(183 days)
The Attenuated Defibrillation/Monitoring Pads are to be used with Defibtech Series AEDs on victims of sudden cardiac arrest ("SCA") when the patient is:
- Unconscious and unresponsive
- Not breathing
- Less than eight years old
Defibtech Attenuated Defibrillation/Monitoring Pads must be used by or on the order of a physician.
Do not delay therapy to determine exact age or weight.
Defibtech Attenuated Defibrillation/Monitoring Pads are intended for use only with Defibtech DDU-100 Series AEDs or compatible Defibtech AEDs, on patients who are less than eight years of age.
Attenuated Defibrillation/Monitoring Pads are indicated for use on victims of sudden cardiac arrest (SCA) when the patient is:
- Unconscious and unresponsive -
- ・ Not breathing
- -Less than eight years old
A pulse check is not required based on the recommendations of the American Heart Association Guidelines 2000 for CPR and ECC.
Attenuated Defibrillation/Monitoring Pads consist of two self-adhesive defibrillation/ monitoring pads used to monitor ECG signals and, if necessary, to deliver defibrillation energy to the patient. Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules. They are provided as a packaged, single-use disposable assembly.
The impedance between the two pads is monitored to ensure proper pad-to-patient contact. Visual and audio prompts inform the operator of possible problems with patient contact. Voice prompts and visual indicators communicate the status of the AED and of the patient to the operator.
Defibrillation energy is delivered as a biphasic truncated exponential waveform. The device delivers 150 Joules into a 50-ohm load. The pads incorporate an attenuator that decreases the energy delivered to the patient to 50 Joules. Delivered energy does not change significantly with patient impedance, although the duration of the generated waveform will vary. The Defibtech Series AED is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms.
This appears to be a 510(k) summary for the Defibtech AED with Attenuated Defibrillation/Monitoring Pads (Model DDU-100 with DDP-200P), intended for pediatric use.
Based on the provided text, there is no detailed study described that establishes specific acceptance criteria and then proves the device meets those criteria with statistical data. Instead, the document makes a general statement about safety and effectiveness.
Here's a breakdown of the requested information based on the provided text, with notes on what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "Testing and performance evaluations demonstrate that the safety and effectiveness of the Attenuated Defibrillation/Monitoring Pads is substantially equivalent to the predicate devices." (General statement, no specific metrics or thresholds provided.) |
| Energy Delivery (Pediatric) | The device is designed to deliver up to 50J of defibrillation energy through a pediatric patient impedance range of 25 - 175 ohms. (This is a design specification, not a performance outcome from a study.) |
| Energy Attenuation | "Attenuated Defibrillation/Monitoring Pads incorporate an energy attenuator, which cuts the nominal defibrillation energy of a Defibtech Series AED (150 Joules) to 50 Joules." (This is a design feature, not a performance metric from a study.) |
Explanation: The document focuses on demonstrating substantial equivalence to a predicate device (Heartstream Attenuated Defibrillation Pads, K003819) rather than presenting a standalone clinical study with predefined acceptance criteria and performance outcomes. The "Conclusion Summary of Safety and Effectiveness" explicitly states this.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document does not describe a clinical test set or its origin. It refers to "testing and performance evaluations," which could mean bench testing, animal studies, or internal verification, but no details are given.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable as no clinical study with ground truth establishment is described.
4. Adjudication Method
- Not applicable as no clinical study requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study is not described. The device is a physical medical device (defibrillator pads) that works in conjunction with an AED. Performance evaluations mentioned are likely related to its physical and electrical characteristics.
7. Type of Ground Truth Used
- Not applicable as no clinical study with ground truth is described. The assessment is based on "substantial equivalence" to a predicate device, implying that the predicate's established safety and effectiveness serve as a benchmark.
8. Sample Size for the Training Set
- Not applicable as no machine learning algorithm development (which would involve a training set) is described.
9. How Ground Truth for the Training Set was Established
- Not applicable as no training set or machine learning algorithm is described.
Summary of the Document's Approach:
The provided 510(k) summary primarily asserts substantial equivalence to a legally marketed predicate device (Heartstream Attenuated Defibrillation Pads, K003819). It states that "Testing and performance evaluations demonstrate that the safety and effectiveness" are equivalent. This type of submission often relies on a combination of:
- Bench testing: To confirm electrical characteristics, energy attenuation, impedance ranges, etc.
- Design specifications: Highlighting how the device's design meets the intended function (e.g., delivering 50J into a specific impedance range).
- Comparison to predicate device's established performance: Assuming the predicate device is safe and effective, the new device needs to demonstrate it functions similarly for the same indications.
It does not present a detailed clinical trial with specific acceptance criteria, statistical performance metrics, or a described ground truth methodology.
§ 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.