AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER

K131786 · Airstrip Technologies, LP · MWI · Jul 3, 2013 · Cardiovascular

Device Facts

• Record ID: K131786
• Device Name: AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
• Applicant: Airstrip Technologies, LP
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• 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 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

Device Story

AirStrip RPM is a software application for mobile devices (cellular phones/wireless devices) that enables remote viewing of physiologic data and waveforms. It functions as a secondary display system, capturing data from hospital-based patient monitoring systems and information systems. Clinicians use the application to review near real-time patient data (e.g., ECG, blood pressure, cardiac output, lab results) when away from the hospital. The device facilitates remote consultation by allowing clinicians to view waveforms and data, supporting clinical decision-making by providing access to patient status outside the clinical setting. It is not intended to replace direct viewing of primary monitoring equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based remote display system; operates on cellular telephones and wireless devices; connects to hospital patient monitoring and information systems to retrieve physiologic data; no hardware sensors; no energy source integral to the device; standalone software application.

Indications for Use

Indicated for clinicians to remotely review physiologic data, waveforms, and patient information (ECG, vitals, pressures, lab data, medications) from hospital-based monitoring systems via cellular or wireless devices. Not for use where wireless devices are prohibited; intended as a diagnostic aid, not a replacement for direct monitoring.

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)

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

## Public Health Service

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

## July 3, 2013

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

. Re: K131786

Trade/Device Name: AirStrip RIPM Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MWI Dated: June 11, 2013 Received: June 18, 2013

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 10 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. Ilsting 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

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

## Page 2 - Mr. Mark Job

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Zillman

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

K131786

510(k) Number (if known):

Device Name: AirStrip RPM

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 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

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) Page 1 of 1

M.A. Hillemann