(165 days)
Not Found
No
The summary describes software that extends the viewing capabilities of a primary monitor and integrates information from various hospital systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device functions as a secondary display for physiological parameters and integrates additional patient information. It does not actively treat or diagnose a medical condition.
No
The device functions as a secondary display for physiological parameters from a primary monitor and integrates additional patient information. It does not independently collect or analyze patient data to provide a diagnosis.
No
The device description explicitly states that the software runs on a "specialized medical grade Patient Vicinity Workstation (PVW)" and a "dedicated Infinity C700 for IT patient vicinity workstation." The performance studies also include electrical safety, EMC, mechanical, and environmental testing on the PVW, indicating the device includes hardware components beyond just the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the Infinity Explorer software and Patient Vicinity Workstation clearly states that it displays physiological parameters received from primary patient monitors. This data is collected directly from the patient, not from a specimen taken from the patient.
- The intended use is for displaying real-time physiological data. The purpose is to extend the viewing capabilities of bedside monitors and integrate other patient information for healthcare professionals to monitor the patient's condition. This is a monitoring function, not a diagnostic test performed on a sample.
- There is no mention of analyzing biological samples. The device description focuses on software running on a workstation to display data from other medical devices.
Therefore, the Infinity Explorer software and PVW fall under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.
The device is intended to be used in an environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
The device is intended for use with adult, pediatric, and neonatal populations.
Product codes
MSX
Device Description
The Infinity Explorer software runs on a specialized medical grade Patient Vicinity Workstation (PVW) and allows the user to extend the viewing capability of the bedside monitor and integrate additional patient information originating from various sources throughout the hospital on a single display. Additional patient information can reside remotely on a clinical information system, HIS, Web, Lab Department, etc.
Specifically, the Infinity Explorer software extends the real-time viewing capabilities of the primary patient monitors that are part of the Infinity modular monitoring series. Infinity Explorer software runs on a dedicated Infinity C700 for IT patient vicinity workstation. The workstation monitors are touch screen computer workstations that allow you to interact with menu functions. However, a keyboard and mouse may also be used to interact with the display. The patient connected bedside monitor is the primary monitoring device and the workstation monitor with Infinity Explorer software is the secondary display monitor. All data to and from the bedside patient monitor is transmitted to or received from Infinity Explorer software over the Infinity Network. Infinity Explorer software can also provide control back to the connected bedside patient monitor. There are no audible alarms on the patient vicinity workstation running Infinity Explorer software. However, there are visual alarms initiated at the primary monitor that present on the workstation display running Infinity Explorer software.
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 populations.
Intended User / Care Setting
Environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Alarm testing as it applies to a secondary monitor was also performed to support the partial compliance to IEC60601-1-8:2006 + A1:2012 "General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems." The software for this device was considered as a "major" level of concern, since the software device provides vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Draeger Medical Systems, Inc. Karen Provencher Regulatory Affairs Manager 6 Tech Drive Andover, Massachusetts 01810
Re: K141756 Trade/Device Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: October 7, 2014 Received: October 9, 2014
Dear Karen Provencher,
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Melissa A. Torres -S
For 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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510(k) Number (if known): K141756
Device Name: Infinity Explorer
Indications for Use:
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.
The device is intended to be used in an environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
The device is intended for use with adult, pediatric, and neonatal populations.
MRI Compatibility Statement:
The Infinity Explorer is not compatible for use in a MRI magnetic field.
Contraindications:
There are no known contraindications.
Prescription Use Over-The –Counter Use OR (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
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K141756 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- I. Submitter: Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434 Tel: (978) 379-8075 Fax: (978) 379-8335 Contact: Karen Provencher Regulatory Affairs Manager E-mail: karen.provencher@draeger.com
Date Prepared: December 3, 2014
II. Device Names / Common Names / Classification Names:
Trade Name: Infinity Explorer Common Name: System Network and Communication Physiological Monitors Classification Name: System Network and Communication Physiological Monitors Product Code: MSX Class: II Regulation Number: 21 CFR §870.2300
III. Identification of Predicate or Legally Marketed Devices:
Infinity Explorer cleared under K060254 on April 4, 2006
IV. Device Description:
The Infinity Explorer software runs on a specialized medical grade Patient Vicinity Workstation (PVW) and allows the user to extend the viewing capability of the bedside monitor and integrate additional patient information originating from various sources throughout the hospital on a single display. Additional patient information can reside remotely on a clinical information system, HIS, Web, Lab Department, etc.
Specifically, the Infinity Explorer software extends the real-time viewing capabilities of the primary patient monitors that are part of the Infinity modular monitoring series. Infinity Explorer software runs on a dedicated Infinity C700 for IT patient vicinity workstation. The workstation monitors are touch screen computer workstations that allow you to interact with menu functions. However, a keyboard and mouse may also be used to interact with the display. The patient connected bedside monitor is the primary monitoring device and the workstation monitor with Infinity Explorer software is the secondary display monitor. All data to and from the bedside patient monitor is transmitted to or received from Infinity Explorer software over the Infinity Network. Infinity Explorer software can also provide control back to the connected bedside patient Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 USA Tel: 978-379-8000
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K141756
monitor. There are no audible alarms on the patient vicinity workstation running Infinity Explorer software. However, there are visual alarms initiated at the primary monitor that present on the workstation display running Infinity Explorer software.
V. Indications / Intended Use:
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors.
The device is intended to be used in an environment where patient care is provided by healthcare professionals such as physicians, nurses, and technicians trained on the use of the device, who will determine when use of the device is indicated based upon their professional assessment of the patient's medical condition.
The device is intended for use with adult, pediatric, and neonatal populations.
MRI Compatibility Statement:
The Infinity Explorer is not compatible for use in a MRI magnetic field.
Contraindications:
There are no known contraindications.
VI. Comparison of Technological Characteristics with the Predicate Device:
The subject device Infinity Explorer software is a modification of the predicate device. The basic technological characteristics remain the same between the 2 versions of the device. The subject and predicate devices are based on the following same technological elements:
- . Both versions of the Infinity Explore software run on specified medical grade cockpits
- Both devices interface with specified Draeger bedside monitors ●
- Both devices are compatible with specified 3rd party applications ●
The following technological differences exist between the subject and predicate devices:
- Operating System
- Compatibility with newer version of Patient Vicinity Workstation
- Compatibility with latest versions of 3th party applications ●
- Newer version of Infinity Explorer software cannot display DICOM images ●
- Compatibility with latest versions of primary bedside monitors ●
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Performance Data: VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility:
Not applicable - The Infinity Explorer is a software application and does not come into contact with the patient.
Sterilization:
Not applicable – The Infinity Explorer is a software application and does not require sterilization for use.
Electrical Safety & Electromagnetic Compatibility (EMC):
Electrical safety and EMC testing was performed on the Patient Vicinity Workstation (PVW) consisting of display, keyboard, mouse and power supply. The PVW complies with IEC 60601-1:2012 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance and IEC 60601-1-2:2007 - Medical Electrical Equipment General Requirements for Electrocompatibility.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Alarm testing as it applies to a secondary monitor was also performed to support the partial compliance to IEC60601-1-8:2006 + A1:2012 "General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems." The software for this device was considered as a "major" level of concern, since the software device provides vital signs monitoring and alarms for potentially life threatening situations in which medical intervention is necessary.
Mechanical & Environmental Testing:
The Patient Vicinity Workstation (PVW) was tested for
- . Functional testing to requirements
- Shock & vibration
- Environmental Controls ●
- Climatic and Thermal Testing
Animal Testing:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 USA Tel: 978-379-8000
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K141756
Not applicable - animal testing was not required to support substantial equivalence to the predicate device.
Clinical Studies:
Not applicable – clinical studies were not required to support substantial equivalence to the predicate device.
VIII. Conclusion:
The modified Infinity Explorer has been tested in accordance with applicable standards and internal design control procedures. The results of the bench testing performed provided sufficient evidence to determine that the modified Infinity Explorer software with upgraded operating system is as safe and effective as the predicate device for its intended use.