SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER

K022766 · Siemens Medical Solutions USA, Inc. · DQA · Sep 5, 2002 · Cardiovascular

Device Facts

• Record ID: K022766
• Device Name: SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended Use

The Siemens Medical Information Bus (MIB / MIB II / MIB Duo) Protocol Converters are intended for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that a third party medical device should be connected to a Siemens Modular Monitor for display of data. Connectable devices include: Siemens SV 300 ventilator, Siemens Servoi Ventilator, Baxter Vigilance blood gas/continuous cardiac output monitor. Siemens SV900 ventilator, Draeger Evita II ventilator, Draeger Evita IV ventilator, Draeger Babylog ventilator, Puritan Bennett 7200 ventilator, Puritan Bennett 840 ventilator, Hamilton Galileo ventilator, Draeger Narkomed II Anesthesia System, Draeger Narkomed IV Anesthesia System, Draeger Julian Anesthesia Machine, Ohmeda 7900 Anesthesia Machine, Abbott Oximetrix 3 Blood Gas Analyzer, AVL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer, Optical Sensors Inc .: OSI- Optical CAM, VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor: and Aspect A-2000 BIS, Abbott O2, and Sensormedics Micro Gas 7650.

Device Story

Device acts as interface/protocol converter; enables connectivity between third-party medical devices (ventilators, anesthesia machines, blood gas analyzers) and Siemens INFINITY modular monitors. Input: digital/analog signals from third-party devices via device-specific accessory cables. Transformation: converts proprietary third-party device protocols into format compatible with Siemens INFINITY monitor network. Output: device-specific data displayed on bedside monitor or MultiView WorkStation (VentCentral application). Used in clinical settings by physicians, nurses, or technicians. Facilitates centralized monitoring of patient data from multiple sources; assists clinicians in real-time patient status assessment; improves clinical workflow by consolidating data display.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Protocol converter; utilizes device-specific accessory cables for physical connection. Complies with IEEE 1073.3.1 (Medical Device Communications-Transport Profile-Connection Mode) and IEEE 1073.3.2-2000 (IrDA Based - Cable Connected). Software-based protocol conversion; non-MRI compatible.

Indications for Use

Indicated for use by healthcare professionals (physicians, nurses, technicians) to connect third-party medical devices (ventilators, anesthesia systems, blood gas/cardiac output monitors) to Siemens INFINITY modular bedside monitors for data display in clinical environments.

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

• Siemens INFINITY MIB II Duo (K012461)
• Siemens INFINITY MIB II Protocol Converter (K010640)
• Siemens Medical Information Bus (MIB) Protocol Converter (K970368, K973222, K991661, K003248, K020277)

Reference Devices

• Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246)

Submission Summary (Full Text)

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Special 510(k): Device Modification

SIEMENS Medical Information Bus (MIB/MIBII) Protocol Converters

## 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: August 19, 2002

Trade Name, Common Name and Classification Name:

- A. Trade Name:
Siemens Medical Information Bus (MIB, MIB Duo) Protocol Converters

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

| Common Name | Classification<br>Number | Class | Regulation<br>Number |
|---------------------------------------------|--------------------------|-------|----------------------|
| Transducer Signal amplifier and conditioner | 73 DRQ | II | 21 CFR 870.2060 |

Legally Marketed Device Identification:

Siemens INFINITY MIB II Duo: 510(k) K012461 Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246)

Description of Modification:

Siemens Medical Information Bus (MIB) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB VF2 software and MIB II VA2 software, along with device specific accessory cables enables MIB connectivity of the following devices to the INFINITY modular monitors (SC 9000/SC7000/SC9000XL/SC8000):

> Puritan Bennett 840 ventilator Hamilton Galileo ventilator Abbott Q2 Sensormedics Micro Gas 7650

These connections enable the display of device specific data on an INFINITY modular monitor. Data from the Puritan Bennett 840 and Hamilton Galileo ventilators can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation.

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Siemens Medical Solutions USA, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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The modifications described have not altered the fundamental technology of the MIB/MIBII Protocol Converters.

The intended use and indications of the MIB with VF2 software and the MIBII with VA2 software, as described in its labeling, are the same as the intended uses and indications for the MIB/MIBII unmodified predicate devices.

Intended Use:

The Siemens Medical Information Bus (MIB / MIB II / MIB Duo) Protocol Converters are intended for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that a third party medical device should be connected to a Siemens Modular Monitor for display of data.

Connectable devices include: Siemens SV 300 ventilator, Siemens Servoi Ventilator, Baxter Vigilance blood gas/continuous cardiac output monitor. Siemens SV900 ventilator, Draeger Evita II ventilator, Draeger Evita IV ventilator, Draeger Babylog ventilator, Puritan Bennett 7200 ventilator, Puritan Bennett 840 ventilator, Hamilton Galileo ventilator, Draeger Narkomed II Anesthesia System, Draeger Narkomed IV Anesthesia System, Draeger Julian Anesthesia Machine, Ohmeda 7900 Anesthesia Machine, Abbott Oximetrix 3 Blood Gas Analyzer, AVL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer, Optical Sensors Inc .: OSI- Optical CAM, VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor: and Aspect A-2000 BIS, Abbott O2, and Sensormedics Micro Gas 7650.

Assessment of non-clinical performance data for equivalence: Section J

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: 1073.3.1 Medical Device Communications-Transport Profile-Connection Mode 1073.3.2 - 2000 IEEE Standard for Medical Communications Transport Profile - IrDA Based - Cable Connected

Siemens Medical Solutions USA, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 5 2002

Siemens Medical Solutions USA, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K022766

Trade Name: Siemens Medical Information Bus (MIB) Protocol Converters Regulation Name: Arrhythmia Detector and Alarm; Oximeter Regulation Number: 21 CFR 870.1025 and 870.2700 Regulatory Class: Class III (three) Product Code: DSI and DQA Dated: August 19, 2002 Received: August 21, 2002

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Penelope H. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ode Teu

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Siemens Medical Information Bus (MIB) Protocol Converters

Indications for Use:

The Medical Information Bus (MIB) Protocol Converters (MIB, II & MIB Duo) are indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party medical devices that provide data should be connected to a Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 8000 / SC 9000XL) for display. Such devices include:

> Siemens SV 300 ventilator Siemens Servoi ventilator Baxter Vigilance blood gas/CCO monitor Siemens SV900 ventilator Draeger Evita II ventilator Draeger Evita IV ventilator Draeger Babylog ventilator Puritan Bennett 7200 ventilator Puritan Bennett 840 ventilator Hamilton Galileo ventilator Draeger Narkomed II Anesthesia System Draeger Narkomed IV Anesthesia System Draeger Julian Anesthesia Machine Ohmeda 7900 Anesthesia Machine Abbott Oximetrix 3 Blood Gas Analyzer Abbott Q2 CCO monitor AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analyzer Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650

Note: * The SC 9000 does not support communication with the Aspect BIS Monitor

## MRI Compatibility Statement:

The MIB, MIB II and MIB DUO Protocol Converters are not compatible for use in a MRI magnetic field.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|---------------------------------------------------|----|--------------------------------------------------|
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Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K022764 |
|---------------|---------|
|---------------|---------|