(214 days)
No
The 510(k) summary describes a communications network and central monitoring system for patient monitoring devices, with no mention of AI or ML capabilities.
No
The device is described as a communications network, workstation, and remote display for patient monitoring systems, which are observational rather than therapeutic.
No
The device is described as a communications network, workstation, and remote display for patient monitoring systems, which are functions related to infrastructure and display, not direct diagnosis.
No
The device description is not provided, but the intended use describes a "communications network," "central monitoring device," and "remote display" for patient monitoring systems and recorders. These functions strongly suggest the involvement of hardware components beyond just software. The predicate devices also include "Communications Network," "Central Station," and "Slave Display," further indicating a system with hardware elements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices act as a communications network, central monitoring device, and slave display for patient monitoring systems. This involves the display and management of physiological data collected from patients, not the examination of specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any activities typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
- Device Description (Not Found): While the device description is not available, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections (Not Found): The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," and details about training/test sets further supports that this is not an IVD, as these are often relevant for devices that analyze biological data or images.
The devices described are components of a patient monitoring system, which is a type of medical device used to observe and display physiological parameters of a patient. This falls under the category of patient monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Olympus Communications Network: To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers.
SC 3000 Workstation: To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network.
SC 3000 Remote Display: To act as a Slave Display for the SC 3000 Workstation.
Product codes
21 CFR 870.2300, 21 CFR 870.2450, 21 CFR 870.1025
Device Description
Not Found
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K920445, K900598, K901072, K912799, K901884
Reference Device(s)
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE
I. GENERAL INFORMATION
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K955059 JUN - 7 1996
| Class II: | 21 CFR 870.2300 Cardiac monitor (Cardiotachometer and Rate Alarm).
21 CFR 870.2450 Medical Cathode-Ray Tube Display |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class III: | 21 CFR 870.1025 Arrhythmia detector and alarm. |
| Common Names: | |
| Olympus Communications Network | Communications Network, Patient Monitoring Network, Information Network; |
| SC 3000 Workstation | Central Station Monitor, Central Nursing Station; |
| SC 3000 Remote Display | Slave Display, Repeater Display; |
| Device Trade Names: | |
| Siemens Olympus Communications Network | |
| SC 3000 Workstation | |
| SC 3000 Remote Display | |
| Intended Uses: | |
| Olympus Communications Network | To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers. |
| SC 3000 Workstation | To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network. |
| SC 3000 Remote Display | To act as a Slave Display for the SC 3000 Workstation. |
| Establishment Name and Address: | Siemens Medical Electronics, Inc.
16 Electronics Avenue
Danvers, MA 01923 |
| Establishment registration Number: | 1220063 |
| Performance Standard: | None established under Section 514 or Section 358 |
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510(k) Notification: Siemens Olympus Communications Network, SC 3000 Workstation and Remote Display
SAFETY AND EFFECTIVENESS INFORMATION II.
ELECTRICAL:
Compliance with Standards:
Olympus Communication and Power Supply (CPS): IEC 601-1, UL 544
SC 3000 Workstation Unit: UL 433, EN 60950, CE Mark
SC 3000 Remote Display: UL 1950, CSA 22.2 No. 950, EN 60950, CE Mark
OPERATION:
The device labeling contains instructions for use which assures safe and effective use of the devices.
DEVELOPMENT:
Medical device development is conducted in accordance with an approved Siemens Product Planning Process and Engineering 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.
2
SUBSTANTIAL EQUIVALENCE III.
The devices listed below have the same intended uses and technological characteristics:
| Siemens' New Device | Equivalent Device
(Siemens) | K # | Equivalent Device
(Marquette) | K # |
|-------------------------------------------|----------------------------------------------------------------------------|--------------------|-------------------------------------------------------------|-------------------------------------------------|
| Olympus Communica-
tions Network | SIRENET Communi-
cations Network | K920445 | Unity Network | applicable to:
K900598
K901072
K912799 |
| SC 3000 Workstation
and Remote Display | SIRECUST 120/121C
Central Station
SIRECUST 120/121S
Slave Display | K920445
K920445 | CentralScope™ 12
Central Station
Remote Color Display | K901072
K901884 |
SIEMENS MEDICAL SYSTEMS. INC
CONFIDENTIAL