(22 days)
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No
The description explicitly states the software displays information generated by other devices and systems, and does not generate the information itself. There is no mention of AI or ML in the provided text.
No.
The device displays physiological and patient information generated by other medical devices but does not provide any treatment or therapy itself.
No
The device is described as a "diagnostic aid" but explicitly states "and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data." It displays data from other medical devices rather than performing diagnostic analysis itself.
Yes
The device description explicitly states "AirStrip RPM is software capable of displaying physiologic and other patient information". It acts as a display interface for data generated by other medical devices and systems, not generating the data itself.
Based on the provided information, AirStrip RPM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- AirStrip RPM's Function: AirStrip RPM's intended use is to display physiologic and other patient information that is generated by other medical devices and patient information systems. It does not analyze or process biological specimens. It acts as a remote viewing and communication tool for clinicians.
- Data Sources: The data it displays comes from sources like ECG monitors, blood pressure cuffs, and laboratory systems, but AirStrip RPM itself is not performing the diagnostic tests on the specimens.
Therefore, AirStrip RPM falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinicians / Not at the hospital
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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 or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
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.
1
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 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
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 | |
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| Division of Cardiovascular Device |
510(k) Number K112235