(272 days)
K061994 Web Viewer, Pocket Viewer and Cellular Viewer (General Electric)
No
The summary explicitly states the device "simply reproduces that numeric, waveform and other clinical data provided to it for communications and display" and that the information "must be analyzed and interpreted by an expert clinician only." There is no mention of any analytical or interpretive functions performed by the software itself, which would be indicative of AI/ML.
No
The device is a software application for displaying physiological data and other patient information to clinicians; it does not provide therapy or a therapeutic effect itself.
Yes
The "Intended Use / Indications for Use" section states: "BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid."
Yes
The device is explicitly described as a "software application" and its function is to display data from other medical devices. It does not include any hardware components or perform any physical interaction with the patient or other devices beyond receiving data.
Based on the provided text, the BetterCare Platform - Advanced Web Client is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- BetterCare Platform Function: The BetterCare Platform - Advanced Web Client's intended use and description clearly state that it displays physiological data and waveforms captured directly from patient monitors. It does not analyze biological specimens. It acts as a display and communication tool for data already generated by other medical devices connected to the patient.
- Lack of Specimen Analysis: There is no mention of the device interacting with or analyzing any biological samples.
Therefore, the BetterCare Platform - Advanced Web Client falls outside the scope of an In Vitro Diagnostic device. It is a software application for displaying patient physiological data.
N/A
Intended Use / Indications for Use
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The Better Care Platform is not indicated for use as a real-time monitor.
The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient. The BetterCare Platform - Advanced Web Client simply reproduces that numeric, waveform and other clinical data provided to it for communications and display.
The Better Care Platform - Advanced Web Client is installed on compatible desktop and mobile devices including cellular telephones, and is intended to be used by clinicians to:
- remotely view patient physiological information as captured by Draeger Infinity Gateway
- remotely view waveforms as captured by Draeger Infinity Gateway
- remotely view other patient data as captured by Draeger Infinity Gateway
The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway:
- ECG Waveform
- Arterial Pressure Waveform
- SpO2 Waveform
- CO2 Waveform
- Central Venous Pressure Waveform
- Pulmonary Arterial Pressure Waveform
- Right Auricular Pressure Waveform
- Left Auricualar Pressure Waveform
- Resp Waveform
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Central Venous Pressure
- Systolic Arterial Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Arterial Pressure Invasive
- Systolic Blood Pressure Non invasive
- Mean Bloood Pressure Non invasive
- Diastolic Blood Pressure Non invasive
- Systolic Pulmonary Arterial Pressure
- Mean Pulmonary Arterial Pressure
- Diastolic Pulmonary Arterial Pressure
- Right Auricular Pressure
- Left Auricular Pressure
BetterCare Platform Advanced Web Client is intended to be installed on wired and wireless devices. including cellular telephones, and is not intended to be used where such devices are prohibited.
BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured by Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only.
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
The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient.
Intended User / Care Setting
trained clinicians in hospital environments
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
Testing included verification of all available listed waveform and near real-time data points. Known data sets were gathered using Draeger Infinity Gateway interfaced with BetterCare Platform and displayed on Advanced Web Client. All waveforms and near-real time physiological information points were verified and in all cases, Advanced Web Client displayed data points accurately.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical data is submitted to support this premarket notification.
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.
K100133 Airstrip RPM (Airstrip Technologies)
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.
K061994 Web Viewer, Pocket Viewer and Cellular Viewer (General Electric)
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
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February 5, 2018
Bettercare S.L. Bernat Sales Chief Executive Officer Xaloc 6 Sabadell, 08203 ES
Re: K171361
Trade/Device Name: BetterCare Platform - Advanced Web Client Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: December 18, 2017 Received: December 21, 2017
Dear Bernat Sales:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M& Millelreme
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171361
Device Name BetterCare Platform - Advanced Web Client
Indications for Use (Describe)
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured from patient monitors by the Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The Better Care Platform is not indicated for use as a real-time monitor.
The BetterCare Platform - Advanced Web Client is intended to display data and waveforms from attached medical devices in a pass-though fashion, the BetterCare Platform - Advanced Web Client is agnostic to the age or condition of patients attached to the medical devices from which data is received. For example, the special requirements for neonatal, pediatric or adult patients are all provided by the medical devices directly attached to the patient. The BetterCare Platform - Advanced Web Client simply reproduces that numeric, waveform and other clinical data provided to it for communications and display.
The Better Care Platform - Advanced Web Client is installed on compatible desktop and mobile devices including cellular telephones, and is intended to be used by clinicians to:
- remotely view patient physiological information as captured by Draeger Infinity Gateway
- remotely view waveforms as captured by Draeger Infinity Gateway
- remotely view other patient data as captured by Draeger Infinity Gateway
The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway:
- ECG Waveform
- Arterial Pressure Waveform
- SpO2 Waveform
- CO2 Waveform
- Central Venous Pressure Waveform
- Pulmonary Arterial Pressure Waveform
- Right Auricular Pressure Waveform
- Left Auricualar Pressure Waveform
- Resp Waveform
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Central Venous Pressure
- Systolic Arterial Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Arterial Pressure Invasive
- Systolic Blood Pressure Non invasive
- Mean Bloood Pressure Non invasive
- Diastolic Blood Pressure Non invasive
- Systolic Pulmonary Arterial Pressure
- Mean Pulmonary Arterial Pressure
- Diastolic Pulmonary Arterial Pressure
3
-
Right Auricular Pressure
-
Left Auricular Pressure
BetterCare Platform Advanced Web Client is intended to be installed on wired and wireless devices. including cellular telephones, and is not intended to be used where such devices are prohibited.
BetterCare Platform Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.
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)
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K171361 - 510(k) Summary
DATE OF SUBMISSION: SUBMITTER NAME: SUBMITTER ADDRESS:
CONTACT: TELEPHONE: e-mail:
COMMON NAME:
PRODUCT CODE:
2016-02-26 BETTERCARE S.L. Xaloc, 6 08203 - BARCELONA SPAIN Bernat Sales +34 65 693964 8 fda-submission@bettercare.es
DEVICE TRADE NAME: BetterCare Platform - Advanced Web Client System, Network And Communication, Physiological Monitors, Web Client, Web Viewer, MView CLASSIFICATION NAME: Cardiac monitor (870.2300) MSX REGULATION DESCRIPTION: Cardiac monitor (including cardiotachometer and rate alarm)
PREDICATE DEVICE(S):
-
K100133 Airstrip RPM (Airstrip Technologies) - Primary Predicate
-
K061994 Web Viewer, Pocket Viewer and Cellular Viewer (General Electric) Reference Predicate
DEVICE DESCRIPTION:
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured by Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wireless devices running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
BetterCare Platform - Advanced Web Client is compared with the following previously cleared devices:
Airstrip RPM (K122133) - Primary Predicate Web Viewer, Pocket Viewer and Cellular Viewer (K061994) - Reference Predicate
Comparison of the proposed devices with the predicate device is summarized in the following table:
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Image /page/5/Picture/0 description: The image shows the logo for Bcare, which is a company that provides better care. The logo features a stylized letter B in a gradient of red and orange, followed by the word "care" in blue. Below the word "care" is the text "BETTER CARE, S.L." in a smaller font.
K171361
| Item | New Device
BetterCare Platform
- Advanced Web
Client | Primary Predicate
K122133
Airstrip RPM | Reference Predicate
K061994
Web viewer, Pocket
Viewer and Cellular
Viewer |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Display of physiologic
data and other patient
information to clinicians
in near real-time through
a web browser as
captured by Draeger
Infinity Gateway
interfaced with the
BetterCare platform. It is
intended to be used by
clinicians to: - remotely view patient
physiological information
as captured by Draeger
Infinity Gateway - remotely view near
real-time waveforms as
captured by Draeger
Infinity Gateway - remotely view other
near real-time patient
data as captured by
Draeger
Infinity
Gateway. | Display of physiologic and other
patient information generated by
other medical devices and patient
information system.
AirStrip RPM is intended to be used
by clinicians for the following
purposes:
- by using a cellular telephone or
other device on which AirStrip RPM
is installed, to review physiologic
data of a patient when the clinician
is not at the hospital - to view the near real-time
waveforms remotely - to remotely review other standard
or critical near real-time patient data
from the monitored system - to provide a request for remote
consultation regarding a patient's
waveform or other data. | Display of Information
received from other
networked devices. It is
comprised of a Mobile Care
Server and Web Viewer or
Pocket Viewer clients |
| Target population | Clinicians | Clinicians | Clinicians |
| Communication | Secure Sockets Layer
(SSL) via HTTPS | Secure Sockets Layer (SSL) via
HTTPS | Secure Sockets Layer
(SSL) via HTTPS |
| Communication
Methods | LAN / WLAN Wi-Fi | Cellular Modem, Wi-Fi | Cellular Modem, Wi-Fi |
| Data
Source
Location | Hospital | Hospital | Hospital |
| Security
Administration | Yes | Yes | Yes |
| Where used | Within the hospital
where the clinician has
wired or wireless access
to the hospital local area
network. | Anywhere the clinician has remote
internet access | Anywhere the clinician has
remote internet access. |
| Client Platforms /
Operating systems | Windows 7 and above;
iOS 6 and above,
Android 4.0 and above | iOS / iPhone | Windows
95/98/ME/NT4.0/2000/XP
or MacOS X 10.1 on
desktop or portable |
| Item | New Device
BetterCare Platform - Advanced Web
Client | Primary Predicate
K122133
Airstrip RPM | Reference Predicate
K061994
Web viewer, Pocket
Viewer and Cellular
Viewer |
| | | | computers,
PcoketPC, PDA or cellular
phone with Windows
Moobile 2003 / 5.0 / Phone
Edition |
| Ability to view near
real-time data | Yes | Yes | Yes |
| Physiologic
data
displayed | Waveform Data - ECG Waveform
- Arterial Pressure
Waveform - SpO2 Waveform
- CO2 Waveform
- Central Venous
Pressure Waveform - Pulmonary Arterial
Pressure Waveform - Right Auricular
Pressure Waveform - Left Auricular
Pressure Waveform - Resp Waveform
Near real-time
physiological data
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Central Venous
Pressure - Systolic Arterial
Pressure Invasive - Mean Arterial
Pressure Invasive - Diastolic Arterial
Pressure Invasive - Systolic Blood
Pressure Non
invasive - Mean Blood
Pressure Non
invasive | Waveform Data - ECG Waveform
- Blood Pressure Waveform
- O2 Waveform
- CO2 Waveform
Near real-time physiological data
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary Capillary Wedge
Pressure - Cardiac Index
- Cardiac Output
- Cerebral Perfusion Pressure
- Urine Output
- Urine / Stool Mix Output
- Systolic Blood Pressure
Invasive - Mean Arterial Pressure
Invasive - Diastolic Blood Pressure
Invasive - Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
Other patient information
displayed
- Vasoactive Infusions
- Antiarrythmics
- Sedation | Waveform Data
- ECG Waveform
- Blood Pressure Waveform
- O2 Waveform
- CO2 Waveform
Near real-time
physiological data
- Heart rate
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary
Capillary Wedge Pressure - Cardiac Index
- Cardiac Output
- Cerebral Perfusion
Pressure - Systolic Blood Pressure
Cuff - Mean Blood Pressure Cuff
- Diastolic Blood Pressure
Cuff - Systolic Blood Pressure
Invasive - Mean Blood
Pressure
Invasive - Diastolic Blood Pressure
Invasive - Temperature |
| Item | New Device
BetterCare Platform - Advanced Web Client | Primary Predicate
K122133
Airstrip RPM | Reference Predicate
K061994
Web viewer, Pocket
Viewer and Cellular
Viewer |
| | - Diastolic Blood Pressure Non invasive - Systolic Pulmonary Arterial Pressure
- Mean Pulmonary Arterial Pressure
- Diastolic Pulmonary Arterial Pressure
- Right Auricular Pressure
- Left Auricular Pressure | Laboratory Data including:
o Blood Gas
o Chemistry
o Hematology
o Coagulation - Allergies
- Medication | |
| Contraindications | BetterCare Platform - Advanced Web Client is intended to be installed on wired and wireless devices, including cellular telephones, and is not intended to be used where such devices are prohibited. | AirStrip RPM software is intended for installation on cellular telephones and other wireless devices and is not intended for use anywhere cellular telephones or wireless devices are prohibited. | N/A |
| Principal operation | BetterCare Platform - Advanced Web Client works by retrieving patient data from the hospital monitoring system and providing that data to the user's computer or device over the hospital local area network. | AirStrip RPM works by retrieving patient data from the hospital monitoring system and providing that data to the end user's device via WiFi or cellular modem over the Internet. | Pocket Viewer / Web Viewer works by retrieving data from the hospital monitoring system and providing that data to the end user's device via WiFi or cellular modem over the Internet. |
| Client devices | Desktop or portable computers or mobile hand-held wireless devices running a web browser | iPhone | Desktop or portable computers or Windows mobile hand held PDA |
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K171361 – 510(k) Summary
7
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K171361 – 510(k) Summary
Table 5.1 Summary comparison of characteristics and features - proposed and predicate devices
8
K171361 – 510(k) Summary
INTENDED USE / INDICATIONS FOR USE:
The BetterCare Platform - Advanced Web Client is a software application capable of displaying physiological data and other patient information to clinicians in near real-time through a web browser. The information is captured by Draeger Infinity Gateway interfaced with the BetterCare Platform and sent through the hospital local area network to wired or wireless running the Advanced Web Client application. The information must be analyzed and interpreted by an expert clinician only. The BetterCare Platform is not indicated for use as a real-time monitor.
The BetterCare Platform - Advanced Web Client is installed in compatible desktop and mobile devices, including cellular telephones, and is intended to be used by clinicians to:
- remotely view patient physiological information as captured by Draeger Infinity Gateway
- remotely view waveforms as captured by Draeger Infinity Gateway
- remotely review other patient data as captured by Draeger Infinity Gateway
The BetterCare Platform - Advanced Web Client is not patient connected and is not a primary alarm source. It can display the following physiological data captured by Draeger Infinity Gateway:
- ECG Waveform
- Arterial Pressure Waveform
- SpO2 Waveform
- CO2 Waveform
- Central Venous Pressure Waveform
- Pulmonary Arterial Pressure Waveform
- Right Auricular Pressure Waveform
- Left Auricular Pressure Waveform
- Resp Waveform
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Central Venous Pressure
- Systolic Arterial Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Arterial Pressure Invasive
- Systolic Blood Pressure Non invasive
- Mean Blood Pressure Non invasive
- Diastolic Blood Pressure Non invasive
- Systolic Pulmonary Arterial Pressure
- Mean Pulmonary Arterial Pressure
- Diastolic Pulmonary Arterial Pressure
- Right Auricular Pressure
- Left AuricularPressure
BetterCare Platform - Advanced Web Client is intended to be installed on wired and wireless devices,
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510(k) Premarket Notification BetterCare Platform - Advanced Web Client
K171361 – 510(k) Summary
including cellular telephones, and is not intended to be used where such devices are prohibited.
BetterCare Platform - Advanced Web Client is intended for use by trained clinicians in hospital environments as a diagnostic aid and not as a replacement for direct viewing of any of the monitoring devices interfaced.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA quidance documents:
-
FDA Guidance on the Content of Premarket Submissions for Software Contained in Medical Devices
-
FDA Guidance on the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
-
FDA Guidance Cybersecurity for Networked Medical Devices Containing Off-the-shelf (OTS) Software
-
FDA Guidance General Principles of Software Validation
-
FDA Guidance Off-the-sheld Software Use in Medical Devices
Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971. Development, integration, verification testing have been successfully completed following standard ISO 62304.
Testing included verification of all available listed waveform and near real-time data points. Known data sets were gathered using Draeger Infinity Gateway interfaced with BetterCare Platform and displayed on Advanced Web Client. All waveforms and near-real time physiological information points were verified and in all cases, Advanced Web Client displayed data points accurately.
SUMMARY DISCUSSION OF CLINICAL DATA:
No clinical data is submitted to support this premarket notification.
CONCLUSIONS:
We believe the intended use, the indications for use and performance of the BetterCare Platform -Advanced Web Client is substantially equivalent to the intended use, indications for use and performance of the primary predicate device. We also believe that the BetterCare Platform - Advanced Web Client does not suppose any new or increased risk compared with the primary predicate device. Based on the information included in this submission, we conclude that BetterCare Platform -Advanced Web Client is substantially equivalent to the stated primary predicate device.