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K Number
K093633
Device Name
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
Manufacturer
Draegerwerk AG & Co. KGaA
Date Cleared
2010-03-30

(127 days)

Product Code
CBK
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infinity Acute Care System Workstations Critical 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 critical care specific therapy. The Infinity Acute Care System Workstations Critical 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 Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas. Evita V500 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 Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.
More Information

Not Found

Not Found

No
The summary does not mention AI, ML, or any related technologies in the intended use, device description, or performance studies.

Yes
The device is explicitly stated to "provide critical care specific therapy" and "offers mandatory ventilation modes and ventilation modes for spontaneous breathing support."

No

The device is described as a system for monitoring, controlling, and providing ventilation therapy, not for diagnosing medical conditions. It monitors "waveforms, parameter information, and alarms" and controls "settings" for "critical care specific therapy" and "ventilation." While it displays patient monitoring data, its primary function is not to diagnose.

No

The device description explicitly states it is made up of hardware components: the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500, with an optional gas supply unit GS500. While software runs on the cockpit, the device is a system of integrated hardware and software.

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

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this system is for monitoring, controlling, and providing ventilation therapy directly to patients (adult, pediatric, and neonatal). It does not mention analyzing blood, urine, tissue, or any other biological samples.
  • The device description focuses on ventilation and patient monitoring. The components described (Medical Cockpit, ventilation unit, gas supply unit) are all involved in delivering and monitoring respiratory support to a living patient.
  • The performance studies mentioned are related to medical device safety and performance standards for ventilators. These standards are not specific to IVD devices.

Therefore, the Infinity Acute Care System Workstations Critical Care, as described, falls under the category of a therapeutic and monitoring medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Infinity Acute Care System Workstations Critical 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 critical care specific therapy. The Infinity Acute Care System Workstations Critical 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 Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.

Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Product codes (comma separated list FDA assigned to the subject device)

CBK

Device Description

The Infinity Acute Care System Workstation Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.

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

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

The ventilation unit of the Infinity Acute Care System is a microprocessor-controlled ventilator. The Evita Infinity V500 provides overpressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes:

· volume-controlled (VC):

  • · VC-SIMV (Synchronized Intermittent Mandatory Ventilation)
  • o VC-AC (Assisted Controlled)
  • o VC-CMV (Continuous Mandatory Ventilation)
  • o VC-MMV (Mandatory Minute Volume Ventilation)
  • · pressure-controlled (PC):
    • o PC-SIMV (Synchronized Intermittent Mandatory Ventilation)
    • o PC-SIMV+ (Pressure Control-biphasic positive airway pressure, spontaneous breathing under continuous positive airway pressure with 2 different pressure levels)
    • 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)
  • · Spontaneous (Spn):
    • o Spn-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. Auto release determines the duration of pressure release using in PC-

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

adult, pediatric and neonatal patients

Intended User / Care Setting

qualified and trained medical personnel, trained healthcare professionals, 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Drägermed

A Dräger and Siemens Company

510(k) Summary according to 21 CFR 807.92

Appendix 14.1

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 Kilroy 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 Critical Care Intensive Care Ventilator

MAR 3 0 2010

、「

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. Below the logo, there is a tagline that reads "A Dräger and Siemens Company."

General description of the device

The Infinity Acute Care System Workstation Critical Care provides critical-care specific functionality. It is made up of the Infinity Medical Cockpit C500 and the ventilation unit Evita Infinity V500. The optional gas supply unit GS500 can be added. The ventilation unit provides critical-care specific ventilation and monitoring data of ventilation parameters. The Infinity Medical Cockpit is the control and display unit witch runs a ventilation application. The patient monitoring data are displayed on the Infinity Medical Cockpit, which is also used to control ventilation settings including alarms. The optional gas supply unit provides compressed air to the ventilation unit in case of central gas failure or in house transport.

Infinity Medical Cockpit

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

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

Evita Infinity V500

The ventilation unit of the Infinity Acute Care System is a microprocessor-controlled ventilator. The Evita Infinity V500 provides overpressure ventilation and adjustable oxygen concentration with pressure- and volume-controlled automatic and spontaneous breathing modes:

· volume-controlled (VC):

  • · VC-SIMV (Synchronized Intermittent Mandatory Ventilation)
  • o VC-AC (Assisted Controlled)
  • o VC-CMV (Continuous Mandatory Ventilation)
  • o VC-MMV (Mandatory Minute Volume Ventilation)
  • · pressure-controlled (PC):
    • o PC-SIMV (Synchronized Intermittent Mandatory Ventilation)
    • o PC-SIMV+ (Pressure Control-biphasic positive airway pressure, spontaneous breathing under continuous positive airway pressure with 2 different pressure levels)
    • 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)
  • · Spontaneous (Spn):
    • o Spn-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. Auto release determines the duration of pressure release using in PC-

2

Image /page/2/Picture/2 description: The image shows the logo for Dräger Medical. The logo is in black and white and features the company name in a bold, sans-serif font. The word "Dräger" is larger than the word "medical". The text "A Dräger and Siemens Company" is below the logo.

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 | |

.

March 2010

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Dräger Medical AG & Company KG C/O Ms. Joyce Kilroy Draeger Medical System, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

MAR 3 0 2010

Re: K093633

Trade/Device Name: Infinity Acute Care System Workstation Critical Care Regulation Number: 21CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 16, 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.

4

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 (OS) 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

5

Indications for Use

510(k) Number (if known): K (P) 36- 33

Device Name: Infinity Acute Care System Workstation Critical Care

Indications for Use:

The Infinity Acute Care System Workstations Critical 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 critical care specific therapy. The Infinity Acute Care System Workstations Critical 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 Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dräger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.

Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.

Prescription Use X (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)

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

510(k) Number: K093633