(344 days)
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.
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 provided text describes the regulatory clearance of the AMC Health CareConsole, a software-only device for remote patient monitoring. However, it does not contain specific details about acceptance criteria, the methodology of a study proving the device meets those criteria, or performance metrics from such a study.
The document mainly focuses on:
- Regulatory information: FDA clearance, regulation numbers, product codes, and general controls.
- Device description and intended use: How CareConsole functions (collects, stores, and transmits biometric data, facilitates communication) and its target users (individuals 12+, not for emergency situations).
- Predicate devices comparison: It asserts the substantial equivalence of the CareConsole to its predicate devices in terms of intended use and technological specifications, mainly through a comparison table.
- Compatibility with third-party devices: A list of integrated biometric devices.
- General statement on performance: Mentions that "validation and verification testing were performed under the company's Design Control Process" and "The testing has confirmed the device's conformity with specifications."
Therefore, based only on the provided text, I cannot complete the requested information about acceptance criteria and detailed study results. The document states that performance validation was done to meet regulatory requirements but does not provide the specifics of that validation.
Here's what I can extract or infer, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from general statements) | Reported Device Performance (Explicitly Stated / Inferred from "conformity") |
|---|---|
| Conformity with specifications (Functional, Performance) | "The testing has confirmed the device's conformity with specifications" |
| Meeting software verification requirements (21 CFR 820.3(z) and (aa) and 820.30(f) and (g)) | Device meets these requirements as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." |
| Data acquisition from third-party devices | "Established pathways for each gateway to extract data from the medical device and input it into AMC's cloud-based data center." |
| Secure data transmission via Internet | "Used an encrypted transport technology with redundant, private connections between the network providers and AMC's cloud-based data center." |
| Secure data storage/access for patient info | "Patient's information is available in a number of tabular and graphical views, providing a detailed analysis of the data." |
| Patient engagement features (messaging, e-visits) | "Provides for interactive eVisits between patient/caregiver and clinician. Generates alerts, notifications, reports and dashboards." |
| Data integration with 3rd party applications | "Securely transfers patient information to 3rd party applications, such as electronic personal health records (PHR) and electronic data capture (EDC)." |
Missing: Specific quantitative acceptance criteria or performance metrics (e.g., accuracy percentages, latency times, success rates for data transmission, etc.). The document states that testing confirmed conformity but doesn't provide the results of that conformity testing.
2. Sample size used for the test set and the data provenance:
- Missing: No information on specific sample sizes for any test sets.
- Data Provenance: Not specified (e.g., country of origin). The document implies the data is gathered remotely from patients using the system. It states "The CareConsole platform securely sends data from a patient monitoring device to a central electronic log of patient information." and lists various third-party devices, suggesting data would come from these sources. It's unclear if a specific "test set" with a defined provenance was used for a formal clinical performance study, or if "testing" refers to internal software validation.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: The document does not describe a study involving expert readers/evaluators for establishing ground truth, as it is a data aggregation and communication platform, not an AI diagnostic imaging device. The "ground truth" here would relate to the successful and accurate transfer, storage, and display of biometric data. The closest mention of experts is "Clinicians," "healthcare professionals," and "authorized caregivers" who view the data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable or not described, as the device is not an imaging AI requiring multiple reader adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Missing: Not applicable. The CareConsole is a data management and communication system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially Addressed/Inferred: The device is "software only." Its primary function is automated data collection, transmission, storage, and presentation. Thus, its core performance is "standalone" in terms of these automated processes. The "human-in-the-loop" aspect comes in with clinicians viewing the data and interacting with patients, but the device's fundamental data handling is algorithmic. However, there are no specific standalone performance metrics provided (e.g., "algorithm achieved X% accuracy in data transmission"). The document states the "testing has confirmed the device's conformity with specifications."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For a device like CareConsole, the "ground truth" would likely be the accuracy and integrity of the data captured from the third-party devices, its faithful transmission, secure storage, and correct display. This would typically be verified against the direct output of the connected biometric device or a known, verified standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's technical performance.
8. The sample size for the training set:
- Missing: No information provided about a training set, as this is a traditional software system, not described as a machine learning/AI model that typically requires a distinct training set. The "testing" mentioned refers to software verification and validation.
9. How the ground truth for the training set was established:
- Missing: Not applicable, as no training set for an AI model is described.
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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"
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(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).
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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
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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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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.
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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.
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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
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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
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COMPARISON TABLE
The following table provides a comparison of indications for use, technological
characteristics, and functionality.
| Predicate Device:AdvancedMonitoredCaregivingVitalCaregivingSystem I | Predicate Device:AirStrip RPMEpiphanyAdapter | Predicate Device:AMC HealthVitalCaregiving SystemII | Subject Device:AMC HealthCareConsole | ||
|---|---|---|---|---|---|
| 510(k) Number | K051544 | K133450 | K151839 | ||
| FDAClassification | Transmitters AndReceivers,Electrocardiograph,Telephone | Monitor,Physiological,Patient (WithoutArrhythmiaDetection OrAlarms) | Transmitters AndReceivers,Electrocardiograph,Telephone; Monitor,Physiological, Patient(Without ArrhythmiaDetection or Alarms) | Transmitters AndReceivers,Electrocardiograph,Telephone; Monitor,Physiological, Patient(Without ArrhythmiaDetection or Alarms) | |
| ClassificationCode | DXH | MWI | MWI; DXH | MWI; DXH | |
| RegulationNumber | 870.2920 | 870.2300 | 870.2300; 870.2920 | 870.2300; 870.2920 | |
| Intended Use | The AdvancedMonitored Care("AMC") System isintended to be usedin conjunction withhome patientmeasuring devicesto send themeasuredparameters from apatient's home to acentral computervia an intermediaryorganization,where reports canbe generated forthe physician anddata can bereviewed over theInternet byphysicians andpatients. | AirStrip RPM issoftwarecapable ofdisplayingphysiologic andother patientinformation.Thisinformation isgenerated byother medicaldevices andpatientinformationsystem, and notby AirStripRPM. AirStripRPM capturesthis informationfrom these othersystems anddisplays it forclinicians.AirStrip RPM isintended to beused byclinicians forthe followingpurposes: | AMC HealthVitalCaregiving System IIis a software-only deviceused alongside vital signsmonitoring devices fordata storage, collectionand transmission. | The AMC HealthCareConsole is asoftware-only deviceused alongside vitalsigns monitoringdevices for trackingactivities andmedications and fordata storage,collection, andtransmission. | |
| Indication for Use | The Advanced Monitored Care("AMC") System isintended to be usedin conjunction withhome patientmeasuring devicesto send themeasuredparameters from apatient's home to acentral computervia an intermediaryorganization,where reports canbe generated for | telephoneor otherdevice onwhichAirStripRPM isinstalled, toreviewphysiologicdata of apatientwhen theclinician isnot at thehospital;2. To view thenear real-timewaveformsremotely;3. Toremotelyreviewotherstandard orcritical nearreal-timepatient datafrom themonitoredsystem;To provide arequest forremoteconsultationregarding apatient'swaveform orother data. | AirStrip RPM issoftwarecapable ofdisplayingphysiologic andother patientinformation.Thisinformation isgenerated byother medicaldevices andpatientinformationsystem, and notby AirStrip | The AMC HealthVitalCaregivingSystem II("VitalCaregivingSystem II") isintended to beused inconjunction withbiometricmeasuringdevices, mobileapplications andquestionnaires tocollect and storedata, and forclinician | TheCareConsole isintended to beused inconjunctionwith biometrichealth caremeasuringdevices,mobileapplications,andquestionnairesto collect andstore data, andfor clinician |
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| 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 viewedby 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 |
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| cannot be at thehospital | by physicians who wishto monitor and interactwith patients remotely. | by physicians whowish to monitor andinteract with patientsremotely. | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| or otherdata. | TheVitalCaregivingSystem II is notintended for usein emergencysituations or by apatient in an acutecare medicalfacility and is notfor active patientmonitoring. | telephones, andother mobiledevices.• The softwaresupportscommunicationbetweenpatients andclinicians,caregivers, orresearchers,such asthroughbidirectionalaudio andvideo e-visits,telephone calls,and mobile textmessages.CareConsole isintended foruse incapturingremote patientmonitoringdata from non-invasiveremotemonitoringdevices and toprovide remotehospital-at-home level ofcare wheredeterminednecessary by ahealth careprofessional.CareConsole isnot intendedfor use inemergencysituations or bya patient in anacute caremedicalfacility, andCareConsole isnot for activepatientmonitoring. | Available overthe counter | No | No | No | No | |||||||
| Intended Users | Patients andphysicians | Clinicians,when they | Caregivers and patients athome or in a non-acute | care medical facility, and | Caregivers andpatients at home or in | a medical facility, and | Standard 60601-2-47 MedicalElectricalEquipment | N/A | N/A | N/A | "This standard doesnot apply to systemsthat do notcontinuously recordand analyze the ECG(for example,'intermittent eventrecorders')."The CareConsole doesnot continuouslyrecord and analyzeECG. | |||
| Standard EC53ECG TrunkCables andPatientLeadwires | N/A | N/A | N/A | The CareConsole doesnot use any ECG trunkcables or Patient leadwires. There is noelectrical connectionto the patient. | ||||||||||
| Standard 11073-10406 HealthInformatics | N/A | N/A | N/A | The CareConsole isnot a basic 1- to 3-leadECG. | ||||||||||
| Clinicians,researchers, carecoordinators,patients and theirinformalcaregiver(s) cansecurely accessthe informationhub and/ormobileapplication viathe Internet byusing a uniqueusername andstrong password | Yes | Yes | Yes | Yes: Clinicians,researchers, carecoordinators, patientsand their informalcaregiver(s) cansecurely access theinformation hub and/ormobile application viathe Internet by using aunique username andstrong password | ||||||||||
| DataAcquisition:Medical devicedata is obtainedfrom a patient'sdevice throughseveral potentialgateways, suchas the wired orwireless modem,a mobile phoneor tablet, acellular-enabled | Yes | Yes | Yes | Yes, and in addition,AMC has establishedpathways for eachgateway to extract datafrom the medicaldevice and input it intoAMC's cloud-baseddata center. |
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| medical deviceor a partnerserviceapplication. | ||||
|---|---|---|---|---|
| DataTransmission:medical devicedata is securelytransferred viaInternet betweenproviders andthe hub. | Yes | Yes | Yes | Yes, in addition, AMCused an encryptedtransport technologywith redundant, privateconnections betweenthe network providersand AMC's cloud-based data center. |
| DataStorage/Access:Securely storesand managesencrypted patientmeasurementsmedical devicedata is availablethrough theinterface ofchoice for thepatient,physicians, orother partners tosecurely accessthe patient'sinformation. | Yes | Yes | Yes | Yes, in addition, afterthe AMC Platform hasreceived thetransmission, thepatient's informationis available in anumber of tabular andgraphical views,providing a detailedanalysis of the data.The patient'scaregiver(s) utilizethese analyses toevaluate the patient'shealth status. |
| PatientEngagement:The systemfacilitatesinteractivepatientengagement viaseveral potentialgateways, suchas securemessaging,interactive voiceand videoresponse(IVVR). | Yes | Yes | Yes | Yes, in addition AMCprovides forinteractive eVisitsbetween patient/caregiver andclinician. Generatesalerts, notifications,reports and dashboardsfor patients andauthorized caregivers.Patients and caregiverscan both enterinformation into thepatient record viamobile and web userinterfaces. All userinteractions are loggedwith rich meta-dataaudit. |
| Data Integration | Yes | Yes | Yes | Yes: On a scheduledor near real-time basis,the system securelytransfers patientinformation to 3rdparty applications,such as electronic |
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| personal health records(PHR) and electronicdata 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 Monitorfor Respimat | n/a | Medication (i.e. puff)dispensed |
| 22. Propeller Health Inhaler Monitorfor Discus Inhalers | n/a | Medication (i.e. puff)dispensed |
| 23. Propeller Health Inhaler Monitorfor Ellipta Inhalers | n/a | Medication (i.e. puff)dispensed |
| 24. Propeller Health Inhaler Monitorfor 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) GlucoseMeter Adaptor | Glucose level | |
| 37. H3 BA-110 (Bayer) GlucoseMeter Adaptor | Glucose level | |
| 38. H3 BA-110 (Abbott) GlucoseMeter Adaptor | Glucose level | |
| 39. H3 BA-110 (Roche) GlucoseMeter Adaptor | Glucose level | |
| 40. H3 BA-400 Glucose MeterAdaptor | Glucose level | |
| 41. Vitalograph Lung Monitor | FEV1/FEV6 |
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| CareConsole Compatibility with Third-Party Devices | ||
|---|---|---|
| Third-Party MeasuringDevice | Samsung Note 2 | Samsung Note 3 |
| BA-110 J&J GMA | Third-Party MeasuringDevice is compatible withall uses of CareConsole runon Samsung Note 2,including biometric datacollection. | Third-Party Measuring Device isnot compatible with CareConsolerun on Samsung Note 3 forbiometric data collection.Third-Party Measuring Device iscompatible with CareConsole runon Samsung Note 3 for eVisit,eMessage, and Mobile Surveysonly. |
| One Touch Ultra | ||
| One Touch UltraII | ||
| One Touch UltraMini | ||
| BA-110 Abbot GMA | ||
| FreeStyle Lite | ||
| FreeStyle Lite FreedomLite | ||
| BA-110 Bayer GMA | ||
| Contour | ||
| Contour Next | ||
| A&D 767PBT-Ci BloodPressure Device | ||
| A&D 351-PBT-ci Weightscale | ||
| Choicemed MD300C318T2Pulse 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.
§ 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).