AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER by AIRSTRIP TECHNOLOGIES, LP

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

Device Description

AI/ML Overview

The provided text is a 510(k) summary from the FDA for the AirStrip RPM device. It largely focuses on regulatory approval, intended use, and general controls. It does not contain the detailed information necessary to answer most of the questions about acceptance criteria and the specific study that proves the device meets those criteria.

However, based on the information provided, here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for the device's performance (e.g., accuracy percentages, latency thresholds). The focus is on the device's ability to display physiological and patient information generated by other medical devices. The "Indications for Use" section outlines what the device does (e.g., "to review physiologic data," "to view near real-time waveforms remotely"). Implicitly, acceptance criteria would likely revolve around the reliable and accurate display of this data, without introducing errors or significant delays.
Reported Device Performance: Similarly, the document does not provide specific quantitative performance metrics (e.g., "the device displayed data with 99.5% accuracy compared to the source"). It states that the device is "capable of displaying physiologic and other patient information."

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.

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. The device primarily displays data from other medical devices, so "ground truth" might refer to the data from the source devices, rather than a subjective expert assessment of the RPM's output.

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 AirStrip RPM is described as a display and remote viewing tool for existing data, not an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.

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

The document implies that the device is standalone in its function of displaying data. Its performance would be assessed on its ability to accurately and reliably receive and display information from other devices. However, no specific standalone performance metrics are provided. The "human-in-the-loop" aspect is the clinician interpreting the displayed data, not the device performing an algorithmic diagnosis.

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

The implicit "ground truth" for this device would be the data as generated by the original medical devices or patient information systems from which AirStrip RPM obtains its data. The device's performance would be evaluated on how faithfully and accurately it replicates and displays this source data. There's no mention of expert consensus, pathology, or outcomes data as a ground truth for the AirStrip RPM itself.

8. The sample size for the training set

This information is not provided in the document. This type of device (a display and communication tool) typically doesn't have a "training set" in the sense that an AI or machine learning model would. Its development would involve software engineering and testing for data integration, transmission, and display accuracy.

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

As above, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to the description of this device. Development would involve testing against known valid data outputs from the source medical devices to ensure correct display.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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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 (800) 638-2041 or (301) 796-7100 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

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Indications for Use

K131786

510(k) Number (if known):

Device Name: AirStrip RPM

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-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

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).