(30 days)
The LabSystem™ EP Laboratory is a computer and software driven data acquisition and analysis tool designed to facilitate the gathering, display, analysis by a physician, pace mapping and storage of cardiac electrophysiologic data. When integrated with the Biosense Webster® CARTO™ 3 system, the Bard® LabSystem™ PRO EP Recording System is designed to: a) send patient demographics to Biosense Webster® CARTO™ 3, and b) acquire (from Biosense Webster® CARTO™ 3), store and display: i) synchronized 3D mapping events, ii) stimulation pacing data, and iii) images of completed 3D electro-anatomical maps of the human heart. The 3D mapping events and images are created by the Biosense Webster® CARTO™ 3 device and stored on the Bard® LabSystem™ PRO EP Recording System for review and insertion into the final clinical report. I Integration also supports bidirectional communication of stimulation pacing channel selection and information sharing between the two systems.
The V2.7 software for the LabSystem™ PRO EP Recording System is substantially similar to the currently commercialized software (V2.6a) with the difference that the V2.7 software runs on a Microsoft Windows 7 platform as compared to V2.6a which runs on a Windows XP platform. Other than the platform update, there are no changes to the LabSystem PRO EP Recording System software functionality. There are no changes to the fundamental scientific technology of the device nor are there any changes to the intended use. The LabSystem™ PRO EP Recording System is a microprocessor based data acquisition system that is used during electrophysiology procedures to acquire ECG, intracardiac, pressure and digital data from other devices like fluoroscopic systems and RF generators. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient via ECG leadwires and catheters. It does not transmit alarms and does not have arrhythmia detection capabilities.
The Boston Scientific Corporation's K141185 submission for the LabSystem™ PRO EP Recording System V2.7 did not include a study with specific acceptance criteria and reported device performance in the form of a table for clinical metrics. Instead, the submission focused on software validation and substantial equivalence to previously cleared devices.
Here's an analysis based on the provided document:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not contain a table of acceptance criteria with reported quantitative device performance for clinical outcomes or metrics. The submission states that "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System." However, these acceptance criteria and the specific results are not provided.
The device is a data acquisition and analysis tool, not one that generates a diagnostic output based on an algorithm or AI. Therefore, the concept of sensitivity, specificity, or similar performance metrics typically associated with AI/CAD devices is not applicable in this context. The "acceptance criteria" referred to are related to software functionality and safety standards compliance.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The submission describes internal software qualification and testing without mention of a distinct "test set" in the context of clinical data or patient samples. The testing would have been against software requirements and design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. Ground truth, in the context of expert consensus or pathological diagnosis, is not relevant for this type of software validation, which focuses on the proper functioning of a data acquisition and display system.
4. Adjudication Method for the Test Set:
Not applicable for the reasons mentioned above.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The LabSystem™ PRO EP Recording System is a data acquisition and display system, not a diagnostic interpretation tool in itself, though it facilitates physician analysis.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a standalone algorithm/software in the sense that its operation doesn't inherently involve a human in real-time within its core function to generate data (it acquires and processes). However, standalone performance in the context of an AI/CAD system (e.g., sensitivity/specificity of an algorithm making a diagnosis) is not applicable here as the device's function is data acquisition and display, not automated diagnosis or interpretation. The system's performance revolves around its ability to accurately acquire, process, and display physiological data according to its specifications.
7. The type of ground truth used:
The "ground truth" for this device's validation would be its functional specifications (e.g., correct acquisition of ECG, intracardiac, and pressure data; accurate display; proper integration with CARTO™ 3). This is established through internal verification and validation against design documents and industry standards (IEEE, EN, IEC). It is not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
Not applicable. The device is not a machine learning or AI algorithm that requires a "training set" of data to learn patterns. Its software is programmed based on defined rules and functionalities.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
Summary of Acceptance Criteria and Study from the Document:
The acceptance criteria for the LabSystem™ PRO EP Recording System V2.7 are primarily derived from compliance with regulatory standards and software development processes. The study that proves the device meets these criteria is the in-house software qualification and testing.
The key aspects of this validation include adherence to:
- Software Quality Assurance Plans (IEEE Standard 730-2002)
- Software Test Documentation (IEEE Standard 829-2008)
- Software Verification and Validation Plans (IEEE Standard 1012-2012)
- Software Requirement Specifications (IEEE Standard 830-1998)
- Software Unit Testing (IEEE Standard 1008-1987)
- EMC, Radiated emissions and Conducted emissions requirements (EN 60601-1-2:2007)
- Patient Leakage current (EN 60601-1:2005 - Section 19, Table IV, Type CF, 50uA)
- Medical Device Software - Software Life Cycle Processes (IEC 62304:2006)
The document explicitly states: "Software qualification is performed in-house on the System with results that meet acceptance criteria, thus confirming the safety and effectiveness of each functional aspect of the LabSystem™ PRO EP Recording System."
The primary goal of this 510(k) submission was to establish substantial equivalence to existing predicate devices (Bard LabSystem PRO EP Recording System K031000 and V2.6 Software K113811) for the V2.7 software update, which primarily concerned running on a new operating system (Windows 7 vs. Windows XP) without changes to core functionality or intended use. This implies that the safety and effectiveness were largely demonstrated by the predicate devices, and the updated software passed rigorous software lifecycle testing to ensure the new platform did not compromise those aspects.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).