AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING by AIRSTRIP TECHNOLOGIES, LP

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-lime 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
· Antiarrhvthmics
· Sedation
· Paralvtics
· Laboratory Data including
Blood Gas
Chemistry
Hematology
Coagulation
· Allergies
· Medications

Device Description

AI/ML Overview

Based on the provided document, the device is the AirStrip Remote Patient Monitor (RPM) Remote Data Viewing software (K112235). The document is an FDA 510(k) clearance letter, which primarily focuses on substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria and performance metrics described as one might find for a PMA.

Therefore, much of the requested information regarding specific acceptance criteria and detailed study results as typically presented for AI/ML device performance is not available in this document. The FDA 510(k) summary for this type of device typically relies on verification and validation testing to demonstrate functional equivalence and safety, rather than a clinical effectiveness study with performance metrics like sensitivity/specificity against ground truth.

However, I can extract the available relevant information:

1. Table of acceptance criteria and the reported device performance:

This document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide a table of reported device performance metrics against such criteria. The FDA 510(k) typically relies on a comparison to a predicate device and verification/validation testing to demonstrate proper functionality.

The "performance" described here is functional: the ability to accurately display various types of patient data from other medical devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document refers to the data as being generated by "other medical devices and patient information system" and "captured from these other systems."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. Given the nature of the device (a remote viewing software for existing patient data), the "ground truth" would likely be the data as presented by the original monitoring devices. Testing would focus on the fidelity of the data display.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The device is a "Remote Data Viewing software" and is explicitly described as a "diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data." It is not an AI-assisted diagnostic tool in the sense of providing automated interpretations or improving human reader performance, but rather a system for displaying existing patient data remotely.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device itself is essentially "standalone" in its function of data display, as it presents data from other systems. However, its stated "Indications for Use" clearly state it is "intended to be used by clinicians" and "by clinicians as a diagnostic aid." Therefore, while the software performs its display function independently, its intended use always involves a human clinician in the loop. The document does not describe "standalone" performance in the context of an algorithm providing a definitive diagnosis or interpretation without human oversight.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The implied "ground truth" for this device would be the accurate and faithful representation of the data generated by the original medical devices (e.g., ECG monitors, blood pressure cuffs, laboratory systems). The software's performance would be assessed on its ability to correctly transmit and display this data without alteration or corruption, not against an independent clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set:

This information is not provided in the document. The device is a data display software, not a machine learning algorithm that typically requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established:

This information is not provided in the document. As mentioned, the concept of a "training set" and its associated ground truth establishment is not directly applicable to this type of device based on the provided clearance letter.

Summary

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

AUG 2 6 2011

Airstrip Technologies, LP c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K112235

Trade Name: Airstrip Remote Patient Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (no alarms) Regulatory Class: Class II (two) Product Code: MWI Dated: August 3, 2011 Received: August 4, 2011

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerman, M.D.

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 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-lime 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
· Antiarrhvthmics
· Sedation
· Paralvtics
· 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.

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

Concurrence of CDRH, Office of Device Evaluation
Page 1 of 1
Division of Cardiovascular Device

510(k) Number K112235

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).