Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bedside monitoring system with enhanced neonatal functionality, focusing on standard physiological parameter monitoring and alarming. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No.
The device is for monitoring various physiological parameters and provides alarms, but it does not treat or cure any conditions.

Diagnostic

No

This device is designed to measure various physiological parameters and produce alarms, which points to a monitoring function rather than diagnosing a specific disease or condition. While the data it collects could be used by a clinician for diagnosis, the device itself doesn't perform diagnostic reasoning or provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "enhanced software version of the Siemens SC9000/ SC9015 Bedside Monitoring System," implying it is software that runs on existing hardware (the Bedside Monitoring System), not a standalone software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use describes the measurement of various physiological parameters (heart rate, respiration rate, pressure, etc.) directly from the patient. IVD devices, on the other hand, are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
Device Description: The description refers to a "Bedside Monitoring System" that monitors patients directly.
Lack of Specimen Handling: There is no mention of the device analyzing or processing biological specimens.

Therefore, the Siemens SC900V SC9015 Bedside Monitoring System, with enhanced Neonatal Functionality, is a patient monitoring device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

74DRT, 74DSI, 73BZQ, 74BWS, 74DXN, 80BWX, 74DQA, 74KFN, 73CCK, 74CAA, 74CAA, 74FLO, 73FLS, 74FLP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Neonatal

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K952054

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 frequency
monitor	73BZQ	II	21 CFR 868.2375
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Non-indwelling blood
pressure 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 blood
pressure 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

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.

6. Intended Use:

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.

Table of device similarities and differences to predicate device

| | Modified Software
SC9000/ SC9015
Neonatal Monitor | Substantially
Equivalent Device
1200 series Neonatal
Monitoring System
(K952054) | Explanation of the modified version
differences when compared to the
1200 series Neonatal Monitoring
System |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens Medical
Systems EMG | Siemens Medical
Systems EMG | |
| 510K number | To be assigned | K952054 | |
| Intended population | Neonatal | Neonatal | Same neonatal application areas |
| Monitoring parameters | Software modules
added for neonatal
application:

ECG, Respiration
(impedance), Cardiac
Output, Invasive
pressure, Pulse,
Temperature, SpO2,
non-invasive pressure,
etCO2 | Software modules for
neonatal application:

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 Software
SC9000/ SC9015
Neonatal Monitor | Substantially
Equivalent Device
1200 series Neonatal
Monitoring System
(K952054) | Explanation of the modified version
differences when compared to the
1200 series Neonatal Monitoring
System |
|------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Heart Rate Limits (default) | 80 & 170 | 100 & 170 | Default was changed to 80 based upon
customer preference. |
| Resp Rate limits (default)
(Impedance) | 20 & 60 | 6 & 85 | Defaults were changed based upon
customer preference. |
| Impedance. Resp. Rate Apnea
Alarm Grade (Default) | Serious | Serious | |
| SpO2 Pulse Limit (default) | 95 % | 100% | Defaults were changed based upon
customer preference. |
| Temperature Alarm Limit
(default) | 34.0 & 39.0 °C | 30.0 & 40.0 °C | Defaults were changed based upon
customer preference. |
| etCO2 alarm limits (default) | 30 & 50 mmHg | 20 &25 mmHg | Defaults were changed based upon
customer 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

r

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) :