(90 days)
The FR2 is intended to be used with disposable Heartstream defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.
When the patient is under 8 years or weighs less than 55 pounds (25 kg), the FR2 should be used with attenuated pediatric defibrillation pads.
The FR2 is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support (BLS), advanced life support (ALS) or other physician-authorized emergency medical response.
At the discretion of emergency care personnel, the M3860A FR2 with ECG display enabled can also be used with the FR2 ECG Cable to display the rhythm of a responsive or breathing patient, regardless of age. The FR2 and ECG Cable system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2 ECG Cable, the FR2 evaluates the patient's ECG and disables it's shock capability.
The Heartstream FR2 is an automated external defibrillator available in two models, including one with ECG display and manual shock capability. Features include selftesting, impedance-compensating biphasic truncated exponential waveform, multiparameter Patient Analysis System (PAS), and human factor designs to facilitate use by lay responders.
A non-rechargeable lithium manganese dioxide battery powers the FR2 with a typical capacity of 300 shocks or 12 hours of operating time.
Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2 continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2 advises a shock and arms - if the ECG spontaneously converts to a nonshockable rhythm prior to a responder pressing the shock button, the FR2 disarms.
If significant artifact is detected in the ECG, Heartstream's PAS suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2 directs the responder to press the shock button to deliver a biphasic shock to the patient.
Event and incident data can be recorded during FR2 use with an optional data card having a recording capacity of four hours of event and ECG data (or thirty minutes with voice recording).
The FR2 has an optional Training and Administration Pack that is used for device training and for customizing FR2 set-up options. Use of the Training and Administration Pack converts the FR2 to a training device with ten training "scripts" that simulate different SCA scenarios.
The FR2 also has an infrared communication port to facilitate communication of set-up parameters.
An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2's main crystal display screen. Three lead wires, connected to standard disposable ECG electrodes, are labeled according to AAMI or IEC conventions. If a potentially shockable rhythm is detected (using the existing FR2 PAS algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are generated.
The provided 510(k) summary for the Heartstream FR2 AED with ECG Cable (K013425) does not contain specific acceptance criteria or a detailed study description proving that the device meets such criteria.
The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with predefined acceptance criteria. This is common for 510(k) submissions, where the primary goal is to show that a new device is as safe and effective as a legally marketed one, often through design comparison and limited bench testing.
Therefore, many of the requested details cannot be extracted from the provided text. However, I can still address the available information and highlight what is missing.
Description of Acceptance Criteria and Study
The provided 510(k) summary does not explicitly state specific acceptance criteria for the Heartstream FR2 AED with ECG Cable or detail a study designed to prove the device meets such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The primary "study" mentioned is bench testing to ensure the ECG Cable meets specifications appropriate for its intended application.
The core argument for substantial equivalence is that "The Heartstream FR2 employs the same technologies as the predicate devices used for comparison. The FR2 acquires and analyzes ECG signals, and utilizes the same shock advisory criteria like the predicates and the FR2 without the ECG Cable."
Therefore, the "acceptance criteria" can be inferred to be that the ECG Cable functions as intended and does not negatively impact the overall safety and effectiveness of the existing FR2 AED, which itself would have met performance criteria in its original 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| ECG Cable performs to specifications. | "Bench testing demonstrates that the performance of the ECG Cable meets specifications is appropriate for its intended application." |
| ECG Cable does not introduce new safety or effectiveness issues. | "The modifications proposed to include an optional ECG Cable to the FR2 accessory offerings do not present new issues of safety or effectiveness." |
| Device (with ECG Cable) maintains functions for displaying Lead II ECG and heart rate. | "An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2's main crystal display screen." |
| Device (with ECG Cable) maintains ability to detect potentially shockable rhythms and disable shock capability. | "If a potentially shockable rhythm is detected (using the existing FR2 PAS algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are generated... While connected to the FR2 ECG Cable, the FR2 evaluates the patient's ECG and disables its shock capability." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document mentions "bench testing," which typically involves testing a sample size of devices, but the exact number is not provided.
- Data Provenance: The bench testing would have been conducted internally by Philips Medical System Heartstream. No details on country of origin of data or whether it was retrospective or prospective are provided, as it's primarily an engineering verification rather than a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnostic algorithms). The described "bench testing" is an engineering validation of the ECG cable's technical performance against specifications, not a clinical study requiring expert consensus on a test set.
4. Adjudication method for the test set
- Not applicable. As the "study" is bench testing for technical performance, there would be no need for an adjudication method in the human-interpretation sense. The determination of whether the cable meets specifications would be based on predefined engineering metrics and testing protocols.
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, an MRMC comparative effectiveness study was not done. This type of study is not relevant to the approval of an ECG cable accessory for an AED in this 510(k) submission. The device is not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in the context of bench testing. The "bench testing" mentioned evaluates the ECG cable's ability to "meet specifications." This implies testing the cable's performance in isolation or as integrated into the AED system, but without human intervention in the measurement of its core technical function. The FR2's existing Patient Analysis System (PAS) algorithm, which is the "standalone" algorithm for rhythm analysis, is stated to be unchanged and used with the ECG cable.
7. The type of ground truth used
- Engineering specifications/predefined electrical and signal integrity standards. For bench testing of the ECG cable, the "ground truth" would be the expected electrical signals, noise levels, frequency response, and general signal quality metrics defined by the device's design and relevant industry standards (e.g., AAMI or IEC conventions for lead wires, as mentioned).
8. The sample size for the training set
- Not applicable. The submission describes an accessory (ECG cable) for an existing device. It does not involve a machine learning model that would require a "training set." The FR2's existing Patient Analysis System (PAS) algorithm was developed prior to this submission and would have had its own validation data, but that information is not part of this specific 510(k).
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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.