SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)

K952054 · Siemens Medical Solutions USA, Inc. · DSI · Jun 7, 1996 · Cardiovascular

Device Facts

• Record ID: K952054
• Device Name: SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jun 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference 510(K) 844187/A). The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits. The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used by Healthcare providers, i.e. Physicians, Nurses, and Technicians. The device labeling contains instructions for use which assures safe and effective use of the device. CAUTION: Federal law in the United States restricts this device to safe by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

Device Story

Multi-parameter bedside monitor series (960/1260/1280) utilizing enhanced software (version VH4-HXE) to enable neonatal monitoring. Inputs: physiological signals (ECG, pressure, CO2, temperature, SpO2, EEG, ventilator data). Processing: software-based parameter calculation and threshold monitoring. Outputs: real-time physiological data, visual/aural alarms for out-of-limit parameters. Used in clinical environments by physicians, nurses, and technicians. Healthcare providers use output for patient assessment and clinical decision-making. Benefits: enables continuous monitoring of neonatal patients to detect physiological instability.

Clinical Evidence

No clinical data provided. Substantial equivalence based on identical software performance specifications to the predicate device and bench testing of electrical/mechanical safety.

Technological Characteristics

Bedside monitoring system; software-based parameter processing; monochrome or color display; compatible with existing Siemens parameter cartridges and peripheral equipment. Software version VH4-HXE. No specific materials or connectivity standards (e.g., DICOM) detailed.

Indications for Use

Indicated for neonatal, pediatric, and adult patient populations requiring physiological monitoring of heart rate, respiration, blood pressure (invasive/noninvasive), cardiac output, CO2, temperature, SpO2, pulse rate, ventilator performance, and EEG waveforms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Siemens Neonatal Monitor Model 404N (K844187/A)

Submission Summary (Full Text)

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SIEMENS
K952054
510 (K) Sirecust 960/961 1260/1261 1280/1281

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The 960/961 1260/1261 and 1280/1281 Series Neonatal Monitoring is an enhanced software version of the 960/961 1260/1261 and 1280/1281 Series monitors. The enhanced software version increases the patient population to include neonatal applications. The enhanced software is substantially equivalent to the software used in the Siemens Neonatal Monitor Model 404N (reference 510(K) 844187/A). The Intended Use Statement for the enhanced software is the same as the Intended Use for the Model 404 Neonatal Monitor.

The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)
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510 (K) Sirecust 960/961 1260/1261 1280/1281

# GENERAL INFORMATION

## A. TRADE NAME

Siemens Sirecust 1200 Series Neonatal Monitoring which includes:
- 1260 Neonatal Monitoring (Monochrome Display)
- 1261 Neonatal Monitoring (Color Display)
- 1280 Neonatal Monitoring (Monochrome Display)
- 1281 Neonatal Monitoring (Color Display)

Siemens Sirecust 960 Series Monitoring (Retrofit) which includes:
- 960 Monitor (Monochrome Display)
- 961 Monitor (Color Display)

Siemens Sirecust 1200 Series Monitoring (Retrofit)
- 1260 Monitor (Monochrome Display)
- 1261 Monitor (Color Display)
- 1280 Monitor (Monochrome Display)
- 1281 Monitor (Color Display)

## B. COMMON NAME, CLASSIFICATION NUMBER, CLASS, and REGULATION NUMBER

| Monitor, Cardiac (Include. Cardiotachometer & Rate Alarm) | 74DRT | II | 870.2300 |
| --- | --- | --- | --- |
| Monitor, Cardiac Output (Thermal) | 74KFN | II | 870.1435 |
| Monitor, Breathing Frequency | 73BZQ | II | 868.2365 |
| Monitor, Indwelling Blood Pressure | 74CAA | II | 870.1110 |
| Monitor, Electrocardiograph | 74BRS | II | 870.2370 |
| Monitor, Electroencephalograph | 84BRR | II | 882.1400 |
| Monitor, Temperature | 80BWX | II | 880.2910 |
| Monitoring Spirometer | 73BZK | II | 868.1850 |
| Oximeter | 74DQA | II | 870.2700 |
| Monitor, Carbon Dioxide | 73ILKD | II | 868.4280 |
| Monitor, Noninvasive Blood Pressure | 74BXD | II | 876.1130 |

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510 (K) Sirecust 960/961 1260/1261 1280/1281

# C. ESTABLISHMENT REGISTRATION NUMBER
1220063

# D. ADDRESS OF MANUFACTURER
Siemens Medical Electronics, Inc.
16 Electronics Avenue
Danvers, MA 01923

Telephone: [phone]
Fax: [phone]

Contact Person: Mr. Thomas Connelly

# E. NEW OR MODIFICATION

The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the Siemens Medical Systems’ Model 404N Neonatal Monitor.

The enhanced software (version VH4-HXE) is fully compatible with previously sold versions of these monitors. A retrofit will be offered to the owners of units with the previous revision software (version VGx-HXE and VHx-HXE) where x is the revision number.

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510 (K) Sirecust 960/961 1260/1261 1280/1281

# INTENDED USE STATEMENT

The 960/1260/1280 Series Neonatal Monitoring is an enhanced software version of the 960/1260/1280 Series monitors. The enhanced version increases the patient population to include neonates along with the pediatric and adult patient covered by earlier versions of these products. The Intended Use Statement for the enhanced software is the same as the Intended Use for the substantially equivalent software of the Model 404N (reference 510(K) 844187/A).

The intended use of this software is to measure: heart rate, respiration rate, invasive blood pressure, noninvasive blood pressure, cardiac output, gaseous carbon dioxide level, temperature, atrial oxygen concentration and pulse rate in neonatal patients and to detect ventilator performance and electroencephalograph waveforms. The software will produce visual and aural alarms if any of these parameters vary beyond preset limits.

## Intended Operator:

The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used by Healthcare providers, i.e. Physicians, Nurses, and Technicians.

The device labeling contains instructions for use which assures safe and effective use of the device.

**CAUTION**: Federal law in the United States restricts this device to safe by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

## Intended Patient Populations:

The enhanced software for the Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used with Neonatal populations.

## Intended Use Environment:

The Siemens 960/1260/1280 Series Neonatal Monitoring is intended to be used in the environment where patient care is provided by Healthcare Professionals.

## Performance Standard:

None established under Section 514 or Section 358

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510 (K) Sirecust 960/961 1260/1261 1280/1281

# 510 (K) Decision Making Chart

1. Is the device compared to Marketed device? Yes, Model 404N Neonatal Monitor (K 844187/A) Manufactured by Siemens Medical Systems, Danvers, Ma.

2. Does the device have the same Indication Statement? Yes the enhanced software has the same intended use as the predicate device.

3. Does the new device have the same intended use and may be “substantially equivalent”? Yes the new device uses the same software that is used in the predicate device.

4. Does the device have the same Technological Characteristics, e.g. Design, materials, etc? Yes, the software is the same as the software used in the predicate device.

5. Are the descriptive characteristics precise enough to ensure equivalence? Yes, the specifications are identical.

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510 (K) Sirecust 960/961 1260/1261 1280/1281

## II. SAFETY AND EFFECTIVENESS INFORMATION

### ELECTRICAL:
The results of the environmental, electrical safety, and mechanical test results which were performed on the monitors are presented in Exhibit P.

### OPERATION:
The device labeling contains instructions for use which assures safe and effective use of the device.

**CAUTION:** Federal law in the United States restricts this device to sale by, or on the order of a physician. All Siemens bedside monitors, parameter cartridges, central displays, recorders, ancillary displays, peripheral equipment, and accessories are intended for use only by qualified medical personnel. Patient monitoring equipment, however sophisticated, should never be used as a substitute for the human care, attention, and critical judgment that only trained health care professionals can provide.

### DEVELOPMENT:
Medical device development is conducted in accordance with an approved Siemens Product Planning Process. Product specifications, hazards analysis, software development plan and device test plan are required parts of the device development process. Qualification test results which demonstrate that the device performs in accordance with its specification are required before product release.

## III. SUBSTANTIAL EQUIVALENCE

The Neonatal Monitors use the same hardware with enhanced software to accommodate the neonatal population of patients. The performance specifications for the neonatal applications are identical to the performance specifications of the Siemens Medical Systems Neonatal Monitor Model 404N (reference 510(K) K844187/A)

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