AirStrip RPM InvisionHeart Adapter

K182226 · Airstrip Technologies, Inc. · MWI · Sep 11, 2018 · Cardiovascular

Device Facts

• Record ID: K182226
• Device Name: AirStrip RPM InvisionHeart Adapter
• Applicant: Airstrip Technologies, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric, 3rd-Party Reviewed

Intended Use

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 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

Device Story

Software application; interfaces with InvisionECG System; retrieves patient data (ECG, vitals, lab results, medications) via Wi-Fi or cellular modem; displays near real-time waveforms and data on mobile devices (iOS/Android) for remote clinician review. Used by clinicians outside hospital setting; provides diagnostic aid; facilitates remote consultation. Does not generate data; acts as viewer/repeater. Benefits include remote access to critical patient information, enabling timely clinical decision-making.

Clinical Evidence

No clinical data included. Bench testing only; software verification and validation performed via integration, system, and regression testing.

Technological Characteristics

Software-only device; operates on mobile (iOS/Android) and server (Windows) platforms. Connectivity via Wi-Fi/cellular; data transmission via HTTPS/SSL. Parses DICOM 12-lead ECG waveforms. Risk management per ISO 14971:2007. Software level of concern: moderate.

Indications for Use

Indicated for clinicians to remotely review physiologic data, waveforms, and patient information from monitored systems when not at the hospital. Applicable to adult and pediatric patients monitored by compatible cardiac devices. Contraindicated for use where cellular or wireless devices are prohibited; not a replacement for direct viewing of primary monitoring devices.

Regulatory Classification

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.

Predicate Devices

• AirStrip RPM Epiphany Adapter (K133450)

Reference Devices

• InvisionECG System (K143436)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## Indications for Use

510(k) Number (if known) K182226

#### Device Name AirStrip RPM InvisionHeart Adapter

#### Indications for Use (Describe)

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 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

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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)

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# AirStrip RPM InvisionHeart Adapter 510(k) Summary

| Submitter Information [21 CFR 807.929(a)(1)] | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | AirStrip Technologies | |
| Address | 335 E. Sonterra Blvd., Suite 200<br>San Antonio, TX 78258 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| 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,<br>MWI. The classification panel 870: Cardiovascular. | |
| Classification panel | Cardiovascular | |
| Regulation | 870.2300 | |
| Product Code(s) | MWI | |
| Legally marketed device(s) to which<br>equivalence is claimed<br>[21 CFR 807.92(a)(3)] | The predicate device is the AirStrip RPM Epiphany Adapter, K133450,<br>cleared February 14, 2014. | |
| Device description<br>[21 CFR 807.92(a)(4)] | AirStrip RPM InvisionHeart Adapter<br><br>The AirStrip RPM InvisionHeart Adapter is a software application that<br>interfaces with the InvisionECG System in hospitals to allow health care<br>professionals the ability to view near real-time patient data remotely. AirStrip<br>RPM works by retrieving patient data from the InvisionECG System monitoring<br>system and providing that data to the end user's device via Wi-Fi or cellular<br>modem over the Internet.<br><br>InvisionECG System<br><br>The InvisionECG System (cleared under K143436; InvisionHeart Inc.) is a<br>mobile solution for capturing and managing 12-lead ECGs, including the<br>ability to read and visually compare, confirm, report and store diagnostic<br>quality electrocardiograms. This is all done on a browser-based, secure,<br>healthcare IT platform which provides access to ECGs anywhere and<br>anytime an authorized healthcare professional has web access via an<br>appropriate browser.<br>The cleared Indications For Use states "The InvisionECG System is | |
| intended to acquire, display and record electrocardiographic information<br>from adult and pediatric patients. The InvisionECG System is intended<br>to be used in a clinical or home environment by trained healthcare<br>professionals." | | |
| Additional information may be obtained at www.invisionheart.com.<br>AirStrip RPM is software capable of displaying physiologic and other patient<br>information. This information is generated by other medical devices and<br>patient information system, and not by AirStrip RPM. AirStrip RPM captures<br>this information from these other systems and displays it for clinicians.<br>AirStrip RPM is intended to be used by clinicians for the following purposes:<br>• By using a cellular telephone or other device on which AirStrip RPM is<br>installed, to review physiologic data of a patient when the clinician is not at the<br>hospital<br>• To view the near real-time waveforms remotely<br>• To remotely review other standard or critical near real-time patient data from<br>the monitored system<br>• To provide a request for remote consultation regarding a patient's waveform<br>or other data | | |
| The AirStrip RPM software can display the following the physiologic data<br>captured by other medical devices: |…