(110 days)
- Defibrillation
- Cardioversion
- Noninvasive Pacing
- ECG Monitoring
- CPR Feedback
For use with ZOLL® Defibrillators, such as: - R Series
- X Series
Trained Personnel only, Including: - Physicians
- Nurses
- Paramedics
- Emergency Medical Technicians
- Cardiovascular Laboratory Technicians
The OneStep Pediatric CPR electrodes are indicated for use on a patient less than 8 years of age or weighing less than 55 lbs (25kg).
As with the currently marketed OneStep Pediatric CPR Multi-Function Electrode (reviewed and cleared with K120907), the modified OneStep Pediatric CPR Multi-Function Electrode (MFE) is intended for use with ZOLL R Series and ZOLL X Series defibrillators for ECG Monitoring, Defibrillation, External Noninvasive Pacing, Cardioversion and CPR Feedback for use on patient less than 8 years of age or weighing less than 55lbs (25kg) in either the hospital environment. The currently marketed OneStep Pediatric CPR MFE provides users with accurate depth compression feedback when CPR is performed on a firm surface – a known recommended practice. A recent publication by the AHA acknowledges that "accelerometers are insensitive to mattress compression" and stresses the need for "continued development of optimal and widely available CPR monitoring." So. with the current submission. we are proposing to modify the OneStep Pediatric CPR MFE to incorporate a second motion sensor on the posterior electrode thereby allowing rescuers to obtain accurate depth compression feedback when CPR is performed on soft/ compressible surfaces. Dual sensor technology, utilized in the proposed OneStep Pediatric CPR MFE. has been reviewed and cleared by the agency with OneStep CPR II MFE (K133441).
As with the predicate device, the proposed electrode and wire harness with a ZOLL proprietary connector will have a pre-connect feature that enhances the user's ability to deliver immediate therapy. And like the predicate device, the OneStep Pediatric CPR electrode is also designed to support the defibrillator's self test and expiration date identification. Each electrode pad is structurally comprised of a 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.
The provided text is a 510(k) summary for the ZOLL OneStep Pediatric CPR Multi-Function Electrode (MFE). It describes a modified device that incorporates a second motion sensor for improved CPR depth feedback on soft surfaces. However, it does not explicitly provide a table of acceptance criteria or detailed results of a study proving the device meets specific performance metrics in the way that would typically be presented for image-based diagnostic or AI-driven medical devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical evidence and performance testing against recognized standards. There is no mention of a study involving human readers or AI in the context of diagnostic accuracy.
Therefore, many of the requested elements cannot be extracted directly from this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a diagnostic outcome, nor does it present device performance in that manner. Instead, it states that the device was 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 performance testing listed consists of categories rather than specific metrics:
- EMC Testing in accordance with IEC 60601-1-2.
- Electrical, mechanical, bio-compatibility and simulated use testing per the applicable requirement of international recognized standards IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5 and ISO 10993-10.
- Testing to qualify the use of the electrode with R Series and X Series devices.
- Usability testing.
The "reported device performance" is essentially that these tests were conducted and the device met its functional requirements and specifications, allowing it to be deemed substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not refer to a "test set" in the context of diagnostic performance data (e.g., medical images or patient records). The "testing" mentioned refers to engineering and safety performance tests of the device itself (electrical, mechanical, usability). Therefore, sample sizes for such a test set and data provenance (country, retrospective/prospective) are not applicable or provided in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. The device is a multi-function electrode for CPR and defibrillation, not an interpretative diagnostic tool. Ground truth in the sense of expert consensus on diagnostic findings is not relevant to the described testing.
4. Adjudication Method:
Not applicable, as there's no diagnostic ground truth being established.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is compared with and without AI assistance. This document describes a physical medical device (electrodes) and its substantial equivalence based on engineering and safety performance, not a diagnostic algorithm.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone algorithm performance study was not done. The device in question is a hardware component with a function to provide feedback (CPR depth), not an independent algorithm for diagnostic interpretation.
7. Type of Ground Truth Used:
The "ground truth" for the performance testing described would be the verifiable measurements and standards for electrical safety, biocompatibility, mechanical integrity, and functional performance (e.g., accurate depth compression feedback as measured by a calibrated system). It is not expert consensus, pathology, or outcomes data in the diagnostic sense.
8. Sample Size for the Training Set:
Not applicable. The device is not an AI/ML algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
Summary regarding acceptance criteria and study in the context of the provided document:
The provided document describes the ZOLL OneStep Pediatric CPR Multi-Function Electrode and seeks 510(k) clearance by demonstrating substantial equivalence to existing predicate devices.
Instead of providing a typical "acceptance criteria" table with specific performance metrics for a diagnostic claim, the document indicates that acceptance was based on the device meeting functional requirements and performance specifications as defined by applicable National/International recognized standards.
The study (or rather, "performance testing") used to demonstrate this involved:
- EMC Testing: In accordance with IEC 60601-1-2.
- Electrical, Mechanical, Biocompatibility, and Simulated Use Testing: Per IEC 60601-1, IEC 60601-2-4, ISO 10993-1, ISO 10993-5, and ISO 10993-10.
- Device Qualification Testing: To ensure compatibility with ZOLL R Series and X Series defibrillators.
- Usability Testing.
The primary change being approved is the addition of a second motion sensor to improve CPR depth feedback on soft surfaces, a technology already cleared in a similar predicate device (OneStep CPR II MFE, K133441). Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." This indicates that the regulatory decision was based on engineering and performance testing against established standards for physical devices, rather than a clinical trial or diagnostic performance study.
§ 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.