(547 days)
Not Found
No
The description focuses on data exchange, connectivity, and interfaces using standard healthcare protocols (HL7, ASTM, SDC). There is no mention of AI, ML, or any algorithms that would learn from data or perform tasks typically associated with AI/ML.
No.
The device is a software application intended for viewing and exchanging patient data, not for treating or diagnosing medical conditions.
No
The device is described as software for viewing and exchanging patient data, supporting clinical workflows and information connectivity, rather than performing diagnostic analysis.
Yes
The device description explicitly states it is a "suite of software applications" and details its functions as data viewing and exchange. While it interacts with hardware (servers, networks, USB dongle for licensing), the core medical device functionality described is purely software-based. The USB dongle is for licensing, not a core functional hardware component of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide clinicians with the capability of viewing patient data remotely and exchanging clinical and administrative information between networks. This focuses on data management and display, not on analyzing biological samples to diagnose or monitor medical conditions.
- Device Description: The description details software applications for data connectivity, interfaces (HL7, ASTM, SDC), remote viewing, and data exchange. It does not mention any components or processes related to the analysis of in vitro samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes in samples.
- Providing information for diagnosis, monitoring, or prognosis based on sample analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The Infinity Gateway software is a data management and communication tool for clinical information, not a device that performs diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Product codes (comma separated list FDA assigned to the subject device)
MSX, LNX
Device Description
The Infinity Gateway Suite is a suite of software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:
- Server Software Health Level seven (HL7) Interface Software Options -
- -American society for testing and materials (ASTM) Stat Lab interface
- -Developer's Tools
- -Remote View Applications
- I Pager Interface
- -Alarm history database
- -Time master functions
- -12-lead electrocardiogram (ECG) export
- Service-Oriented Device Compatibility (SDC) interface with encryption -
Infinity Gateway is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.
The Infinity Gateway Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow.
Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway developer's tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine technology, which facilitates cost-effective software deployments and reduces the total cost of ownership.
Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Draeger Infinity Network and other hospital systems.
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
Not Found
Intended User / Care Setting
Intended Operator: The Infinity Gateway software application is intended for use by Healthcare Providers, ie. Physicians, Nurses, and Technicians.
Intended Use Environment: The infinity Gateway software application is intended for use in a healthcare environment.
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)
Verification and Validation Testing: The verification and validation that was conducted confirmed the Infinity Gateway product performs according to intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected. Testing confirmed that identified Product Risk mitigations functioned with the new code, with all test cases passing without exception. Additionally, all possibly known use related hazards, inclusive those beyond the primary operating functions, that are related to usability have been reviewed. As a result of this review, all risk control measures identified in the risk management process are deemed adequate to further mitigate and control the risks at an acceptable level under consideration of the intended use. The results of the Verification and Validation testing confirm the modified software is substantially equivalent to the predicate device.
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
§ 870.2300 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).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.
Draeger Medical Systems, Inc. Eileen Boyle Manager, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810 May 17, 2024
Re: K203579
Trade/Device Name: Infinity Gateway Suite Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MSX
Dear Eileen Boyle:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 7, 2022. Specifically, FDA is updating this SE letter as an administrative correction. A second product code, LNX, was inadvertently included.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning@fda.hhs.gov.
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
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June 7, 2022
Draeger Medical Systems, Inc. Eileen Boyle Manager, Regulatory Affairs 6 Tech Drive Andover, Massachusetts 01810
Re: K203579
Trade/Device Name: Infinity Gateway Suite Regulation Number: 21 CFR 870.2300 Regulation Name: System, Network and Communication, Physiological Monitors Regulatory Class: Class II Product Code: MSX, LNX Dated: June 1. 2022 Received: June 2, 2022
Dear Eileen Boyle:
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.
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
2
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 (OS) 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 mediation-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,
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203579
Device Name Infinity Gateway Suite
Indications for Use (Describe)
Indications for Use:
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Intended Use
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Intended Operator
The Infinity Gateway software application is intended for use by Healthcare Providers, ie. Physicians, Nurses, and Technicians.
Intended Patient Population
The Infinity Gateway software application is not intended to be connected to patients.
Intended Use Environment
The infinity Gateway software application is intended for use in a healthcare environment.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/1 description: The image shows the word "Dräger" in a bold, sans-serif font. The word is in blue, and the two dots above the "a" are also blue. The word is slightly italicized, and the letters are close together.
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434
510(k) SUMMARY
I. Submitter: Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810 USA
Contact Person: Eileen M. Boyle Manager, Regulatory Affairs Draeger Medical Systems, Inc. Phone: 781-439-8120 E-mail:eileen.boyle@draeger.com November 19, 2021 - Date Prepared
II. Device
Names / Common Names / Classification Names:
| Common Name: | Computers and Software, Medical |
|---|---|
| Trade Name: | Infinity® Gateway Suite |
| Classification Name: | System Network and Communication Physiological Monitors |
| Product Code: | MSX |
| Subsequent Code: | LNX |
| Regulatory Class: | II |
| Regulation Number: | §870.1025 |
III. Predicate Device
The Infinity® Gateway Suite, VF4 K043549 cleared on January 21, 2005.
| 510(k)
No. | Trade Name | Manufacturer | Product Code/Common Name | Regulation
Number |
|----------------------|------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------|
| K043549
1/21/2005 | Infinity
Gateway Suite
(VF4) | Draeger Medical
Systems, Inc. | MSX - System, Network and
Communication, Physiological
Monitors
LNX - Computers and Software,
Medical | 21CFR
870.1025 |
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Image /page/5/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.
Device Description IV.
The Infinity Gateway Suite is a suite of software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Infinity Gateway Suite is designed to support the unique needs of hospitals, and provide a complete range of options for information connectivity, including:
- Server Software Health Level seven (HL7) Interface Software Options -
- -American society for testing and materials (ASTM) Stat Lab interface
- -Developer's Tools
- -Remote View Applications
- । Pager Interface
- -Alarm history database
- -Time master functions
- -12-lead electrocardiogram (ECG) export
- Service-Oriented Device Compatibility (SDC) interface with encryption -
Infinity Gateway is designed as a client-server application that provides a way for users to view patient information on a hospital workstation that is connected via the hospital network. The server portion runs on a Windows server that is connected directly to the hospital Local Area Network (LAN) and to the Infinity Network. Data access methods are available as options that customers can purchase and enable independently once they install the basic Infinity Gateway application.
The Infinity Gateway Server facilitates the exchange of important clinical information between the Infinity/SDC protocol and existing hospital and patient care systems. The Infinity Gateway Server is designed to provide flexibility by using common healthcare protocols and data format standards for managing communications between multiple disparate systems. The user may select one or more Infinity Gateway Developer's Tools and Interface Options to create a seamless flow of information tailored to support clinical work flow.
Infinity Gateway Developer's Tools and Interface Options are licensed or "unlocked" by using option passwords that are associated with a USB license dongle. An option password is the electronic proof of purchase for the Infinity Gateway software. During the at-hospital setup procedure, the user will be asked for an option or license password which is a unique number associated with the licensing dongle issued. The licenses are always associated with the physical dongle. The Infinity Gateway developer's tools (such as WinAccess API) enable the development of custom applications to support customers' homegrown applications to support clinical research projects or downstream information systems. Finally, Infinity Gateway provides flexible deployment opportunities by leveraging the virtual machine
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technology, which facilitates cost-effective software deployments and reduces the total cost of ownership.
Infinity Gateway also promotes patient safety with efficient workflows for timely decisionmaking by integrating patient data and providing continuity-of-care support. Furthermore, it makes comprehensive clinical data available at the point-of-care by facilitating the exchange of lab reports and admission information between the Draeger Infinity Network and other hospital systems.
V. Indications for Use / Intended Use
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Intended Use
The Infinity Gateway software applications are intended to provide clinicians with the capability of viewing patient data remotely via the Infinity Network and for the data exchange of select clinical and administrative information between the Infinity Network and the hospital network.
Intended Operator
The Infinity Gateway software application is intended for use by Healthcare Providers, ie. Physicians, Nurses, and Technicians.
Intended Patient Population
The Infinity Gate4way software application is not intended to be connected to patients.
Intended Use Environment
The infinity Gateway software application is intended for use in a healthcare environment.
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VI. Comnarison of Technological Characteristics with Predicate Device
The intended use, indications for use, performance and technological characteristics are substantially equivalent to the predicate device.
A summary of the main changes compared to the predicate device are listed in the comparison table below:
| Attribute | Predicate Device
Infinity Gateway Suite
K043549- VF4 | Subject Device
Infinity Gateway Suite
510(k)#K203579 – VF9.0 | Explanation of Similarities
and Differences |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Draeger Medical
Systems, Inc. | Draeger Medical Systems,
Inc. | Same |
| 510(k) Number | K043549 | K203579 | - |
| Model Number | MS16076 | MS40046 | - |
| Intended Use | The Infinity Gateway
software applications are
intended to provide
clinicians with the
capability of viewing
patient data remotely via
the Infinity Network and
for the data exchange of
select clinical and
administrative
information between the
Infinity Network and the
hospital network. | The Infinity Gateway
software applications are
intended to provide clinicians
with the capability of
viewing patient data
remotely via the Infinity
Network and for the data
exchange of select clinical
and administrative
information between the
Infinity Network and the
hospital network. | Same, no change since VF4 |
| Update the supported
version Microsoft
SQL to 2017 | 2008 | 2017 | 2008 will no longer be a
supported version |
| Incorporate support
for Microsoft SQL
2017 and Microsoft
Server Operating
System 2016 | Windows NT 4.0,
Windows 2000 or
Windows XP | New feature in VF9.0
Support Microsoft SQL 2017
Express and Standard.
Support Microsoft Server
Operating System 2016 for
the server application. | Windows NT 4.0, Windows
2000, Windows XP will no
longer be supported
versions. |
| Make the Service-
Oriented Device
Compatibility (SDC)
a locked option with
encryption | Not part of VF4
software. | SDC defines a
communication architecture
to establish distributed
systems of medical devices
in clinical environments. | This new feature is for use
with Draeger SDC devices.
This license option allows
for interoperability and
connectivity with the
integrated Clinical
Assistance Package which |
| Attribute | Predicate Device
Infinity Gateway Suite
K043549 - VF4 | Subject Device
Infinity Gateway Suite
510(k)#K203579 - VF9.0 | Explanation of Similarities
and Differences |
| | | | consists of an anesthesia
workstation, a patient
monitoring system and the
Hospital Information
System:
Infinity Gateway software
VF9.0
Infinity Acute Care System
(IACS) patient monitor with
software version VG7.1
Connectivity Converter
CC300 with software
version 1.1
Perseus A500 Anesthesia
Machine
Babylog VN500
Evita Infinity V500
Ventilator |
| Redundant Server
Option | Not part of VF4
software. | An administrator performs
the switchover manually by
powering up or enabling the
Gateway service on the
redundant server. | Gateway supports the use of
an optional redundant
server. This is a licensed
option. It allows a separate
server to be configured in
advance which can
temporarily replace a failed
Gateway server. |
| IHE/HL7 Alarm
Interface Locked
Option (For SDC
Only) | Not part of VF4
software. | New feature in VF9.0
The IHE/HL7 Alarm
Communication interface
exports Alarm data from
devices on the SDC network
to a CIS for long term
storage and record keeping.
The interface support IEEE
11073 output and can be
configured to be IHE PCD
ACM Compliant. | The IHE/HL7 alarm
communication
management interface is
only available for use with
SDC devices. |
| Attribute | Predicate Device
Infinity Gateway Suite
K043549- VF4 | Subject Device
Infinity Gateway Suite
510(k)#K203579 – VF9.0 | Explanation of Similarities
and Differences |
| Intended Population | The communication
network and central
monitoring device are
not connected to patients. | The communication network
and central monitoring
device are not connected to
patients. | Same |
| Intended Environment | A healthcare facility
where healthcare
professionals provide
patient care. | A healthcare facility where
healthcare professionals
provide patient care. | Same |
| Gateway Pager
Access application | Yes | Yes | Same |
| Global Session
Manager | Yes | No | Global Session Manager is
no longer supported. No
change to intended use. |
| Display either the
patient name or the
patient identifier on
WinView/Webviewer
Gateway | Yes | Yes, WinView/WebViewer
is renamed to PatientWatch | Same.
WinView/WebViewer is
renamed to PatientWatch |
| Network Technology | • TCP/IP
• Health Level 7 (HL7
2.3)
• ASTM
• HTML, Active X
• Windows Dynamic
Link
• Library (DLL)
• TAP | • TCP/IP
• Health Level 7 (HL7 2.x)
• ASTM
• HTML, Active X
• Windows Dynamic Link
• Library (DLL)
• TAP | VF9.0 added additional
support for protocol
interfaces and supports
different versions of the
HL7 2.x protocols for
various interfaces |
| Alarm (audible) | Yes | Yes | Audible alarm information
is available only if a paging
service provides the
capability.
No change since VF4, no
impact to the intended use. |
| Alarm Display String | Advisory (ADV)
Serious (SER)
Life Threatening (LT) | Advisory (ADV)
Serious (SER)
Life Threatening (LT) | Available for informational
purposes only. The primary
alarm notification is at the
patient bedside or the
Infinity Central Station.
No change since VF4, no
impact to the intended use. |
| Alarm (Visual) | Yes | Yes | Same |
| Attribute | Predicate Device
Infinity Gateway Suite
K043549 - VF4 | Subject Device
Infinity Gateway Suite
510(k)#K203579 - VF9.0 | Explanation of Similarities
and Differences |
| Alarm Grade | Life-Threatening
Serious
Advisory via
WinView/WebViewer | Yes, WinView/WebViewer
is renamed to PatientWatch | PatientWatch alarms are
available for informational
purposes and are not
available for SDC
The alarm grades have not
changed between VF4 and
VF9. |
| Alarm State | Active
Silenced
None | Yes, via PatientWatch | PatientWatch alarms are
available for informational
purposes and are not
available for SDC
The alarm states have not
changed between VF4 and
VF9. |
Comparison Table Between the Predicate Device K043549, VF4 and the Subject 510(k) K203579, VF9.0:
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9
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VII. Performance Data
Verification and Validation Testing:
The verification and validation that was conducted confirmed the Infinity Gateway product performs according to intended use with no adverse effects upon other medical devices in the Infinity system to which it is connected. Testing confirmed that identified Product Risk mitigations functioned with the new code, with all test cases passing without exception.
Additionally, all possibly known use related hazards, inclusive those beyond the primary operating functions, that are related to usability have been reviewed. As a result of this review, all risk control measures identified in the risk management process are deemed adequate to further mitigate and control the risks at an acceptable level under consideration of the intended use. The results of the Verification and Validation testing confirm the modified software is substantially equivalent to the predicate device.
Biocompatibility: The proposed enhancement to the Infinity Gateway Suite involves software only. No modifications affecting biocompatibility of the device is being proposed at this time and does not apply.
Sterilization: Sterilization and shelf-life do not apply as the Infinity Gateway Suite is software only.
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Standards/Compliance Testing:
The Infinity Gateway Suite software modifications have been tested and developed in compliance with the following standards:
- ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to ﻬ medical devices
- IEEE Std 11073 -10101-2019 Health informatics Point-of-care medical device ﻬ communication. Part 10101: Nomenclature
- IEEE Std 11073-10201-2018 Health informatics Point-of-care medical device r communication Part 10201: Domain Information Model
- ANSI AAMI IEC 62304:2006/a1:2016 ﮩ
- Medical device software Software life cycle processes [Including Amendment 1 r (2016)]
- ANSI AAMI IEC 62366-1:2015 Medical devices Part 1: Application of usability ﻬ engineering to medical devices
VIII. Conclusion
The Infinity Gateway Suite significant change modifications are substantially equivalent to the predicate device cleared under K043549 on January 21, 2005. The intended use of the Infinity Gateway Suite as described in the product labeling has not changed as a result of the proposed modifications. Verification and Validation results for the proposed modifications support substantial equivalence to the predicate device.