(229 days)
The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial orygen saturation, pulse rate, cardiac output, end-tidal carbon dioxice and (central) apnea. This device will produce visual and alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network.
The Siemens SC900V SC9015 Bedside Monitoring System, with enhanced Neonatal Functionality is an enhanced software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The enhancement adds neonatal monitoring.
This 510(k) notification describes an enhanced software version of an existing bedside monitoring system, adding neonatal functionality. The submission does not contain a study that establishes acceptance criteria and proves the device meets them in the traditional sense of an AI/algorithm-driven device performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Siemens Sirecust 1260/1261/960961 series Neonatal Monitoring system, K952054) by comparing features and default settings.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not present:
Description of Acceptance Criteria and Device Performance Study
The document outlines changes to default settings for various monitoring parameters in the enhanced Siemens SC9000/SC9015 Bedside Monitoring System with Neonatal Functionality. The "acceptance criteria" here are implicitly tied to the performance and safety of the predicate device, as the new device is an enhanced software version. The study to "prove" the device meets acceptance criteria is not a separate performance study, but rather a comparison of specifications and features to the predicate device, with an explanation for any differences.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a comparison to a predicate device and not a standalone performance study with defined acceptance criteria, a direct table of "acceptance criteria" for the new device's performance metrics isn't provided. Instead, the document compares default settings with the predicate device. The "reported device performance" refers to these new default settings.
| Parameter | Predicate Device (K952054) Default | Enhanced Device (SC9000/SC9015) Default | Explanation of Difference |
|---|---|---|---|
| Apnea delay time | 10 seconds | 15 seconds | User selectable, changed based on customer preference. |
| Neonatal Resp. Rate Monitoring | ON | ON | Same |
| Heart Rate Limits | 100 & 170 | 80 & 170 | Changed 80 based on customer preference. |
| Resp Rate limits (Impedance) | 6 & 85 | 20 & 60 | Changed based on customer preference. |
| Impedance. Resp. Rate Apnea Alarm Grade | Serious | Serious | Same |
| SpO2 Pulse Limit | 100% | 95% | Changed based on customer preference. |
| Temperature Alarm Limit | 30.0 & 40.0 °C | 34.0 & 39.0 °C | Changed based on customer preference. |
| etCO2 alarm limits | 20 & 25 mmHg | 30 & 50 mmHg | Changed based on customer preference. |
| Max. NBP cuff inflation time | 120 sec. | 90 sec. | Reduced per customer preference. |
| Max. NBP cuff pressure | 150 mmHg | 150 mmHg | Same |
| QRS duration measurement (neonatal) | 40 to 120 msec | 40 to 120 msec | Same |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission is for enhanced software functionality, and there is no mention of a "test set" in the context of clinical performance data in this document. The assessment explicitly states "Assesment of non-clinical performance data for equivalence: Not applicable" and "Assesment of clinical performance data for equivalence: Not applicable." This indicates that a separate performance study with a test set was not conducted or reported in this 510(k) summary for the purpose of demonstrating equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. No ground truth establishment by experts is mentioned as part of this submission, as no new performance study was reported.
4. Adjudication Method for the Test Set
Not applicable. No test set mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This submission is for a bedside monitoring system with enhanced software. MRMC studies are typically for imaging or diagnostic algorithms where human readers interpret results, and an "AI" component would assist. This is not the type of device for which an MRMC study would typically be conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The device is a monitoring system that provides measurements to clinicians. The "enhancements" are in software that impacts default settings for these measurements, not a standalone diagnostic algorithm.
7. The type of ground truth used
Not applicable. As no new clinical performance study was conducted to establish new performance metrics, the concept of "ground truth" for a test set is not discussed. The "ground truth" in this context is implicitly the established reliability and safety of the predicate device, and the modifications are presented as merely changes to default settings based on user preference without altering fundamental measurement accuracy or safety (which would typically require new performance data).
8. The sample size for the training set
Not applicable. This document is not describing an AI/machine learning algorithm that requires a training set. It's an enhancement to existing monitoring software.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
Summary of the Document's Approach:
This 510(k) notification relies on demonstrating substantial equivalence to an existing cleared device. The "study" here is essentially a comparison of the new device's specifications and default settings to those of the predicate device. Where differences exist (e.g., apnea delay time, heart rate limits, SpO2 pulse limit), the explanation is typically "customer preference" or a similar justification, implying these changes do not alter the fundamental safety or effectiveness of the device compared to the predicate. The document explicitly states that both non-clinical and clinical performance data for equivalence are "Not applicable," meaning no new studies were submitted to confirm the performance of these changed parameters.
§ 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.