(185 days)
Not Found
No
The description explicitly states the software displays data generated by other devices and systems, and there is no mention of AI/ML in the intended use, device description, or performance studies.
No.
The device is described as software that displays physiological and other patient information generated by other medical devices, and its intended use is for clinicians to review patient data remotely. It does not exert any direct therapeutic effect on the patient.
No
Explanation: The device is software that displays existing physiological and other patient information generated by other medical devices and patient information systems. It does not generate new information or interpret data to make diagnoses.
Yes
The device description explicitly states "AirStrip RPM is software that runs on devices capable of running Apple iPhone OS." The intended use and device description focus solely on the software's function of displaying data from other medical devices and systems, without mentioning any proprietary hardware components included with the AirStrip RPM product itself.
Based on the provided information, AirStrip RPM is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of AirStrip RPM clearly state that it displays physiologic and other patient information generated by other medical devices and patient information systems. It does not analyze or process biological specimens.
- The data displayed by AirStrip RPM comes from external sources (patient monitors, information systems), not from direct analysis of patient samples. The data points listed are physiological measurements, laboratory results (which are already generated by laboratory IVD devices), and other clinical information.
- The purpose of AirStrip RPM is remote viewing and consultation of existing patient data. It is a display and communication tool, not a diagnostic test itself.
Therefore, AirStrip RPM falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 following the physiologic data captured by other medical devices:
- . ECG Waveform
- . Blood Pressure Waveform
- . 02 Waveform
- . CO2 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
- . 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 · .
- o Blood Gas
- o Chemistry
- Hematology o
- Coagulation o
- . Allergies
- . Medications
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
AirStrip RPM is software that runs on devices capable of running Apple iPhone OS. It interfaces with third-party centralized monitoring systems that in turn gather data from patient monitors and other devices in the hospital. AirStrip RPM gives health care providers the ability to view near-real-time patient physiological data remotely.
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
Intended User: Clinicians
Care Setting: Not at the hospital (remote internet access)
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
AirStrip Technologies conducted verification testing of all data points listed. In this test, known datasets were gathered from Cerner iBus and displayed on AirStrip RPM. These datasets included all data points proposed in AirStrip RPM; all monitored data, all manual data, including patient demographics. In all cases, AirStrip RPM was able to display data points with complete accuracy. The verification test report is provided as Appendix SSSSS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing of all data points. Known datasets from Cerner iBus were displayed on AirStrip RPM. All monitored data and all manual data, including patient demographics, were included. In all cases, AirStrip RPM was able to display data points with complete accuracy.
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.
GE Pocket Viewer (K061994), Cerner iBus (K093134)
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
AIRSTRIP
TECHNOLOGIES
000133
510(k) Summary
| Date: | May 25, 2010 |
|---|---|
| Submitter: | AirStrip Technologies Inc. |
| 3303 Oakwell Court #120 | |
| San Antonio, TX 78218 | |
| 'JUL 2 8 2010 | |
| Contact Person: | Andy Miller |
| Director, QA/RA | |
| Phone: 210-805-0444 | |
| Fax: 210-805-0446 | |
| E-Mail: andymiller@airstriptech.com | |
| Trade Name: | AirStrip RPM |
| Common/Usual Name: | Doctor's Remote Data Viewing Software |
| Classification Reference: | Patient monitoring software has been classified as |
| Class II, 870.2300. The classification panel 870: | |
| Cardiovascular. No performance standards have been | |
| established under Section 514 of the Food, Drug and | |
| Cosmetic Act for remote data viewing of cardiovascular | |
| data. | |
| Predicate Devices: | GE Pocket Viewer (K061994) |
| Cerner iBus (K093134) |
Device Description
AirStrip RPM is software that runs on devices capable of running Apple iPhone OS. It interfaces with third-party centralized monitoring systems that in turn gather data from patient monitors and other devices in the hospital. AirStrip RPM gives health care providers the ability to view near-real-time patient physiological data remotely.
Predicate Devices
The AirStrip RPM client is substantially equivalent to two FDA cleared devices. The GE Pocket Viewer (K061994) device provides the ability for the clinician to view real-time waveforms and other physiological patient data via Windows Mobile based PDA Smart Phones. Pocket Viewer works by retrieving patient data from the hospital monitoring system and providing that data to the end user's device via WiFi or cellular modem over the Internet. This is the same approach used for the AirStrip RPM product.
Physiological parameters that will be displayed by AirStrip RPM are collected through the Cerner iBus (K093134), which is listed as a predicate device to AirStrip RPM. These physiological parameters include ECG, invasive blood pressure, non-invasive blood pressure, heart rate, pulse oximetry and carbon dioxide. The complete list of physiological parameters captured is included in the Indications for Use below.
page 1/10
1
Image /page/1/Picture/1 description: The image shows the logo for Airstrip Technologies. The logo features a circular emblem on the left, containing a stylized "W" shape. To the right of the emblem, the word "Airstrip" is prominently displayed in a bold, sans-serif font, with the word "Technologies" appearing in a smaller font size beneath it.
In addition to physiological data, the iBus provides other patient data such as patient demographics and other non-physiological Electronic Medical Record (EMR) data. This data will also be made available through AirStrip RPM.
Indications for Use
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 following the physiologic data captured by other medical devices:
- . ECG Waveform
- . Blood Pressure Waveform
- . 02 Waveform
- . CO2 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
- . Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive .
- . Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff .
- Diastolic Blood Pressure Cuff .
- . Vasoactive Infusions
2
Image /page/2/Picture/1 description: The image shows the logo for Airstrip Technologies. The logo consists of a circular emblem on the left, followed by the word "Airstrip" in bold, sans-serif font. Below "Airstrip" is the word "Technologies" in a smaller, sans-serif font. The logo appears to be in black and white.
- . Antiarrhythmics
- Sedation .
- Paralytics .
- Laboratory Data including · .
- o Blood Gas
- o Chemistry
- Hematology o
- Coagulation o
- . 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.
Substantial Equivalence
AirStrip Technologies identified GE's Pocket Viewer and Cerner's iBus, formerly known as MDBus, as predicate devices to AirStrip RPM.
Pocket Viewer was originally submitted by Datex-Ohmeda and cleared by the FDA on October 29, 2003 through 510(k) K033078. A subsequent Pocket Viewer 510(k) submission submitted by GE was cleared by the FDA on January 20, 2006 through 510(k) number K052975. A third Pocket Viewer 510(k) submission submitted by GE was cleared by the FDA on August 11, 2006 through 510(k) number K061994. Further, the Pocket Viewer clearance is based on substantial equivalence to the Datex-Ohmeda Network and Central device which was cleared by the FDA on July 13, 2000.
Cerner's iBus was cleared by the FDA on November 27, 2009 through 510(k) K093134.
Device description and Substantial Equivalence Comparison between AirStrip RPM and the predicate devices, Pocket Viewer and iBus, are captured below.
Device Description and Comparison
AirStrip RPM is a software application that interfaces with centralized monitoring systems in hospitals to allow health care professionals the ability to view near real-time patient data remotely. The AirStrip RPM platform is designed around a reusable architecture allowing display of any waveform or other patient data through the creation of an adapter to allow for data exchange with patient monitoring systems.
The AirStrip RPM client is substantially equivalent to the FDA cleared GE Pocket Viewer device which received initial FDA clearance as a Datex-Ohmeda product on October 29, 2003 through 510(k) K033078. The most recent FDA clearance for Pocket Viewer was granted in 510(k) number K061994 on August 11, 2006. GE Pocket Viewer provides the ability for the clinician to view real-time waveforms and other physiological patient data via Windows Mobile based PDA
3
Image /page/3/Picture/1 description: The image shows the logo for Airstrip Technologies. The logo consists of a circular icon with a stylized "W" inside, followed by the word "Airstrip" in bold, sans-serif font. Below "Airstrip" is the word "Technologies" in a smaller font size.
Smart Phones. Pocket Viewer works by retrieving patient data from the hospital system and providing that data to the end user's device via WiFi or cellular modem over the Internet. This is the same approach used for the AirStrip RPM product.
The initial adapter proposed in this submission is the FDA-cleared Cerner CareAware iBus, also known as MDBus, which was cleared through 510(k) K093134 on November 27, 2009. Physiological parameters that will be displayed include those physiological parameters collected through the iBus interface from FDA-cleared patient monitors. These physiological parameters include such parameters as ECG, invasive blood pressure, non-invasive blood pressure; heart rate, temperature, cardiac output, respiration, pulse oximetry and carbon dioxide.
In addition to the physiological data that iBus provides, other patient data such as patient demographics data and Electronic Medical Record (EMR) data are also available within the application and made available to AirStrip RPM.
Substantial Equivalence - Client
GE's Pocket Viewer device provides the ability for clinicians to remotely view patient data on a Windows Mobile handheld PDA. It displays patient physiological data and waveforms based on data that is made available via the Datex-Ohmeda Network or Unity network. Based on the Pocket Viewer brochure, the data that can be displayed includes waveforms and vital signs. Based on the Pocket Viewer User's Guide, the type of waveforms that are available include ECG, EEG, O2, and CO2. These waveforms are captured as selection options on pages 47-48 of the User's Guide. The data that the Pocket Viewer is cleared to display is based on the data that the Web Viewer was cleared to display through 510(k) submission K013387 dated January 8, 2002 as it served as the predicate device. The predicate device for the Web Viewer is the Datex-Ohmeda S/5 Network and Central device which was cleared through 510(k) K000647 dated July 13, 2000. These two clearance letters are included in Appendix B. In the device description section of the 510(k) clearance letter for of the Datex-Ohmeda Network and Central device, one of the monitors listed is the Cardiocap 5 Critical Care monitor. The brochure for the Datex-Ohmeda Cardiocap 5 monitor describes the types of waveforms that are displayed on the monitor including ECG. The table below captures the relationship between the predicate devices and our proposed device regarding the ability to display ECG waveform data. It is clear from this table that the GE Pocket Viewer device is cleared to display ECG waveform data and therefore can serve as a predicate device to the AirStrip RPM client for displaying ECG waveform data.
4
Image /page/4/Picture/1 description: The image shows the number K100133 on the left side. To the right of the number is a logo that appears to be a circle with a design inside. Next to the logo is the text "Airstrip Technologies" with the word "Airstrip" in a larger font than the word "Technologies."
| Datex-Ohmeda
Cardiocap 5
Monitor | Datex-Ohmeda
S/5 Network and
Central | Datex-Ohmeda
Web Viewer | GE Pocket Viewer | AirStrip RPM |
|----------------------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| 510(k): K992323 | 510(k): K000647 | 510(k): K013387,
K023497 | 510(k): K033078,
K061994 | Proposed |
| ECG Waveform
display | Includes ability to
display waveforms
from the
Cardiocap 5
monitor. | Provides same
ability as S/5
Network and
Central to view
waveform data
which would
include ECG. | Provides same
ability as Web
Viewer to view
waveform data
which would
include ECG. | Provides ability to
view ECG
waveforms
through interface
with iBus |
| | Predicate device | Predicate device | Predicate device for | |
| | for Web Viewer | for Pocket Viewer | AirStrip RPM 3.1 | |
Table 1- ECG Waveform Clearance in Predicate Device
The client portion of the AirStrip RPM software application has the following similarities to GE's Pocket Viewer which previously received 510(k) clearance:
- . has the same indicated use,
- has the same target population, .
- . uses the same operating principle,
- . uses the same communication methods and protocols,
- uses the same data source location,
- uses the same data presentation type, and
- . incorporates the same basic software design.
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Image /page/5/Picture/1 description: The image shows the Airstrip Technologies logo and the number K100133. The logo features a circle with a sine wave inside, followed by the text "Airstrip" in bold, sans-serif font. Below "Airstrip" is the word "Technologies" in a smaller, sans-serif font. The number K100133 is written in a handwritten style to the left of the logo.
| Function
Specification | GE Pocket Viewer
(FDA Cleared) | AirStrip RPM
(Proposed) |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function –
Indications for Use | Smart Client application that allows users
at remote locations (anywhere there is
internet access) to view patient
information including physiological data,
waveforms and other EMR related data. | Smart Client application that allows users at
remote locations (anywhere there is internet
access) to view patient information including
physiological data, waveforms and other EMR
related data. |
| Target Population | Clinicians | Clinicians |
| Materials | Software application and configured PDA | Software application and configured PDA |
| Internet
Communication | Secure Sockets Layer (SSL) via HTTPS | Secure Sockets Layer (SSL) via HTTPS |
| Communication
Methods | Cellular Modem, Wi-Fi | Cellular Modem, Wi-Fi |
| Data Source
Location | Hospital | Hospital |
| Security
Administration | Yes | Yes |
| Where Used | Anywhere the clinician has remote
internet access | Anywhere the clinician has remote internet access |
| Operating Systems | Microsoft Windows CE.NET family of
operating systems | iPhone OS |
| Presentation of
Data | Smart Client | Smart Client |
| Ability to view near
Real-time Data | Yes | Yes |
Substantial equivalence of operating function is detailed in the table below:
Table 2- Substantial Equivalence Operation Functional Comparison
Substantial Equivalence - Adapter
Cerner's CareAware iBus is the adapter through which AirStrip RPM will capture patient data. CareAware iBus was cleared through the FDA on November 27, 2009 through 510(k) K093134.
CareAware iBus provides the ability to gather data from connected medical devices by capturing the data from the connected device and making it available the hospital's healthcare IT system. The proposed AirStrip RPM solution provides the ability to gather data from connected medical devices by capturing the data from the connected device and making it available to the AirStrip RPM server via the CareAware iBus adapter.
6
Image /page/6/Picture/2 description: The image shows the logo for Airstrip Technologies. The logo features a stylized "A" inside a circle on the left. To the right of the circle, the word "Airstrip" is written in bold, sans-serif font, with the word "Technologies" written in a smaller font size below it.
The patient monitoring data presented in the AirStrip RPM software application has the following similarities to the Cerner CareAware iBus which previously received 510(k) concurrence through 510(k) K093134 dated November 27, 2009:
- . has the same operating principle,
- has the same target population, .
- . uses the same type of data sources.
| Function
Specification | Cerner CareAware iBus
(FDA Cleared) | AirStrip RPM
(Proposed) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Function –
Indications for Use | Capture patient data from externally
connected devices and make available to
networked clinical information systems | Capture patient data from clinical information
system and display on remote devices |
| Target Population | Clinicians | Clinicians |
| Data Source
Location | Hospital | Hospital |
| Data Types | Patient physiological data including blood
pressure, cardiac monitor, breathing
frequency, oxygen uptake | Patient physiological data including blood
pressure, cardiac monitor, breathing
frequency, oxygen uptake |
| Security
Administration | Yes | Yes |
| Where Used | Anywhere the physician has Clinical
Information System access | Anywhere the physician has remote internet
access |
| Presentation of
Data | Networked Clinical Information System | Smart Client |
| Ability to View
Near Real-time
Data | Yes | Yes |
Table 4 - Substantial Equivalence Comparison
7
Image /page/7/Picture/2 description: The image shows the logo for Airstrip Technologies. The logo consists of a circle with a sine wave inside of it on the left, and the word "Airstrip" in a stylized font on the right. Below the word "Airstrip" is the word "Technologies" in a smaller font.
The table below lists the data physiological and non-physiological data elements provided by FDA-cleared Cerner iBus, the level of concern of each element, and which of these are displayed by the FDA-cleared Pocket Viewer and proposed AirStrip RPM.
| Data Element Provided by Cerner iBus
(FDA Cleared) | Level of
Concern | GE Pocket Viewer
(FDA Cleared) | AirStrip RPM
(Proposed) |
|----------------------------------------------------------------------------------|---------------------|-----------------------------------|----------------------------|
| Logon | High | Displays | Displays |
| Patient Census | High | Displays | Displays |
| Automatically Gathered (Monitored) Waveform Physiological
Data with Scrolling | | | |
| ECG | High | Displays | Displays |
| Blood Pressure | High | Displays | Displays |
| O2 | High | Displays | Displays |
| CO2 | High | Displays | Displays |
| Automatically Gathered (Monitored) Near-Real-Time Patient
Physiological Data | | | |
| Heart Rate | High | Displays | Displays |
| Respiratory Rate | High | Displays | Displays |
| Oxygen Saturation | High | Displays | Displays |
| Intracranial Pressure | High | Displays | Displays |
| Central Venous Pressure | High | Displays | Displays |
| Pulmonary Capillary Wedge Pressure | High | Displays | Displays |
| Cardiac Index | High | Displays | Displays |
| Cardiac Output | High | Displays | Displays |
| Cerebral Perfusion Pressure | High | Displays | Displays |
| Systolic Blood Pressure Cuff | High | Displays | Displays |
| Mean Blood Pressure Cuff | High | Displays | Displays |
| Diastolic Blood Pressure Cuff | High | Displays | Displays |
| Systolic Blood Pressure Invasive | High | Displays | Displays |
| Mean Blood Pressure Invasive | High | Displays | Displays |
| Diastolic Blood Pressure Invasive | High | Displays | Displays |
| Temperature | High | Displays | Displays |
| Manually Gathered (Non-Monitored) Patient Physiological Data | | | |
| Urine Output | Low | Does Not Display | Displays |
| Urine/Stool Mix Output | Low | Does Not Display | Displays |
| Vasoactive Infusions | Low | Does Not Display | Displays |
| Antiarrhythmics | Low | Does Not Display | Displays |
| Sedation | Low | Does Not Display | Displays |
| Paralytics | Low | Does Not Display | Displays |
| Manually Gathered (Non-Monitored) Patient Laboratory Data | | | |
| Blood Gas | Low | Does Not Display | Displays |
| Chemistry | Low | Does Not Display | Displays |
| Hematology | Low | Does Not Display | Displays |
| Coagulation | Low | Does Not Display | Displays |
| Other Manually Gathered (Non-Monitored) Patient Information | | | |
| Patient Allergies | Low | Does Not Display | Displays |
| Patient Medications | Low | Does Not Display | Displays |
| Patient Demographics | Low | Does Not Display | Displays |
Table 3 - Equivalent Data Function Comparison
As the table above illustrates, GE Pocket Viewer does not currently display every data point AirStrip RPM displays. However, GE Pocket Viewer does display every automatically gathered – or monitored – physiologic data point AirStrip RPM proposes to display. These data points are
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Image /page/8/Picture/1 description: The image shows the logo for Airstrip Technologies. The logo consists of a circular emblem with a stylized "W" inside, followed by the word "Airstrip" in bold, sans-serif font. Below "Airstrip" is the word "Technologies" in a smaller, sans-serif font.
considered to be of a higher level of concern since they are compiled without human intervention.
AirStrip Technologies conducted verification testing of all data points listed. In this test, known datasets were gathered from Cerner iBus and displayed on AirStrip RPM. These datasets included all data points proposed in AirStrip RPM; all monitored data, all manual data, including patient demographics. In all cases, AirStrip RPM was able to display data points with complete accuracy. The verification test report is provided as Appendix SSSSS.
Testing and Labeling
Since a comparison of the descriptive characteristics of the proposed and predicate devices may not be sufficient to precisely and effectiveness, AirStrip Technologies used "Radio-Frequency Wireless Technology in Medical Guidance: Draft Guidance for Industry and FDA Staff" as a guide to determine what testing should be done on AirStrip RPM and to determine what additional labeling should be included with the product.
Testing
AirStrip RPM is only intended for installation on Apple iPhone, iPod Touch or iPad. AirStrip Technologies reviewed testing conducted by the Original Equipment Manufacturer (OEM), Apple Computer, on these devices. Additional testing was performed on AirStrip RPM when needed.
Other guidance used:
- . ANSI/AAMI/IEC 60601-1-2: Medical electrical equipment – Part 1-2: General Requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . ISO/TR 2130: Health informatics - Use of mobile wireless communication and computing technology in healthcare facilities - Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
- . ANSI C63.18-1997: American National Standard Recommended Practice for an On-Site. Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters
AirStrip Technologies testing included:
- . AirStrip RPM Software Waveform Functional Testing
- . AirStrip RPM Software Non-Waveform Functional Testing
- AirStrip RPM In-Band Interference and Wireless Network Coexistence Testing .
- . AirStrip RPM On-Site Ad Hoc Electromagnetic Immunity Testing
AirStrip RPM was found to have met all testing requirements.
9
Image /page/9/Picture/2 description: The image shows the logo for Airstrip Technologies. The logo consists of a circular emblem on the left, containing a stylized "W" shape. To the right of the emblem is the word "Airstrip" in bold, sans-serif font, with the word "Technologies" in a smaller font size underneath. There is a trademark symbol above and to the right of the word "Airstrip".
Labeling
AirStrip RPM is intended for use by clinicians when they cannot be at the hospital. It 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. Further, since AirStrip RPM is installed on a cellular telephone or other wireless device, it is possible that radiated emissions from other medical devices could interfere with its operation. For this reason, AirStrip RPM is not intended for use in hospitals. These contraindications are clearly explained in end-user training and product documentation. Further, a warning message is prominently display to the end user on the AirStrip RPM logon screen.
Manufacturer's guidance is also included in AirStrip RPM documentation. This guidance was developed using IEC 60601-1-2 as a template and instructs the user on how to minimize risk of using AirStrip RPM in areas with medical equipment and other sources of radiated and conducted electromagnetic disturbances. AirStrip Technologies also provides clients with guidance on how to test AirStrip RPM for use in their environment based on recognized testing standards.
Conclusion
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetics Act and various guidance documents issued by the Center for Device and Radiological Health.
. "
10
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUL 2 3 2010
AirStrip Technologies, LP c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th St, NW Buffalo MN 55313
Re: K100133
Trade/Device Name: AirStrip RPM 3.1 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MWI Dated: July 8, 2010 Received: July 9, 2010
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.
11
Page 2 - Mr. Mark Job
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 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.
ia R. vihmer
ABram D. Zuckerman, M.D. -Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
12
Indications for Use
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| 510(k) Number (if known) | K100133 |
|---|---|
| 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 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 hospitalTo view the near real-time waveforms remotelyTo remotely review other standard or critical near real-time patient data from the monitored systemTo 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: Heart Rate MonitoredRespiratory RateOxygen SaturationIntracranial PressureCentral Venous PressurePulmonary Capillary Wedge Pressure |
| Prescription Use
(Part 21 CFR 801 Subpart D) | X AND/OR Over-The-Counter Use
(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) |
Dinar. Irtumer
്ച് ചിച്ച് കുട്ടിക്കുകയും പ്രവം എം...
(Division Sign-Off)
Division of Cardiovascular Device:
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:10(k) Number_KLC0 0 | 23 |
13
- 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
- 0 Blood Gas
- Chemistry 0
- Hematology 0
- Coagulation 0
- 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
R.V. lines
(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices
510(k) Number_Ki0033----------------------------------------------------------------------------------------------------------------------------------------------------------
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