The Infinity Medical Information Bus (MIB) Protocol Converters (MIB, 11 & 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 Draeger Infinity Modular Monitor for display. Such devices include:

Maquet SV 300 ventilator
Maquet Servoi Ventilator
Maquet SV900 ventilator
Draeger Evita 2 ventilator
Draeger Evita 4 ventilator
Draeger EvitaXL ventilator
Draeger Savina ventilator
Draeger Babylog ventilator
Draeger FabiusGS Anesthesia System
Draeger Narkomed 2 Anesthesia System
Draeger Narkomed 4 Anesthesia System
Draeger Narkomed 6000 / 6400 Anesthesia Systems
Draeger Julian Anesthesia Machine
Puritan Bennett 7200 ventilator
Puritan Bennett 840 ventilator
Hamilton Galileo ventilator
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
Baxter Vigilance blood gas/continuous cardiac output monitor
Optical Sensors Inc .: OSI - Optical CAM
VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor
Aspect A-2000 BIS Monitor*
Sensormedics Micro Gas 7650
Draeger Fabius Tiro
Draeger Primus
Viasys Bear 1000

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

Device Description

Draeger's Infinity Medical Information Bus Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB VF5.1 software enables connectivity of the Viasys Bear 1000 ventilator to the Infinity modular monitors.

This connection enables the display of device specific data on an Infinity modular monitor. Data from the Viasys Bear 1000 ventilator can also be displayed and alarms annunciated on the VentCentral application (K003246) of the MultiView.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Draeger's Infinity Medical Information Bus Protocol Converter). This summary outlines device information, intended use, and substantial equivalence, but it does not contain details about acceptance criteria, device performance studies, or clinical trial data.

Specifically, the document states:

"Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5.1 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This indicates that some non-clinical testing was done to confirm the software update didn't change the core functionality or safety, but it doesn't provide specific criteria or results.
"Assessment of clinical performance data for equivalence: Not applicable" This explicitly states that clinical performance data was not required for this 510(k) submission.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it is not present:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, and for this particular device (a protocol converter for medical data display), extensive clinical performance studies or specific acceptance criteria for diagnostic accuracy (as would be seen in an AI/diagnostic imaging device) were deemed "not applicable."

Summary

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Image /page/0/Picture/1 description: The image contains the logo for Dräger medical. The logo is in black and features the word "Dräger" in a bold, stylized font, followed by the word "medical" in a smaller, less bold font. Below the logo, there is some smaller text, and to the right of the logo, there is some additional text that is partially visible.

A Dräger and Siem

APR 2 9 2005

510(k) SUMMARY

as required per 807.92(c)

Submitter's Name and Address:	Draeger Medical Systems, Inc.16 Electronics AvenueDanvers, MA 01923
Contact Person:	Penelope H. GrecoRegulatory Affairs Manager(978) 907-7503(978) 750-6879
Date submission was prepared:	April 12, 2005
Device Name:
Common Name:	Amplifier and Signal Conditioner,Transducer Signal
Classification Name:	DRQ
Regulation Number:	21 CFR 870.2060
Class:	2
Legally Marketed Device Identification:	Infinity Medical Information BusProtocol Converter

Device Description:

Page 1 of 2

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers. MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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Image /page/1/Picture/1 description: The image shows the logo for Dräger medical. The logo is in black and white, with the word "Dräger" in a bold, sans-serif font. The word "medical" is in a thinner, sans-serif font. Below the logo, it says "A Dräger and Siemens Company" in a smaller font.

Image /page/1/Picture/2 description: The image shows handwritten text that appears to be a combination of letters and numbers. The first line reads 'K050974', and the second line reads 'P 3/2'. The handwriting is somewhat rough, but the characters are generally legible. The text may represent a code, identifier, or some other form of notation.

Intended Use:

The Draeger Medical Information Bus 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 an Infinity Modular Monitor for display of data.

Connectable devices include: Maquet SV 900, SV 300, Servoi ventilators, Baxter Vigilance blood gas/continuous cardiac output monitor. Draeger Evita II, VI, EvitaXL, Babylog, & Savina ventilators, Puritan Bennett 7200 & 840 ventilators, Hamilton Galileo ventilator, Draeger Narkomed 6000 & 6400 / Narkomed II & VI Anesthesia Systems, Draeger Julian Anesthesia machine, Ohmeda 7900 Anesthesia Machine, Abbott Oximetric 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 Q2, Sensormedics Micro Gas 7650, Draeger Fabius Tiro, Draeger Primus, and Viasys Bear 1000 ventilator.

Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

Verification and validation testing performed indicates that the modifications implemented with software version VF5.1 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

Assessment of clinical performance data for equivalence: Not applicable

Biocompatibility: Not applicable

Sterilization: Not applicable
Standards and Guidance:

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

Page 2 of 2

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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APR 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Affairs Manager 16 Electronics Avenue Danvers, MA 01923

Re: K050974

Trade Name: Infinity Medical Information Bus Protocol Converter Regulation Number: 21 CFR 870.2060 Regulation Name: Transducer Signal Amplifier and Signal Conditioner Regulatory Class: II (two) Product Code: DRQ Dated: April 12, 2005 Received: April 18, 2005

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neversioned your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreases 9776, 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, do noos mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may a news 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 Errt 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Oixision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blymmmoe for

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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K050974

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Infinity Medical Information Bus Protocol Converter Indications for use

Maquet SV 300 ventilator Maquet Servoi Ventilator Maquet SV900 ventilator Draeger Evita 2 ventilator Draeger Evita 4 ventilator Draeger EvitaXL ventilator Draeger Savina ventilator Draeger Babylog ventilator Draeger FabiusGS Anesthesia System Draeger Narkomed 2 Anesthesia System Draeger Narkomed 4 Anesthesia System Draeger Narkomed 6000 / 6400 Anesthesia Systems Draeger Julian Anesthesia Machine Puritan Bennett 7200 ventilator Puritan Bennett 840 ventilator Hamilton Galileo ventilator 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 Baxter Vigilance blood gas/continuous cardiac output monitor Optical Sensors Inc .: OSI - Optical CAM VIA Medical: VIA V-ABG1 Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650 Draeger Fabius Tiro Draeger Primus Viasys Bear 1000

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Regulation Number and Section

§ 870.2060 Transducer signal amplifier and conditioner.

(a)
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.(b)
Classification. Class II (performance standards).