The Infinity Acute Care System Workstations Neonatal Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal Care are intended to be used by qualified and trained medical personnel.

The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Babylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.

Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Device Description

The Infinity Acute Care System Workstation Neonatal Care provides Neonatal-Care specific functionality. It is made up of the ventilation unit Babylog VN500 and the Infinity Medical Cockpit C500.

The ventilation unit provides Neonatal-Care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit C500 is the control and display unit which runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit C500, which is also used to control ventilation settings including alarms.

The ventilation unit Babylog VN500 of the Infinity Acute Care System Workstation Neonatal Care is a microprocessor-controlled ventilator. The Babylog VN500 provides overpressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes.

The ventilation application software on the Infinity Medical Cockpit C500 is needed to allow the user to display and control all ventilation parameters of the ventilation unit. The combination of the ventilation software application on the Infinity Medical Cockpit C500, together with the Babylog VN500, provides the functionality of a complete ventilator (e.g. Evita XL).

The ventilation application supports simultaneous display of patient waveforms, parameter data, alarm display and annunciation, in addition to supporting graphical or textual display of historical data.

The Infinity Acute Care System can interface with specific Dräger Medical therapeutic and diagnostic equipment, as well as third party devices via a MEDIBUS data connection.

The user interface of the Infinity Acute Care System Workstation Neonatal Care is the Infinity Medical Cockpit C500, a standardized display and control unit for the connected monitoring and therapy units.

The Infinity Medical Cockpit C500 is a standard platform, using common hardware, software, and user interface components to facilitate ease of use for clinicians.

AI/ML Overview

The provided text is a 510(k) summary for the Dräger Infinity Acute Care System Workstation Neonatal Care, a medical device that includes a ventilator. This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards for safety and performance.

It is important to note that this document is a 510(k) summary for a ventilator, not an AI/ML-powered diagnostic device. Therefore, many of the requested criteria (such as sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are generally not applicable to this type of traditional medical device submission.

The document details the device's functionality, indications for use, and a list of performance testing against various IEC and ISO standards, as well as FDA guidance for ventilators. This performance testing confirms the device's safety and effectiveness according to established engineering and medical device standards.

Here's an attempt to address the requested information based on the provided text, indicating when information is not present or not applicable:

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

Acceptance Criteria (Standards Adhered To)	Reported Device Performance (Implied by Submission)
IEC 60601-1:2006 (General requirements for basic safety and essential performance)	Device meets general requirements for basic safety and essential performance.
IEC 60601-1-2:2007 (Electromagnetic compatibility)	Device meets requirements for electromagnetic compatibility.
IEC 60601-2-12:2001 (Particular Requirements for the safety of lung ventilators - critical care ventilators)	Device meets specific safety requirements for lung ventilators.
IEC 60601-1-6:2004 (Usability)	Device meets usability requirements.
IEC 60601-1-8:2006 (Alarm systems in medical electrical equipment)	Device meets requirements for alarm systems.
EN ISO 14971:2003 (Application of risk management to medical devices)	Risk management principles applied during development.
EN ISO 17664:2004 (Sterilization of medical devices)	Information provided for reprocessing of resterilizable medical devices.
FDA Guidance for Ventilators: 1995	Device complies with FDA guidance for ventilators.

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/not mentioned. Traditional ventilator submissions typically involve bench testing, engineering verification and validation, and clinical good-use practices rather than test sets with patient data.
Data Provenance: Not applicable. The testing is primarily engineering and performance-based, not data-driven in the sense of patient datasets.

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)

Not applicable. The "ground truth" for a ventilator's performance is its ability to meet specified engineering and safety parameters, often validated by qualified engineers and verified through objective measurements against regulatory standards. There is no concept of "expert ground truth" in the diagnostic sense for this device.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or expert consensus on medical images or clinical cases. This is not relevant to a ventilator's performance testing.

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

Not applicable. MRMC studies are used for evaluating the performance of diagnostic imaging devices, especially those involving human interpretation, and comparing human performance with and without AI assistance. This device is a ventilator, not a diagnostic AI tool.

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

Not applicable. This device is a standalone ventilator system; however, it is not an algorithm-only device or an AI system that would have a "standalone" algorithmic performance distinct from its human-in-the-loop operation. Its performance is its standalone mechanical and electronic functionality.

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

Type of Ground Truth: The "ground truth" for this device's performance is defined by its adherence to the specified technical standards (e.g., IEC 60601 series, ISO 14971) and functional specifications (e.g., accurate delivery of ventilation modes, stable oxygen concentration, correct alarm functionality). This is established through engineering testing, verification, and validation against a predetermined set of technical requirements and regulatory benchmarks.

8. The sample size for the training set

Not applicable. This device is a traditional ventilator and does not employ AI/Machine Learning models that require training sets.

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

Not applicable. No training set is used for this type of device.

Summary

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A Dräger and Siemens Company

510(k) Summary according to 21 CFR 807.92

APR - 5 2010

Applicants Name and Address:

Draeger Medical AG & Co. KG Moislinger Allee 53-55 23542 Luebeck Germany

Establishment Registration Number: 9611500

Contact Person:

Ulrich Schröder Director of Regulatory & Clinical Affairs

Tel. No.: + 49 (451) 882-3648 Fax No.: + 49 (451) 882-3018

Applicants US Contact Person

Ms. Joyce Kilrov VP Processes, Quality & Regulatory Affairs

Tel. No .: (215) 660-2626 Fax No.: (267) 885-9989

Date submission was prepared:

March 2010

Device Name:

Trade Name: Common Name: Infinity Acute Care System Workstation Neonatal Care Intensive Care Ventilator

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Appendix 14.1

Image /page/1/Picture/2 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 and is placed to the right of "Dräger". The logo is simple and modern, and it is likely used on the company's products and marketing materials.

A Dräger and Siemens Company

Classification:

Class II
Regulation No.	Device	Product Code
Preferred Code:868.5895For predicates:	Ventilator, continuous, facility use	73CBK
868.5895	Ventilator, continuous, facility use	73CBK

Reason for the 510(k): Substantial Equivalence

Besides the more recent technological concept and modular approach, the functionality of the Infinity Acute Care System Workstation Neonatal Care is equivalent to Babylog 8000 and Evita XL Neo. Both intensive-therapy ventilators are intended to be used for neonates. The Evita XL ventilator is also used for the ventilation of pediatric patients.

Legally Marketed Device to which Substantial Equivalence is claimed:

510(k) number	Trade name	Company
K903089,K926292,K974176	Babylog 8000 plus	Dräger Medical AG & Co. KG
K961687,K983219,K980642 K992608,K010093,K051263,K072412	Evita XL	Dräger Medical AG & Co. KG

Executive Summary

This documentation covers the Infinity Acute Care System Workstation Neonatal Care as part of the Infinity Acute Care System (IACS).

The Infinity Acute Care System (IACS) is a modular and flexible solution for the acute point of care. It is designed to consist of different point-of-care specific workstations. All workstations consist of an Infinity Medical Cockpit, a standardized display and control unit for connected monitoring and therapy units.

The IACS Workstation Neonatal Care is intended to be used as integrated, networked, and configurable workstation to provide neonatal care specific therapy.

As of today, this workstation consists of the following main components with accessories and in combination with other devices:

Infinity Medical Cockpit C500 and the -
Babylog VN500

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Image /page/2/Picture/2 description: The image shows the logo for Dräger medical. The word "Dräger" is in bold, and the word "medical" is in a lighter font. Below the logo, it says "A Dräger and Siemens Company". The logo is simple and professional.

The Infinity Medical Cockpit C500 is the control and display unit which runs a ventilation application. It enables setting of ventilation including alarms and displays patient ventilation monitoring data.

The Babylog VN500 provides neonatal care specific ventilation and monitoring data of ventilation parameters. It is intended for the ventilation of neonatal and pediatric patients.

General description of the device

The Infinity Acute Care System Workstation Neonatal Care provides Neonatal-Care specific functionality. It is made up of the ventilation unit Babylog VN500 and the Infinity Medical Cockpit C500.

Babylog VN500

· pressure-controlled (PC):
- o PC-SIMV (Synchronized Intermittent Mandatory Ventilation)
- o PC-AC (Assisted Controlled)
- o PC-CMV (Continuous Mandatory Ventilation)
- o PC-APRV (Option) (Airway Pressure Release Ventilation)
- o PC-PSV (Pressure Support Ventilation)
- o PC-MMV (Mandatory Minute Volume Ventilation)
· Spontaneous (Spn):
- o Son-CPAP/VS (Continuous Positive Airway Pressure / Ventilation Support)
- o Spn-CPAP/PS (Continuous Positive Airway Pressure / Pressure Support)
- o Spn-PPS (Option) (Proportional Pressure Support)

Additionally the ventilation unit features special modes to complement the ventilation modes. If breathing of a spontaneously breathing patient stops, Apnea Ventilation switches over automatically to volume-controlled mandatory ventilation. Automatic Tube Compensation ATC reduces the breathing effort attributable to the tube. By switching on the flow trigger, the mandatory strokes are synchronised with the patient's spontaneous breathing attempts. Inspiratoric termination determines the duration of inspiration in PS, VS and PPS mode. It defines at which relation (in percent) of max. insp. flow the inspiration ends and the expiration starts. Atelectasis can be prevented by the Sigh function. Auto release determines the duration of pressure release using in PC-APRV mode.

Ventilation Application

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The Infinity Acute Care System can interface with specific Dräger Medical therapeutic and diagnostic equipment, as well as third party devices via a MEDIBUS data connection.

Infinity Medical Cockpit C500

The Infinity Medical Cockpit C500 is a standard platform, using common hardware, software, and user interface components to facilitate ease of use for clinicians.

Indications for Use

The Infinity Acute Care Systems Workstations Neonatal Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide neonatal care specific therapy. The Infinity Acute Care Systems Workstations Neonatal Care are intended to be used by qualified and trained medical personnel.

The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Babylog VN500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.

Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

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Image /page/4/Picture/2 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 and is placed to the right of "Dräger". Below the logo, there is the text "A Dräger and Siemens Company".

List of performance testing:

Performance was tested in compliance with following standards:

IEC 60601-1 :2006	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance
IEC 60601-1-2 :2007	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral standard:Electromagnetic compatibility -Requirements and tests
IEC 60601-2-12:2001	Medical electrical equipment - Part 2-12:Particular Requirements for the safety oflung ventilators - critical care ventilators
IEC 60601-1-6 :2004	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateral standard- Usability
IEC 60601-1-8:2006	Medical electrical equipment - Part 1-8:General requirements for basic safety andessential performance - Collateralstandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems
EN ISO 14971:2003	Medical devices - Application of riskmanagement to medical devices
EN ISO 17664:2004	Sterilization of medical devices -information to be provided by themanufacturer for the reprocessing ofresterilizable medical devices
FDA Guidance for Ventilators: 1995

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(

APR - 5 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Drager Medical AG & Company KGAA C/O Ms. Joyce Kilroy Vice President Drager Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K093632

Trade/Device Name: Infinity Acute Care System Workstation Neonatal Carc Regulation Number: 21CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 15, 2010 Received: March 18, 2010

Dear Ms. Kilroy:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kilroy

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

S10(k) Number (if known): K 09 3632

Device Name: Infinity Acute Care System Workstation Neonatal Care

Indications for Use:

The Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 Ibs) up to 10 kg (22 Ibs) and pediatric patients from 5 kg (11 Ibs) up to 20 kg (44 Ibs) bodyweight. Babylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.

Babylog VN500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

17 10

Page 1 of 1

(Posted November 13, 2003)

(Division Sign-Off) Orvision of Anesthesiology, General Hospital infection Control, Dental Devices

-10(k) Number: 09 363 2

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).