AIRSTRIP REMOTE PATIENT MONITORING

K133450 · Airstrip Technologies, LP · MWI · Feb 14, 2014 · Cardiovascular

Device Facts

• Record ID: K133450
• Device Name: AIRSTRIP REMOTE PATIENT MONITORING
• Applicant: Airstrip Technologies, LP
• Product Code: MWI · Cardiovascular
• Decision Date: Feb 14, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by 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 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 - · Paralvtics - · Laboratory Data including - Blood Gas - Chemistry - Hematology - Coagulation - · Allergies - · Medications

Device Story

AirStrip RPM is a software-only remote patient monitoring system. It interfaces with hospital-based patient information systems and medical devices to capture physiologic data (ECG, hemodynamics, lab results, medications). The software transmits this data to mobile devices (e.g., cellular phones) for clinician review. It functions as a remote viewing tool, allowing clinicians to visualize near real-time waveforms and patient data when off-site. It facilitates remote consultation by enabling clinicians to review data and request input from colleagues. The device does not generate physiologic data itself; it acts as a conduit for data visualization. It is intended for use by clinicians as a diagnostic aid to support clinical decision-making by providing access to patient information outside the hospital environment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and verification of software functionality, demonstrating that the device accurately captures and displays data from connected hospital systems.

Technological Characteristics

Software-only device. Operates as a remote data viewing interface. Connects to hospital patient information systems and medical devices to retrieve physiologic data (ECG, hemodynamic, lab, medication). Displays data on mobile/wireless devices. No hardware components. Cybersecurity and data integrity are maintained through the integration with existing hospital infrastructure.

Indications for Use

Indicated for clinicians to remotely view physiologic waveforms, patient data, and laboratory results from hospital-based monitoring systems via mobile devices when not at the hospital. Intended as a diagnostic aid; not a replacement for direct viewing of primary monitoring devices. Contraindicated in areas where wireless devices are prohibited.

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

• Epiphany Adapter (K133450)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 14, 2014

AirStrip Technologies, LP C/O Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K133450

Trade/Device Name: AirStrip RPM Epiphany Adapter Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (No Alarms) Regulatory Class: Class II Product Code: MWI Dated: January 16, 2014 Received: January 22, 2014

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Mark Job

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen=P.Earis -S

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):

Device Name: AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software

Indications for Use:

AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by 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 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
- · Paralvtics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- · Allergies
- · Medications

## Counter-Indications

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.

Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Page 1 of 1 | Digitally signed by Owen P. |
| | Date: 2014.02.14 11:38:12 |