The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

The IACS and optional connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for Use

The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)
Apnea
Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC, (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity 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.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multi-parameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for Use

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)
Apnea
Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC, (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

Device Description

The Infinity® Acute Care System™ (IACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside. The IACS is a combination of the following devices Infinity M540 Patient Monitor (Model # MS20401) with the Infinity M500 Docking Station (Model #MS20407) integrated with the Infinity Medical Cockpit (Model # MK31501 - 17" screen or MK31701 - 21" screen) and respective software, powered by the Infinity P2500 power supply (Model #MS22277).

The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 Patient Monitor and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 Patient Monitor is a lightweight hand-held portable patient monitor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without any integration with the Infinity Medical Cockpit.

Associated accessories may include:

· Infinity MCable Masimo SET Model #MS20667
•Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
·Infinity MCable Nellcor OxiMax Model #MS20668
· Infinity MPod Quad Hemo Model #MS20725
•Infinity MCable Dual Hemo Model #MS20783
•Infinity MCable Mainstream CO2 Model #6871950
●Infinity MCable Analog/Sync Model #MS20662
•Infinity MCable Nurse Call Model #8417370
•PS120 Desktop Power Supply Model #2606270
•Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Draeger Medical Systems, Inc. Infinity Acute Care System (IACS) Monitoring Solution, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a direct table comparing them to reported device performance. It focuses on demonstrating equivalence to a predicate device and adherence to recognized standards. However, it does highlight areas where "verification testing was conducted to confirm the new requirements."

Based on the information, the implicit acceptance criteria are compliance with relevant safety and performance standards, and successful verification of new software requirements and algorithms.

Feature Area / Standard	Reported Device Performance Summary
Biocompatibility	Device and components not intended for direct patient contact; transient contact with intact skin.
Electrical Safety	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 606001-2-25, IEC 60601-2-27, ISO 80601-2-55.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2.
Software Verification & Validation	Testing conducted; documentation provided as recommended by FDA guidance ("Major Level of Concern" assigned due to diagnostic information driving treatment decisions and vital signs monitoring).
Cardiac Rhythm & ST Segment Algorithms	EC57 testing conducted for performance.
Human Factors/Usability Engineering	Validation testing conducted based on changes to Instructions for Use.
Substantial Equivalence	Found substantially equivalent to the predicate device (K113798).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for test sets in relation to patient data or specific parameters. It references "verification testing" and "EC57 testing" but does not provide details on the number of cases or data points used.

The data provenance is also not explicitly stated. The studies mentioned appear to be internal performance bench testing rather than studies involving external clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish a ground truth for any test set or their qualifications. The testing described appears to be technical verification against standards and internal requirements.

4. Adjudication Method

No adjudication method is described, as there is no mention of expert review of test set results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or conducted. The submission is for a monitoring solution, and the focus is on technical performance and equivalence to a predicate, not on human-AI assistive improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone (algorithm only) performance was indirectly assessed through the "Performance Bench Testing" and "EC57 testing conducted for performance of cardiac rhythm and ST segment measurement algorithms." This testing evaluates the device's algorithms and functions independent of human interpretation in a clinical setting.

7. Type of Ground Truth Used

The ground truth for the performance bench testing and EC57 testing would implicitly be:

Established Standards: Compliance with the requirements of relevant IEC and ISO standards (e.g., IEC 60601 series, ISO 80601-2-55, EC57 for ECG performance).
Engineering Specifications/Reference Values: For internal verification, ground truth would be against predetermined engineering specifications, simulated inputs, or known reference signals.

There is no mention of ground truth established via expert consensus, pathology, or direct outcomes data from human patients for the clearance of this device.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is a multi-parameter patient monitoring system, which typically involves rule-based algorithms, signal processing, and established physiological measurement techniques, rather than machine learning models that require extensive training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned as being used for machine learning, this point is not applicable. The device's functionality is based on established medical device engineering principles and adherence to regulatory standards.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 9, 2021

Draeger Medical Systems, Inc. Tom Hirte Director of Regulatory Affairs 6 Tech Dr. Andover, Massachusetts 01810

Re: K201764

Trade/Device Name: Infinity Acute Care System (IACS) Monitoring Solution Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MSX, DRT, DQA, DSK, MLD, DXN, DSF, DSA, DSB, DOE, DXG, BZO, FLS, CCK, KOI, BSZ, CBK, BTL, FLL, OLW, OLT, OMC, ORT, DSI, DPS, IPF, CBQ, CBS, CBR, CCL, NHP, NHQ, NHO, BSZ Dated: December 3, 2021 Received: December 8, 2021

Dear Tom Hirte:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K201764

Device Name Infinity® Acute Care System™ (IACS)

Indications for Use (Describe) Intended Use

Infinity® Acute Care System™ (IACS)

The IACS and optional connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for use

The IACS, in connection with the M540 Patient Monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)
Apnea
Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC. (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity Medical Cockpits, consisting of 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

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

settings.

The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patient information in environments where patient care is provided by trained health care professionals.

The M540 obtains physiological data from connection to optional accessory devices. The real-time physiologic and multiparameter data collected from the M540 is made available on the Infinity network. The M540 is intended to monitor one patient at a time.

The M540 and any connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for use

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)
Apnea
Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC, (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue.

510(k) Summary

510(k) SUMMARY

1. Submitter:

Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434

Contact Person:	Deborah HerringtonSenior Manager, Regulatory Affairs
Email:Tel:	Deborah.Herrington@Draeger.com(978) 379-6574
Alternate Contact:	Thomas HirteSenior Director of Regulatory Affairs
E-mail:Tel:	Tom.Hirte@Draeger.com(978) 379-8291
Date Prepared:	29-Jun-21

2. Device

The Device Names / Common Names / Classification Names are provided below:

Device name:	Infinity® Acute Care System™ Monitoring Solution
Classification Name:	Monitor, Physiological, Patient (with Arrhythmiadetection or alarms)
Common Name:	Multi-parameter Patient Monitor
Classifications:	See Table 5.1 below

Table 5.1: DeviceClassification / Pro Code /Common Name
Classification	Pro Code	Common Name
Primary ProductClassification§870.1025	MHX	Monitor, physiological, Patient(with Arrhythmia Detection orAlarms)
Subsequent Product Codes§870.2300	MSX	System, Network andCommunication, PhysiologicalMonitors
§870.2300	DRT	Monitor, Cardiac (incl. Cardio-tachometer & Rate Alarm)

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is blue and the background is white. The two dots above the "a" are also blue.

§870.2700	DQA	Oximeter
§870.1110	DSK	Computer, Blood Pressure
§870.1025	MLD	Monitor, ST Segment withAlarm
§870.1130	DXN	System, Measurement, Blood-Pressure, Non-Invasive
§870.2810	DSF	Recorder, Paper Chart
§870.2900	DSA	Cable, Transducer andElectrode, Patient
§820.2770	DSB	Plethysmograph, Impedance
§870.1230	DQE	Catheter, Oximeter, Fiber-Optic
§870.1435	DXG	Computer, Diagnostic, Pre-Programmed, Single-Function
§868.2375	BZQ	Monitor, Breathing Frequency
§868.2377	FLS	Monitor, Apnea, Facility Use
§868.1400	CCK	Analyzer Gas, Carbon-Dioxide, Gaseous-Phase
§880.2910	FLL	Thermometer, electronic,clinical
§870.1025	DSI	detector and alarm, arrhythmia
§870.2340	DPS	Electrocardiograph

3. Predicate Device:

K113798 - Infinity® Acute Care System™ Monitoring Solution This predicate has not been subject to a design-related recall.

4. Device Description:

K201764 Page 2 of 8

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue.

vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and transmits the data over the network. The Infinity M540 Patient Monitor can be used as a stand-alone medical device without any integration with the Infinity Medical Cockpit.

Associated accessories may include:

· Infinity MCable Masimo SET Model #MS20667
•Infinity MCable Masimo SET Rainbow Model #MS27900 / MS27003
·Infinity MCable Nellcor OxiMax Model #MS20668
· Infinity MPod Quad Hemo Model #MS20725
•Infinity MCable Dual Hemo Model #MS20783
•Infinity MCable Mainstream CO2 Model #6871950
●Infinity MCable Analog/Sync Model #MS20662
•Infinity MCable Nurse Call Model #8417370
•PS120 Desktop Power Supply Model #2606270
•Y-Adapter (for PS120) Model #MS29702

The IACS, Monitoring Solution is a software driven device that is supplied and used non-sterile in a hospital environment by trained personnel. The IACS, Monitoring Solution is capital equipment.

5. Intended Use/Indications for Use:

Intended Use

Infinity® Acute Care System™ (IACS)

The IACS and optional connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for Use

The IACS, in connection with the M540 Patient Monitor, monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The word is centered in the image and takes up most of the space.

- Apnea

Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC, (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

The IACS can connect to third-party devices to display physiologic, multi-parameter data and stored trends. It can also send information across the Infinity network.

Intended Use

The Infinity 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.

Indications for Use

As the Infinity Medical Cockpits are used in conjunction with the Infinity Acute Care System and the M540 Patient Monitors they do not have their own indication for use.

Intended Use

The M540 and any connected hardware are not intended for use in the following hospital environments:

Hyperbaric chambers
Environments containing MRI equipment

Indications for Use

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric patients only)
12-lead Rest ECG analysis (adult and pediatric patients only)
ST segment analysis including TruST (adult and pediatric patients only)
Apnea

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The word is the logo for the Dräger company, which is a German company that makes medical and safety technology.

Impedance respiratory rate RRi
Invasive blood pressure IBP
Non-invasive blood pressure NIBP
Temperature
Cardiac output - only available when the M540 is docked in an IACS configuration (adult and pediatric patients only)
Carbon dioxide etCO2, inCO2, RRc
Arterial oxygen saturation SpO2
Pulse rate
Perfusion index PI
Total hemoglobin SpHb, (adult and pediatric patients only)
Total oxygen content SpOC, (adult and pediatric patients only)
Carboxyhemoglobin saturation SpCO (adult and pediatric patients only)
Methemoglobin saturation SpMet
Pleth variability index PVI

The Intended Use/Indications for Use statements for Infinity Acute Care System, Medical Cockpit and M540 Patient Monitor are not identical to the predicate device, however, the differences are minor for alignment and do not alter the intended use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate device. Both the subject devices and the predicate devices have the same intended use for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained health care professionals.

As with the predicate, the subject IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The real-time physiologic and multi-parameter data collected from the IACS is made available on the Infinity network.

Both the subject and predicate devices have technological characteristics with respect to product design, materials of construction, and energy source.

6. Comparison of Technological Characteristics with the Predicate Device

Both the subject and predicate devices use the same basic fundamental scientific technology and are

comprised of the same components which include the:

Infinity C500 or C700 Medical Cockpit, -
Infinity Communications Hub (power supply), -
Infinity M500 Docking Station, -
Infinity M540 Patient Monitor, and -
various accessories. -

At a high level, the subject and predicate devices have the same technological characteristics pertaining to:

Intended use: ●
- Patient categories -
  - Intended hospital environments O
  - Physiologic patient information obtained from connected hardware O
  - Device connection to an R50N recorder, either directly or via the Infinity Network. O

{10}------------------------------------------------

■

Image /page/10/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue. The background is white.

● Indications for use:

o Measured parameters:
- Heart Rate, Arrhythmia,
- ST Segment Analysis,
- . 12-Lead ST Segment Analysis,
- 트 Apnea,
- Respiration Rate,
- Invasive Blood Pressure,
- Non-Invasive Blood Pressure.
- Temperature,
- Cardiac Output,
- E Arterial Oxygen Saturation,
  - Pulse Rate,
- Perfusion Index,
- Mainstream End Tidal CO2,
- Total Hemoglobin,
- . Total Oxygen Content,
- Carboxyhemoglobin Saturation,
- . Methemoglobin saturation,
- . Pleth Varibility Index
Physical characteristics: ●
o Cockpit & M540 display, weight, dimensions, cooling, power, alarm indicator light
Battery indicator, AC Power LED, Navigation O
- User Interface: .

Waveform area, parameter boxes-displays of physiological parameters
- ECG heartrate leads & measuring range
- Respiration leads, measuring method and measuring range, detection threshold
- Arrhythmia types ●
- Invasive blood pressure measuring method and range, display, frequency
- 0 Non-invasive blood pressure measuring method. display
Temperature measuring range O
QRS detection O

The following technological differences exist between the subject and predicate devices:

Software changes: ●
- Improvements: O

■ .

■

Added header bar touch functionality, graphical volume indicator and reset tone to the ■ Medical Cockpit
- Configurable QRS detection threshold
- Connectivity to 3rd party ventilators and anesthesia machines
ST algorithm improvements
ST algorithm modified decimation filter - M540
- New System Settings & Patient Profile Settings Medical Cockpit
- Target bed automatic discharge before network transfer complete Medical Cockpit
Configurable button & increased options - Medical Cockpit
. Alarm for units of measure mismatch when M540 is undocked from the Medical

Cockpit

Battery alarms recorded in alarm history Medical Cockpit ■
Multicast configurable option - Medical Cockpit
I Configurable clinical password – M540

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The two dots above the "a" are also dark blue.

Section 5- 510(k) Summary

. M540 alarm volume escalation in stand-alone configuration, docked & not connected to a Central Station
- Storage of arrhythmia events
IEC 60601-1-8 Third edition related changes: O
- Audible alarms speaker volume increase on Cockpit & M540 ■
- Audio alarms set during audio pause
- 트 Configurable Alarms
- Updated banner colors & alarms
- New IEC tones
- . Transducer failure detection
- Quiet mode on/off
- . Data storage - Alarm Volume and Store Events configured for both the Masimo & Nellcor Sensor messages
- E Configurable low battery alarm - M540
- Alarm volume controls - M540
Defect corrections: O
- Non-invasive blood pressure intervals adjusted to actual time and setting of 5 minutes
- or up ■

Real-time clock error handling Medical Cockpit
Display of ECG Artifact Message w/ESU Artifacts
Y-Adapter Cable for M540 in stand-alone configuration

7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility:

The Infinity® Acute Care System™ Monitoring Solution and its components are not intended to directly contact the patient. If patient contact is made it is transient with intact skin.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on devices equivalent to the IACS VG4.0.3 and M540

VG4.1.1 devices. The system complies with:

IEC 60601-1 ●
IEC 60601-1-2
IEC 60601-1-8 ●
IEC 606001-2-25 ●
. IEC 60601-2-27
. ISO 80601-2-55

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDAs Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is a dark blue color. The "ä" in Dräger has two dots above it.

Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major Level of Concern", since the device provides diagnostic information that directly drives a decision regarding treatment or therapy, such that if misapplied it could result in serious injury or death. Additionally, the device provides vital signs monitoring and alarms for potentially life-threatening situations in which medical intervention is necessary.

Performance Bench Testing

Verification testing was conducted to confirm the new requirements that were added for the IACS system, Medical Cockpit or M540 Patient Monitor based on the differences between the subject and predicate devices as listed above. EC57 testing was conducted for performance of cardiac rhythm and ST segment measurement algorithms.

Human Factors/Usability Engineering Validation testing was conducted regarding the changes made to the Instructions for Use relevant to the device modifications since the IACS VG2 devices were cleared.

Animal Studies

Animal performance testing was not performed or required for the device modifications subject of this 510(k).

Clinical Studies

Clinical studies were not performed or required for the device modifications subject of this 510(k).

8. Conclusions

The predicate device was cleared based on results which did not include clinical studies. The non-clinical data supports the substantial equivalence of the device and software verification and validation demonstrate that the subject device, IACS VG4.0.3/M540 VG4.1.1, should perform as intended in the specified use conditions.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.