(403 days)
K 844187/A
K 844187/A
No
The document describes a software enhancement to an existing patient monitor to include neonatal patients. It focuses on measuring standard physiological parameters and providing alarms based on preset limits. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is a monitoring device that measures and detects patient parameters, and provides alarms, but it does not directly treat or alleviate a medical condition.
Yes
The device measures various physiological parameters (heart rate, respiration rate, blood pressure, etc.) and produces alarms if these parameters vary beyond preset limits, which is characteristic of a diagnostic device used for monitoring patient conditions.
No
The device description explicitly states that the enhanced software uses "the same hardware" as previous versions of the monitors, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device measures physiological parameters directly from the patient (heart rate, respiration rate, blood pressure, etc.) and detects waveforms (ventilator performance, EEG). It does not analyze samples taken from the patient.
- Intended Use: The intended use is to monitor vital signs and detect variations in neonatal patients, not to perform diagnostic tests on biological samples.
Therefore, this device falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 pediatic 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, artial 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.
Product codes (comma separated list FDA assigned to the subject device)
74DRT, 74KFN, 73BZQ, 74CAA, 74BRS, 84BRR, 80BWX, 73BZK, 74DQA, 73ILKD, 74BXD
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatal, pediatric, adult
Intended User / Care Setting
Healthcare providers, i.e. Physicians, Nurses, and Technicians / environment where patient care is provided by Healthcare Professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of the environmental, electrical safety, and mechanical test results which were performed on the monitors are presented in Exhibit P.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K 844187/A
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.
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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
§ 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.
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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, artial 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: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD)
ે જે
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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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C. ESTABLISHMENT REGISTRATION NUMBER 1220063
D. ADDRESS OF MANUFACTURER
Siemens Medical Electronics, Inc. 16 Electronics Avenue Danvers, MA 01923
Telephone: (508) 750-7500 Fax: (508) 774-8342
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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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 pediatic 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, artial 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 be 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 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.
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
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Is the device compared to Marketed device? Yes, Model 404N Neonatal Monitor (K 844187/A) Manufactured by Siemens Medical Systems, Danvers, Ma.
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Does the device have the same Indication Statement? Yes the enhanced software has the same intended use as the predicate device.
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- 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.
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- 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.
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- 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
SAFETY AND EFFECTIVENESS INFORMATION II.
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, perioheral 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. Oualification 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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