(171 days)
The DDU-2400/2450 Semiautomatic External Defibrillator (AED) is indicated for use on victims of sudden cardiac arrest (SCA) who are:
- . Unconscious and unresponsive
- . Not breathing
For patients under 8 years old, or less than 55 (25kg), use child/infant electrode pads. Do not delay therapy to determine exact age or weight.
The DDU-2400/2450 AED must be used by or on the order of a physician.
The DDU-2400/2450 is a portable, Automated External Defibrillator (AED) intended for use on victims of sudden cardiac arrest (SCA). It is powered by a user-replaceable nonrechargeable battery and supports both adult and pediatric user-replaceable single-use defibrillation/monitoring pads.
The default mode of operation for the DDU-2400/2450 AED is Semiautomatic External Defibrillator (AED mode). In AED mode, after applying the defibrillation pads to the patient's chest, the AED automatically analyzes the patient's electrocardiogram (ECG) and, if needed, advises the operator to push the button and deliver a shock. The AED guides the operator through the rescue protocol using a combination of voice and text prompts, audible alerts, and visible indicators. The LCD display shows instructional videos and text prompts.
The DDU-2400/2450 provides some optional features for the advanced user. When used in AED mode, the user can set the LCD display to show the patient's ECG trace. These models also provide a non-diagnostic ECG monitoring mode to allow for rhythm and heart rate monitoring using an optional 3-wire monitoring pads adaptor with standard ECG electrodes.
The DDU-2400 (only) supports a Manual override mode. Manual mode permits the user to override the AED features of the defibrillator. Manual mode is intended for use by personnel trained in ECG recognition who want to use the defibrillator to deliver a shock independent of AED mode. Manual mode provides a display of the patient's ECG trace. operator-selected energy level along with charge, shock, and disarm functions.
The DDU-2400/2450 has a compact design and offers an easy-to-understand user interface with an LCD display. Voice prompts and a graphical user interface provide simple instructions for the operator. The DDU-2400/2450 AED is capable of recording event information including ECG, audio data and SHOCK/NO SHOCK recommendations.
The provided text describes a 510(k) summary for a Semiautomatic External Defibrillator (AED) and focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria in the way a de novo or PMA submission might.
Therefore, many of the requested categories for acceptance criteria and study details cannot be fully populated from this document. The submission relies on the concept of "substantial equivalence" to cleared devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria for a new study. The core "acceptance criteria" here is substantial equivalence to predicate devices. | The DDU-2400/2450 AED uses similar technologies to provide functionally equivalent performance characteristics as the predicate device. |
| Testing demonstrates that the DDU-2400/2450 meets functional and performance specifications, and safety testing assures compliance with applicable industry safety standards. | |
| Implicit Acceptance Criteria (based on substantial equivalence to predicates): | |
| ECG analysis algorithm performance (e.g., sensitivity, specificity for shockable rhythms) | Implied to be equivalent to the Defibtech DDU-2300 AED (K081259) as it uses the "same cardiac rhythm analysis algorithm." |
| Defibrillation energy and waveform | Implied to be equivalent to the Defibtech DDU-2300 AED (K081259) when used as an AED, and to the Heartstart XLT Defibrillator/Monitor (K992543) for selectable energy and waveforms in Manual mode. |
| General functional and safety performance | Demonstrated through testing to meet functional and performance specifications and assure compliance with industry safety standards. New issues of safety or effectiveness are not presented. |
| ECG display/monitoring and manual override features | Substantially equivalent to the Heartstart FR2 AED (K013425). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided in the document. The submission states that "Testing demonstrates that the DDU-2400/2450 meets functional and performance specifications, and safety testing assures compliance with applicable industry safety standards." However, it does not detail the nature of this testing (e.g., specific clinical studies, bench testing, etc.), sample sizes used for performance validation, or data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided. Given that the submission relies on substantial equivalence and does not detail a new clinical efficacy study with a ground truth established by experts, this is expected.
4. Adjudication Method for the Test Set
This information is not explicitly provided.
5. 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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not done or described in this document. This device is an Automated External Defibrillator (AED), which functions largely autonomously in its primary AED mode, advising the operator on shock delivery. While it has an optional ECG display for advanced users and a manual override, the core of the submission for substantial equivalence is not based on a human-AI interaction study of this nature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The cardiac rhythm analysis algorithm is a standalone component of the AED. The document states that the DDU-2400/2450 uses "the same cardiac rhythm analysis algorithm" as the predicate device (DDU-2300 AED, K081259). This implies that the standalone performance of this algorithm, assessed during the clearance of the predicate device, is considered sufficient for this submission. However, specific details of those standalone performance tests (e.g., sensitivity, specificity for shockable rhythms, dataset used) are not provided in this current document.
7. The Type of Ground Truth Used
The type of ground truth used for the original cardiac rhythm analysis algorithm (from the predicate DDU-2300) would typically involve expert-annotated ECG recordings, which is a form of expert consensus and/or reference standard based on clinical outcomes for shockable vs. non-shockable rhythms. This document does not provide details specific to the DDU-2400/2450 validation, but rather leverages the ground truth established for the predicate device's algorithm.
8. The Sample Size for the Training Set
This information is not provided. This document relies on the prior clearance of the algorithm within the predicate device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. This document relies on the prior clearance of the algorithm within the predicate 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.