SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER

K970368 · Siemens Medical Solutions USA, Inc. · DQA · May 6, 1997 · Cardiovascular

Device Facts

• Record ID: K970368
• Device Name: SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: May 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Device Story

Device acts as interface/protocol converter; transforms data from third-party medical devices (ventilators, infusion pumps, SvO2 monitors) into IEEE 1073 Medical Information Bus (MIB) format. Inputs include serial RS-232 or analog signals from third-party equipment. Output is IEEE 1073-compliant data transmitted to Siemens SC9000/SC9015 bedside monitors for display. Used in OR or ICU environments by clinicians. Facilitates centralized monitoring of disparate medical equipment data on a single display, aiding clinical decision-making by integrating patient data from multiple sources.

Clinical Evidence

No clinical data; not applicable.

Technological Characteristics

Protocol converter; inputs: RS-232, analog; output: IEEE 1073 (MIB) connector. Complies with IEEE 1073.3.1-1994 (Transport Profile) and IEEE 1073.4.1-1994 (Physical Layer Interface).

Indications for Use

Indicated for connecting third-party medical devices (e.g., ventilators, SvO2 devices, infusion pumps) to Siemens SC9000/SC9015 bedside monitors. No specific patient population or contraindications defined; device is not connected to patients.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• Hewlett-Packard Model M1032A Vuelink Interface Plug In Module (K923682)

Submission Summary (Full Text)

{0}

510 (K) Notification
Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter

K970368

# 510(k) SUMMARY

as required per 807.92(c)

MAY - 6 1997

## 2: Submitters Name, Address:

Siemens Medical Systems, Inc.
16 Electronics Avenue
Danvers, MA 01923
Tel: [phone]
Fax: [phone]
Official Correspondent: David Simard, Director Quality Assurance and Regulatory Affairs
Contact person for this submission: Jacqueline E. M. Emery
Date submission was prepared: January 7, 1997

## 3: Trade Name, Common Name and Classification Name:

A. Trade Name: Siemens SC9000/ SC9015 Series Medical Information Bus (MIB) Protocol Converter

B. Common Name, Classification Number, Class and Regulation Number:

| Common Name | Classification Number | Class | Regulation Number |
| --- | --- | --- | --- |
| Transducer Signal amplifier and conditioner | 73 DQA | II | 21CFR870.2060 |

## 4: Predicate Device Identification: Hewlett-Packard Model M1032A Vuelink Interface Plug In Module cleared under 510(K) number: K923682

## 5. Device Description: The Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter transforms data generated by third party devices (e.g. ventilators, SvO2 devices and infusion pumps) into a common format per the IEEE 1073 Medical Information Protocol and transmits this data to the Siemens SC9000/SC9015 Bedside Monitor. Attachment cables specific to third party device are offered as accessories.

## 6. Intended Use: The Medical Information Bus (MIB) Protocol Converter is intended to connect third party medical devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard to the Siemens SC9000/SC9015 Bedside Monitor for display.

Siemens Medical Systems, Inc.
Electromedical Group
16 Electronics Avenue
Danvers, MA 01923
USA
Tel: [phone]
Fax: [phone]
Telex: 511958 (Siemensm SD)

{1}

510 (K) Notification

Siemens SC9000/SC9015 Medical Information Bus (MIB) Protocol Converter

7. Table of device similarities and differences to predicate device

| | Substantial Equivalent Device
Hewlett Packard Co
Model M1032A VueLink Module | Applicant
Siemens Medical Systems
SC 9000/9015 Series Medical Information Bus (MIB)
Protocol Converter |
| --- | --- | --- |
| Manufacturer | Hewlett Packard | Siemens Medical Systems -
Electromedical Group |
| 510K Number | K923682 | To be assigned |
| Intended Use | Provides an external device interface
capability to third party devices that
have a serial RS-232 and/or analog
output | Same |
| Intended Population | NA
Not connected to patients | Same |
| Intended Environment | OR or ICU | Same |
| Input port | RS-232, Analog, Analog/Digital
combination | Same |
| Output Port | HP specific | IEEE 1073 (MIB Connector) |

8. Assessment of non-clinical performance data for equivalence:

Substantial equivalence is claimed to the Hewlett Packard Model M1032A Vuelink Interface Plug-In Module cleared under 510(K) number K923682.

9. Assessment of clinical performance data for equivalence: Not applicable

10. Biocompatibility: Not applicable

11. Sterilization: Not applicable

12. Standards and Guidelines:

Currently there are no FDA standards for this device. However, the Siemens SC9000/SC9015 Series Medical Information Bus (MIB) Protocol Converter complies with:

- 1073.3.1-1994 IEEE Standard for Medical Device Communications
- Transport Profile- Connector Mode
- 1073.4.1-1994 IEEE Standard for Medical Device Communications
- Physical Layer Interface - Cable Connected

Siemens Medical Systems, Inc.

Electromedical Group

16 Electronics Avenue

Danvers, MA 01923

USA

Tel: [phone]

Fax: [phone]

Telex: 511958 (Siemensm SD)