(26 days)
No
The device description and intended use clearly state that the software displays data generated by other devices and systems. There is no mention of the software analyzing, interpreting, or learning from this data using AI/ML techniques. The focus is on remote viewing and data transmission.
No
The device is described as software that displays data generated by other medical devices and is explicitly stated to be for diagnostic aid, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "AirStrip RPM is intended for use by clinicians as a diagnostic aid".
Yes
The device is explicitly described as "software capable of displaying physiologic and other patient information" and "a software application". It retrieves data from other medical devices and systems and displays it, without generating the data itself or including any hardware components.
Based on the provided text, the AirStrip RPM device is not an In Vitro Diagnostic (IVD).
Here's why:
- Definition of IVD: An IVD is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases or other conditions. These tests are performed in vitro (in a test tube or other artificial environment).
- AirStrip RPM's Function: The text clearly states that AirStrip RPM is software that displays physiologic and other patient information generated by other medical devices and patient information systems. It does not perform any tests on biological samples. Its purpose is to provide remote access and viewing of data already collected by other devices.
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. 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 waveform 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 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
Product codes (comma separated list FDA assigned to the subject device)
MWI
Device Description
The AirStrip RPM InvisionHeart Adapter is a software application that interfaces with the InvisionECG System in hospitals to allow health care professionals the ability to view near real-time patient data remotely. AirStrip RPM works by retrieving patient data from the InvisionECG System monitoring system and providing that data to the end user's device via Wi-Fi or cellular modem over the Internet.
InvisionECG System
The InvisionECG System (cleared under K143436; InvisionHeart Inc.) is a mobile solution for capturing and managing 12-lead ECGs, including the ability to read and visually compare, confirm, report and store diagnostic quality electrocardiograms. This is all done on a browser-based, secure, healthcare IT platform which provides access to ECGs anywhere and anytime an authorized healthcare professional has web access via an appropriate browser. The cleared Indications For Use states "The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients. The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals." Additional information may be obtained at www.invisionheart.com.
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
• 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
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
The Electrocardiogram cannot and does not differentiate between patient groups, therefore, the monitoring of any patient using the Epiphany Adapter (elderly or pediatric) is within the scope of this device. Therefore Airstrip which is only reproducing the information from InvisionHeart also cannot differentiate between patient populations using the electrocardiogram.
Intended User / Care Setting
AirStrip RPM is intended for use by clinicians when they cannot be at the 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)
The InvisionHeart Adapter Software is a moderate level of concern. The software was designed and developed adhering to in-house design and development process. The software underwent verification and validation testing and was in the form of combined integration and system testing as well as final regression testing.
Test results indicate that the InvisionHeart Adapter Software complies with its predetermined specifications and the applicable guidance documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2018
AirStrip Technologies, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K182226
Trade/Device Name: AirStrip RPM InvisionHeart Adapter Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: August 14, 2018 Received: August 16, 2018
Dear Mark 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Stephen C. Browning -S5
for 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) K182226
Device Name AirStrip RPM InvisionHeart Adapter
Indications for Use (Describe)
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 waveform 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 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
Contraindications
3
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
AirStrip RPM InvisionHeart Adapter 510(k) Summary
| Submitter Information [21 CFR 807.929(a)(1)] | ||
|---|---|---|
| Name | AirStrip Technologies | |
| Address | 335 E. Sonterra Blvd., Suite 200 | |
| San Antonio, TX 78258 | ||
| Phone number | +1 210 805 0444 | |
| Fax number | +1 210 805 0446 | |
| Establishment Registration Number | Establishment Registration Number: 3006104191 | |
| Name of contact person | Kirk Johnson | |
| Date prepared | September 4, 2018 | |
| Name of the device [21 CFR 807.92(a)(2)] | ||
| Trade or proprietary name | AirStrip RPM InvisionHeart Adapter | |
| Common or usual name | Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) | |
| Classification name | Remote Patient Monitoring has been classified as Class II, 870.2300, | |
| MWI. The classification panel 870: Cardiovascular. | ||
| Classification panel | Cardiovascular | |
| Regulation | 870.2300 | |
| Product Code(s) | MWI | |
| Legally marketed device(s) to which | ||
| equivalence is claimed | ||
| [21 CFR 807.92(a)(3)] | The predicate device is the AirStrip RPM Epiphany Adapter, K133450, | |
| cleared February 14, 2014. | ||
| Device description | ||
| [21 CFR 807.92(a)(4)] | AirStrip RPM InvisionHeart Adapter |
The AirStrip RPM InvisionHeart Adapter is a software application that
interfaces with the InvisionECG System in hospitals to allow health care
professionals the ability to view near real-time patient data remotely. AirStrip
RPM works by retrieving patient data from the InvisionECG System monitoring
system and providing that data to the end user's device via Wi-Fi or cellular
modem over the Internet.
InvisionECG System
The InvisionECG System (cleared under K143436; InvisionHeart Inc.) is a
mobile solution for capturing and managing 12-lead ECGs, including the
ability to read and visually compare, confirm, report and store diagnostic
quality electrocardiograms. This is all done on a browser-based, secure,
healthcare IT platform which provides access to ECGs anywhere and
anytime an authorized healthcare professional has web access via an
appropriate browser.
The cleared Indications For Use states "The InvisionECG System is | |
| intended to acquire, display and record electrocardiographic information
from adult and pediatric patients. The InvisionECG System is intended
to be used in a clinical or home environment by trained healthcare
professionals." | | |
| Additional information may be obtained at www.invisionheart.com.
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
• 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 | |
| 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. | | |
| Summary of the technological characteristics of the device compared to the predicate device
[21 CFR 807.92(a)(6)] | | |
| Function
Specification | AirStrip RPM InvisionHeart
Adapter (Proposed) | AirStrip RPM Epiphany Adapter
510(k) #K133450 |
| Purpose | Provides ability to view patient
physiological waveforms and other | Provides ability to view physiological
waveforms and other data remotely |
| | data remotely through interface with
InvisionECG. | through interface with Epiphany
Cardiology. |
| Function –
Indications for Use | Smart Client application that allows
users at remote locations (anywhere
there is internet access) to view
patient information in near real time
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 in near real time including
physiological data, waveforms and
other EMR related data. |
| Target Population | Clinicians (users) Target population
(clinical patients) are anyone using a
monitoring device for cardio. The use
of this device is not controlled by
patient group. Instead it is controlled
by diagnosis and the use of a specific
cardio monitoring device. The
software and the portal can only
differentiate between "source" of the
waveform information (“adapters") as
the software only reads and repeats
the information for display remotely.
Invision Heart device is the source of
data. The Electrocardiogram cannot
and does not differentiate between
patient groups, therefore, the
monitoring of any patient using the
Epiphany Adapter (elderly or
pediatric) is within the scope of this
device. Therefore Airstrip which is
only reproducing the information from
InvisionHeart also cannot differentiate
between patient populations using the
electrocardiogram. | Clinicians (users) Target population
(clinical patients) are anyone using a
monitoring device for cardio. The use
of this device is not controlled by
patient group. Instead it is controlled
by diagnosis and the use of a specific
cardio monitoring device. The software
and the portal can only differentiate
between "source" of the waveform
information ("adapters") as the
software only reads and repeats the
information for display remotely.
Invision Heart device is the source of
data. The Electrocardiogram cannot
and does not differentiate between
patient groups, therefore, the
monitoring of any patient using the
Epiphany Adapter (elderly or pediatric)
is within the scope of this device.
Therefore Airstrip which is only
reproducing the information from
Epiphany Adapter also cannot
differentiate between patient
populations using the
electrocardiogram. |
| 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 |
| System Technology | File Based Service | File Based Service |
| | Web based service and file based
service are two methods of picking up
a snapshot of ECG data from the
collecting medical device (in this
application Invisionheart) for viewing
through the AirStrip software on
mobile devices. Whether gathering
the data from a web service call (e.g.
K100133) or a file based system (e.g.
K110503, K133450/Epiphany Adapter
or the proposed K182226/
InvisionHeart Adapter) each is a
mechanism for capturing the snapshot
to be used by AirStrip RPM. Once
captured by AirStrip RPM, the
information is treated the same and
the data in the file is parsed for the
information required. There is no
dependency on the method of capture
for how the data is parsed. For the
web based approach, a query is made
and data is gathered from that query,
as compared to the file based method
where AirStrip is pointed to a
particular directory where the file
resides and AirStrip picks it up. Once
in Airstrip RPM, both methods are
processed the same way inside of
AirStrip and then transmitted to
mobile users. There is no dependency
on the original system file so once the
file is successfully parsed, the system
file is then removed from the specified
directory by AirStrip to prevent
repetitive processing. | Web based service and file based
service are two methods of picking up a
snapshot of ECG data from the
collecting medical device (in this
application Invisionheart) for viewing
through the AirStrip software on
mobile devices. Whether gathering the
data from a web service call (e.g.
K100133) or a file based system (e.g.
K110503, K133450/Epiphany Adapter)
each is a mechanism for capturing the
snapshot to be used by AirStrip RPM.
Once captured by AirStrip RPM, the
information is treated the same and
the data in the file is parsed for the
information required. There is no
dependency on the method of capture
for how the data is parsed. For the web
based approach, a query is made and
data is gathered from that query, as
compared to the file based method
where AirStrip is pointed to a particular
directory where the file resides and
AirStrip picks it up. Once in Airstrip
RPM, both methods are processed the
same way inside of AirStrip and then
transmitted to mobile users. There is
no dependency on the original system
file so once the file is successfully
parsed, the system file is then removed
from the specified directory by AirStrip
to prevent repetitive processing. |
| Security
Administration | Yes | Yes |
| Operating
Environment | Anywhere the clinician has remote
Internet access for iOS or Android
device and use is not prohibited | Anywhere the clinician has remote
Internet access for iOS or Android
device and use is not prohibited |
| | Hospital data center for server | Hospital data center for server |
| Programming
Languages | Apple Objective C and Swift on client | Apple Objective C on client |
| | Android Java and Kotlin | Android |
| | Microsoft Windows .NET on server | Microsoft Windows .NET on server |
| Operating Systems | Apple iPhone OS on client
Android OS on client
Microsoft Windows Server on servers | Apple iPhone OS on client
Android OS on client
Microsoft Windows Server on servers |
| Database System | Microsoft SQL Server | Microsoft SQL Server |
| Hardware Platform | Apple iPhone OS devices for client
Android OS devices for client
Microsoft Windows Server compatible
server computers | Apple iPhone OS devices for client
Android OS devices for client
Microsoft Windows Server compatible
server computers |
| Presentation of Data | Smart Client | Smart Client |
| Ability to view near
Real-time Data | Yes | Yes |
5
6
7
8
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
The InvisionHeart Adapter Software is a moderate level of concern. The software was designed and developed adhering to in-house design and development process. The software underwent verification and validation testing and was in the form of combined integration and system testing as well as final regression testing.
The software testing and documentation is in accordance with internal requirements and the following FDA Guidance documents:
· General principles of software validation, Final Guidance for Industry and FDA Staff; January 11, 2002
· Off -The-Shelf Software Use In Medical Devices; September 09, 1999
· Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: October 02, 2014
The adapter is in accordance with the following standards:
The InvisionHeart Adapter accepts and transmits as a viewer the DICOM file information compliant with DICOM SOP 1.2.840.10008.5.1.4.1.1.9.1.1 12-lead ECG Waveform Storage. See
https://www.dicomlibrary.com/dicom/sop/
ISO 14971:2007 Medical devices – Applications of risk management to medical devices
Test results indicate that the InvisionHeart Adapter Software complies with its predetermined specifications and the applicable guidance documents.
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]
This section is not applicable to this submission. Clinical Data are not included.
InvisionHeart ECG System (by Nuline/InvisionHeart) Standard Compliance
The InvisionHeart ECG System is compliant to 60601-2-25:2011 (Medical electrical equipment-Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs). For
9
additional information refer to link https://www.accessdata.fda.gov/cdrh_docs/pdf14/[K143436](https://510k.innolitics.com/search/K143436).pdf.
Conclusions drawn [21 CFR 807.92(b)(3)]
Based on the results of testing, the AirStrip RPM InvisionHeart Adapter is substantially equivalent to the AirStrip RPM Epiphany predicate device.