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

The device is for use on individual adult and pediatric patients in hospital areas and hospital-type facilities, such as clinics. Clinical users may use the monitor during hospital transport. These indications were previously cleared under K030931 and K041434.

The purpose and function of the LIFEGARD II Family is to monitor:

ECG
Heart rate
Non-invasive blood pressure (NIBP)
Functional arterial oxygen saturation (SpO2)
Respiration rate
Temperature and
End-tidal carbon dioxide (EtCO2)
Impedance Cardiography (ICG)
Arrhythmia with ST segment detection
Continuous non-invasive blood pressure (CNIBP)

The Impedance Cardiography (ICG) is intended for use on individual adult patients that meet the limits specified below:

Height: 4 ft - 7 ft - 6 in (122 - 229 cm)
Weight: 67 - 350 lbs (30 - 159 Kg)

The CNIBP is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This device is intended to be used on patients by trained medical personnel to continuously monitor systolic, diastolic and mean blood pressure and pulse rate. This pressure information is intended to guide clinicians in the therapeutic management of their patients by providing accurate and frequent updated blood pressure information in a safe, non-invasive, easily obtained and comfortable manner.

Device Description

The LIFEGARD II Family is a compact, lightweight device for measuring, processing, printing, and displaying information derived from nine physiological measurements:

Electrocardiogram (ECG). A three lead or five lead ECG is acquired and a waveform can be displayed real-time on the LCD screen or permanently recorded on the optional printer. The design of the ECG function is derived directly from the predicate devices, the parent C3 Family of patient monitors.
Respiration. Waveform and numeric respiration rate value from ECG. Airway respiration rate from EtCO2 if available. The design of the respiration parameter is derived directly from the predicate devices, the parent C3 Family of patient monitors.
Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement. The design of arrhythmia with ST segment function provides VF and ST segment deviation functionality similar to the predicate device, M3046A (M2/M3/M4) Compact Portable Patient Monitor
Pulse Oximetry (SpO2). Functional Oxygen Saturation is calculated from the ratio of light transmissivity through the capillary bed at two wavelengths. The SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System and Sandman SD20 Amplifier patient monitor and system.
The temperature is measured using thermistor probes for continuous temperature measurements. These are pre-amendment devices.
Blood pressure is measured non-invasively (NIBP) by the oscillometric method. This is the same as in the predicate devices, parent C3 Family of patient monitors.
Continuous non-invasive blood pressure (CNIBP) is a non-invasive blood pressure monitor which uses a pressure sensor placed on the wrist over the radial artery. This is the same technology as in the predicate device, Vasotrac APM205A.
End-tidal CO2 (EtCO2) This method pulls a constant sample flow of exhaled breath from the patient, and analyzes it with a remote CO2 sensor built into the measurement system. This is the same as in the predicate devices, parent C3 Family of patient monitors.
Impedance Cardiograph (ICG). This mode uses Thoracic Electrical Bioimpedance (TEB). This is identical in all aspects to the predicate device, the C3 ICG.
An internal thermal printer records waveforms, hemodynamic parameters and tabular trends on a 50-mm wide strip chart.
External USB printing identical to the parent C3 Family.

The LIFEGARD II Family is powered by internal sealed lead-acid batteries or from the mains supply via a battery eliminator. A fully charged battery will power the monitor for three hours.

AI/ML Overview

The provided text describes a 510(k) summary for the Analogic Corporation LIFEGARD II Family of patient monitors. It extensively details the device's characteristics, intended use, and comparison to predicate devices, focusing on regulatory equivalency rather than specific detailed clinical study results to demonstrate acceptance criteria performance.

Therefore, much of the requested information regarding a detailed study proving the device meets acceptance criteria, including sample sizes, expert qualifications, adjudication methods, and ground truth establishment for AI performance, is not present in this document. This document primarily outlines non-clinical tests and regulatory compliance to establish substantial equivalence with predicate devices.

However, based on the information available, I can construct the table of acceptance criteria (as inferred from the non-clinical tests) and indicate the reported device performance in a general sense where mentioned.

Here's the breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance

The document lists various non-clinical tests and standards that the device will be subjected to. These standards implicitly define the acceptance criteria for various aspects of the device's safety and performance. The "reported device performance" is generally stated as "will be conducted" or "demonstrates that the performance... is substantially equivalent."

Acceptance Criteria (Inferred from Standard/Test)	Reported Device Performance
Safety and General Performance:
IEC 60601-1 (Amendments 1 & 2): Medical Electrical Equipment - General Requirements for Safety	Verification testing activities will be conducted to establish compliance, performance and reliability.
IEC 60601-1-2: 2001: Electromagnetic compatibility (emission limits meet Group 1 Class B)	Verification testing activities will be conducted to establish compliance, performance and reliability.
IEC 60601-2-49: Safety of multifunction patient monitoring equipment	Verification testing activities will be conducted to establish compliance, performance and reliability.
ECG Performance:
IEC 60601-2-27: Safety of electrocardiographic monitoring equipment	Verification testing activities will be conducted to establish compliance, performance and reliability. ECG function derived directly from predicate devices.
ANSI/AAMI EC 13: Cardiac monitors, heart rate meters, and alarms	Verification testing activities will be conducted to establish compliance, performance and reliability.
ANSI/AAMI EC 57: Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms	Test schedule combined with AAMI EC 57 tests already performed demonstrates substantially equivalent performance. Arrhythmia with ST segment functionality similar to predicate device.
NIBP Performance:
IEC 60601-2-30: Safety and essential performance of automatic cycling non-invasive blood pressure monitoring equipment	Verification testing activities will be conducted to establish compliance, performance and reliability. Identical NIBP measurement method as predicate devices.
ANSI/AAMI SP10: Manual, Electronic, or Automated Sphygmomanometers	Verification testing activities will be conducted to establish compliance, performance and reliability.
SpO2 Performance:
EN 865: Pulse Oximeters	Current test data from Nellcor showing equivalent performance of the SpO2 module demonstrates substantially equivalent performance.
EtCO2 Performance:
EN 864: Capnometers for use with humans	Verification testing activities will be conducted to establish compliance, performance and reliability. Identical method of measurement as predicate device.
Environmental/Physical Durability:
IEC 60068 series (Mechanical shock and vibration)	Tests will be performed to ensure transport does not damage the device.
IEC 60068-2-27 (Shipping container transportation)	Tests will be performed to ensure packaging is not adversely affected during shipping.
Altitude tests	Tests will be performed to ensure operation at higher altitudes does not adversely affect electrical safety or performance.
Enclosure material robustness and resistance to cleaning materials tests	Tests will be performed to verify robustness and resistance to commonly used hospital cleaning materials.

2. Sample size used for the test set and the data provenance:

Not provided. The document focuses on non-clinical testing and regulatory compliance rather than detailed clinical study results with specific sample sizes. The "AAMI EC 57 tests already performed" implies some test data exists, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. This information would typically be found in a clinical study report, which is not part of this 510(k) summary.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not provided. This information is absent.

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 / Not provided. The LIFEGARD II Family device is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results in a comparative effectiveness study. The "Arrhythmia with ST segment analysis software" is an algorithm within the device, not an AI for human interpretation enhancement. The document primarily focuses on the device's technical specifications and equivalency, not its impact on human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The context of the "Arrhythmia with ST segment analysis software" and other measurement parameters (SpO2, NIBP, EtCO2, etc.) indicates these perform their functions as standalone algorithms within the device. The document states: "Arrhythmia with ST segment analysis software performs five distinct operations: beat detection, lead selection, beat classification, ventricular tachyarrhythmia detection, and ST segment measurement." Similarly, SpO2 calculates saturation, and NIBP measures blood pressure. These are inherent functions of the device's algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly detailed, but inferred from testing standards. For parameters like ECG, NIBP, SpO2, and EtCO2, ground truth would typically be established by established reference methods or highly accurate (often invasive or laboratory-grade) measurement devices during testing against the standards mentioned (e.g., AAMI EC 57 for ECG, ANSI/AAMI SP10 for NIBP, EN 865 for SpO2, EN 864 for EtCO2). The document suggests that the performance of these integrated modules is evaluated against these industry-accepted standards, implying that the "ground truth" is defined by such reference methods.

8. The sample size for the training set:

Not applicable / Not provided. This device pre-dates the widespread use of deep learning and large-scale training sets for medical devices, particularly for a summary from 2005. The mention of "design of the ECG function is derived directly from the predicate devices" and "SpO2 subsystem uses software and firmware that is used in the OxiMAX Pulse Oximetry System" points to established, possibly rule-based or conventional signal processing algorithms, rather than models requiring large training sets in the modern AI sense.

9. How the ground truth for the training set was established:

Not applicable / Not provided. As mentioned above, the concept of a "training set" with ground truth in the current AI/ML context is likely not relevant to this device's development as described in a 2005 510(k) summary. The algorithms' development would have relied on engineering principles, signal processing, and testing against known physiological signals and reference measurements, rather than ground truth established for a statistical learning model.

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.