(214 days)
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.
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This document describes the safety and effectiveness information for the Siemens Olympus Communications Network, SC 3000 Workstation, and SC 3000 Remote Display. However, the provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The document primarily focuses on:
- General Information: Device classification, common names, trade names, intended uses, and establishment details.
- Safety and Effectiveness Information II: Compliance with electrical standards (IEC 601-1, UL 544, UL 433, EN 60950, UL 1950, CSA 22.2 No. 950, CE Mark), operational instructions, and adherence to a product development process for design and testing.
- Substantial Equivalence III: Comparison to previously cleared predicate devices from Siemens (SIRENET Communications Network, SIRECUST 120/121C Central Station, SIRECUST 120/121S Slave Display) and Marquette (Unity Network, CentralScope™ 12 Central Station, Remote Color Display).
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the given text.
To answer your request, the input document would need to include sections detailing:
- Specific performance metrics (e.g., accuracy, reliability, latency for communication networks; display resolution, refresh rates for workstations/displays).
- Quantitative acceptance thresholds for these metrics.
- Protocols and results of a study (e.g., validation testing, clinical trials) designed to demonstrate that the device meets these thresholds.
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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 AvenueDanvers, 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.
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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:K900598K901072K912799 |
| SC 3000 Workstationand Remote Display | SIRECUST 120/121CCentral StationSIRECUST 120/121SSlave Display | K920445K920445 | CentralScope™ 12Central StationRemote Color Display | K901072K901884 |
SIEMENS MEDICAL SYSTEMS. INC
CONFIDENTIAL
§ 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.