(16 days)
K11 0503
Not Found
No
The description explicitly states that the software displays information generated by other medical devices and systems, and does not generate the information itself. There is no mention of analysis, interpretation, or any other function that would typically involve AI/ML.
No.
The device is described as software that displays physiological and other patient information generated by other medical devices, intended for clinicians to review patient data remotely. It does not exert any direct therapeutic action or provide treatment.
No
The device, AirStrip RPM, is described as software that displays physiologic and other patient information generated by other medical devices and patient information systems. It does not generate its own diagnostic information or analyze data for diagnostic purposes; it merely displays existing data for review by clinicians.
Yes
The device description explicitly states "AirStrip RPM is software capable of displaying physiologic and other patient information." It clarifies that the information is generated by other medical devices and systems, and AirStrip RPM's function is to capture and display this data. There is no mention of any hardware component being part of the AirStrip RPM device itself.
Based on the provided information, AirStrip RPM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This examination is performed in vitro (outside the living organism).
- AirStrip RPM's Function: AirStrip RPM's intended use and device description clearly state that it displays physiologic and other patient information that is generated by other medical devices and patient information systems. It does not perform any tests or analyses on specimens from the human body. It acts as a display and communication tool for data already collected and processed by other systems.
Therefore, AirStrip RPM falls outside the scope of an In Vitro Diagnostic device. It is a software-based medical device used for remote monitoring and data review.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians, hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K11 0503
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.
Not Found
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).
Not Found
§ 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
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
1
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
2
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 |
|---|---|---|
| ----------------------------------------------------------------------- | --------------------- | ------------------------------------ |
510(k) Number K110503