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.

Device Description

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.

AI/ML Overview

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.

Summary

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JAN 29 1997

K96.291

510 (K) Notification 510 (K) Nonication

510(k) SUMMARY

as required per 807.92(c)

2; Submitters Name, Address:

Siemens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398 Official Correspondent: Robert W. Becker Contact person for this submission: Jacqueline E. M. Emery Date submission was prepared: June 1, 1996

3: Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC9000/ SC9015 Bedside Monitoring System

B. Common Name. Classification Number. Class and Regulation Number:

Common Name	Classification Number	Class	Regulation Number
Cardiac monitor	74DRT	II	21 CFR 870.2300
Arrhythmia detector& Alarm System	74DSI	III	21 CFR 870.1025
Breathing frequencymonitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling bloodpressure monitor	74DXN	II	21 CFR 870.1130
Clinical electronic thermometer	80BWX	II	21 CFR 880.2910
Pulse Oximeter	74DQA	II	21 CFR 870.2700
Cardiac Output Monitor	74KFN	II	21 CFR 870.1435
end-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Indwelling bloodpressure monitor	74CAA	II	21 CFR 870.1110
Heart Rate Monitor, Neonatal	74FLO	II	21 CFR 870.2300
Ventilatory Effort Monitor(Apnea Detector)	73FLS	II	21 CFR 868.2375
Monitor Bloodpressure, Neonatal,Invasive	74FLP	II	21 CFR 870.1110

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

{1}------------------------------------------------

510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with Neonatal Functionality

4: Predicate Device Identification:

The Siemens Sirecust 1260/1261/960961 series Neonatal Monitoring system, 510(K) file number K952054.

5. Device Description

6. Intended Use:

Table of device similarities and differences to predicate device

	Modified SoftwareSC9000/ SC9015Neonatal Monitor	SubstantiallyEquivalent Device1200 series NeonatalMonitoring System(K952054)	Explanation of the modified versiondifferences when compared to the1200 series Neonatal MonitoringSystem
Manufacturer	Siemens MedicalSystems EMG	Siemens MedicalSystems EMG
510K number	To be assigned	K952054
Intended population	Neonatal	Neonatal	Same neonatal application areas
Monitoring parameters	Software modulesadded for neonatalapplication:ECG, Respiration(impedance), CardiacOutput, Invasivepressure, Pulse,Temperature, SpO2,non-invasive pressure,etCO2	Software modules forneonatal application:ECG, Respiration(impedance), CardiacOutput, Invasivepressure, Pulse,Temperature, SpO2,non-invasive pressure,etCO2
Apnea delay time (default)	15 seconds	10 seconds	Apnea alarm time is user selectable.Default was changed to 15 secondsbased upon customer preference.
Neonatal Resp. RateMonitoring (default)	ON	ON

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)

{2}------------------------------------------------

510 (K) Notification Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with Neonatal Functionality

	Modified SoftwareSC9000/ SC9015Neonatal Monitor	SubstantiallyEquivalent Device1200 series NeonatalMonitoring System(K952054)	Explanation of the modified versiondifferences when compared to the1200 series Neonatal MonitoringSystem
Heart Rate Limits (default)	80 & 170	100 & 170	Default was changed to 80 based uponcustomer preference.
Resp Rate limits (default)(Impedance)	20 & 60	6 & 85	Defaults were changed based uponcustomer preference.
Impedance. Resp. Rate ApneaAlarm Grade (Default)	Serious	Serious
SpO2 Pulse Limit (default)	95 %	100%	Defaults were changed based uponcustomer preference.
Temperature Alarm Limit(default)	34.0 & 39.0 °C	30.0 & 40.0 °C	Defaults were changed based uponcustomer preference.
etCO2 alarm limits (default)	30 & 50 mmHg	20 &25 mmHg	Defaults were changed based uponcustomer preference.
Max. NBP cuff inflation time	90 sec.	120 sec.	Reduced per customer preference.
Max. NBP cuff pressure	150 mmHg	150 mmHg
QRS duration measurement(neonatal)	40 to 120 msec	40 to 120 msec

Assesment of non-clinical performance data for equivalence: Not applicable
Assesment of clinical performance data for equivalence: Not applicable
Not applicable

Not applicable

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue Danvers, MA 01923 USA

Tel: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) :

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.