FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Lethal Arrhythmia Detection and ST Segment Analysis, for which the target populations are adult and pediatric only, and
Interpretation of Resting 12 Lead ECG, for which the target population is adult only.

The monitor is intended for use in the health care facility setting.

The device has the capability of interfacing with Datascope's Gas Module II, displaying the measurements of Anesthetic Gases, O3, N2O, and CO2.

The device monitors the SpO2 parameter via the Masimo SET® 2000 Pulse Oximeter Technology and Accessories (K990966). The Masimo SET® 2000 Pulse Oximeter Technology and Accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by an SpO3 sensor) and are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

Device Description

The View 12 ECG Analysis Module provides means for performing diagnostic ECG analysis in conjunction with the monitoring functions of Datascope's Passport 2 Vital Signs Monitor (K993531). The View 12 ECG Analysis Module for the Passport 2 Vital Signs Monitor enables 12-Lead ECG Acquisition. Continuous 12-Lead ST Segment Analysis and Arrhythmia Analysis all with print capabilities. The View 12 ECG Analysis Module consists of a PCMCIA ECG processor card that interfaces with the Passport 2, a front-end electronics cable, and a detachable patient cable with integral leadwire set. The data acquired by this module is interpreted utilizing Mortara Instrument's algorithm (cleared by FDA under notification numbers: K920627, K920626A and K933143) for interpretive electrocardiographs. With the View 12 ECG Analysis Module installed and enabled, the Passport 2 makes interpretive statements on printouts. These statements are categorized into three (3) sections: an interpretive statement, a condition statement, and a rhythm statement.

AI/ML Overview

The provided 510(k) summary (K020532) for the Datascope Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module does not directly provide acceptance criteria or detailed results from a study specifically conducted for this 510(k) submission to prove the device meets acceptance criteria.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. Here's what can be extracted and inferred regarding the study that proves the device meets acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a specific table outlining acceptance criteria and reported performance for the View 12 ECG Analysis Module itself.

However, the submission states:

"The diagnostic ECG algorithm used in Datascope's View 12 ECG Analysis Module is identical to that found in the Spacelabs' Integrated Multiparameter Module 90496, as well as in the Mortara Instrument ELI-100 (K920627), ELI-200 (K920626A) and ELI-300 (K933143.)"
"The functionality of the Passport 2 Vital Signs monitor with View 12 ECG Analysis Module is identical to that of the Spacelabs Ultraview 1050 monitor equipped with Integrated Multiparameter Module 90496."

Therefore, the "acceptance criteria" for the ECG analysis algorithm are implicitly the performance specifications already met and cleared for the predicate Mortara Instrument devices (K920627, K920626A, K933143) and the Spacelabs Module 90496. The reported device performance is, by definition of substantial equivalence in this context, assumed to be identical to these predicate devices. The submission asserts that the Datascope device's algorithm performs as well as the previously cleared Mortara algorithm because it is the Mortara algorithm.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size (number of patients/ECGs) for a test set for this specific 510(k) submission to validate the ECG algorithm.

Given the reliance on the predicate Mortara algorithm, the testing data would have been part of the original 510(k) submissions for Mortara Instrument ELI-100 (K920627), ELI-200 (K920626A) and ELI-300 (K933143). Without access to those original submissions, the sample size and data provenance remain unknown from this document. It is highly likely the data would have been retrospective, as is common for established ECG algorithm validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the K020532 document, as the ECG algorithm itself was cleared in prior 510(k)s (Mortara Instrument devices). The original Mortara submissions would contain this detail. Typically, expert cardiologists or electrophysiologists with significant experience would be used for manual adjudication of ECGs to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the K020532 document. It would have been part of the original Mortara submissions. Standard adjudication methods for ECGs often involve a consensus of multiple cardiologists (e.g., 2-out-of-3 agreement, or a tie-breaker by a senior expert).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned for the View 12 ECG Analysis Module in this 510(k) summary. The submission's argument is that the algorithm is the predicate algorithm, thus no new large-scale comparative study is required for algorithm performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, implicitly. The performance of the diagnostic ECG algorithm (Mortara's algorithm) was assessed in a standalone manner when it was originally cleared under K920627, K920626A, and K933143. This 510(k) leverages that prior clearance.

7. The Type of Ground Truth Used:

For ECG interpretation algorithms, the ground truth is almost exclusively expert consensus by qualified cardiologists or electrophysiologists. This would have been the case for the underlying Mortara algorithm.

8. The Sample Size for the Training Set:

This information is not provided in the K020532 document. The training data for the Mortara algorithm would have been developed prior to its initial 510(k) clearances.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided in the K020532 document. For ECG algorithms, ground truth for training data would also typically be established through expert consensus, often with a similar process to, but distinct from, the ground truth establishment for the independent test set.

Summary of Device Acceptance Rationale (based on the provided text):

The Datascope Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module's acceptance is based on its substantial equivalence to legally marketed predicate devices. Specifically:

Functionality: The overall device functionality (Passport 2 with View 12) is stated to be identical to the Spacelabs Ultraview 1050 monitor with Integrated Multiparameter Module 90496.
ECG Algorithm: The diagnostic ECG algorithm itself is identical to one already cleared and used in several Mortara Instrument devices (K920627, K920626A, K933143) and the Spacelabs module. These predicate devices have already demonstrated compliance with performance standards and safety through their own clearance processes.
Safety and Performance Testing: The Datascope device underwent "extensive safety and performance testing" and complies with various industry and safety standards (e.g., ANSI/AAMI EC11, EC13, IEC 60601 series, ISO 10993-1, EN 1441). This testing would focus on the integration of the module, electrical safety, EMC, and ensuring that the overall device still meets general performance requirements, not necessarily re-validating the intrinsic accuracy of the ECG interpretation algorithm, which is assumed from its predicate status.

In conclusion, the "study that proves the device meets the acceptance criteria" for the ECG analysis algorithm refers to the studies conducted for the original Mortara Instrument devices (K920627, K920626A, K933143) because the Datascope device uses the identical, previously cleared algorithm. This 510(k) primarily establishes that the integration of this already cleared algorithm into a new monitor platform does not raise new questions of safety or effectiveness.

Summary

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.