(344 days)
Not Found
No
The summary describes a platform for collecting and transmitting patient data, facilitating communication, and generating reports and alerts. There is no mention of AI or ML being used for data analysis, interpretation, or decision support. The decision-making is explicitly stated to be made by clinicians based on the data.
No
The device collects and stores data, generates notifications/alerts, and facilitates communication, but does not directly treat or provide therapy to patients. Clinicians then determine treatment based on the data.
No
Explanation: The "Intended Use / Indications for Use" section states that CareConsole collects and stores data, generates notifications, alerts, and reports, and allows healthcare professionals to view data. It explicitly states, "Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data." This indicates that the device presents information for clinicians to make diagnostic and treatment decisions, rather than performing a diagnosis itself. It facilitates monitoring and communication but does not autonomously diagnose conditions.
Yes
The device description explicitly states, "The CareConsole ("CareConsole") is a software only device." The summary also mentions that validation and verification testing were performed under the company's Design Control Process and meet software verification requirements, further supporting its software-only nature. While it interacts with third-party biometric devices, the CareConsole itself is described as solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CareConsole's Function: CareConsole's primary function is to collect, store, and transmit data from external biometric measuring devices, mobile applications, and questionnaires. It also facilitates communication between patients and healthcare professionals.
- Lack of Specimen Analysis: The description explicitly states that CareConsole collects data from "non-invasive remote monitoring devices" and patient-reported information. There is no mention of the device itself analyzing biological specimens.
The data collected by CareConsole (like biometric measurements from third-party devices) might be used by clinicians for diagnostic or treatment purposes, but CareConsole itself is a platform for data management and communication, not a device that performs in vitro diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition.
Data can be sent via intranet networks, the internet, landline telephones, and other mobile devices.
The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.
CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXH
Device Description
The CareConsole ("CareConsole") is a software only device. CareConsole enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements, using third party devices, can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinicians can also use CareConsole to exchange messages with patients by text or telephone.
The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.
The 3rd-party device typologies integrated into the CareConsole platform include blood pressure monitors (systolic and diastolic pressure, pulse, and, depending on the model, whether an irregular heart rhythm was detected), blood glucose meters (mg/dl blood sugar), weight scales (lbs. and kgs), thermometers (Fahrenheit and Celsius), pulse oximeters (SaO2 and pulse), prothrombin time and international normalized ratio blood testers (PT/INR), spirometers (FEV1/FEV6), and inhaler monitors (medication puff dose dispensed).
The readings from these 3rd-party devices are transmitted via one of the hub modalities described in this submission to AMC Health's servers, where they are reproduced in the CareConsole dashboard (along with both the date/time stamp on the originating 3rd-party device, and the transmission time) for review by the clinician end-user.
In addition to reproducing the raw readings from the 3rd-party devices on the CareConsole dashboard, CareConsole provides data summary tools to assist the clinician end-user in more easily visualizing data trends. These tools include summary statistics (e.g., highs, lows, averages and percentages of readings that lay outside the target parameters set by the clinician), and longitudinal graphic representations of the measurements over time periods established by the clinician end-user.
Were anything to interrupt data transfer between the 3rd-party measuring devices and CareConsole (e.g., the patient moves out of Bluetooth range to the transmission hubs before the data can be uploaded to the servers), there is no risk of data loss, due to the ability of these 3rd-party devices to store the readings locally with appropriate time/date stamps until that reconnection is made. It is for this reason that CareConsole posts both the reading date/time and the transmission date/time for each reading, so that the clinician end-user can determine if there has been a transmission lag.
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
12 years and older
Intended User / Care Setting
healthcare professionals, authorized caregivers, and patients.
monitoring at home and/or in medical facilities.
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 CareConsole is a software only device and the validation and verification testing were performed under the company's Design Control Process. This device meets all necessary software verification requirements in 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The testing has confirmed the device's conformity with specifications do not include any significant differences from those of the predicates.
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.
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
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2024
AMC Health Hernani Castro Vice President of Quality and Process Improvement 1 World Trade Center, 85th Floor New York, New York 10007
Re: K233446
Trade/Device Name: AMC Health CareConsole Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI, DXH Dated: October 16, 2023 Received: October 19, 2023
Dear Hernani Castro:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Robert T. Kazmierski -S for
LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
CareConsole
Indications for Use (Describe)
CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinician-scheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition.
· Data can be sent via intranet networks, the internet, landline telephones, and other mobile devices.
· The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.
CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
Submitted by: Hernani Castro
Contact Person: Hernani Castro Telephone: 914.774.5805 Email: hcastro@amchealth.com Product Name: AMC Health CareConsole Common Name: Patient Monitoring System Classification: Cardiovascular, MWI, 21 CFR 870.2300; DXH, 21 CFR 870.2920
Predicate Devices:
Primary Device: AMC Health VitalCaregiving System K151839 Additional Devices: Vital Caregiving System K051544
AirStrip Remote Patient Monitoring K133450
Intended Use:
The AMC Health CareConsole ("CareConsole") is a software-only device used alongside vital signs monitoring devices for tracking activities and medications and for data storage, collection, and transmission.
Indications for Use:
The CareConsole is intended to be used in conjunction with biometric health care measuring devices, mobile applications, and questionnaires to collect and store data, and for clinicianscheduled monitoring at home and/or in medical facilities. The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications, alerts, and reports can be generated and data can be securely viewed by healthcare professionals, authorized caregivers, and patients. Clinicians would then determine how and when to best treat their patients in response to the notifications, alerts, and biometric data. For use by individuals 12 years and older who do not have an emergency health care condition.
- Data can be sent via intranet networks, the internet, landline telephones, cellular ● telephones, and other mobile devices.
- 0 The software supports communication between patients and clinicians, caregivers, or researchers, such as through bidirectional audio and video e-visits, telephone calls, and mobile text messages.
CareConsole is intended for use in capturing remote patient monitoring data from non-invasive remote monitoring devices and to provide remote hospital-at-home level of care where determined necessary by a health care professional. CareConsole is not intended for use in emergency situations or by a patient in an acute care medical facility.
5
Device Description:
The CareConsole ("CareConsole") is a software only device. CareConsole enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements, using third party devices, can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinicians can also use CareConsole to exchange messages with patients by text or telephone.
The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.
Comparison with Predicate Devices:
The submission device and the predicate device have substantially equivalent intended use and technological specifications.
The 3rd-party device typologies integrated into the CareConsole platform include blood pressure monitors (systolic and diastolic pressure, pulse, and, depending on the model, whether an irregular heart rhythm was detected), blood glucose meters (mg/dl blood sugar), weight scales (lbs. and kgs), thermometers (Fahrenheit and Celsius), pulse oximeters (SaO2 and pulse), prothrombin time and international normalized ratio blood testers (PT/INR), spirometers (FEV1/FEV6), and inhaler monitors (medication puff dose dispensed).
The readings from these 3rd-party devices are transmitted via one of the hub modalities described in this submission to AMC Health's servers, where they are reproduced in the CareConsole dashboard (along with both the date/time stamp on the originating 3rd-party device, and the transmission time) for review by the clinician end-user.
In addition to reproducing the raw readings from the 3rd-party devices on the CareConsole dashboard, CareConsole provides data summary tools to assist the clinician end-user in more easily visualizing data trends. These tools include summary statistics (e.g., highs, lows, averages and percentages of readings that lay outside the target parameters set by the clinician), and longitudinal graphic representations of the measurements over time periods established by the clinician end-user.
Were anything to interrupt data transfer between the 3rd-party measuring devices and CareConsole (e.g., the patient moves out of Bluetooth range to the transmission hubs before the data can be uploaded to the servers), there is no risk of data loss, due to the ability of these 3rd-party devices to store the readings locally with appropriate time/date stamps until that reconnection is made. It is for this reason that CareConsole posts both the reading date/time and the transmission date/time for each reading, so that the clinician end-user can determine if there has been a transmission lag.
6
Device Description:
Third Party Measurement Devices
The Subject Device has been Tested with the Following Third-Party Devices: A&D UA-767PBT-Ci A&D UA-767PBT-CiV A&D UA-651BLE A&D UA-651BLE-V Welch Allyn RPM-BP100 1500 Series Welch Allyn H-BP100SBP 1700 Series A&D UC-351PBT-Ci A&D UC-352PBT-Ci A&D UC-355PBT-Ci A&D UC-356BLE ForaCare TNG-550 Omron HN-290T Welch Allyn RPM-Scale100 Foracare IR20b Foracare IR20b BLE ChoiceMMed MD300C318T2 O2 Sensor ChoiceMMed MD300C1218 Nonin 3230 Pulse ox Nonin 9560 Pulse ox Propeller Health Inhaler Monitor for Metered Dose Inhalers Propeller Health Inhaler Monitor for Respimat Propeller Health Inhaler Monitor for Discus Inhalers Propeller Health Inhaler Monitor for Ellipta Inhalers Propeller Health Inhaler Monitor for Symbicort Inhalers Coag-sense PT2 Coag-Sense PT3 Mytrex MXD-LTE PERS Mytrex MXD PERS Securatrac MD4 mPERS H3G-900 GATEWAY H3G-980 GATEWAY H3G-1000 GATEWAY H3G-1100 Gateway Insung HH-800a Hub Insung HH-930 Hub H3 BA-110 (Nipro) Glucose Meter Adaptor H3 BA-110 (Bayer) Glucose Meter Adaptor H3 BA-110 (Abbott) Glucose Meter Adaptor H3 BA-110 (Roche) Glucose Meter Adaptor H3 BA-400 Glucose Meter Adaptor Vitalograph Lung Monitor
7
Device Description:
CareConsole Compatibility with Third-Party Devices
BA-110 J&J GMA One Touch Ultra One Touch UltraII One Touch UltraMini BA-110 Abbot GMA FreeStyle Lite FreeStyle Lite Freedom Lite BA-110 Bayer GMA Contour Contour Next A&D 767PBT-Ci Blood Pressure Device A&D 351-PBT-ci Weight scale Choicemed MD300C318T2 Pulse Oximeter
8
COMPARISON TABLE
The following table provides a comparison of indications for use, technological
characteristics, and functionality.
| Predicate Device:
Advanced
Monitored
Caregiving
VitalCaregiving
System I | Predicate Device:
AirStrip RPM
Epiphany
Adapter | Predicate Device:
AMC Health
VitalCaregiving System
II | Subject Device:
AMC Health
CareConsole | | |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K051544 | K133450 | K151839 | | |
| FDA
Classification | Transmitters And
Receivers,
Electrocardiograph,
Telephone | Monitor,
Physiological,
Patient (Without
Arrhythmia
Detection Or
Alarms) | Transmitters And
Receivers,
Electrocardiograph,
Telephone; Monitor,
Physiological, Patient
(Without Arrhythmia
Detection or Alarms) | Transmitters And
Receivers,
Electrocardiograph,
Telephone; Monitor,
Physiological, Patient
(Without Arrhythmia
Detection or Alarms) | |
| Classification
Code | DXH | MWI | MWI; DXH | MWI; DXH | |
| Regulation
Number | 870.2920 | 870.2300 | 870.2300; 870.2920 | 870.2300; 870.2920 | |
| Intended Use | The Advanced
Monitored Care
("AMC") System is
intended to be used
in conjunction with
home patient
measuring devices
to send the
measured
parameters from a
patient's home to a
central computer
via an intermediary
organization,
where reports can
be generated for
the physician and
data can be
reviewed over the
Internet by
physicians and
patients. | 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: | AMC Health
VitalCaregiving System II
is a software-only device
used alongside vital signs
monitoring devices for
data storage, collection
and transmission. | The AMC Health
CareConsole is a
software-only device
used alongside vital
signs monitoring
devices for tracking
activities and
medications and for
data storage,
collection, and
transmission. | |
| Indication for Use | The Advanced Monitored Care
("AMC") System is
intended to be used
in conjunction with
home patient
measuring devices
to send the
measured
parameters from a
patient's home to a
central computer
via an intermediary
organization,
where reports can
be generated for | 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;
2. To view the
near real-
time
waveforms
remotely;
3. 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. | 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 | The AMC Health
VitalCaregiving
System II
("VitalCaregiving
System II") is
intended to be
used in
conjunction with
biometric
measuring
devices, mobile
applications and
questionnaires to
collect and store
data, and for
clinician | The
CareConsole is
intended to be
used in
conjunction
with biometric
health care
measuring
devices,
mobile
applications,
and
questionnaires
to collect and
store data, and
for clinician |
9
10
| the physician and | RPM. AirStrip | scheduled | scheduled |
|---|---|---|---|
| data can be | RPM captures | monitoring at | monitoring at |
| reviewed over the | this information | home and in non- | home and/or in |
| Internet by | from these other | acute medical | medical |
| physicians and | systems and | facilities. The | facilities. The |
| patients. | displays it for | VitalCaregiving | CareConsole |
| clinicians. | System II securely | platform | |
| sends data from a | securely sends | ||
| AirStrip RPM is | patient monitoring | data from a | |
| intended to be | device to a central | patient | |
| used by | electronic log of | monitoring | |
| clinicians for | patient | device to a | |
| the following | information, from | central | |
| purposes: | which | electronic log | |
| 4. By using a | notifications/alerts | of patient | |
| cellular | and reports can be | information, | |
| telephone | generated and | from which | |
| or other | data can be | notifications, | |
| device on | securely viewed | ||
| by authorized | alerts, and | ||
| which | reports can be | ||
| AirStrip | caregivers and | generated and | |
| RPM is | patients. | data can be | |
| installed, to | Clinicians would | securely | |
| review | then determine | viewed by | |
| physiologic | how and when to | healthcare | |
| data of a | respond to the | professionals, | |
| patient | alerts/notifications | authorized | |
| when the | and biometric | caregivers, and | |
| clinician is | data. For use by | patients. | |
| not at the | adults 18 years | Clinicians | |
| hospital; | and older who do | would then | |
| 5. To view the | not have an acute | determine how | |
| near real- | care or emergency | and when to | |
| time | health care | best treat their | |
| waveforms | condition. | patients in | |
| remotely; | response to the | ||
| 6. To | • Data can be sent | notifications, | |
| remotely | via intranet | alerts, and | |
| review | networks, the | biometric data. | |
| other | internet, landline | For use by | |
| standard or | and cellular | individuals 12 | |
| critical near | telephones and | years and older | |
| real-time | other mobile | who do not | |
| patient data | devices. | have an | |
| from the | • The software | emergency | |
| monitored | also supports | health care | |
| system; | communication | condition. | |
| 7. To provide | between patients | ||
| a request | and caregivers or | • Data can be | |
| for remote | researchers, such | sent via | |
| consultation | as bidirectional | intranet | |
| audio and video | networks, the | ||
| regarding a | e-visits, telephone | internet, | |
| patient's | and mobile text | landline | |
| waveform | messaging. | telephones, | |
| cellular |
11
| | | | | | | | cannot be at the
hospital | by physicians who wish
to monitor and interact
with patients remotely. | by physicians who
wish to monitor and
interact with patients
remotely. | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------------------------------|------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------------------------------------------------------|-----|-----|-----|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | or other
data. | The
VitalCaregiving
System II is not
intended for use
in emergency
situations or by a
patient in an acute
care medical
facility and is not
for active patient
monitoring. | telephones, and
other mobile
devices.
• The software
supports
communication
between
patients and
clinicians,
caregivers, or
researchers,
such as
through
bidirectional
audio and
video e-visits,
telephone calls,
and mobile text
messages.
CareConsole is
intended for
use in
capturing
remote patient
monitoring
data from non-
invasive
remote
monitoring
devices and to
provide remote
hospital-at-
home level of
care where
determined
necessary by a
health care
professional.
CareConsole is
not intended
for use in
emergency
situations or by
a patient in an
acute care
medical
facility, and
CareConsole is
not for active
patient
monitoring. | Available over
the counter | No | No | No | No | | | | | |
| Intended Users | | Patients and
physicians | | Clinicians,
when they | | Caregivers and patients at
home or in a non-acute | care medical facility, and | Caregivers and
patients at home or in | a medical facility, and | Standard 60601-
2-47 Medical
Electrical
Equipment | N/A | N/A | N/A | "This standard does
not apply to systems
that do not
continuously record
and analyze the ECG
(for example,
'intermittent event
recorders')."
The CareConsole does
not continuously
record and analyze
ECG. |
| Standard EC53
ECG Trunk
Cables and
Patient
Leadwires | N/A | N/A | N/A | The CareConsole does
not use any ECG trunk
cables or Patient lead
wires. There is no
electrical connection
to the patient. | | | | | | | | | | |
| Standard 11073-
10406 Health
Informatics | N/A | N/A | N/A | The CareConsole is
not a basic 1- to 3-lead
ECG. | | | | | | | | | | |
| Clinicians,
researchers, care
coordinators,
patients and their
informal
caregiver(s) can
securely access
the information
hub and/or
mobile
application via
the Internet by
using a unique
username and
strong password | Yes | Yes | Yes | Yes: Clinicians,
researchers, care
coordinators, patients
and their informal
caregiver(s) can
securely access the
information hub and/or
mobile application via
the Internet by using a
unique username and
strong password | | | | | | | | | | |
| Data
Acquisition:
Medical device
data is obtained
from a patient's
device through
several potential
gateways, such
as the wired or
wireless modem,
a mobile phone
or tablet, a
cellular-enabled | Yes | Yes | Yes | Yes, and in addition,
AMC has established
pathways for each
gateway to extract data
from the medical
device and input it into
AMC's cloud-based
data center. | | | | | | | | | | |
12
13
| medical device
or a partner
service
| application. | ||||
|---|---|---|---|---|
| Data | ||||
| Transmission: | ||||
| medical device | ||||
| data is securely | ||||
| transferred via | ||||
| Internet between | ||||
| providers and | ||||
| the hub. | Yes | Yes | Yes | Yes, in addition, AMC |
| used an encrypted | ||||
| transport technology | ||||
| with redundant, private | ||||
| connections between | ||||
| the network providers | ||||
| and AMC's cloud- | ||||
| based data center. | ||||
| Data | ||||
| Storage/Access: | ||||
| Securely stores | ||||
| and manages | ||||
| encrypted patient | ||||
| measurements | ||||
| medical device | ||||
| data is available | ||||
| through the | ||||
| interface of | ||||
| choice for the | ||||
| patient, | ||||
| physicians, or | ||||
| other partners to | ||||
| securely access | ||||
| the patient's | ||||
| information. | Yes | Yes | Yes | Yes, in addition, after |
| the AMC Platform has | ||||
| received the | ||||
| transmission, the | ||||
| patient's information | ||||
| is available in a | ||||
| number of tabular and | ||||
| graphical views, | ||||
| providing a detailed | ||||
| analysis of the data. | ||||
| The patient's | ||||
| caregiver(s) utilize | ||||
| these analyses to | ||||
| evaluate the patient's | ||||
| health status. | ||||
| Patient | ||||
| Engagement: | ||||
| The system | ||||
| facilitates | ||||
| interactive | ||||
| patient | ||||
| engagement via | ||||
| several potential | ||||
| gateways, such | ||||
| as secure | ||||
| messaging, | ||||
| interactive voice | ||||
| and video | ||||
| response | ||||
| (IVVR). | Yes | Yes | Yes | Yes, in addition AMC |
| provides for | ||||
| interactive eVisits | ||||
| between patient/ | ||||
| caregiver and | ||||
| clinician. Generates | ||||
| alerts, notifications, | ||||
| reports and dashboards | ||||
| for patients and | ||||
| authorized caregivers. | ||||
| Patients and caregivers | ||||
| can both enter | ||||
| information into the | ||||
| patient record via | ||||
| mobile and web user | ||||
| interfaces. All user | ||||
| interactions are logged | ||||
| with rich meta-data | ||||
| audit. | ||||
| Data Integration | Yes | Yes | Yes | Yes: On a scheduled |
| or near real-time basis, | ||||
| the system securely | ||||
| transfers patient | ||||
| information to 3rd | ||||
| party applications, | ||||
| such as electronic |
14
| | | personal health records
(PHR) and electronic
data capture (EDC) |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | | |
| Third Party Measurement Devices (reference devices) | Physiological Measurements Obtained and Verified by Subject Device from Third-Party Device | Non-Physiological Measurements Obtained by Subject Device from Third-Party Device |
| The Subject Device has been Tested with the Following Third-Party Devices: | | |
| 1. A&D UA-767PBT-Ci | Systolic pressure; diastolic pressure; pulse rate | |
| 2. A&D UA-767PBT-CiV | Systolic pressure; diastolic pressure; pulse rate | |
| 3. A&D UA-651BLE | Systolic pressure; diastolic pressure; pulse rate | |
| 4. A&D UA-651BLE-V | Systolic pressure; diastolic pressure; pulse rate | |
| 5. Welch Allyn RPM-BP100 1500 Series | Systolic pressure; diastolic pressure; pulse rate | |
| 6. Welch Allyn H-BP100SBP 1700 Series | Systolic pressure; diastolic pressure; pulse rate | |
| 7. A&D UC-351PBT-Ci | Weight | |
| 8. A&D UC-352PBT-Ci | Weight | |
| 9. A&D UC-355PBT-Ci | Weight | |
| 10. A&D UC-356BLE | Weight | |
| 11. ForaCare TNG-550 | Weight | |
| 12. Omron HN-290T | Weight | |
| 13. Welch Allyn RPM-Scale100 | Weight | |
| 14. Foracare IR20b | Thermometer | |
| 15. Foracare IR20b BLE | Thermometer | |
| 16. ChoiceMMed MD300C318T2 O2 Sensor | Oxygen saturation; pulse rate; | |
| 17. ChoiceMMed MD300C1218 | Oxygen saturation; pulse rate; | |
| 18. Nonin 3230 Pulse ox | Oxygen saturation; pulse rate; | |
| 19. Nonin 9560 Pulse ox | Oxygen saturation; pulse rate; | |
| 20. Propeller Health Inhaler Monitor for Metered Dose Inhalers | n/a | Medication (i.e. puff) dispensed |
| 21. Propeller Health Inhaler Monitor
for Respimat | n/a | Medication (i.e. puff)
dispensed |
| 22. Propeller Health Inhaler Monitor
for Discus Inhalers | n/a | Medication (i.e. puff)
dispensed |
| 23. Propeller Health Inhaler Monitor
for Ellipta Inhalers | n/a | Medication (i.e. puff)
dispensed |
| 24. Propeller Health Inhaler Monitor
for Symbicort Inhalers | n/a | Medication (i.e. puff)
dispensed |
| 25. Coag-sense PT2 | PT/INR | |
| 26. Coag-Sense PT3 | PT/INR | |
| 27. Mytrex MXD-LTE PERS | n/a | PERS unit activated |
| 28. Mytrex MXD PERS | n/a | PERS unit activated |
| 29. Securatrac MD4 mPERS | n/a | PERS unit activated |
| 30. H3G-900 GATEWAY | n/a | |
| 31. H3G-980 GATEWAY | n/a | |
| 32. H3G-1000 GATEWAY | n/a | |
| 33. H3G-1100 Gateway | n/a | |
| 34. Insung HH-800a Hub | n/a | |
| 35. Insung HH-930 Hub | n/a | |
| 36. H3 BA-110 (Nipro) Glucose
Meter Adaptor | Glucose level | |
| 37. H3 BA-110 (Bayer) Glucose
Meter Adaptor | Glucose level | |
| 38. H3 BA-110 (Abbott) Glucose
Meter Adaptor | Glucose level | |
| 39. H3 BA-110 (Roche) Glucose
Meter Adaptor | Glucose level | |
| 40. H3 BA-400 Glucose Meter
Adaptor | Glucose level | |
| 41. Vitalograph Lung Monitor | FEV1/FEV6 | |
15
16
17
| CareConsole Compatibility with Third-Party Devices | ||
|---|---|---|
| Third-Party Measuring | ||
| Device | Samsung Note 2 | Samsung Note 3 |
| BA-110 J&J GMA | Third-Party Measuring | |
| Device is compatible with | ||
| all uses of CareConsole run | ||
| on Samsung Note 2, | ||
| including biometric data | ||
| collection. | Third-Party Measuring Device is | |
| not compatible with CareConsole | ||
| run on Samsung Note 3 for | ||
| biometric data collection. |
Third-Party Measuring Device is
compatible with CareConsole run
on Samsung Note 3 for eVisit,
eMessage, and Mobile Surveys
only. |
| One Touch Ultra | | |
| One Touch UltraII | | |
| One Touch UltraMini | | |
| BA-110 Abbot GMA | | |
| FreeStyle Lite | | |
| FreeStyle Lite Freedom
Lite | | |
| BA-110 Bayer GMA | | |
| Contour | | |
| Contour Next | | |
| A&D 767PBT-Ci Blood
Pressure Device | | |
| A&D 351-PBT-ci Weight
scale | | |
| Choicemed MD300C318T2
Pulse Oximeter | | |
Performance:
The CareConsole is a software only device and the validation and verification testing were performed under the company's Design Control Process. This device meets all necessary software verification requirements in 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The testing has confirmed the device's conformity with specifications do not include any significant differences from those of the predicates.
Conclusion:
The CareConsole has the same intended use as the predicate devices. As can be seen from the comparison data and evaluations, the technology and performance characteristics for the CareConsole are also the same as the predicate. The CareConsole is substantially equivalent to the predicate.