SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM

K962404 · Siemens Medical Solutions USA, Inc. · DSI · Jan 17, 1997 · Cardiovascular

Device Facts

• Record ID: K962404
• Device Name: SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and central apnea. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

Device Story

SC 6000 and SC 6000P are portable bedside patient monitors. Device inputs include ECG signals, impedance pneumography for respiration, absorption-spectrophotometry for SpO2, resistive strain gauge transducers for invasive pressure, and oscillometric sensors for non-invasive blood pressure. Software processes these physiological signals to calculate heart rate, respiration rate, blood pressure, and temperature. Device provides visual and aural alarms when parameters exceed preset limits and generates recordings. Used in clinical settings by healthcare professionals. Output allows clinicians to track patient status and make timely clinical decisions. Neonatal enhancement expands patient population to include neonates.

Clinical Evidence

Bench testing only. Comparison of performance specifications (ECG, respiration, SpO2, temperature, NBP, IBP) against predicate device demonstrates substantial equivalence. No clinical study data provided.

Technological Characteristics

Portable bedside monitor. Sensing: ECG (leads I, II, III, aVR, aVF, aVL, V), impedance pneumography (respiration), absorption-spectrophotometry (SpO2), oscillometric (NBP), resistive strain gauge (IBP). Connectivity: Integrated module. Software-enhanced for neonatal monitoring. Accuracy: ECG ±5-8%, SpO2 ±2% (70-100%), NBP ±3 mmHg, IBP ±2 mmHg.

Indications for Use

Indicated for neonatal, pediatric, and adult patient populations requiring monitoring of heart rate, respiration, invasive/non-invasive blood pressure, temperature, SpO2, and central apnea.

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 SIRECUST 1261 (K952054)

Submission Summary (Full Text)

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K962404

JAN 17 1997

510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement

## Section 2: Summary & Certification

510(k) Summary per 807.92(c)

(2) Subscribers Name & Address:

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923

Tele: 508 750 7500
Fax: [phone]

Official Correspondent: Robert W. Becker
Contact Person for this submission: Mark E. Kolnsberg

(3) Trade Name:

Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System

Common name. Classification number. Class & Regulation Number:

| Common Name | Classification Number | Class | Regulation Number |
| --- | --- | --- | --- |
| Cardiac monitor | 74DRT | II | 21 CFR 870.2300 |
| Pulse rate monitor | 74BWS | II | 21 CFR 870.2300 |
| Pulse oximeter | 74DQA | II | 21 CFR 870.2700 |
| Breathing frequency monitor | 73BZQ | II | 21 CFR 868.2375 |
| Clinical electronic thermometer | 80BWX | II | 21 CFR 880.2910 |
| Indwelling blood pressure monitor | 74CAA | II | 21 CFR 870.1110 |
| Noninvasive blood pressure monitor | 74DXN | II | 21 CFR 870.1130 |
| Heart Rate Monitor, Neonatal | 74FLO | II | 21 CFR 870.2300 |
| Monitor Blood pressure, Neonatal, Invasive | 74FLP | II | 21 CFR 870.1110 |
| Arrhythmia detector & Alarm | 74DSI | III | 21 CFR 870.1025 |

(4) Predicate Device Identification:

Siemens SIRECUST 1261 granted premarket approval under 510 K file number K952054.

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510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement

(5) Device Description:

The SC 6000 and SC 6000P Portable patient monitors with neonatal monitoring enhancement are software enhanced versions of the SC 6000 and SC 6000P Portable patient monitors. The software modifications have been undertaken to expand the Intended Patient Population from pediatric and adults to also include neonatal patients.

(6) Intended Use of the Device:

The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and central apnea. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

(7) Summary of technological characteristics of Device and Predicate Device:

The comparison of intended use and technological features of these devices to other legally marketed devices taken together with the validation results and other information in this submission indicate that these devices are substantially equivalent to legally marketed predicated devices in safety, effectiveness and intended use.

| Parameter | SC6000 & SC6000 P Specification | Predicate Device: SIRECUST 1261 Specification ((When equipped with Large Integrated Module(LIM)) |
| --- | --- | --- |
| ECG & Heart Rate | | |
| Available leads: | I, II, III, aVR, aVF, aVL, V | I, II, III, aVR, aVF, aVL, V |
| Measuring range: | 15 - 300 bpm | 15 - 300 bpm |
| Accuracy: | ± 5% for 15 - 200 bpm
± 8% for 201 - 300 bpm | ± 10% for 15 - 300 bpm |
| Respiration | | |
| Method: | Impedance pneumography | Impedance pneumography |
| Measuring range: | 2 - 155 breaths per min. | 2 - 155 breaths per min. |
| Measuring accuracy: | ± 3 bpm | ± 3 bpm |
| Apnea Detection?: | Yes | Yes |
| SpO2 | | |
| Measuring method: | Absorption-spectrophotometry | Absorption-spectrophotometry |
| Measuring range: | | |
| SpO2: | 1 - 100% | 1 - 100% |
| Pulse Rate: | 30 - 300 bpm | 30 - 300 bpm |
| SpO2 Accuracy: | | |
| Range 70 - 100% | ± 2% | ± 2% |
| Range 0 - 69%: | not specified | not specified |
| Pulse Rate Accuracy: | ± 10% | ± 10% |
| Temperature | | |

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510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement

| Parameter | SC6000 & SC6000 P Specification | Predicate Device: SIRECUST 1261 Specification
((When equipped with Large Integrated Module(LIM)) |
| --- | --- | --- |
| Measurement Range: | 0° C to 50° C | -5° C to 50° C |
| Accuracy: | | |
| Range 30 - 50°C | ± 0.1°C | ± 0.1°C |
| Range 0 - 30°C | ± 0.2°C | ± 0.2°C |
| Non Invasive Blood Pressure (NBP) | | |
| Parameter display: | Systolic, Diastolic, Mean | Systolic, Diastolic, Mean |
| Measuring method: | Oscillometric technique | Oscillometric technique |
| Measurement range: | | |
| heart rate:
systolic pressure
mean pressure
diastolic pressure | 40-240 bpm
30-130 mmHg
20-110 mmHg
10-100 mmHg | 40-240 bpm
30-130 mmHg
20-110 mmHg
10-100 mmHg |
| Initial inflation pressure: | 110 mmHg +/- 15 mmHg | 110 mmHg +/- 15 mmHg |
| Static cuff accuracy: | ± 3 mmHg | ± 3 mmHg |
| Invasive Blood Pressure (IBP) | | |
| Measuring method: | resistive strain gauge transducer | resistive strain gauge transducer |
| Measuring range: | -50 to + 399 mmHg | -50 to + 399 mmHg |
| Accuracy:
After transducer zeroing | ± 2 mmHg exclusive of transducer | ± 2 mmHg exclusive of transducer |
| Transducer specifications | Siemens-approved transducers with a resistance of 200 to 3000 Ω and an equivalent pressure sensitivity of 5μV/V/mmHg ± 10% | Siemens-approved transducers with a resistance of 200 to 3000 Ω and an equivalent pressure sensitivity of 5μV/V/mmHg ± 10% |

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