(16 days)
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/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
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.
The provided text is a 510(k) premarket notification letter from the FDA to AirStrip Technologies, LP, concerning their AirStrip RPM I2 Support device. This document primarily focuses on the FDA's "substantial equivalence" determination and regulatory compliance requirements. It does not contain information about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in a clinical study report or a more detailed technical submission.
Therefore, I cannot directly extract the requested information from this document.
What the document does indicate is:
- Device Name: AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
- Intended Use: To allow clinicians to remotely review physiologic data, waveforms, and other near real-time patient data from monitored systems using a cellular telephone or other device when not at the hospital. It is intended as a diagnostic aid, not a replacement for direct viewing of monitoring devices.
- Data Displayed: ECG Waveform, Heart Rate, 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/Cuff, Mean Arterial Pressure Invasive/Cuff, Diastolic Blood Pressure Invasive/Cuff, Vasoactive Infusions, Antiarrhythmics, Sedation, Paralytics, Laboratory Data (Blood Gas, Chemistry, Hematology, Coagulation), Allergies, Medications.
- Regulatory Class: Class II (two)
- Product Code: MWI
- 510(k) Number: K110503
- Predicate Device: Not explicitly stated in this segment, but a substantial equivalence determination implies comparison to a legally marketed predicate device.
To answer your questions, additional documentation, such as the full 510(k) submission, a clinical study report, or a user manual, would be required. This letter confirms regulatory clearance but does not detail the technical validation study performed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration i 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AirStrip Technologies. LP c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25" Street NW Buffalo, MN 55313
MAR 1 0 2011
Re: K110503
Trade/Device Name: AirStrip RPM I2 Support Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: February 18, 2011 Received: February 22, 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.
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 -- AirStrip Technologies, LP, c/o 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 libsting (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 (2) 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/ucm1118800.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" (21 CFR) 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
R. behmer
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): K400433 K11 0503
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 informati: is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip R : M 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 ፣ : ta 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 dev : es:
- · 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, anः is not intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is inter led for use by clinicians when they cannot be at the hospital. AirStrip RPM is Intended for use by clinicians as a di : gnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which It obtains its di I. .
| Prescription Use(Part 21 CFR 801 Subpart D) | Over-The-Counter Use(21 CFR 801 Subpart C) | |
|---|---|---|
| ------------------------------------------------- | -- | ------------------------------------------------ |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) R.Richner
| Concurrence of CDRH, Office of Device Evaluation (ODE)Page 1 of 1 | (Division Sign-Off) | Division of Cardiovascular Devices |
|---|---|---|
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510(k) Number K110503
§ 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).