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.

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.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria and study details you requested for the "BetterCare Platform - Advanced Web Client" device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Here's what the document does provide, and why it doesn't fulfill your request:

Intended Use and Indications for Use: These describe what the device is for and how it should be used, but not specific performance metrics.
Comparison to Predicate Devices: It outlines the similarities and differences in features and functionality, which is the basis for the substantial equivalence claim.
Non-Clinical Data Summary: This section mentions design, development, testing, verification, and validation according to documented procedures and FDA guidance documents (ISO 14971, ISO 62304). It states: "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."
Clinical Data Summary: Explicitly states: "No clinical data is submitted to support this premarket notification."

Therefore, I cannot provide the requested information because it is not present in the given text.

To answer your questions, I would need a different type of document, such as a detailed test report, verification and validation plan, or a more comprehensive study summary that includes specific acceptance criteria and the results of performance studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

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);

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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

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Indications for Use

510(k) Number (if known) K171361

Device Name BetterCare Platform - Advanced Web Client

Indications for Use (Describe)

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

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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.

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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Image /page/4/Picture/0 description: The image shows the logo for Bcare BETTER CARE, S.L. The logo features a stylized, curved shape in shades of orange and red on the left side. To the right of this shape is the word "care" in a blue sans-serif font. Below the word "care" is the text "BETTER CARE, S.L." in a smaller, sans-serif font, underlined with a thin gray line.

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 DeviceBetterCare Platform- Advanced WebClient	Primary PredicateK122133Airstrip RPM	Reference PredicateK061994Web viewer, PocketViewer and CellularViewer
Intended use	Display of physiologicdata and other patientinformation to cliniciansin near real-time througha web browser ascaptured by DraegerInfinity Gatewayinterfaced with theBetterCare platform. It isintended to be used byclinicians to:- remotely view patientphysiological informationas captured by DraegerInfinity Gateway- remotely view nearreal-time waveforms ascaptured by DraegerInfinity Gateway- remotely view othernear real-time patientdata as captured byDraegerInfinityGateway.	Display of physiologic and otherpatient information generated byother medical devices and patientinformation system.AirStrip RPM is intended to be usedby clinicians for the followingpurposes:- by using a cellular telephone orother device on which AirStrip RPMis installed, to review physiologicdata of a patient when the clinicianis not at the hospital- to view the near real-timewaveforms remotely- to remotely review other standardor critical near real-time patient datafrom the monitored system- to provide a request for remoteconsultation regarding a patient'swaveform or other data.	Display of Informationreceived from othernetworked devices. It iscomprised of a Mobile CareServer and Web Viewer orPocket Viewer clients
Target population	Clinicians	Clinicians	Clinicians
Communication	Secure Sockets Layer(SSL) via HTTPS	Secure Sockets Layer (SSL) viaHTTPS	Secure Sockets Layer(SSL) via HTTPS
CommunicationMethods	LAN / WLAN Wi-Fi	Cellular Modem, Wi-Fi	Cellular Modem, Wi-Fi
DataSourceLocation	Hospital	Hospital	Hospital
SecurityAdministration	Yes	Yes	Yes
Where used	Within the hospitalwhere the clinician haswired or wireless accessto the hospital local areanetwork.	Anywhere the clinician has remoteinternet access	Anywhere the clinician hasremote internet access.
Client Platforms /Operating systems	Windows 7 and above;iOS 6 and above,Android 4.0 and above	iOS / iPhone	Windows95/98/ME/NT4.0/2000/XPor MacOS X 10.1 ondesktop or portable
Item	New DeviceBetterCare Platform- Advanced WebClient	Primary PredicateK122133Airstrip RPM	Reference PredicateK061994Web viewer, PocketViewer and CellularViewer
			computers,PcoketPC, PDA or cellularphone with WindowsMoobile 2003 / 5.0 / PhoneEdition
Ability to view nearreal-time data	Yes	Yes	Yes
Physiologicdatadisplayed	Waveform Data- ECG Waveform- Arterial PressureWaveform- SpO2 Waveform- CO2 Waveform- Central VenousPressure Waveform- Pulmonary ArterialPressure Waveform- Right AuricularPressure Waveform- Left AuricularPressure Waveform- Resp WaveformNear real-timephysiological data- Heart Rate- Respiratory Rate- Oxygen Saturation- Central VenousPressure- Systolic ArterialPressure Invasive- Mean ArterialPressure Invasive- Diastolic ArterialPressure Invasive- Systolic BloodPressure Noninvasive- Mean BloodPressure Noninvasive	Waveform Data- ECG Waveform- Blood Pressure Waveform- O2 Waveform- CO2 WaveformNear real-time physiological data- Heart Rate- Respiratory Rate- Oxygen Saturation- Intracranial Pressure- Central Venous Pressure- Pulmonary Capillary WedgePressure- Cardiac Index- Cardiac Output- Cerebral Perfusion Pressure- Urine Output- Urine / Stool Mix Output- Systolic Blood PressureInvasive- Mean Arterial PressureInvasive- Diastolic Blood PressureInvasive- Systolic Blood Pressure Cuff- Mean Arterial Pressure Cuff- Diastolic Blood Pressure CuffOther patient informationdisplayed- Vasoactive Infusions- Antiarrythmics- Sedation	Waveform Data- ECG Waveform- Blood Pressure Waveform- O2 Waveform- CO2 WaveformNear real-timephysiological data- Heart rate- Respiratory Rate- Oxygen Saturation- Intracranial Pressure- Central Venous Pressure- PulmonaryCapillary Wedge Pressure- Cardiac Index- Cardiac Output- Cerebral PerfusionPressure- Systolic Blood PressureCuff- Mean Blood Pressure Cuff- Diastolic Blood PressureCuff- Systolic Blood PressureInvasive- Mean BloodPressureInvasive- Diastolic Blood PressureInvasive- Temperature
Item	New DeviceBetterCare Platform- Advanced Web Client	Primary PredicateK122133Airstrip RPM	Reference PredicateK061994Web viewer, PocketViewer and CellularViewer
	- 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 Gaso Chemistryo Hematologyo 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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Image /page/6/Picture/0 description: The image shows the logo for "Bcare BETTER CARE, S.L.". The logo features a stylized, flowing red line that resembles a cursive letter. To the right of this symbol, the word "care" is written in blue, sans-serif font. Below the word "care", the text "BETTER CARE, S.L." is written in a smaller, sans-serif font, underlined by a thin gray line.

K171361 – 510(k) Summary

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Image /page/7/Picture/0 description: The image contains the logo for "Bcare BETTER CARE, S.L.". The logo features a stylized, red, beta symbol on the left. To the right of the symbol is the word "care" in a blue, sans-serif font. Below the word "care" is the text "BETTER CARE, S.L." in a smaller, sans-serif font, underlined by a thin gray line.

K171361 – 510(k) Summary

Table 5.1 Summary comparison of characteristics and features - proposed and predicate devices

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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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Image /page/9/Picture/0 description: The image shows the logo for "Bcare BETTER CARE, S.L.". The logo features a stylized, curved line in shades of red and orange on the left side, resembling a check mark. To the right of this mark is the word "care" in a blue, sans-serif font. Below "care" is the text "BETTER CARE, S.L." in a smaller, sans-serif font, underlined with a thin line.

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.

Regulation Number and Section

§ 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).