(64 days)
The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless.
Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. Synchronous defibrillation is indicated for termination of atrial fibrillation.
Non-invasive External Pacing Therapy: The pacing option is intended for treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
Pulse Oximetry: The SpO2 option is intended for use when it is beneficial to assess a patient's oxygen saturation level.
Non-invasive Blood Pressure Monitoring: The NBP option is intended for non-invasive measurement of a patient's arterial blood pressure.
End-tidal CO2: The EtCO2 option is intended for non-invasive monitoring of a patient's exhaled carbon dioxide and to provide a respiration rate.
12-Lead ECG: The 12-Lead ECG function is to provide a conventional diagnostic 12-Lead ECG report, which may include measurements and interpretative statements.
Q-CPR: The Q-CPR™ option provides feedback designed to encourage rescuers to perform resuscitation in accordance with AHA/ERC guidelines for chest compression rate, depth, and duty cycle and ventilation rate, volume and flow rate (inflation time). The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less that 25 kg). The Q-CPR option is not for use when CPR is contraindicated.
Invasive Pressure: The Invasive Pressure option is indicated for measuring arterial, venous, intracranial and other physiological pressures on patients.
Temperature: The Temperature option is indicated for measuring temperature in patients.
The modification is a change that provides an optional Bluetooth™ wireless technology option to transfer data from the MRx to a Bluetooth enabled device. This wireless connection is an alternative to the current RS232 cable connection capability.
The provided text is a 510(k) summary for the Philips HeartStart MRx Monitor/Defibrillator Software Release 7.01. It describes a modification to an existing device, primarily the addition of an optional Bluetooth wireless technology-based data transfer.
This submission is for a modification to a previously cleared device. The summary generally focuses on asserting that the new features (Bluetooth connectivity) do not negatively impact the device's existing performance, rather than re-proving the core functionalities of the monitor/defibrillator. Therefore, many of the typical elements of an AI/algorithm-based device study (like sample sizes, ground truth, expert adjudication, etc.) are not applicable or not explicitly detailed in this type of submission for a physical device with a software update.
Here’s an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical acceptance criteria or performance metrics for the device's core functions (ECG, NBP, SpO2, defibrillation, etc.) for this particular 510(k). Instead, it states:
| Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | "Pass/Fail criteria were based on the specifications cleared for the predicate device." | "Test results showed substantial equivalence. The results demonstrate that the device meets all performance claims." |
| New Feature (Bluetooth) | The Bluetooth wireless technology option should function as intended for data transfer and not compromise existing functionalities, safety, or effectiveness. | Tested as part of "system level tests, integration tests, environmental tests, and safety testing from hazard analysis." The conclusion is that the device "meets all performance claims." |
| Safety and Effectiveness | Should be substantially equivalent to the predicate device and meet all relevant safety and effectiveness requirements. | "The new device is substantially equivalent to the previously cleared HeartStart MRx Monitor/Defibrillator software... and has the same Indications for Use as the legally marketed predicate device." |
2. Sample Sizes Used for Test Set and Data Provenance
- Test Set Sample Size: Not specified. The testing described ("system level tests, integration tests, environmental tests, and safety testing from hazard analysis") refers to device validation and verification testing, not typically patient-based clinical trials with a "test set" in the context of an algorithm.
- Data Provenance: Not applicable in the context of an algorithm-based "test set" here. This is a hardware/software update to a medical device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus for an algorithm, is not relevant for this type of device modification submission. The "ground truth" for the device's functionality would be its adherence to engineering specifications and regulatory standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This refers to consensus among experts, which is not relevant for the type of testing described (system, integration, environmental, safety).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study assesses how an AI system impacts human reader performance, which is not applicable to a non-AI device modification.
- Effect size: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is a monitor/defibrillator; its performance is not "algorithm only" in the sense of a diagnostic AI tool. The software update is for connectivity.
7. Type of Ground Truth Used
- Ground Truth Type: For the device's core functionalities, the "ground truth" would be established by reference standards, engineering specifications, and established medical diagnostics (e.g., a calibrated pressure sensor for NBP, a known electrical signal for ECG, etc.). For the Bluetooth functionality, the ground truth would be successful and reliable data transmission as per engineering specifications. The documentation does not specify the exact methods for establishing this but implies it was based on existing specifications for the predicate device.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning algorithm that requires a "training set" of data in the typical sense. The software development follows traditional engineering and validation processes.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" in the AI sense.
In summary:
This 510(k) submission (K063375) describes a software update (Release 7.01) to an existing Philips HeartStart MRx Monitor/Defibrillator, adding Bluetooth connectivity. The regulatory submission primarily relies on demonstrating substantial equivalence to predicate devices and proving that the new feature does not adversely affect the device's existing safety or effectiveness. The "study" mentioned consists of verification and validation activities (system, integration, environmental, and safety tests) against existing specifications, rather than clinical studies with patient data or AI algorithm performance evaluations. As such, many of the questions related to AI/algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not pertinent to this specific regulatory filing.
§ 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.