SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER

K012461 · Siemens Medical Solutions USA, Inc. · DSI · Aug 17, 2001 · Cardiovascular

Device Facts

• Record ID: K012461
• Device Name: SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Aug 17, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The INFINITY MIB II Duo Protocol Converter is intended for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 7000 / SC 8000 / SC 9000 / SC 9000XL) for display of data from devices such as: Siemens SV 300 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 . A VL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer . Optical Sensors Inc .: OSI Optical CAM . VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor . Aspect A-2000 BIS Monitor* . *The SC 9000 does not support communication with the Aspect BIS Monitor

Device Story

Device acts as protocol converter/interface bridge; enables data communication between third-party medical devices (ventilators, anesthesia machines, blood gas analyzers) and Siemens INFINITY modular bedside monitors. Inputs: proprietary or non-IEEE 1073 data signals from third-party devices. Transformation: converts non-standard signals into IEEE 1073-compliant format for monitor display. Output: integrated patient data displayed on bedside monitor. Used in clinical settings (ICU, OR) by healthcare professionals. Facilitates centralized monitoring of patient status; improves clinical decision-making by consolidating data from disparate devices into a single interface.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated through verification of communication protocols between the converter, INFINITY modular monitors, and supported third-party medical devices. Electromagnetic compatibility testing performed per EN 60601-1-2.

Technological Characteristics

Protocol converter supporting IEEE 1073.3.1 and 1073.3.2-2000 standards. Features dual connector types (SDL and RJ45) for device interfacing. Connectivity: wired interface between third-party medical devices and Siemens INFINITY monitors. Not 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 analyzers, cardiac output monitors) that do not natively support IEEE 1073 standards to Siemens INFINITY Modular Monitors for data display. Not MRI compatible.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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K012461 p. 1/3

## AUG 1 7 2001

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 May 25, 2001 Date submission was prepared:

Trade Name, Common Name and Classification Name:

- A. Trade Name:
Siemens INFINITY MIB II Duo Protocol Converter

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

| A ST ST M S M S C . C<br>ommon Name | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Product<br>COOP | - 1855 | Number<br>Regulation I |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-------------------------|
| Transducer Signal amplifier and conditioner<br>Complete of the contract and the program of the propertion of the status and the status and the contribution of the comments of | | | 870,2066<br>A 1977 1977 |

Legally Marketed Device Identification:

Siemens INFINITY MIB II Protocol Converter: 510(k) K010640 Siemens Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248

### Description of Modification:

The new INFINITY MIB II Duo Protocol Converter employs the same fundamental scientific technology and has the same intended use as that of the predicate device. The INFINITY MIB II Duo Protocol and no all band internets and device specific cables as that of the predicate device, 510(k) Converter Supperts original MIB Protocol Converter (K970368, K973222, K991661, K003248) uses SDL style connectors. The MIB II (K010640) uses RJ45 connectors. Modifications have been implemented to enable use of both connector types. The INFINITY MIB II Duo Protocol Converter supports IEEE Standards 1073.3.1 (Medical Device Communications-Transport Profile-Connection Mode) and 1073.3.2-2000 (Medical Communications - Transport Profile - IrDA Based - Cable Connected).

The only difference between the INFINITY MIB II and INFINITY MIB II Duo Protocol Converter is that the "Duo" has an additional interface and is compatible with the IEEE Standard 1073.3.1. No other modifications were required to implement this change. Testing has been performed to validate the overall performance of the modified MIB II Duo Protocol Converter and to verify proper communication with the INFINITY modular bedside monitors and the MIB supported devices.

Electromagnetic compatibility testing has been performed by Chomerics Test Services in accordance with EN 60601-1-2, Part 2, Medical Electrical Equipment Collateral Standard: Electromagnetic compatibility, and in accordance with FDA suggestions.

1/2

### COMPANY CONFIDENTIAL

### Siemens Medical Systems, Inc.

Electromedical Systems Group, PCS

16 Electronics Avenue Danvers, MA 01923

Tel: [phone] Fax: [phone]

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K012461 p. 2/3

### Intended Use:

The INFINITY MIB II Duo Protocol Converter is intended for use in an environment where patient of experience is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines
is provided by healthcare professionals (Physician, Nurse, March Marke Is provided by nealtheare professionals (1 a Siemens INFINITY Modular Monitors (SC 7000 / SC 8000 / SC 9000 / SC 9000XL) for display of data from devices such as:

- Siemens SV 300 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 .
- A VL Medical Instruments: Opti Critical Care Analyzer Portable Blood Gas Analyzer .
- Optical Sensors Inc .: OSI Optical CAM .
- VIA Medical: VIA V-ABGI Blood Gas Chemistry Monitor .
- Aspect A-2000 BIS Monitor* .

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

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

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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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K012461 p.3/3

# Premarket Notification Truthful and Accurate Statement

(As required per 21 CFR 807.87[j])

I certify, in my capacity as Director of Quality Assurance and Regulatory Affairs of Siemens Medical Systems, Inc., Electromedical Systems Group, PCS, that I believe, to the best of my knowledge, that all data and information submitted in this premarket notification to be truthful and accurate and that no material fact has been omitted.

Lisete Coleman perty for Connie Hertel 7/31/01
Connie Hertel, Director Date

Connie Hertel, Director Quality Assurance & Regulatory Affairs Official Correspondent

Date

[Premarket Notification 510(k) Number]

### 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines representing the body and a head-like shape at the top.

AUG 1 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Penelope H. Greco Siemens Medical Systems, inc. Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923

Re: K012461

Trade Name: INFINITY MIB II Duo Converter Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: 74 DSI Dated: July 31, 2001 Received: August 1, 2001

Dear Ms. Greco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the

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### Page 2 - Ms. Penelope H. Greco

submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dale Tella

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

## 510(k) Number (if known): KO1Z46 /

Device Name: Siemens INFINITY MIB II Duo Protocol Converter

Indications for Use:

Siemens INFINITY MIB II Duo Protocol Converter is indicated for use in an environment where patient care is provided by healthcare professionals (Physician, Nurse, Technician) when the professional determines that third party devices that do not provide data per the IEEE 1073 Medical Information Protocol Standard should be connected to a Siemens INFINITY Modular Monitor (SC 9000 / SC 8000 / SC 9000XL) for the display of data. MIB connectivity to third party medical devices such as:

> Siemens SV 300 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 A VL 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

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

#### MRI Compatibility Statement:

The INFINITY MIB II Duo Protocol Converter is 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<br>(Per 21 CFR 801.109) | <div> <span>✓</span> </div> |
| | OR |
| Over-The-Counter Use | |
| | (Optional Format 1-2-96) |