INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
Device Facts
| Record ID | K093788 |
|---|---|
| Device Name | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION |
| Applicant | Draeger Medical Systems, Inc. |
| Product Code | MHX · Cardiovascular |
| Decision Date | Mar 8, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
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. 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.
Device Story
Infinity Acute Care System (IACS) is a multi-parameter physiological monitoring solution for hospital use. System comprises M540 portable monitor, M500 docking station, and C500/C700 Medical Cockpit displays. M540 acquires real-time vital signs (ECG, pressure, SpO2, etCO2, etc.) and provides continuous trending; functions as standalone or integrated with Medical Cockpit via Infinity network. Medical Cockpit extends viewing, integrates patient data, and provides monitoring control. Healthcare professionals use visual/audible alarms to identify parameter limit violations. Device supports clinical decision-making by providing real-time patient status and historical trends. Benefits include continuous patient surveillance and centralized data management in acute care environments.
Clinical Evidence
Clinical performance evaluations were conducted to demonstrate substantial equivalence to the Infinity Alpha and Infinity Explorer systems. No specific quantitative clinical trial metrics (e.g., sensitivity/specificity) are provided in the summary; the determination relies on clinical performance evaluations and adherence to electrical safety standards.
Technological Characteristics
Multi-parameter physiological monitor; includes portable M540 unit and Medical Cockpit displays. Connectivity via Infinity network. Electrical safety per IEC 60601-1. Non-sterile; transient contact with intact skin only. Software-based monitoring and alarm system.
Indications for Use
Indicated for adult, pediatric, and neonatal patients requiring multi-parameter physiological monitoring in professional healthcare settings. Parameters include heart rate, arrhythmia (adult/pediatric), 12-lead analysis, ST segment analysis (adult/pediatric), apnea, respiration rate, invasive/non-invasive pressure, temperature, cardiac output, SpO2, pulse rate, and etCO2. Contraindicated for use in hyperbaric chambers or MRI environments.
Regulatory Classification
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.
Special Controls
*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.
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)
Submission Summary (Full Text)
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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) Monitoring<br>Solution | | |
|--------------------------|--------------------------------------------------------------------------|--|--|
| Common Name: | Physiological Patient Monitoring Solution | | |
| Classification Name: | Monitor, Physiological, Patient<br>(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:
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.
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Infinity Acute Care System (IACS) Monitoring Solution 510(k) Premarket Notification
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.
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
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
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- 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
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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
> . .
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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.
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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
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# 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:
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
#### 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 |
|---------------|---------|
|---------------|---------|
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