AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
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

The AirStrip RPM software can display the following the physiologic data captured by other medical devices:

• ECG Waveform
• Heart Rate Monitored
• 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
• Vasoactive Infusions
• Antiarrhythmics
• Sedation
• Paralytics
• Laboratory Data including

Blood Gas
Chemistry
Hematology
Coagulation
• Allergies
• Medications

Contraindications
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. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.

Device Description

The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System in hospitals to allow health care professionals the ability to view near real-time patient data remotely. AirStrip RPM works by retrieving patient data from the InvisionECG System monitoring system and providing that data to the end user's device via Wi-Fi or cellular modem over the Internet.

AI/ML Overview

The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System to display near real-time patient data remotely to healthcare professionals.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Specification	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Purpose	Provides ability to view patient physiological waveforms and other data remotely through interface with InvisionECG.	"Provides ability to view patient physiological waveforms and other data remotely through interface with InvisionECG." (Directly stated as matching the predicate device's purpose).
Function – Indications for Use	Smart Client application that allows users at remote locations (anywhere there is internet access) to view patient information in near real time including physiological data, waveforms and other EMR related data.	"Smart Client application that allows users at remote locations (anywhere there is internet access) to view patient information in near real time including physiological data, waveforms and other EMR related data." (Directly stated as matching the predicate device's function and indications for use).
Target Population	Clinicians (users); Clinical patients using a monitoring device for cardio. The device should not differentiate between patient groups (e.g., elderly, pediatric).	"Clinicians (users) Target population (clinical patients) are anyone using a monitoring device for cardio... The Electrocardiogram cannot and does not differentiate between patient groups, therefore, the monitoring of any patient... is within the scope of this device. Therefore Airstrip... cannot differentiate between patient populations." (Claimed to match the predicate device which does not differentiate patient groups).
Materials	Software application and configured PDA/wireless device.	"Software application and configured PDA" (Directly stated as matching the predicate device).
Internet Communication	Secure Sockets Layer (SSL) via HTTPS.	"Secure Sockets Layer (SSL) via HTTPS" (Directly stated as matching the predicate device).
Communication Methods	Cellular Modem, Wi-Fi.	"Cellular Modem, Wi-Fi" (Directly stated as matching the predicate device).
Data Source Location	Hospital.	"Hospital" (Directly stated as matching the predicate device).
System Technology	File Based Service (and the capability to parse and transmit the information).	"File Based Service... mechanism for capturing the snapshot to be used by AirStrip RPM. Once captured by AirStrip RPM, the information is treated the same and the data in the file is parsed for the information required. There is no dependency on the method of capture for how the data is parsed." (Stated to effectively operate like the predicate device's file-based and web-based services).
Security Administration	Yes.	"Yes" (Directly stated as matching the predicate device).
Operating Environment	Anywhere the clinician has remote Internet access for iOS or Android device and use is not prohibited; Hospital data center for server.	"Anywhere the clinician has remote Internet access for iOS or Android device and use is not prohibited; Hospital data center for server" (Directly stated as matching the predicate device).
Programming Languages	Apple Objective C and Swift on client, Android Java and Kotlin, Microsoft Windows .NET on server.	"Apple Objective C and Swift on client, Android Java and Kotlin, Microsoft Windows .NET on server" (Matches/updates the predicate device's languages, implying compatibility).
Operating Systems	Apple iPhone OS on client, Android OS on client, Microsoft Windows Server on servers.	"Apple iPhone OS on client, Android OS on client, Microsoft Windows Server on servers" (Directly stated as matching the predicate device).
Database System	Microsoft SQL Server.	"Microsoft SQL Server" (Directly stated as matching the predicate device).
Hardware Platform	Apple iPhone OS devices for client, Android OS devices for client, Microsoft Windows Server compatible server computers.	"Apple iPhone OS devices for client, Android OS devices for client, Microsoft Windows Server compatible server computers" (Directly stated as matching the predicate device).
Presentation of Data	Smart Client.	"Smart Client" (Directly stated as matching the predicate device).
Ability to view near Real-time Data	Yes.	"Yes" (Directly stated as matching the predicate device).
DICOM Compliance	Compliance with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage.	"The InvisionHeart Adapter accepts and transmits as a viewer the DICOM file information compliant with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage." (Explicitly stated).
Risk Management	Adherence to ISO 14971:2007.	"ISO 14971:2007 Medical devices – Applications of risk management to medical devices" (Stated as followed).
Software Validation/V&V	Designed and developed adhering to in-house processes; underwent verification and validation testing, integration/system testing, and regression testing. Compliance with FDA guidance documents.	"The software was designed and developed adhering to in-house design and development process. The software underwent verification and validation testing and was in the form of combined integration and system testing as well as final regression testing." "Test results indicate that the InvisionHeart Adapter Software complies with its predetermined specifications and the applicable guidance documents."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for a test set in terms of patient data or clinical cases. The performance evaluation primarily focuses on demonstrating substantial equivalence through non-clinical testing of the software's functionality, interoperability, and adherence to standards.

The data provenance for any internal testing is not explicitly mentioned, but the system is designed to interface with the InvisionECG System, which handles patient data. The context implies that the testing involves how the adapter processes and displays data originating from the InvisionECG System, which in turn acquires data from actual patients in a hospital setting. The study is retrospective in the sense that it evaluates the software's ability to display data that has already been generated by other medical devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. Given that no formal clinical study with human interpretation of results is detailed, there's no mention of experts establishing ground truth for a test set. The evaluation is focused on the technical performance of the software in accurately displaying information from the source system.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-centric test set requiring adjudication. The evaluation centers on software verification and validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission explicitly. The device's purpose is to display data to clinicians, not to perform interpretations or make diagnoses itself. Therefore, a study to measure human reader improvement with AI assistance (as the device is a medical device data system, not an AI diagnostic tool) is not relevant to its stated function or the type of evaluation presented.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The evaluation conducted is essentially a standalone (algorithm only) performance assessment, though not in the typical sense of a diagnostic algorithm. The device itself is software that transmits and displays data. The "performance" tested is its adherence to technical specifications, cybersecurity, risk management, and the accurate rendering of data (ECG waveforms, other physiological parameters) from a source system. The "algorithm" here refers to the software's logic for data capture, processing, and presentation, rather than a diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be the predetermined specifications of the software and the expected output or behavior when interfacing with the InvisionECG System, as well as adherence to relevant standards (e.g., DICOM, ISO 14971). For example, the ground truth for DICOM compliance is the DICOM standard itself. For accurate waveform display, the ground truth would be the waveform as generated by the InvisionECG System.

8. The Sample Size for the Training Set

The document does not mention a training set as this device is a data display and communication system, not a machine learning or AI model that typically requires training data. Its functionality is based on established software engineering principles and interoperability standards.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for this type of medical device data system, this point is not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2018

AirStrip Technologies, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K182226

Trade/Device Name: AirStrip RPM InvisionHeart Adapter Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: August 14, 2018 Received: August 16, 2018

Dear Mark Job:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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.

Stephen C. Browning -S5

for Bram D. Zuckerman, M.D. 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) K182226

Device Name AirStrip RPM InvisionHeart Adapter

Indications for Use (Describe)

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 waveform 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.

The AirStrip RPM software can display the following physiologic data captured by other medical devices:

·ECG Waveform
· Heart Rate Monitored
·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
· Vasoactive Infusions
· Antiarrhythmics
·Sedation
·Paralytics
· Laboratory Data including
- -Blood Gas
- -Chemistry
- -Hematology
- -Coagulation
· Allergies
●Medications

Contraindications

{3}------------------------------------------------

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. AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

AirStrip RPM InvisionHeart Adapter 510(k) Summary

Submitter Information [21 CFR 807.929(a)(1)]
Name	AirStrip Technologies
Address	335 E. Sonterra Blvd., Suite 200San Antonio, TX 78258
Phone number	+1 210 805 0444
Fax number	+1 210 805 0446
Establishment Registration Number	Establishment Registration Number: 3006104191
Name of contact person	Kirk Johnson
Date prepared	September 4, 2018
Name of the device [21 CFR 807.92(a)(2)]
Trade or proprietary name	AirStrip RPM InvisionHeart Adapter
Common or usual name	Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)
Classification name	Remote Patient Monitoring has been classified as Class II, 870.2300,MWI. The classification panel 870: Cardiovascular.
Classification panel	Cardiovascular
Regulation	870.2300
Product Code(s)	MWI
Legally marketed device(s) to whichequivalence is claimed[21 CFR 807.92(a)(3)]	The predicate device is the AirStrip RPM Epiphany Adapter, K133450,cleared February 14, 2014.
Device description[21 CFR 807.92(a)(4)]	AirStrip RPM InvisionHeart AdapterThe AirStrip RPM InvisionHeart Adapter is a software application thatinterfaces with the InvisionECG System in hospitals to allow health careprofessionals the ability to view near real-time patient data remotely. AirStripRPM works by retrieving patient data from the InvisionECG System monitoringsystem and providing that data to the end user's device via Wi-Fi or cellularmodem over the Internet.InvisionECG SystemThe InvisionECG System (cleared under K143436; InvisionHeart Inc.) is amobile solution for capturing and managing 12-lead ECGs, including theability to read and visually compare, confirm, report and store diagnosticquality electrocardiograms. This is all done on a browser-based, secure,healthcare IT platform which provides access to ECGs anywhere andanytime an authorized healthcare professional has web access via anappropriate browser.The cleared Indications For Use states "The InvisionECG System is
intended to acquire, display and record electrocardiographic informationfrom adult and pediatric patients. The InvisionECG System is intendedto be used in a clinical or home environment by trained healthcareprofessionals."
Additional information may be obtained at www.invisionheart.com.AirStrip RPM is software capable of displaying physiologic and other patientinformation. This information is generated by other medical devices andpatient information system, and not by AirStrip RPM. AirStrip RPM capturesthis information from these other systems and displays it for clinicians.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 isinstalled, to review physiologic data of a patient when the clinician is not at thehospital• To view the near real-time waveforms remotely• To remotely review other standard or critical near real-time patient data fromthe monitored system• To provide a request for remote consultation regarding a patient's waveformor other data
The AirStrip RPM software can display the following the physiologic datacaptured by other medical devices:
• ECG Waveform• Heart Rate Monitored• 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 Pressure Invasive• Mean Arterial Pressure Invasive	• Diastolic Blood Pressure Invasive• Systolic Blood Pressure Cuff• Mean Arterial Pressure Cuff• Diastolic Blood Pressure Cuff• Vasoactive Infusions• Antiarrhythmics• Sedation• Paralytics• Laboratory Data including- Blood Gas- Chemistry- Hematology- Coagulation• Allergies• Medications
ContraindicationsAirStrip RPM software is intended for installation on cellular telephones andother wireless devices, and is not intended for use anywhere cellulartelephones or wireless devices are prohibited. AirStrip RPM is intended for useby clinicians when they cannot be at the hospital. AirStrip RPM is intended foruse by clinicians as a diagnostic aid, and not as a replacement for directviewing of any of the monitoring devices from which it obtains its data.
Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
FunctionSpecification	AirStrip RPM InvisionHeartAdapter (Proposed)	AirStrip RPM Epiphany Adapter510(k) #K133450
Purpose	Provides ability to view patientphysiological waveforms and other	Provides ability to view physiologicalwaveforms and other data remotely
	data remotely through interface withInvisionECG.	through interface with EpiphanyCardiology.
Function –Indications for Use	Smart Client application that allowsusers at remote locations (anywherethere is internet access) to viewpatient information in near real timeincluding physiological data,waveforms and other EMR relateddata.	Smart Client application that allowsusers at remote locations (anywherethere is internet access) to view patientinformation in near real time includingphysiological data, waveforms andother EMR related data.
Target Population	Clinicians (users) Target population(clinical patients) are anyone using amonitoring device for cardio. The useof this device is not controlled bypatient group. Instead it is controlledby diagnosis and the use of a specificcardio monitoring device. Thesoftware and the portal can onlydifferentiate between "source" of thewaveform information (“adapters") asthe software only reads and repeatsthe information for display remotely.Invision Heart device is the source ofdata. The Electrocardiogram cannotand does not differentiate betweenpatient groups, therefore, themonitoring of any patient using theEpiphany Adapter (elderly orpediatric) is within the scope of thisdevice. Therefore Airstrip which isonly reproducing the information fromInvisionHeart also cannot differentiatebetween patient populations using theelectrocardiogram.	Clinicians (users) Target population(clinical patients) are anyone using amonitoring device for cardio. The useof this device is not controlled bypatient group. Instead it is controlledby diagnosis and the use of a specificcardio monitoring device. The softwareand the portal can only differentiatebetween "source" of the waveforminformation ("adapters") as thesoftware only reads and repeats theinformation for display remotely.Invision Heart device is the source ofdata. The Electrocardiogram cannotand does not differentiate betweenpatient groups, therefore, themonitoring of any patient using theEpiphany Adapter (elderly or pediatric)is within the scope of this device.Therefore Airstrip which is onlyreproducing the information fromEpiphany Adapter also cannotdifferentiate between patientpopulations using theelectrocardiogram.
Materials	Software application and configuredPDA	Software application and configuredPDA
InternetCommunication	Secure Sockets Layer (SSL) via HTTPS	Secure Sockets Layer (SSL) via HTTPS
CommunicationMethods	Cellular Modem, Wi-Fi	Cellular Modem, Wi-Fi
Data Source Location	Hospital	Hospital
System Technology	File Based Service	File Based Service
	Web based service and file basedservice are two methods of picking upa snapshot of ECG data from thecollecting medical device (in thisapplication Invisionheart) for viewingthrough the AirStrip software onmobile devices. Whether gatheringthe data from a web service call (e.g.K100133) or a file based system (e.g.K110503, K133450/Epiphany Adapteror the proposed K182226/InvisionHeart Adapter) each is amechanism for capturing the snapshotto be used by AirStrip RPM. Oncecaptured by AirStrip RPM, theinformation is treated the same andthe data in the file is parsed for theinformation required. There is nodependency on the method of capturefor how the data is parsed. For theweb based approach, a query is madeand data is gathered from that query,as compared to the file based methodwhere AirStrip is pointed to aparticular directory where the fileresides and AirStrip picks it up. Oncein Airstrip RPM, both methods areprocessed the same way inside ofAirStrip and then transmitted tomobile users. There is no dependencyon the original system file so once thefile is successfully parsed, the systemfile is then removed from the specifieddirectory by AirStrip to preventrepetitive processing.	Web based service and file basedservice are two methods of picking up asnapshot of ECG data from thecollecting medical device (in thisapplication Invisionheart) for viewingthrough the AirStrip software onmobile devices. Whether gathering thedata from a web service call (e.g.K100133) or a file based system (e.g.K110503, K133450/Epiphany Adapter)each is a mechanism for capturing thesnapshot to be used by AirStrip RPM.Once captured by AirStrip RPM, theinformation is treated the same andthe data in the file is parsed for theinformation required. There is nodependency on the method of capturefor how the data is parsed. For the webbased approach, a query is made anddata is gathered from that query, ascompared to the file based methodwhere AirStrip is pointed to a particulardirectory where the file resides andAirStrip picks it up. Once in AirstripRPM, both methods are processed thesame way inside of AirStrip and thentransmitted to mobile users. There isno dependency on the original systemfile so once the file is successfullyparsed, the system file is then removedfrom the specified directory by AirStripto prevent repetitive processing.
SecurityAdministration	Yes	Yes
OperatingEnvironment	Anywhere the clinician has remoteInternet access for iOS or Androiddevice and use is not prohibited	Anywhere the clinician has remoteInternet access for iOS or Androiddevice and use is not prohibited
	Hospital data center for server	Hospital data center for server
ProgrammingLanguages	Apple Objective C and Swift on client	Apple Objective C on client
	Android Java and Kotlin	Android
	Microsoft Windows .NET on server	Microsoft Windows .NET on server
Operating Systems	Apple iPhone OS on clientAndroid OS on clientMicrosoft Windows Server on servers	Apple iPhone OS on clientAndroid OS on clientMicrosoft Windows Server on servers
Database System	Microsoft SQL Server	Microsoft SQL Server
Hardware Platform	Apple iPhone OS devices for clientAndroid OS devices for clientMicrosoft Windows Server compatibleserver computers	Apple iPhone OS devices for clientAndroid OS devices for clientMicrosoft Windows Server compatibleserver computers
Presentation of Data	Smart Client	Smart Client
Ability to view nearReal-time Data	Yes	Yes

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Performance Data [21 CFR 807.92(b)]

Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]

The InvisionHeart Adapter Software is a moderate level of concern. The software was designed and developed adhering to in-house design and development process. The software underwent verification and validation testing and was in the form of combined integration and system testing as well as final regression testing.

The software testing and documentation is in accordance with internal requirements and the following FDA Guidance documents:

· General principles of software validation, Final Guidance for Industry and FDA Staff; January 11, 2002

· Off -The-Shelf Software Use In Medical Devices; September 09, 1999

· Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: October 02, 2014

The adapter is in accordance with the following standards:

The InvisionHeart Adapter accepts and transmits as a viewer the DICOM file information compliant with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage. See

https://www.dicomlibrary.com/dicom/sop/

ISO 14971:2007 Medical devices – Applications of risk management to medical devices

Test results indicate that the InvisionHeart Adapter Software complies with its predetermined specifications and the applicable guidance documents.

Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]

This section is not applicable to this submission. Clinical Data are not included.

InvisionHeart ECG System (by Nuline/InvisionHeart) Standard Compliance

The InvisionHeart ECG System is compliant to 60601-2-25:2011 (Medical electrical equipment-Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs). For

{9}------------------------------------------------

additional information refer to link https://www.accessdata.fda.gov/cdrh_docs/pdf14/[K143436](https://510k.innolitics.com/search/K143436).pdf.

Conclusions drawn [21 CFR 807.92(b)(3)]

Based on the results of testing, the AirStrip RPM InvisionHeart Adapter is substantially equivalent to the AirStrip RPM Epiphany 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).