AMC Health VitalCaregiving System

K151839 · Amc Health · MWI · Sep 9, 2016 · Cardiovascular

Device Facts

Record IDK151839
Device NameAMC Health VitalCaregiving System
ApplicantAmc Health
Product CodeMWI · Cardiovascular
Decision DateSep 9, 2016
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.2300
Device ClassClass 2
AttributesSoftware as a Medical Device

Intended Use

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 for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient informations/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition. Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices. The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging. 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.

Device Story

Software-only remote patient monitoring system; collects biometric data from third-party devices, patient-reported outcomes via questionnaires, and facilitates bidirectional audio/video e-visits, text, and telephone communication. Data transmitted via internet, intranet, landline, or cellular networks to a cloud-based data center. Clinicians access data via a central electronic log to view reports, trends, and alerts; clinicians determine response protocols. System enables remote interaction between patients and clinicians/caregivers. Benefits include improved management of non-acute conditions through scheduled monitoring and enhanced patient-clinician communication. Used in home or non-acute medical facilities; operated by patients and clinicians.

Clinical Evidence

Bench testing only. Verification and validation performed under Design Control Process per 21 CFR 820.30(f) and (g). Testing confirmed conformance to specifications and software requirements.

Technological Characteristics

Software-only device. Cloud-based data center architecture. Connectivity via intranet, internet, landline, and cellular. Supports bidirectional audio/video, text, and telephone. Integrates with third-party biometric devices via gateways. No electrical connection to patient. Not a continuous ECG monitor.

Indications for Use

Indicated for adults 18+ with non-acute conditions for clinician-scheduled remote monitoring of biometric data, patient-reported outcomes, and self-care activities. Not for emergency use or active patient monitoring in acute care facilities.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2016 AMC Health Jonathan Shankman Sr. VP. Clinical Innovation 39 Broadway, Suite 540 New York, New York 10006 Re: K151839 Trade/Device Name: AMC Health VitalCaregiving System II Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: July 1, 2015 Received: July 6, 2015 Dear Jonathan Shankman: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Mada Jellman 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) K151839 Device Name AMC Health VitalCaregiving System II #### Indications for Use (Describe) 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 for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient informations/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition. · Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices. · The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging. 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. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------|----------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(K) SUMMARY Prepared September 8, 2016 Submitted by: Jonathan Shankman Contact Person: Jonathan Shankman Telephone: 212-422-3037 Email: jshankman@amchealth.com Product Name: AMC Health VitalCaregiving System II Common Name: Patient Monitoring System Classification: Cardiovascular, MWI, 21 CFR 870.2300; DXH, 21 CFR 870.2920 Predicate Device: Advanced Monitored Caregiving VitalCaregiving System and AirStrip Remote Patient Monitoring #### Intended Use: The AMC Health VitalCaregiving System II is a software-only device used alongside vital signs monitoring devices for data storage, collection and transmission. #### Indications for Use: 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 scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II 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 authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition. - Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices. • The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging. The VitalCaregiving System II is not intended for use in emergency situations or by a {4}------------------------------------------------ # K151839 patient in an acute care medical facility and is not for active patient monitoring. #### Device Description: The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is a software only device. VitalCaregiving System II 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 clinician. Clinicians can also use VitalCaregiving System II 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. #### COMPARISON TABLE The following table provides a comparison of indications for use, technological characteristics, and functionality. | | Predicate Device: | Predicate Device: | Subject Device: | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Advanced Monitored Caregiving | AirStrip RPM Epiphany | AMC Health | | | VitalCaregiving System I | Adapter | VitalCaregiving System II | | 510(k) Number | K051544 | K133450 | | | FDA Classification | Transmitters And Receivers, | Monitor, Physiological, | Transmitters And | | | Electrocardiograph, Telephone | Patient (Without | Receivers, | | | | Arrhythmia Detection Or | Electrocardiograph, | | | | Alarms) | Telephone; Monitor, | | | | | Physiological, Patient | | | | | (Without Arrhythmia | | | | | Detection or Alarms) | | Classification<br>Code | DXH | MWI | MWI; DXH | | Regulation<br>Number | 870.2920 | 870.2300 | 870.2300; 870.2920 | | Intended Use | The Advanced Monitored Care<br>( | | | | | | | | | | the measured parameters from a<br>patient's home to a central computer<br>via an intermediary organization,<br>where reports can be generated for<br>the physician and data can be<br>reviewed over the Internet by<br>physicians and patients. | information is generated<br>by other medical devices<br>and patient information<br>system, and not by AirStrip<br>RPM. AirStrip RPM<br>captures this information<br>from these other systems<br>and displays it for<br>clinicians. | monitoring devices for<br>data storage, collection<br>and transmission. | | Indication for Use | The Advanced Monitored Care<br>("AMC") System is intended to be<br>used in conjunction with home<br>patient measuring devices to send<br>the measured parameters from a<br>patient's home to a central computer<br>via an intermediary organization,<br>where reports can be generated for<br>the physician and data can be<br>reviewed over the Internet by<br>physicians and patients. | AirStrip RPM is intended to<br>be used by clinicians for<br>the following purposes:<br>1. By using a cellular<br>telephone or other<br>device on which<br>AirStrip RPM is<br>installed, to review<br>physiologic data of a<br>patient when the<br>clinician is not at the<br>hospital;<br>2. To view the near real-<br>time waveforms<br>remotely;<br>3. To remotely review<br>other standard or<br>critical near real-time<br>patient data from the<br>monitored system;<br>To provide a request for<br>remote consultation<br>regarding a patient's<br>waveform or other data.<br>AirStrip RPM is software<br>capable of displaying<br>physiologic and other<br>patient information. This<br>information is generated<br>by other medical devices<br>and patient information<br>system, and not by AirStrip<br>RPM. AirStrip RPM<br>captures this information<br>from these other systems<br>and displays it for<br>clinicians.<br>AirStrip RPM is intended to<br>be used by clinicians for<br>the following purposes:<br>4. By using a cellular | The AMC Health<br>VitalCaregiving<br>System II<br>("VitalCaregiving<br>System II") is<br>intended to be<br>used in<br>conjunction with<br>biometric<br>measuring<br>devices, mobile<br>applications and<br>questionnaires to<br>collect and store<br>data, and for<br>clinician scheduled<br>monitoring at<br>home and in non- | | | | telephone or other | acute medical | | | | device on which | facilities. The | | | | AirStrip RPM is | VitalCaregiving | | | | installed, to review | System II securely | | | | physiologic data of a | sends data from a | | | | patient when the | patient monitoring | | | | clinician is not at the | device to a central | | | | hospital; | electronic log of | | | 5. | To view the near real- | patient | | | | time waveforms | information, from | | | | remotely; | which | | | 6. | To remotely review | notifications/alerts | | | | other standard or | and reports can be | | | | critical near real-time | generated and | | | | patient data from the | data can be | | | | monitored system; | securely viewed by | | | 7. | To provide a request…
Innolitics
510(k) Summary
Decision Summary
Classification Order
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