI DF80 and EN 60601-2-4' but doesn't list specific metrics or results.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No specific clinical test set, sample size, or data provenance (country, retrospective/prospective) is described. The document refers to "clinical service since the latter part of October, 2006" for a previous version of the device, implying historical clinical use, but not a specific study with a defined test set for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Since no specific clinical test set is detailed, information about experts for ground truth establishment is not available.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no specific clinical test set is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrode for defibrillators, ECG monitoring, pacing, and CPR sensing. It does not involve "human readers" or AI assistance in the way a diagnostic imaging AI would.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical electrode system, not a standalone algorithm. Its function is to facilitate medical procedures.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for cancer detection) does not directly apply here. The performance is assessed against technical standards for electrical and mechanical properties, and compatibility with defibrillators.
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The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set in the conventional sense.
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How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Provided Text (within the context of the device):
- Device Type: Electrocardiograph, Multi-Function Electrode with CPR Sensor.
- Purpose of current submission (Special 510(k)): To address the relocation of the self-test continuity circuit.
- Performance Assessment:
- The device 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."
- The electrodes use the same hydrogel, acrylic adhesive closed-cell foam, and have a conductive area of the same dimensional size as predicate devices.
- The device "meet/exceed National and International Standards ANSI/AAMI DF80 and EN 60601-2-4 respectively."
- Validation Project Number (VPN) 0730 ensures "safety and effectiveness considerations have been successful in integrating the OneStep electrode with previously stated ZOLL defibrillators and performs as well and/or better than the legally marketed predicate devices."
In essence, the "study" proving the device meets acceptance criteria referred to here is a set of engineering and compliance tests against established national and international standards for medical electrodes and defibrillation accessories, along with design validation comparing its performance to predicate devices, focusing on the changes made (self-test circuit). Specific quantitative data from these tests are not present in this summary.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.