(87 days)
The ZOLL SurePower Single Bay Charger is a single-bay unit that can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery.
The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries:
· SurePower Battery Pack
· SurePower II Battery Pack
The ZOLL SurePower Charger System was cleared by the agency under 510(k) application K060559. This device is a four bay charger system that contains circuitry to monitor the battery's current, temperature, and voltage to ensure safe and effective battery charging and testing. The charging bays in the SurePower Charger Station are designed to accommodate the following ZOLL rechargable lithium ion battery:
· SurePower Battery Pack
· SurePower II Battery Pack
and the following ZOLL rechargable lead acid batteries:
· Battery Pack PD4410
· Smart Ready Battery
· Smart Battery
· XL Smart Ready Battery
· XL Smart Battery
The batteries communicate with the ZOLL SurePower Charger Station over a serial communication interface utilizing the SMBus communications protocol.
The SurePower Single Bay Charger is a product line extension of the SurePower (four bay) Charger Station currently in production. The following is a comparison summary of the proposed ZOLL SurePower Single Bay Battery Charger when compared to the ZOLL SurePower Charger:
- The SurePower Single Bay Charger is a one bay version of the existing SurePower . Charger.
- The SurePower Single Bay Charger charges ZOLL Lithium Ion battery packs only . which includes the SurePower and SurePower II battery packs
This document describes a 510(k) submission for the ZOLL SurePower Single Bay Charger, a medical device for charging defibrillator batteries.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical acceptance criteria in the typical sense for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criterion for this product line extension is "substantial equivalence" to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device can test, recalibrate, and charge a single ZOLL rechargeable defibrillator battery. | "The SurePower Single Bay Charger is a one bay version of the existing SurePower Charger. ... Extensive performance testing ensures that the ZOLL SurePower Single Bay Charger performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications." |
| Safety Equivalence | Device complies with applicable sections of recognized industry and safety standards. | "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." |
| Technological Characteristics Equivalence | The technological characteristics are substantially equivalent to the predicate device (ZOLL SurePower Charger, K060559). | "The technological characteristics of the ZOLL SurePower Single Bay Charger are substantially equivalent to the currently marketed ZOLL SurePower Charger (K060559, cleared for use on 8/17/2006)." |
| Intended Use | Accommodates SurePower Battery Pack and SurePower II Battery Pack for charging. | "The charging bay in the SurePower Single Bay Charger is designed to accommodate the following ZOLL rechargeable lithium ion batteries: SurePower Battery Pack, SurePower II Battery Pack." |
The study concludes that "Performance and safety testing of the ZOLL SurePower Single Bay Charger demonstrates that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate device with regard to performance, safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in terms of a clinical dataset for evaluating diagnostic or treatment performance. Instead, the performance testing described is likely a series of engineering and functional tests on the device itself and its interaction with the specified batteries. Therefore, specific sample sizes for a "test set" and data provenance (e.g., country of origin, retrospective/prospective) are not applicable in the classical sense of clinical studies. The testing would have been conducted internally by ZOLL Medical Corporation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. For a device like a battery charger, "ground truth" is established through engineering specifications, standards adherence, and direct measurement of electrical characteristics, not through expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set:
Not applicable. The "testing" involves functional and safety verification against engineering specifications and standards, not clinical adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. A battery charger does not involve human interpretation or a diagnostic task that would necessitate an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done:
Yes, in a sense. The "performance testing" described for the ZOLL SurePower Single Bay Charger is inherently a standalone evaluation of the device's functionality, safety, and adherence to specifications without a "human-in-the-loop" component in the clinical interpretation sense. The device's algorithms for charging and monitoring batteries operate autonomously.
7. The Type of Ground Truth Used:
The "ground truth" for this device would be:
- Engineering Specifications: The design and functional requirements for charging, recalibration, and battery compatibility.
- Industry and Safety Standards: Compliance with established electrical, safety, and performance standards relevant to medical device chargers (though specific standards are not listed in this summary, they are implied by the statement "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards").
- Predicate Device Performance: The established performance characteristics of the ZOLL SurePower Charger (K060559) served as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. The ZOLL SurePower Single Bay Charger is a hardware device with embedded control logic, not a machine learning or AI algorithm that requires a "training set" of data in the typical sense for image analysis or prediction tasks. Its design and functionality are based on engineering principles and established protocols, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device.
§ 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.