(90 days)
Not Found
No
The document describes a standard multi-parameter physiological patient monitoring system and does not mention any AI or ML capabilities.
No.
The device is a patient monitor that acquires and displays physiological data. It does not provide therapy.
Yes
The device is intended for "multi-parameter, physiologic patient monitoring" and "obtains the physiologic, multi-parameter data" to display information such as heart rate, SpO2, and various other physiological parameters. This collection and display of physiological data for patient monitoring constitutes a diagnostic function.
No
The device description explicitly states it is a "combination of two devices; Infinity M540 patient monitor with Infinity M500 docking station integrated with the Infinity C500 Medical Cockpit or optional C700 (larger screen size) Medical Cockpit and respective software." This indicates the device includes significant hardware components in addition to software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Infinity Acute Care System (IACS) Monitoring Solution and the Infinity M540 Patient Monitor are designed for physiological patient monitoring. They acquire data directly from the patient's body (e.g., heart rate, blood pressure, oxygen saturation) through connected hardware and sensors.
- Lack of Specimen Analysis: There is no mention of the device analyzing any specimens taken from the patient. The data is obtained from the patient's body directly.
- Parameters Monitored: The list of parameters monitored (Heart rate, Arrhythmia, Blood pressure, SpO2, etc.) are all physiological measurements taken from the living patient, not from in vitro samples.
Therefore, the device falls under the category of physiological monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intended Use: 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 professional. 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 (only available when the M540 is docked in an IACS configuration)
- Arterial oxygen saturation (SpO2)
- Pulse rate
- Perfusion Index (PI)
- Total hemoglobin (SpHb) (adult and pediatric only)
- Total oxygen content (SpCO) (adult and pediatric only)
- Methemoglobin saturation (SpMet)
- Pleth variability index (PVI)
- Mainstream etCO2
Product codes (comma separated list FDA assigned to the subject device)
MHX, DQA, MSX, DRT, BZQ, FLL, DSK, FLS, MLD, DXN, CCK
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 Monitoring Solution is a combination of two devices ; Infinity M540 patient monitor with Infinity M500 docking station integrated with the Infinity C500 Medical Cockpit or optional C700 (larger screen size) Medical Cockpit and respective software.
The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 patient, and is transmitted via network to the patient bedside Infinity Medical Cockpit. The Infinity M540 patient monitor is a light weight hand held portable patient mor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond present 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 Cockpits similar to other Draeger Medical Pick-And-Go patient monitors.
The Infinity Mcable Masimo Rainbow SET is a new Pulse CO-Oximeter model for use with the IACS Infinity M540 Patient Monitor to provide continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), perfusion index (PI), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), pleth variability index (PVI) and total oxygen content (SpOC).
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
trained healthcare professionals
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)
Not Found
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.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The letters are black and the background is white. The two dots above the "a" are also black.
510(k) SUMMARY of SAFETY AND EFFECTIVENESS
MAR 2 2 2012
Draeger Medical Systems, Inc. Submitter : 6 Tech Drive Andover, MA 01810 Tel : (978) 379-8265 Fax: (978) 379-8335 Contact : Beth A. Zis, RAC Director of Requlatory Affairs
February 29, 2012 Date Prepared :
Device Names/Common Names/Classification Names:
Trade Name: Infinity® Acute Care System™ (IACS) Monitoring Solution Physiological Patient Monitor Common Name : Classification Name : Monitor, Physiological, Patient (with arrhythmia detection or Alarms) Product Code : MHX
| Trade Name : | Infinity MCable - Masimo Rainbow SET ® |
|---|---|
| Common Name : | Pulse CO-Oximeter |
| Classification Name : | Oximeter |
| Product Code : | DQA |
Class : ll
Regulation Numbers : 21 CFR 870.1025, 21 CFR 870.2700
Identification of Predicate or Legally Marketed Devices :
The modified devices are substanitally equivalent to the previously cleared :
Infinity® Acute Care System™ (IACS) Monitoring Solution and the Infinity® MCable - Masimo SET® MCable (smart pod) manufactured by Draeger Medical Systems, Inc. cleared under 510(k) #K093788 and #K061329.
Masimo Radical 7 Pulse CO-Oximeter and Accessories manufactured by Masimo Corporation cleared under 510(k) #K110028.
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 Monitoring Solution is a combination of two devices ; Infinity M540 patient monitor with Infinity M500 docking station integrated with the Infinity C500 Medical Cockpit or optional C700 (larger screen size) Medical Cockpit and respective software.
The physiological patient data acquired from the interconnected components is displayed on the Infinity M540 patient, and is transmitted via network to the patient bedside Infinity Medical
Page 1 of 3
1
Image /page/1/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font, with two dots above the "a". Below the word "Dräger" is the number "K113798". The number is written in a handwritten style, with some of the digits overlapping.
Cockpit. The Infinity M540 patient monitor is a light weight hand held portable patient mor that displays real-time vital signs, provides continuous trending and produces visual and audible alarms if any of the physiological parameters monitored vary beyond present 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 Cockpits similar to other Draeger Medical Pick-And-Go patient monitors.
The Infinity Mcable Masimo Rainbow SET is a new Pulse CO-Oximeter model for use with the IACS Infinity M540 Patient Monitor to provide continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), perfusion index (PI), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin (SpMet), total hemoglobin (SpHb), pleth variability index (PVI) and total oxygen content (SpOC).
Intended Use: 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 profess sionals. 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 professional. 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 analvsis
-
ST segment analysis including TruST® (adult and pediatric only)
-
12-lead ST seament analysis (adult and pediatric only)
-
Apnea
-
Respiration rate
-
Invasive pressure
-
Non-invasive pressure
-
Temperature
-
Cardiac output (only available when the M540 is docked in an IACS configuration)
-
Arterial oxygen saturation (SpO2)
-
Pulse rate
-
Perfusion Index (PI)
-
Total hemoglobin (SpHb) adult and pediatric only
-
Total oxygen content (SpCO) adult and pediatric only
-
Methemoglobin saturation (SpMet)
-
Pleth variability index (PVI)
-
Mainstream etCO2
Page 2 of 3
2
Image /page/2/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. Below the word "Dräger" is the number "K113798" in a handwritten style. The word "Dräger" is the name of a German company that makes medical and safety technology products. The number "K113798" may be a serial number or product code.
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.
Substantial Equivalence:
The modified Infinity Acute Care System (IACS) Monitoring Solution VG2 software and Infinity MCable - Masimo Rainbow SET have been tested in accordance with applicable standards and internal design con trol procedures and were determined to be as safe and effective for its intended use as the predicate devices.
Biocompatibility:
Not applicable – The Infinity Acute Care System Monitoring Solution and its components are not intended to contact the patient. If patient contact is made, it is transient with intact skin.
Sterilization:
Not applicable – The Infinity Acute Care System (IACS) Monitoring Solution and its components are not supplied sterile.
Standards:
Electrical Safety: EC60601-1: Medical electrical equirements for safety and essential performance; and applicable collateral standards.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the logo is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 2 2012
Draeger Medical Systems, Inc. c/o Ms. Beth A. Zis Director of Regulatory Affairs 6 Tech Drive Andover, MA 01810
Re: K113798
Trade/Device Name: Infinity acute care system, Infinity Mcable-Masimo rainbow SET Regulation Number: 21 CFR 878.1025
Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Regulatory Class: Class II
Product Code: MHX, MSX, DRT, DQA, BZQ, FLL, DSK, FLS, MLD, DXN, CCK Dated: March 7, 2012 Received: March 8, 2012
Dear Ms. Zis:
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. Beth A. Zis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Additional Information for K113798 Infinity® Acute Care System™ Monitoring Solution
Image /page/5/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. Above the "a" are two dots, which is a common feature in the German spelling of the word. Below the word "Dräger" is the number "K113798" written in a handwritten style.
Indications for Use
510(k) Number (if known): K113798
Infinity® Acute Care System™ (IACS) Monitoring Solution Device Name:
Intended Use: 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 professional. 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 (only available when the M540 is docked in an IACS configuration)
- Arterial oxygen saturation (SpO2)
- Pulse rate
- Perfusion Index (PI)
- Total hemoglobin (SpHb) (adult and pediatric only)
- Total oxygen content (SpCO) (adult and pediatric only)
- Methemoglobin saturation (SpMet)
- Pleth variability index (PVI)
- Mainstream etCO2
Page 1 of 2
6
Additional Information for K113798 Infinity® Acute Care System™ Monitoring Solution
Image /page/6/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font, with two dots above the "a". Below the word, there is a handwritten number "K113798". The number appears to be a serial number or identification code.
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.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
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
Division of Cardiovascular Devices
510(k) Number
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