The Infinity 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 Draeger INFENTTY 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-ABGI Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650

Note: * The SC 9000 does nor support communication with the Aspect BIS Monitor

Device Description

Draeger's Infinity Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters have received numerous 510(k) clearances for connectivity to third party devices. The release of MIB/MIBII VF4 software enables MIB connectivity of the following Draeger devices to the INFINITY modular monitors:

Narkomed 6000 & 6400 Fabius GS Savina Evita XL

These connections enable the display of device specific data on an INFINITY modular monitor. Data from the devices can also be displayed on the VentCentral application (K003246) of the MultiView WorkStation and alarms received from the Evita XL and Savina ventilators annunciated.

AI/ML Overview

This submission, K033807, describes a modification to the Draeger Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters. The primary change is the enablement of MIB connectivity for new Draeger devices (Narkomed 6000 & 6400, Fabius GS, Savina, Evita XL) to the INFINITY modular monitors through VF4 software. The key takeaway from the document is that no new clinical or non-clinical performance data was deemed necessary to establish substantial equivalence for this modification.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication and ground truth establishment is not applicable to this specific 510(k) submission, as it relies on the predicate device's established performance without introducing new performance claims that would require new and extensive testing.

Here's a breakdown of the applicable information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Since this is a modification to an already cleared device and the submission states "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable," specific acceptance criteria and detailed reported performance for the modified aspects are not explicitly defined in this document. The implicit acceptance criterion is that the modified device maintains the fundamental technology, intended use, and safety/effectiveness of the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Maintenance of fundamental technology and intended use of predicate device	The modifications have not altered the fundamental technology of the MIB/MIBII Protocol Converters. The intended use and indications are the same as for the unmodified predicate devices.
Successful connectivity and display of data from new Draeger devices to INFINITY monitors	MIB connectivity of new Draeger devices to INFINITY modular monitors is enabled, allowing display of device-specific data and annunciation of alarms.
Compliance with relevant standards (e.g., medical device communications)	Adherence to 1073.3.1 and 1073.3.2 IEEE Standards for Medical Communications Transport Profile is implied by their listing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample size for test set: Not applicable (no new testing for this modification was deemed necessary beyond demonstrating functionality of the new connections).
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication method: Not applicable.

5. 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:

MRMC study: Not applicable. The device is a protocol converter, not an AI-driven diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone performance study: Not applicable. The device is a hardware/software protocol converter for data display, not an algorithm with standalone performance metrics in the typical sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Type of ground truth: Not applicable for new testing specific to this modification. The "ground truth" for the predicate device would have been the accurate transmission and display of physiological data, which, for a protocol converter, relies on functional verification rather than clinical outcomes or expert consensus in the same way a diagnostic imaging device would.

8. The sample size for the training set:

Sample size for training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Ground truth establishment: Not applicable.

In summary, this 510(k) submission is for a device modification that extends connectivity, and it leverages the substantial equivalence of its predicate devices without requiring new, extensive performance studies for clearance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text "K033807" in a handwritten style. The text is slightly tilted, with the "K" being the largest character and the numbers decreasing in size as they progress to the right. The handwriting appears to be done with a dark ink or marker, creating a bold and clear impression.

Special 510(k): Device Modification DRAEGER Medical Information Bus (MIB/MIBII and MIB Duo) Protocol Converters

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: December 5, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name:
Draeger Medical Information Bus (MIB, MIB II, MIB Duo) Protocol Converters
Common Name, Classification Name, Class and Regulation Number: R

Common Name	ClassificationNumber	Class	RegulationNumber
Transducer Signal amplifier and conditioner	73 DRQ	II	21 CFR 870.2060

Legally Marketed Device Identification:

INFINITY MIB/MIB II / MIB DUO (K022766) INFINITY MIB II Duo: 510(k) K012461 INFINITY MIB II Protocol Converter: 510(k) K010640 Medical Information Bus (MIB) Protocol Converter: 510(k) K970368, K973222, K991661, K003248, K020277 MVWS and INFINITY Network with INFINITY VentViewer (K003246)

Description of Modification:

Narkomed 6000 & 6400 Fabius GS Savina Evita XL

1/2

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

{1}------------------------------------------------

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

The intended use and indications of the MIB/MIBII with VF4 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 Draeger Medical Information Bus (MIB / MIB II) 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 9000, SV 300, Servoi Ventilators, Baxter Vigilance blood gas/continuous cardiac output monitor, Draeger Evita II, IV, EvitaXL, Babylog, & Savina ventilators, Furitan Bennett 7200 & 840 ventilators, Hamilton Galileo ventilator, Draeger Narkomed 6000 & 6400 / Narkomed II & IV Anesthesia Systems, 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 Q2, 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

2/2

Draeger Medical Systerns, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's emblem, which consists of a stylized depiction of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Ms. Penelope H. Greco Regulatory Submission Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K033807

Trade/Device Name: INFINITY Medical Information Bus Protocol Converter Regulation Number: 870.2060 Regulation Name: Amplifier and Signal Conditioner, Transducer Signal Regulatory Class: II Product Code: DRQ, BSZ, CBK Dated: February 19, 2004 Received: February 20, 2004

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.

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

{3}------------------------------------------------

Page 2 - Ms. Penelope H. Greco

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), please contact the Office of Compliance at (301) 594-4646. 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 from the Division 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 vours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

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

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-ABGI Blood Gas Chemistry Monitor Aspect A-2000 BIS Monitor* Sensormedics Micro Gas 7650

Note: * The SC 9000 does nor 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 M (Part 21 CFR 801 Subpart D)

AND/OR

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

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Seffon

Division Sign-Off Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number

K033807

Page 1 of 1

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).