(6 days)
Not Found
Not Found
No
The document describes software for remote viewing of physiological data from other medical devices and does not mention any analytical or predictive capabilities that would typically involve AI/ML.
No
The device is described as software that displays data from other medical devices for clinicians to review remotely; it does not perform any therapeutic function itself.
No
AirStrip RPM is software that displays physiological data captured by other medical devices for review by clinicians. It does not perform any diagnostic analysis or interpretation itself.
Yes
The device description explicitly states "AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software," and the intended use describes it as software capable of displaying data captured by other medical devices. There is no mention of hardware components 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: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- AirStrip RPM's Function: AirStrip RPM is described as software that displays physiologic data captured by other medical devices. It does not perform any tests or analysis on biological specimens. Its purpose is to provide remote viewing of data already generated by other equipment.
Therefore, AirStrip RPM falls outside the scope of what is considered an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential 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 phy 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 payafam as ather deta
• To remotely review other standard of entilour roar time patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
• 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
- Coaqulation
• Alleraies
• Medications
Contraindications
AirStrip RPM software is intended for installation on cellular wireless devices, and is intended for AirStrip RPM software is intended for installation on other AirStrip RPM intended for use intended for use anywhere cellular telephones or wireles are prohibited Airenti intended for use anywhere cellular telephones of within intended for use by clipicians as a diagnostic aid, by clinicians when they cannot be at the hospital. AirStip Review by climicians when they cannot be at the nospital. All other to the incorder to the monitorit obtains its data. and not as a replacement for direct viewing of any of the mon
Product codes (comma separated list FDA assigned to the subject device)
74 MWI
Device Description
AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential and displays it for clinicians.
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 (remotely)
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.
Not Found
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3 2012 JUL
AirStrip Technologies, LP c/o Mr. Mark Job Reviewer Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 53313
Re: K121871
AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software Regulatory Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: June 26, 2012 Received: June 27, 2012
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
1
Page 2 - Mr. Mark Job
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 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,
Beam 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
2
Indications for Use 510(k) Number (if known):
Device Name: AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
Indications for Use:
Indications for Use:
AirStrip RPM is software capable of displaying physiologic and nathy AirStrin RPM AirStrin RPM AirStrip RPM is sortware capable of displaying prysiclogio and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
AirStrip RPM is intended to be used by cinficians for the rolowing parposos.
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review phy patient when the clinician is not at the hospital
· To view the near real-time waveforms remotely
• To view the near-line wavelomis remotery
• To remotely review other standard or critical near real-time payafam as ather deta
• To remotely review other standard of entilour roar time patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
· 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
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
· Diastolic Blood Pressure Cuff
· Vasoactive Infusions
· Antiarrhythmics
· Sedation
· Paralytics
· Laboratory Data including
-
Blood Gas
-
Chemistry
-
Hematology
-
Coaqulation
· Alleraies
· Medications
Contraindications
Contraindications
AirStrip RPM software is intended for installation on cellular wireless devices, and is intended for AirStrip RPM software is intended for installation on other AirStrip RPM intended for use
intended for use anywhere cellular telephones or wireles are prohibited Airenti intended for use anywhere cellular telephones of within intended for use by clipicians as a diagnostic aid,
by clinicians when they cannot be at the hospital. AirStip Review by climicians when they cannot be at the nospital. All other to the incorder to the monitorit obtains its data.
and not as a replacement for direct viewing of any of the mon
Over-The-Counter Use Prescription Use (21 CFR 801 Subpart C) AND/OR (Part 21 CFR 801 Subpart D) (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
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K121871