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 healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.

Intended Use: Infinity M540 Patient Monitor

The Infinity M540 is intended for the monitoring of multi-parameter, physiological patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. The M540 is intended to monitor one patient at a time.

Indications for Use

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric only)
12-lead analysis
ST segment analysis including TruST® (adult and pediatric only)
12-lead ST segment analysis (adult and pediatric only)
Apnea
Respiration rate
Invasive pressure
Non-invasive pressure
Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate (SpO2)
Mainstream etCO2

Device Description

The Infinity® Acute Care System™ (1ACS) Monitoring Solution is a multi-parameter physiological patient monitoring system that acquires and displays patient data at the bedside and in transport within the hospital setting. The IACS Monitoring Solution is a combination of two devices; Infinity M540 patient monitor with Infinity M500 docking station; and Infinity C500 software with Infinity C500 Medical Cockpit. Infinity C700 software with C700 Medical Cockpit is an option for a larger screen.

The Infinity M540 patient monitor is a light weight hand held portable patient monitor that displays real-time vital signs and provides continuous trending. The Infinity M540 patient monitor is capable of monitoring Heart rate, Arrhythmia (adult and pediatric only), 12-lead monitoring, ST segment analysis including TruST (adult and pediatric only), 12-lead ST segment analysis (adult and pediatric only), Apnea, Respiration rate, Invasive pressure, Noninvasive pressure, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate (SpO2), and Mainstream etCO2. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The Infinity M540 patient monitor can be used as a stand alone medical device without any integration with the Infinity C500 Medical Cockpit.

The Infinity C500 software allows the user to extend the viewing capability of the Infinity M540 patient monitor and integrates additional patient information on Infinity C500 Medical Cockpit. The Infinity C500 Medical Cockpit is a medical grade display monitor with limited monitoring control features. The Infinity C500 software is capable of displaying real-time patient data, providing control back to the Infinity M540 and integrating other applications with patient data on the Infinity C500 Medical Cockpit.

AI/ML Overview

The provided 510(k) premarket notification for the "Infinity Acute Care System (IACS) Monitoring Solution" is not a study proving the device meets specific acceptance criteria in the way a clinical study for a new AI diagnostic would. Instead, it is a submission demonstrating substantial equivalence to already legally marketed predicate devices.

Therefore, the document does not contain the specific information requested in the prompt, such as a table of acceptance criteria with reported device performance metrics, sample sizes, expert qualifications for ground truth, or details of a multi-reader multi-case (MRMC) study. The focus is on showing that the new device is as safe and effective as existing ones, primarily through a comparison of technological characteristics and adherence to safety standards.

Here's an analysis of what is available in relation to your request, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics (like sensitivity/specificity for arrhythmia detection). Instead, the acceptance criterion is implicitly "as safe and effective for its intended use as the predicate device(s)" and adherence to applicable standards.
Reported Device Performance: The document states: "Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display." This is a qualitative statement of equivalence, not a quantitative report of performance metrics against specific criteria.

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

Sample Size: Not reported.
Data Provenance: Not reported (e.g., country of origin, retrospective/prospective).
Context: Because this is a substantial equivalence submission relying on comparison to predicate devices and adherence to standards, a specific "test set" and corresponding sample size for clinical performance evaluation in the way you might expect for an AI diagnostic algorithm is not detailed here. The clinical performance evaluation mentioned is likely a high-level assessment rather than a detailed study generating novel performance metrics for this specific device.

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

Number of Experts: Not applicable/not reported.
Qualifications: Not applicable/not reported.
Reasoning: Ground truth generation by experts is typically done for diagnostic accuracy studies. This submission focuses on comparing the safety and effectiveness to predicate devices and adhering to standards, not on establishing a new diagnostic accuracy claim requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not reported. (e.g., 2+1, 3+1, none)
Reasoning: See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned as having been done.
Effect Size: Not applicable as no MRMC study was performed.
Reasoning: MRMC studies are common for evaluating the impact of AI on human reader performance in diagnostic tasks. This submission is for a physiological monitoring system and does not describe such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable/not reported as a separate, isolated algorithm performance.
Reasoning: The Infinity Acute Care System is a monitoring solution, an integrated system that includes hardware and software for displaying physiological parameters. Its "performance" is implicitly tied to its function in continuously acquiring and displaying data, and triggering alarms, rather than a standalone diagnostic algorithm. The monitoring functions (like arrhythmia detection) are part of the integrated system and are implicitly compared to predicate devices.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated for performance evaluation of the IACS itself. The claims are based on "clinical performance evaluations" showing substantial equivalence to predicate devices and adherence to standards. For the predicates, the "ground truth" would have been established through prior regulatory pathways (e.g., device's ability to accurately measure physiological parameters, correctly detect events, etc.).
Context: For physiological monitors, ground truth often involves calibration against known standards, comparisons to reference devices, or clinical observation by trained professionals to verify correct parameter display and alarm functionality. However, detailed methodology is not in this 510(k) summary.

8. The Sample Size for the Training Set

Sample Size: Not applicable/not reported.
Reasoning: The document doesn't describe the development of a novel algorithm using a training set in the way AI/ML models typically do. This seems to be a hardware/software system that performs known physiological monitoring functions.

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

How Ground Truth Was Established: Not applicable/not reported.
Reasoning: See point 8.

Summary of Device Performance and Equivalence Statement:

The document states:

"The Infinity Acute Care System (IACS) Monitoring Solution has been tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device(s)."
"Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display."

This 510(k) submission primarily relies on demonstrating that the new device meets relevant electrical safety standards (IEC 60601-1) and that its technological characteristics and performance are comparable to the previously cleared predicate devices (Infinity Alpha, Infinity Kappa and Delta Series Monitors, Infinity Explorer). It does not present detailed quantitative performance data or specific clinical studies in the format requested.

Summary

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

K093788 P1/4

Infinity Acute Care System (IACS) Monitoring Solution 510(k) Premarket Notification

510(k) SUMMARY

MAR - 8 2010

Submitter:

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

Contact Person:

Charles Morganson, RAC Senior Manager Regulatory Affairs Tel: (978) 379-8309 Fax: (978) 379-8335 Charles.morganson@draeger.com

Date submission was prepared: December 4, 2009

Device Name: .

Trade Name:	Infinity® Acute Care System™ (IACS) MonitoringSolution
Common Name:	Physiological Patient Monitoring Solution
Classification Name:	Monitor, Physiological, Patient(with arrhythmia detection or Alarms)
Product Code:	MHX
Class:	II
Regulation Number:	21 CFR 870.1025
Legally Marketed Device:	Infinity Alpha

Infinity Explorer

Device Description:

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

Infinity Acute Care System (IACS) Monitoring Solution 510(k) Premarket Notification

Intended Use: The Infinity® Acute Care System™ (IACS) Monitoring Solution:

The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in cnvironments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network.

Intended Use: Infinity M540 Patient Monitor

Indications for Use:

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric only)
12-lead analysis
ST segment analysis including TruST® (adult and pediatric only)
-- 12-lead ST segment analysis (adult and pediatric only)
Apnea
Respiration rate
Invasive pressure
Non-invasive pressure

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

Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate (SpO2)
Mainstream etCO2

MRI Compatibility Statement:

The IACS, Infinity M540 and any connected optional hardware are not intended for use in hyperbaric chambers and environments containing MRI equipment

Predicate Devices:

Infinity Alpha with software VA0	K051658
Infinity Kappa and Delta Series Monitors with VF7 modifications	K070566

Infinity Explorer with VF6 modifications and MDS III display K060254 .

Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

The Infinity Acute Care System (IACS) Monitoring Solution has been tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device(s).

Assessment of clinical performance data for equivalence:

Clinical performance evaluations indicate that the Infinity Acute Care System (IACS) Monitoring Solution is substantially equivalent to the Infinity Alpha patient monitor and Infinity Explorer with MDS III display.

Biocompatibility:

Not applicable - The Infinity Acute Care System (IACS) Monitoring Solution and its components do not directly contact with the patient. If patient contact is made, it is transient and with the intact unbroken skin.

Sterilization:

Not applicable - The Infinity Acute Care System (IACS) Monitoring Solution and its components are not supplied sterile.

Standards and Guidance:

Electrical Safety:

IEC 60601-1: Medical electrical equipment general requirements for safety and essential performance; and applicable and collateral standards

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

Guidance Documents: "Deciding When to Submit a 510(k) for a
Change to an Existing Device" released on January 10, 1997 "Format for traditional and Abbreviated 510(k)s" issued on August 12, 2005

. .

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

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, symbolizing health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

MAR - 8 2010

Mr. Bryan Cowell, RAC Senior Regulatory Compliance Specialist Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434

Re: K093788

Device Name: Infinity® Acute Care System™ (IACS) Monitoring Solution Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: Class II (Two) Product Code: MHX Dated: December 4, 2009 Received: December 9, 2009

Dear Mr. Cowell:

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.

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

Page 2 - Mr. Bryan Cowell. RAC

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: Infinity® Acute Care System™ (IACS) Monitoring Solution

Intended Use: The Infinity® Acute Care System™ (IACS) Monitoring Solution:

Intended Use: Infinity M540 Patient Monitor

Indications for Use

The M540 monitors the following parameters:

Heart rate
Arrhythmia (adult and pediatric only)
12-lead analysis
ST segment analysis including TruST® (adult and pediatric only)
12-lead ST segment analysis (adult and pediatric only)
Apnea
Respiration rate
Invasive pressure
Non-invasive pressure
Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate (SpO2)
Mainstream etCO2

MRI Compatibility Statement:

The IACS, Infinity M540 and any connected optional hardware are not intended for use in hyperbaric chambers and environments containing MRI equipment

Prescription Use (Part 21 CFR 801 Subpart D)	X	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 Cardiovascular Devices

510(k) Number	K093788
---------------	---------

000022

1 of 1

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.