K Number
K093632
Device Name
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
Date Cleared
2010-04-05

(133 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

No
The summary describes a microprocessor-controlled ventilator with standard ventilation modes, monitoring, and display capabilities. There is no mention of AI, ML, or any features that suggest learning or adaptive algorithms beyond standard control systems.

Yes
The device explicitly states its intended use is to "provide specific therapy in neonatal intensive care" and describes itself as a "ventilation unit" that provides "overpressure ventilation and adjustable oxygen concentration."

No
The descriptions indicate that the device is primarily a ventilator ("specific therapy," "ventilation unit") and a monitoring and control display for ventilation parameters. While it monitors parameters, its primary stated purpose is therapeutic (ventilation) rather than diagnostic. It supports displaying patient waveforms and parameter data, which is part of monitoring related to ongoing therapy, but it does not claim to diagnose conditions.

No

The device description explicitly states that the system is made up of a ventilation unit (Babylog VN500) and a control and display unit (Infinity Medical Cockpit C500). The ventilation unit is described as a microprocessor-controlled ventilator, which is a hardware component. While the system includes ventilation application software, it is part of a larger hardware system.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly describes the device as a system for monitoring and providing therapy (ventilation) to neonatal and pediatric patients. This involves direct patient care and life support.
  • Device Description: The description focuses on the components and functionality related to ventilation, monitoring of ventilation parameters, and control of ventilation settings. It does not mention any components or processes related to testing biological samples (blood, urine, tissue, etc.) outside of the body to diagnose diseases or conditions.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
    • Reagents or assays
    • Sample collection or preparation
    • Analysis of biological specimens
    • Diagnostic interpretation based on laboratory results

The device is a medical device, specifically a ventilator and monitoring system, used for patient treatment and monitoring, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

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 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.

Product codes

73CBK

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.

Babylog VN500

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:

  • · 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

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.

Infinity Medical Cockpit C500

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

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.

Intended User / Care Setting

qualified and trained medical personnel.
stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance was tested in compliance with following standards:
IEC 60601-1 :2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 :2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular Requirements for the safety of lung ventilators - critical care ventilators
IEC 60601-1-6 :2004 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard - Usability
IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
EN ISO 14971:2003 Medical devices - Application of risk management to medical devices
EN ISO 17664:2004 Sterilization of medical devices - information to be provided by the manufacturer for the reprocessing of resterilizable medical devices
FDA Guidance for Ventilators: 1995

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K903089, K926292, K974176, K961687, K983219, K980642, K992608, K010093, K051263, K072412

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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

1

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.DeviceProduct Code
Preferred Code:
868.5895
For predicates:Ventilator, continuous, facility use73CBK
868.5895Ventilator, continuous, facility use73CBK

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) numberTrade nameCompany
K903089,
K926292,
K974176Babylog 8000 plusDräger Medical AG & Co. KG
K961687,
K983219,
K980642
K992608,
K010093,
K051263,
K072412Evita XLDräger 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

Image /page/1/Picture/20 description: The image shows a solid black circle. The circle is centered in the image and takes up a significant portion of the frame. There are no other objects or details present in the image.

2

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.

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.

Babylog VN500

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:

  • · 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

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).

3

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.

Infinity Medical Cockpit C500

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.

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 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 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.

Image /page/3/Picture/12 description: The image contains a black circle against a white background. The circle is solid black and appears to be centered in the frame. There are no other objects or details present in the image.

4

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 and
essential performance |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 :2007 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - Collateral standard:
Electromagnetic compatibility -
Requirements and tests |
| IEC 60601-2-12:2001 | Medical electrical equipment - Part 2-12:
Particular Requirements for the safety of
lung ventilators - critical care ventilators |
| IEC 60601-1-6 :2004 | Medical electrical equipment - Part 1-6:
General requirements for basic safety and
essential performance - Collateral standard

  • Usability |
    | IEC 60601-1-8:2006 | Medical electrical equipment - Part 1-8:
    General requirements for basic safety and
    essential performance - Collateral
    standard: General requirements, tests and
    guidance for alarm systems in medical
    electrical equipment and medical electrical
    systems |
    | EN ISO 14971:2003 | Medical devices - Application of risk
    management to medical devices |
    | EN ISO 17664:2004 | Sterilization of medical devices -
    information to be provided by the
    manufacturer for the reprocessing of
    resterilizable medical devices |
    | FDA Guidance for Ventilators: 1995 | |

Image /page/4/Picture/6 description: The image contains a solid black circle on a white background. The circle is positioned on the left side of the image, with some white space to its right. The circle appears to be uniformly filled with black color, and its edges are relatively smooth.

5

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The text is in all caps and is written in a simple, sans-serif font. The logo is black and white.

(

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.

6

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

7

Indications for Use

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

Device Name: Infinity Acute Care System Workstation Neonatal Care

Indications for Use:

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 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