← Product Code [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA) · K970368 # SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER (K970368) _Siemens Medical Solutions USA, Inc. · DQA · May 6, 1997 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K970368 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [DQA](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA.md) - **Decision Date:** May 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.2700 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for 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). ## Regulatory 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](/device/K923682.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: (508) 750-7500 Fax: (508) 777-3398 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: (508) 750-7500 Fax: (508) 777-3398 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: (508) 750-7500 Fax: (508) 777-3398 Telex: 511958 (Siemensm SD) --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K970368](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQA/K970368) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com