SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER

K020277 · Siemens Medical Solutions USA, Inc. · DRQ · Feb 19, 2002 · Cardiovascular

Device Facts

• Record ID: K020277
• Device Name: SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DRQ · Cardiovascular
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2060
• Device Class: Class 2

Indications for Use

The Siemens Medical Information Bus (MIB/MIB II and 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 that provides data, such as: 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, 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; Aspect A-2000 BIS Monitor should be connected to a Siemens INFINITY Modular Monitor for display.

Device Story

Protocol converter facilitates connectivity between third-party medical devices (ventilators, anesthesia systems, blood gas analyzers, cardiac output monitors) and Siemens INFINITY modular bedside monitors. Device accepts digital data signals from third-party equipment; transforms signals via protocol conversion; outputs data for visualization on INFINITY bedside monitors and VentCentral displays. Used in clinical settings by physicians, nurses, and technicians. Enables centralized monitoring of patient data from disparate devices; supports clinical decision-making by providing integrated view of patient status. Not MRI compatible.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Transducer signal amplifier and conditioner. Connectivity via 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. Not MRI compatible.

Indications for Use

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

Regulatory Classification

Identification

A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.

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)

Reference Devices

• Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246)
• Siemens Servoi Ventilator (K010925)

Submission Summary (Full Text)

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## 510(k) SUMMARY

FEB 1 9 2002

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: January 24, 2002

Trade Name, Common Name and Classification Name:

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

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

Siemens MVWS and INFINITY Network with INFINITY VentViewer (K003246)

Description of Modification:

The Medical Information Bus (MIB) Protocol Converters have received six 510(k) clearances for connectivity with third party devices.

- 1. 510(k) K970368 was cleared for interface with Siemens SV300 ventilator and the Baxter Vigilance blood gas/continuous cardiac output monitor.
- 2. 510(k) K973222 was cleared for interface with Puritan Bennett 7200 ventilator, the Draeger Evita II, Draeger Evita IV, and Draeger Babylog ventilators, and Siemens SV900 ventilator.

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COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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| 3. | 510(k) K991661 was cleared for interface with |
|----|-----------------------------------------------------------------|
| | Anesthesia Systems |
| | Dräger Narkomed II Dräger Narkomed IV Dräger Julian Ohmeda 7900 |
| | Point of Care Blood Gas Analyzers |
| | Abbott Oximetrix 3 |
| | 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 |

- 510K) K003248 was cleared for interface with the Aspect BIS monitor 4.
- 510(k) K010640 introduced Siemens INFINITY MIB II Protocol Converter 5.
- 510(k) K012461 introduced Siemens INFINITY MIB II Duo Protocol Converter 6.

Minor software modifications have been implemented in the MIB/MIB II and MIB Duo protocol converters, and a device specific accessory cable is now available that allows an interface connection for Siemens Servoi Ventilator (K010925) to the INFINITY modular moritors (SC 9000/SC7000/SC9000XL/SC8000). This connection enables the display of Servoi Ventilator data on an INFINITY modular monitor and on the VentCentral display (K003246) of the MultiView WorkStation.

Intended Use:

The Siemens Medical Information Bus (MIB/MIB II and 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 that provides data, such as: 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, 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; Aspect A-2000 BIS Monitor should be connected to a Siemens INFINITY Modular Monitor for display.

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# COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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

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

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#### COMPANY CONFIDENTIAL

Siemens Medical Systems, Inc. Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2002

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

Re: K020277

KU20277
Trade/Device Name: Siemens Medical Information Bus (MIB II) Protocol Converter Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Conditioner Regulatory Class: II (two) Product Code: DRQ Dated: January 24, 2002 Received: January 28, 2002

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications ferenced above and nave decembiled the article devices marketed in interstate for use stated in the encrosule) to regally manced provice Americal Device America America America Argon Drug commerce prior to May 20, 1970, the charger and the provisions of the Federal Food. Drug, devices that have been reciassified in accordance what as revear to la pplication (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The Act. The You may, therefore, market the devices, boyses of the ments for annual registration, listing of
general controls provisions of the Act include requirements for annual regist general controls provisions of the necessary of the end prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ( If your device is classified (secures) in existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional bontroller and one of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of I sactal Regarning 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 Please be advised that FDA s issualice of a subscribe with other requirements of the Act
that FDA has made a determination that your device of as Forders . You must that FDA has made a decommance in a Joursel by other Federal agencies. You must or any Federal statules and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not ice requirements as set comply with all the Act s requirements, mortalians practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Parts (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally premarket notification. The PDA midning of substance of the more of the supermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your device diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please conta additionally 21 CFR Part 809.10 Iol in Vitto utegions on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and adve Compliance at [phone]. Additionally, for question of 594-4639. Also, please note the your device, prease comace the Ories of een and and in the times be obtained from the regulation entitled, "Misoraliding of references the Act may be obtained from the Other general information on your responsional 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,

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

Enclosure

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# 510(k) Number (if known): KO2O273

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

Indications for Use:

The Medical Information Bus (MIB) II & MIB Duo) are indicated for use in an
The Medical Information Bus (MB) Protocol Coureticals (MBS) Physician, Nurse, Technician)
environment where patient care is provided by healthcare than provide data, such as: environment where patient care is provided by nealthoute provide data, such as:
when the professional determines that third party medical devices that provide data, such as:

> Siemens SV 300 ventilator Siemens Servoi ventilator Slemens Selvor venthator
> 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 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 Oximetrix 3 Blood Gas Analyzer, Portable Blood Gas Analyzer, Portable Blood Gas Analyzer
> AVL Medical Instruments: Opti Critical Care Analyzer, Portable Blood Gas Analy Optical Sensors Inc .: OSI - Optical CAM Optical Sonsolo IA V-ABG1 Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor

should be connected to a Siemens INFINITY Modular Bedside Monitor (SC 9000 / SC 8000 / SC 9000XL) for display.

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

## MRI Compatibility Statement:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------------|
| Prescription Use | <div style="text-align:left;">✓</div> |
| (Per 21 CFR 801.109) | |
| | OR |
| | Over-The-Counter Use ____ |

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K02027 |
|---------------|--------|
|---------------|--------|