(93 days)
The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.
The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.
The Monitor B40 is not intended for use during MRI.
The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network.
The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring.
Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.
The proposed Monitor B40V2.1 still is a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2 (K130584) and now includes supporting for an additional optional extension module Airway Gas Option (N-CAiO), and few software improvements by adding alarm breakthrough, extending the upper limit of ECG PVC (Premature Ventricular Contraction) alarm and providing four waveform scale options for Masimo SpO2 and Nellcor SpO2. Same as the predicate Monitor B40V2 (K130584), the proposed Monitor B40V2.1 continues interfacing with following optional extension modules: E-MiniC module (K052582), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and E-Entropy module (K061907). The compatibility with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) is also provided but with spirometry function disabled.
The proposed Monitor B40V2.1 still has a 12.1 inch LCD display but is from different LCD manufacturer and LCD backlight is changed from CCFL to LED due to RoHS compliance.
As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 still includes features and subsystems that are optional or configurable. The proposed Patient Monitor B40V2.1 will continue interfacing to a variety of existing central station systems via a cabled network interface.
As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.
The provided text describes a 510(k) premarket notification for a multi-parameter patient monitor (Monitor B40V2.1) and its substantial equivalence to a predicate device, the Monitor B40V2 (K130584).
Here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI/algorithm. Instead, the "acceptance criteria" are implied by the determination of "substantial equivalence" to a predicate device. The performance is assessed based on whether the changes made to the device have a significant impact on its ability to obtain patient measurements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant impact of design changes on the device's ability to obtain patient measurements. | "The design changes made to the proposed Monitor B40V2.1 have no effect on the device's ability to obtain patient measurements as there are no changes to the parameter measuring hardware." |
| Related risks re-evaluated and found to be unchanged. | "To assess if the changes had any significant impact to the device, all related risks were re-evaluated and found to be unchanged." |
| Device is as safe and effective as the predicate device. | "GE Healthcare considers the proposed Monitor B40V2.1 to be as safe, as effective, and performance is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The proposed Monitor B40V2.1 did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size and no data provenance mentioned for a clinical study related to this specific device (B40V2.1). The evaluation was based on non-clinical tests and a comparison to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical studies were performed for the B40V2.1, there were no experts used to establish ground truth for a test set. The evaluation relies on the established safety and efficacy of the predicate device and the non-clinical assessment of the changes.
4. Adjudication method for the test set:
As no clinical test set was used, there was no adjudication method employed.
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:
No MRMC comparative effectiveness study was done as this device is a multi-parameter patient monitor, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of AI assistance. The focus is on the device's ability to continuously monitor physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a standalone multi-parameter patient monitor, meaning it operates to collect and display physiological data. However, the evaluation described is not a "standalone algorithm performance" study in the typical sense of AI, but rather a demonstration of the device's inherent functionality as a medical instrument. No specific algorithm-only performance study details are provided beyond the statement that "there are no changes to the parameter measuring hardware."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the specific device (Monitor B40V2.1), no explicit ground truth based on expert consensus, pathology, or outcomes data was used because clinical studies were not required. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety of the predicate device (Monitor B40V2) and the assessment that the changes introduced did not alter these fundamental aspects. The non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) are intended to ensure the device performs as intended and meets relevant standards.
8. The sample size for the training set:
Not applicable. This document describes a traditional medical device (patient monitor) and its modifications, not an AI/machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
§ 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.