AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING

K122133 · Airstrip Technologies, LP · MWI · Oct 2, 2012 · Cardiovascular

Device Facts

• Record ID: K122133
• Device Name: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
• Applicant: Airstrip Technologies, LP
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 2, 2012
• 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. 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 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/Stoo! 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 - Coaqulation - Allergies - Medications

Device Story

AirStrip RPM is a software-only remote data viewing system; it does not generate physiologic data itself. It captures near real-time waveforms, vital signs (ECG, BP, SpO2, etc.), and laboratory/medication data from existing hospital medical devices and information systems. The software transmits this data to a clinician's mobile device (e.g., cellular telephone). Clinicians use the mobile interface to review patient status remotely, facilitate consultations, and support clinical decision-making. The device is intended for use by clinicians when they are away from the hospital setting. It serves as a diagnostic aid to supplement, not replace, direct monitoring at the bedside.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only device; operates on mobile platforms (cellular telephones/mobile devices). Functions as a remote display interface for data aggregated from hospital-based physiologic monitors and information systems. Connectivity via wireless/cellular networks. No hardware components or physical sensors.

Indications for Use

Indicated for clinicians to remotely review physiologic data, waveforms, and patient information from monitored systems via cellular telephone or mobile device when not at the hospital. Intended as a diagnostic aid; not a replacement for direct viewing of primary monitoring devices. Contraindicated in areas where cellular/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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

OCT

2 2012

AirStrip Technologies, LP c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLP 1394 25th Street NW Buffalo, MN 55313

## Re: K122133

Trade/Device Name: AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (no alarms) Regulatory Class: Class II Product Code: MWI Dated: August 27, 2012 Received: September 26, 2012

Dear Mr. 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, 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.

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Page 2 - Mr. Mark Job

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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 Indications for Use
510(k) Number (if known): K | 22133

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. 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 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/Stoo! 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
- Coaqulation
- · Allergies
- · Medications
-

Counter-Indications

Ocamer manageno intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use the hour 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.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

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| Concurrence of CDRH, Office of Device Evaluation (QDE)<br>Page 1 of 1 | |
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| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122133 |