(528 days)
Not Found
No
The document describes a standard multi-parameter patient monitoring system and does not mention any AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is a multi-parameter physiological patient monitoring system designed to acquire and display patient data, and it does not provide therapy.
No
The device is a multi-parameter physiological patient monitoring system that acquires and displays patient data. It monitors various parameters like heart rate, blood pressure, temperature, etc., and provides real-time data and alarms, but it does not diagnose medical conditions.
No
The device description explicitly states that the IACS is a "combination of the following devices Infinity M540 Patient Monitor... with the Infinity M500 Docking Station... integrated with the Infinity Medical Cockpit... and respective software, powered by the Infinity P2500 power supply". It also lists associated hardware accessories. This clearly indicates the device includes significant hardware components in addition to software.
Based on the provided text, the device described (Infinity® Acute Care System™ (IACS)) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The IACS is described as a multi-parameter, physiologic patient monitoring system. It acquires and displays real-time physiological data directly from the patient (heart rate, blood pressure, temperature, etc.) through external sensors and connections. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states "multi-parameter, physiologic patient monitoring." This involves monitoring the patient's vital signs directly, not analyzing samples in a lab setting.
Therefore, the IACS falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use
Infinity Acute Care System (IACS)
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
Product codes (comma separated list FDA assigned to the subject device)
MHX, MSX, DRT, DQA, DSK, MLD, DXN, DSF, DSA, DSB, DQE, DXG, BZQ, FLS, CCK, FLL, DSI, DPS
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.
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 health care professionals in hospital environments, excluding hyperbaric chambers and environments containing MRI equipment.
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)
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 FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket 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
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).
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.
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.
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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 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 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.
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510(k) Summary
510(k) SUMMARY
1. Submitter:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434
| Contact Person: | Deborah Herrington
Senior Manager, Regulatory Affairs |
|--------------------|----------------------------------------------------------|
| Email:
Tel: | Deborah.Herrington@Draeger.com
(978) 379-6574 |
| Alternate Contact: | Thomas Hirte
Senior 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 Arrhythmia |
| detection or alarms) | |
| Common Name: | Multi-parameter Patient Monitor |
| Classifications: | See Table 5.1 below |
| Table 5.1: Device
Classification / Pro Code /
| Common Name | ||
|---|---|---|
| Classification | Pro Code | Common Name |
| Primary Product | ||
| Classification | ||
| §870.1025 | MHX | Monitor, physiological, Patient |
| (with Arrhythmia Detection or | ||
| Alarms) | ||
| Subsequent Product Codes | ||
| §870.2300 | MSX | System, Network and |
| Communication, Physiological | ||
| Monitors | ||
| §870.2300 | DRT | Monitor, Cardiac (incl. Cardio- |
| tachometer & Rate Alarm) |
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| §870.2700 | DQA | Oximeter |
|---|---|---|
| §870.1110 | DSK | Computer, Blood Pressure |
| §870.1025 | MLD | Monitor, ST Segment with |
| Alarm | ||
| §870.1130 | DXN | System, Measurement, Blood- |
| Pressure, Non-Invasive | ||
| §870.2810 | DSF | Recorder, Paper Chart |
| §870.2900 | DSA | Cable, Transducer and |
| Electrode, 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:
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
K201764 Page 2 of 8
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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 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)
8
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- 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
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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
- Patient categories -
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● 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: .
O
- 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
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- 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
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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 ■
I
- 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
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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.