(480 days)
The i-PAD NF1200 is used to treat a person suffering from sudden cardiac arrest (SCA) and who exhibits symptoms of
- No movement and no response when shaken .
- No normal breathing .
The i-PAD NF1200 is a semi-automated external defibrillator designed for minimally trained individuals. It provides simple and direct voice prompts and indications for a straightforward rescue operation. The i-PAD NF1200 needs the user to press its SHOCK button to deliver a defibrillating shock.
During a resoue operation, it continuously acquires the electrocardiogram (ECG) of the patient. It also conducts arrhythmia detection continuously except during cardiopulmonary resuscitation (CPR). The timing and duration of the CPR are in accordance with the recommendations of the American Heart Association (AHA) 2005 Guidelines for CPR and Emergency Cardiovascular Care (ECC).
The i-PAD NF1200 is lightweight and battery powered for maximum portability. Its battery pack has a capacity of 200 shocks (10 hours of operating time.)
It delivers a 150-Joule biphasic truncated exponential shock waveform that it compensates for patient impedance by adjusting its timing parameter. If the user decides not to deliver a charge, the i-PAD NF1200 disarms itself by dumping the charge into an internal resistive load.
The i-PAD NF1200 is capable of saving data and transmitting them to an external device.
The i-PAD NF1200 conducts periodic (daily, weekly, and 28-day) self-tests, a battery insertion self-test, and self-tests during power-ON and run-time. It informs the user if an error is detected through audio and visual indicators.
The provided text describes a 510(k) premarket notification for the i-PAD NF1200 Semi-automated External Defibrillator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to establish novel safety and effectiveness. Therefore, the information provided does not detail acceptance criteria and a study in the same way one might for a new drug or a de novo device. Instead, the study aims to show that the new device performs comparably to existing, approved devices.
Here's a breakdown of the available information regarding acceptance criteria and the "study" (which is more accurately described as a set of verification and validation tests):
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding device performance for the entire device. Instead, it describes compliance with recognized standards and a comparison to predicate devices.
| Acceptance Criteria Category | Description of Acceptance / Test Method | Reported Device Performance |
|---|---|---|
| Shock Waveform Effectiveness and Safety | Substantial equivalence to predicate device demonstrated by bench testing. Statistical analysis to show mean values of i-PAD NF1200 shock waveform parameters are closer to Philips HeartStart FR2+ than Defibtech DDU-100A. | Bench testing performed. Statistical analysis concluded that the mean values of the i-PAD NF1200's shock waveform parameters are closer to the mean values of the Philips HeartStart FR2+ shock waveform parameters compared to the Defibtech DDU-100A. (Specific numerical values for parameters or statistical significance are not provided in this summary.) |
| Arrhythmia Detection Algorithm | Tested using recommendations of the American Heart Association (AHA) and the ANSI/AAMI DF80 Standard. | The algorithm was tested against AHA recommendations and ANSI/AAMI DF80 Standard. (Specific performance metrics like sensitivity, specificity, or false alarm rates for arrhythmia detection are not provided in this summary.) |
| Electrical Safety and Compliance | Tested using EN60601-1 and EN60601-2-4. (EN60601-2-4 has contents similar to ANSI/AAMI DF80, with some additional sections for DF80). | The device was tested and found compliant with EN60601-1 and EN60601-2-4. (Specific test results or deviations are not detailed.) |
| Overall Safety and Effectiveness | Device does not raise new issues of safety and effectiveness compared to predicate devices. | Testing shows that the submission device does not raise new issues of safety and effectiveness, supporting substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Shock Waveform Effectiveness and Safety: The summary mentions "bench testing" and "statistical analysis" but does not specify the number of shocks or test cycles performed to derive the mean values for comparison, nor does it detail the specific types of impedance loads used. Data provenance is implied to be laboratory-generated (bench testing).
- Arrhythmia Detection Algorithm: The summary states the algorithm was tested using recommendations from the AHA and the ANSI/AAMI DF80 Standard. These standards typically involve databases of annotated ECG recordings. However, the exact sample size (number of ECG records or patient hours) of the test set, the specific ECG databases used, or their provenance (e.g., country of origin, retrospective/prospective) are not specified in this submission summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
For the arrhythmia detection algorithm testing against AHA recommendations and ANSI/AAMI DF80, these standards usually rely on expertly annotated ECG databases. However, the number of experts, their qualifications, or their role in establishing the ground truth for the specific test set used for the i-PAD NF1200 are not mentioned in this document. It is assumed that the ground truth for the standard databases would have been established by qualified cardiologists or electrophysiologists.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is an automated external defibrillator, where the primary function is automated arrhythmia detection and shock delivery, not human interpretation of images or signals. The "human reader" in this context is largely a user who follows voice prompts.
6. Standalone Performance Study
Yes, a standalone (algorithm only) performance assessment was done for the Arrhythmia Detection Algorithm. The algorithm was tested "using the recommendations of the American Heart Association and the ANSI/AAMI DF80 Standard." This implies an evaluation of the algorithm's performance in detecting treatable arrhythmias (Ventricular Fibrillation and Ventricular Tachycardia) and correctly identifying non-shockable rhythms, without human intervention during the analysis phase.
7. Type of Ground Truth Used
For the Arrhythmia Detection Algorithm, the ground truth would be based on expert annotations of the ECG waveforms within the standardized databases recommended by the AHA and ANSI/AAMI DF80. This falls under expert consensus (or expertly annotated databases).
8. Sample Size for the Training Set
The document does not specify the sample size used for the training set of the arrhythmia detection algorithm. It only mentions the testing against standards.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established, as the training set itself is not explicitly mentioned. For algorithms compliant with standards like ANSI/AAMI DF80, it's generally assumed that any training data would also be derived from expertly annotated ECG datasets.
§ 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.