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510(k) Data Aggregation
(63 days)
Philips IntelliVue reusable ECG lead sets/trunk cables and Philips OR ECG trunk cables are indicated for continuous monitoring of cardiac signals for both diagnostic and monitoring purposes. These devices are limited by the indications for use of the connected monitoring and diagnostic equipment in healthcare facilities. These devices are intended to interact with patient intact skin only.
Philips Reusable ECG Lead Sets and Trunk Cables are non-invasive reusable medical devices designed to transfer ECG signals from the patient to the monitor used in the healthcare facilities, which includes intensive care unit (ICU) for both adults and neonates and the operating room (OR). The ECG cables and lead sets are used to forward an electrical cardiac signal via electrical wires from the electrode attached on patient skin to the ECG measurement hardware in the patient monitor and to support other outputs as needed. The portfolio consists of two types of trunk cables and two types of lead sets: ICU and OR, including various electrode connectors with AAMI and IEC coloring. The ECG Trunk cables and lead sets are suitable for multiple patient use. The Philips Reusable ECG Lead Sets and Trunk Cables have a service life of 18 months. The Philips Reusable ECG Lead Sets and Trunk Cables can be used with any Philips monitors including Philips monitor/defibrillator product lines and Philips monitoring or diagnostic equipment which claim compatibility to Philips Reusable ECG Lead Sets and Trunk Cables.
This document is a 510(k) premarket notification for Philips Reusable ECG Lead Sets and Trunk Cables. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a standalone study with clinical accuracy metrics. Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth are not applicable or explicitly stated in this type of submission.
However, I can extract the information that is present regarding performance testing and standards.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific quantitative clinical acceptance criteria and device performance metrics, this submission relies on compliance with recognized harmonized standards. The "performance" is demonstrated through successful completion of tests outlined in these standards.
| Acceptance Criteria (Compliance with Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005+A1:2012+A2:2020 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. |
| ANSI AAMI EC53:2013/(R)2020 (ECG trunk cables and patient lead wires) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. |
| IEC 60601-2-25:2011/(R)2016 (Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. |
| IEC 60601-2-27:2011(R)2016 (Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic equipment) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. |
| IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION (Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. (Specifically, ICU Lead Sets and Trunk cables comply with this additional standard). |
| IEC 62366-1:2015+AMD1:2020: (Part 1: Application of usability engineering to medical devices) | The subject devices have passed all safety tests for demonstrated compliance with this recognized standard. |
| Reprocessing Standards: ISO 17664-2:2021, AAMI TIR12 (2020)/(R)2023, and ANSI AAMI ST98:2022, and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" | The subject device adheres to these standards, and its proposed reprocessing instructions are as effective as the predicate device, meeting regulatory requirements for reusable devices. |
| Biocompatibility: (ISO 10993-1, as inferred from comparison to predicate) | Both the subject and predicate devices meet standards for biocompatibility. |
| Electrical Conductivity, Mechanical Strength: (as inferred from comparison to predicate) | Both the subject and predicate devices meet standards for electrical conductivity and mechanical strength. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document explicitly states: "The subject devices, like the primary predicate devices, did not require clinical trials." Therefore, there is no "test set" in the context of a clinical study for external validation of performance. Performance is primarily demonstrated through compliance with recognized standards via non-clinical bench testing. The data provenance would be from internal lab testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No clinical test set requiring expert ground truth was used as per the statement above.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.
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
Not applicable. This device is an ECG cable and lead set, a hardware accessory. It is not an AI algorithm for interpreting medical images or signals, nor does it involve "human readers" or "AI assistance" in that sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware accessory, not an algorithm. Performance is assessed through its physical and electrical properties, not algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of clinical ground truth. For non-clinical bench testing, the "ground truth" would be established by the specifications and measurement techniques defined within the harmonized standards (e.g., electrical resistance, mechanical durability measured against stated tolerances, biocompatibility testing results).
8. The sample size for the training set
Not applicable. This is a hardware accessory, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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