(210 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard physiological monitoring parameters and software enhancements for a new patient population.
No
The device is a patient monitor designed to measure vital signs and alert users to deviations from preset limits. It does not actively treat or ameliorate a disease or condition.
No.
The device measures vital signs and provides alarms, which are monitoring functions, not diagnostic ones. It indicates whether parameters vary beyond limits but doesn't identify the underlying cause of such variations.
No
The device description explicitly states it is a "software enhanced version" of existing "Portable patient monitors," implying the existence of hardware components (the monitors themselves) that the software enhances.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure physiological parameters directly from a patient (heart rate, respiration rate, pressure, SpO2, temperature, etc.). This is in vivo measurement, not in vitro (outside the body).
- Device Description: The device is a patient monitor, which is used to monitor a patient's vital signs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
74DRT, 74BWS, 74DQA, 73BZQ, 80BWX, 74CAA, 74DXN, 74FLO, 74FLP, 74DSI
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.
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
The software modifications have been undertaken to expand the Intended Patient Population from pediatric and adults to also include neonatal patients.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K962404
JAN 17 1997
510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement
Summary & Certification Section 2:
Summary per 807.92(c) 510 (k)
Subscribers Name & Address: (2)
Siemens Medical Systems, Inc. Electromedical Group 16 Electronics Avenue Danvers, MA 01923
Tele: 508 750 7500 Fax: 508 777 3398
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 |
|--------------------------------------------------|--------------------------|-------|-------------------|
| 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 |
Common name. Classification number. Class & Regulation Number:
(4) Predicate Device Identification:
Siemens SIRECUST 1261 granted premarket approval under 510 K file number K952054.
1
510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement
Device Description: (ર)
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.
Intended Use of the Device: (6)
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.
Summary of technological characteristics of Device and Predicate Device: (7)
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: | 1 - 100% | 1 - 100% |
| 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 | | |
2
510(k) SC 6000 & SC 6000 P Neonatal Monitoring Enhancement
产品 - - - - - -
| 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: | 40-240 bpm | 40-240 bpm |
| systolic pressure | 30-130 mmHg | 30-130 mmHg |
| mean pressure | 20-110 mmHg | 20-110 mmHg |
| diastolic pressure | 10-100 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: | ± 2 mmHg exclusive of transducer | ± 2 mmHg exclusive of transducer |
| After transducer zeroing | | |
| Transducer
specifications | Siemens-approved transducers with a
resistance of 200 to 3000 Ω and an
equivalent pressure sensitivity of
5uV/V/mmHg ± 10% | Siemens-approved transducers with a
resistance of 200 to 3000 Ω and an
equivalent pressure sensitivity of
5uV/V/mmHg + 10% |