(177 days)
No reference devices were used in this submission.
No
The summary describes a data aggregation and display system for remote patient monitoring, without mentioning any AI/ML capabilities for analysis or interpretation.
No.
The description explicitly states, "Zyter RPM is not intended to directly diagnose or treat patients or to be used in the prevention of a disease or condition." Instead, it provides an interface for monitoring patient data and alerts from other medical devices, serving as a data aggregation and display tool rather than a therapeutic intervention itself.
No
The text explicitly states: "Zyter RPM is not intended to be used for diagnostic purposes." and "Information provided by the Zyter RPM software is not intended for diagnosis or active patient monitoring where immediate action is required."
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and a "software product" that "cannot come into physical contact with patients." While it interacts with hardware devices, the 510(k) summary focuses on the software's function of receiving, aggregating, processing, distributing, and displaying data, and does not describe any hardware components of the Zyter RPM itself.
Based on the provided text, the Zyter RPM is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Zyter RPM is not intended to be used for diagnostic purposes."
- Nature of Data: The device collects and transmits physiological data from other medical devices (blood pressure, glucose, temperature, weight, pulse oximetry). This is in vivo data (from within the living body), not in vitro data (from samples taken from the body, like blood or urine).
- Function: The primary function is data aggregation, routing, display, and notification. It does not perform any tests on biological samples to diagnose a condition.
- Comparison to Predicates: The predicate devices listed (BoxView Smart Alarm Interface and EarlySense Central Display Station) are also systems for monitoring and displaying physiological data, not IVD devices.
Therefore, the Zyter RPM falls under the category of a remote patient monitoring system or a medical device data system (MDDS), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient's healthcare provider.
Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations.
Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
Zyter RPM is a Software as a Medical Device (SaMD) intended to provide healthcare professionals with supplemental information about events and alerts originating from medical devices, or other event or alert producing systems within a clinical or home setting. This device can route notifications including all or a subset of the event or alert information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
Zyter RPM is intended to provide remote central monitoring and display of information as recorded by multiple specifically compatible FDA cleared devices on a central screen and to provider alert and alert notifications on the screen and to other provider devices.
The Zyter RPM software application will receive, aggregate, process, distribute and display parameters, alerts, and events at locations other than at the patient for multiple patients.
Information provided by the Zyter RPM software is not intended for diagnosis or active patient monitoring where immediate action is required.
Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alert notification is the device or system producing the alert or event.
Zyter RPM is not intended to directly diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Zyter RPM come into direct contact with patients.
Zyter RPM serves as a convenient user interface to integrate data and provide health care professionals the ability to access and monitor parameters of devices and data that have been cleared by the FDA. Zyter RPM does not affect the intended use, or alter the indications for use, for the cleared devices with which it is intended to function.
The Zyter RPM has two separate user interfaces: one is the provider web application and the second is the patient mobile application. The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.
Zyter RPM is comprised of two main components:
- Mobile App (for patient users)
- Web App (for healthcare provider users)
The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.
The patient-user is provided with a pre-configured Zyter Tablet for remote health monitoring. The patientuser may also choose to use their own smartphone and download the Zyter Mobile App. The patient is also assigned a number of health devices by their healthcare provider. The patient-user is responsible for connecting the health devices to the Zyter Tablet (or mobile phone). Pairing of the health devices with the tablet (or mobile phone) ensures wireless communication between both devices. Instructions for connecting health devices to the patient mobile app are included in the patient app guide. Zyter RPM mobile application also has a functionality that allows the patient to schedule a tele-visit with their healthcare provider. The patient may choose to take a self-assessment questionnaire found in the Zyter RPM prior to scheduling a visit.
Zyter RPM is a digital healthcare platform that automatically collects and routes data from the patient's pre-configured, compatible, at-home medical devices (blood pressure cuffs, glucometers, thermometers, digital weight scales, and smart watches) to the hospital office via a 4G cellular or Wireless connection.
The health devices are configured to a user in the Zyter user management using the Device Mac address. Zyter validation algorithm doesn't allow the duplicate Mac address entries. Zyter RPM provides patients with Tablets pre-installed with Zyter mobile application. Users connect with the wireless health devices through the mobile app. Zyter also supports BYOD model where patients use their own mobile devices to install the Zyter app from the App store and Google Play store to connect with the wireless devices.
Zyter RPM supports two transmission protocols, device data transmission through Bluetooth technology where the Bluetooth device needs to be paired with the mobile app and the 4G/LTE devices where the device data is transmitted to Zyter via device cloud via APIs and no device pairing required.
Zyter RPM achieves EMR connectivity using on-prem or on-cloud solutions.
The vitals reading from the health devices are securely processed through device SDKs/APIs and they are accessed through the patient and provider RPM dashboard. The Zyter RPM Dashboard enables the monitoring of multiple patients with an information tab for each patient. All physiological patient data, plus alerts and notifications from each patient's RPM devices, go directly to the dashboard for physician review, as well as intervention via a telehealth virtual visit if a patient's readings are out of the normal range.
Physicians can also configure alerts for custom parameters of device readings for individual patients. Zyter RPM devices also send alerts to the physician dashboard, email and SMS, and a reminder to the patient's Zyter RPM app, if a device has been dormant for a pre-determined amount of time.
Physicians can set a Zyter RPM alert based on any patient device reading that is out of range. Depending on the device(s) the patient receives, alert ranges can be set to measure the following values:
- BP (Systolic), mmHg
- BP (Diastolic), mmHg
- Pulse Oximeter, % Sp02
- Temperature, Fº or Cº
- Weight Scale, lbs
- Blood Glucose, mmoI/L
Zyter RPM is compatible with the following medical devices and accessories:
- BodyTrace Blood Pressure Monitor (K131395)
- iHealth BP Monitor - iHealth Track (KN550BT) (K160014)
- BodyTrace Weighing Scale (N/A - Wellness device)
- iHealth Weighing Scale (N/A - Wellness device)
- Smart Meter iGlucose Blood Glucose Monitor Starter Kit (K161790)
- iHealth Blood Glucose - iHealth Gluco + (BG5s): (K181070)
- iHealth Thermometer PT3 (K202753)
- iHealth Air Pulse Oximeter - iHealth Air (PO3M): (K131111)
- Nonin Pulse Oximeter (K131021)
- Apple Health Kit (N/A - Apple Health System)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.
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)
Performance testing of the Zyter RPM included:
- Risk Analysis
- Software verification and validation
- Performance bench testing
Performance testing done on number of concurrent transaction (readings from device or alerts generated from a reading) APIs can handle within a stipulated interval. The transactions are stimulated through auto scripts to the test the server capacity to identify when the application performance begins to degrade.
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.
No reference devices were used in this submission.
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
February 11, 2022
Zyter, Inc. % Mary Vater 510(k) Consultant Medical Device Academy, Inc 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K212622
Trade/Device Name: Zyter RPM Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX Dated: August 17, 2021 Received: August 18, 2021
Dear Mary Vater:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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).
Sincerely,
for
Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212622
Device Name Zyter RPM
Indications for Use (Describe)
The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient's healthcare provider.
Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations.
Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
l. SUBMITTER Zyter, Inc. 2600 Tower Oaks Blvd. Suite 700 Rockville, MD 20852 Tel: +1.301.355.7760 Fax: N/A
Contact Person: Mary Vater, 510(k) Consultant Date Prepared: January 6, 2022
| II. DEVICE | |
|---|---|
| 510(K) Number: | K212622 |
| Name of Device: | Zyter RPM |
| Classification Name: | Cardiac Monitor (including cardiotachometer) |
| Regulation: | 21 CFR §870.2300 |
| Regulatory Class: | Class II |
| Product Classification Code: | MSX |
| III. PREDICATE DEVICE | |
|---|---|
| Primary Predicate Manufacturer: | BoxView, LLC |
| Primary Predicate Trade Name: | BoxView Smart Alarm Interface (SAI), Model SA-01 |
| Primary Predicate 510(k): | K193421 |
| Secondary Predicate Manufacturer: | EARLYSENSE LTD. |
| Secondary Predicate Trade Name: | EarlySense Central Display Station (CDS) |
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Secondary Predicate 510(k):
Zyter RPM is a Software as a Medical Device (SaMD) intended to provide healthcare professionals with supplemental information about events and alerts originating from medical devices, or other event or alert producing systems within a clinical or home setting. This device can route notifications including all or a subset of the event or alert information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.
Zyter RPM is intended to provide remote central monitoring and display of information as recorded by multiple specifically compatible FDA cleared devices on a central screen and to provider alert and alert notifications on the screen and to other provider devices.
The Zyter RPM software application will receive, aggregate, process, distribute and display parameters, alerts, and events at locations other than at the patient for multiple patients.
Information provided by the Zyter RPM software is not intended for diagnosis or active patient monitoring where immediate action is required.
Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alert notification is the device or system producing the alert or event.
4
Zyter RPM is not intended to directly diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Zyter RPM come into direct contact with patients.
Zyter RPM serves as a convenient user interface to integrate data and provide health care professionals the ability to access and monitor parameters of devices and data that have been cleared by the FDA. Zyter RPM does not affect the intended use, or alter the indications for use, for the cleared devices with which it is intended to function.
The Zyter RPM has two separate user interfaces: one is the provider web application and the second is the patient mobile application. The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.
Zyter RPM:
Zyter RPM is comprised of two main components:
- Mobile App (for patient users) ●
- . Web App (for healthcare provider users)
The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data.
The patient-user is provided with a pre-configured Zyter Tablet for remote health monitoring. The patientuser may also choose to use their own smartphone and download the Zyter Mobile App. The patient is also assigned a number of health devices by their healthcare provider. The patient-user is responsible for connecting the health devices to the Zyter Tablet (or mobile phone). Pairing of the health devices with the tablet (or mobile phone) ensures wireless communication between both devices. Instructions for connecting health devices to the patient mobile app are included in the patient app guide. Zyter RPM mobile application also has a functionality that allows the patient to schedule a tele-visit with their healthcare provider. The patient may choose to take a self-assessment questionnaire found in the Zyter RPM prior to scheduling a visit.
Zyter RPM is a digital healthcare platform that automatically collects and routes data from the patient's pre-configured, compatible, at-home medical devices (blood pressure cuffs, glucometers, thermometers, digital weight scales, and smart watches) to the hospital office via a 4G cellular or Wireless connection.
The health devices are configured to a user in the Zyter user management using the Device Mac address. Zyter validation algorithm doesn't allow the duplicate Mac address entries. Zyter RPM provides patients with Tablets pre-installed with Zyter mobile application. Users connect with the wireless health devices through the mobile app. Zyter also supports BYOD model where patients use their own mobile devices to install the Zyter app from the App store and Google Play store to connect with the wireless devices.
Zyter RPM supports two transmission protocols, device data transmission through Bluetooth technology where the Bluetooth device needs to be paired with the mobile app and the 4G/LTE devices where the device data is transmitted to Zyter via device cloud via APIs and no device pairing required.
Zyter RPM achieves EMR connectivity using on-prem or on-cloud solutions.
5
The vitals reading from the health devices are securely processed through device SDKs/APIs and they are accessed through the patient and provider RPM dashboard. The Zyter RPM Dashboard enables the monitoring of multiple patients with an information tab for each patient. All physiological patient data, plus alerts and notifications from each patient's RPM devices, go directly to the dashboard for physician review, as well as intervention via a telehealth virtual visit if a patient's readings are out of the normal range.
Physicians can also configure alerts for custom parameters of device readings for individual patients. Zyter RPM devices also send alerts to the physician dashboard, email and SMS, and a reminder to the patient's Zyter RPM app, if a device has been dormant for a pre-determined amount of time.
Physicians can set a Zyter RPM alert based on any patient device reading that is out of range. Depending on the device(s) the patient receives, alert ranges can be set to measure the following values:
- BP (Systolic), mmHg .
- . BP (Diastolic), mmHg
- Pulse Oximeter, % Sp02
- . Temperature, Fº or Cº
- . Weight Scale, lbs
- . Blood Glucose, mmoI/L
Zyter RPM is compatible with the following medical devices and accessories:
| Accessory | 510(k) Number |
|---|---|
| BodyTrace Blood Pressure Monitor | K131395 |
| iHealth BP Monitor - iHealth Track (KN550BT) | K160014 |
| BodyTrace Weighing Scale | N/A - Wellness device |
| iHealth Weighing Scale | N/A - Wellness device |
| Smart Meter iGlucose Blood Glucose Monitor Starter Kit | K161790 |
| iHealth Blood Glucose - iHealth Gluco + (BG5s): | K181070 |
| iHealth Thermometer PT3 | K202753 |
| iHealth Air Pulse Oximeter - iHealth Air (PO3M): | K131111 |
| Nonin Pulse Oximeter | K131021 |
| Apple Health Kit | N/A - Apple Health System |
Zyter Component Architecture:
Image /page/5/Figure/14 description: The image shows a diagram of a healthcare network. The diagram is divided into five sections: Connected Devices and Health Parameters (3.1), Connected and Local Gateway (3.2), Platform Infrastructure (3.3), Healthcare Network (3.4), and RPM (3.5). The Connected Devices and Health Parameters section includes weight, glucose levels, heart rate, and blood pressure. The Connected and Local Gateway section includes iOS and Android devices and a Health IoT Gateway with security, connectivity, compliance, device management, data exchange, and data management.
6
V. INDICATIONS FOR USE
The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient's healthcare provider.
Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations.
Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.
7
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The following characteristics were compared between the predicate devices in order to demonstrate substantial equivalence:
| Zyter RPM | BoxView Smart Alarm Interface (SAI) – K193421 | EarlySense Central Display Station (CDS) – K151006 | |
|---|---|---|---|
| Regulation | |||
| Number | 21 CFR 870.2300 | 21 CFR 870.2300 | 21 CFR 870.2300 |
| Regulation | |||
| Name | Cardiac Monitor (Including | Cardiac Monitor (Including | Cardiac Monitor (Including |
| Cardiotachometer and Rate Alarm) | Cardiotachometer and Rate Alarm) | Cardiotachometer and Rate Alarm) | |
| Primary Product | |||
| Code | MSX | MSX | MSX |
| Indications for | |||
| Use | The intended use of the Zyter RPM is to | ||
| provide an interface with physiological | |||
| patient monitoring systems to forward | |||
| recorded device information to the | |||
| patient's healthcare provider. |
Zyter RPM does not alter the behavior of
the primary medical devices and
associated alert annunciations.
Zyter RPM is not intended to be used for
diagnostic purposes. Zyter RPM is
intended for use by professional clinical
personnel and relies on proper use and
operation of both the communication
infrastructure in place at the use
environment (e.g., healthcare facility or
home setting) and the display interface
used. Zyter RPM is a software product
and cannot come into physical contact
with patients. | The intended use of the BoxView Smart
Alarm Interface (SAI), Model SA-01 is
to provide an interface with
physiological patient monitoring systems
to forward information associated to an
alarm event to a designated display
device(s).
For medical, near real time alarms, the
BoxView Smart Alarm Interface, Model
SA-01 is intended to serve as a parallel,
redundant, mechanism to inform
healthcare professionals of particular
medical alarm events. The BoxView
Smart Alarm Interface, Model SA-01
does not alter the behavior
of the primary medical devices and
associated alarm annunciations.
The BoxView Smart Alarm Interface,
Model SA-01 is intended for use as a
secondary alarm notification system. It
does not replace the primary alarm
function on the monitor. | The Early Sense Central Display System
is intended to provide remote central
monitoring and display of information as
recorded by multiple EarlySense bedside
units, on a central remote screen. The
system can be used in hospitals or
hospital type and clinic environment. |
8
| Zyter, Inc. | |
|---|---|
| ------------- | -- |
| The BoxView Smart Alarm Interface, Model SA-01 is not intended to be used for diagnostic purposes. The BoxView Smart Alarm Interface, Model SA-01 is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the healthcare facility and the display devices used. The BoxView Smart Alarm Interface, Model SA-01 is a software product and cannot come into physical contact with patients. | |||
|---|---|---|---|
| Rx or OTC | Rx only | Rx only | Rx only |
| Intended User | Healthcare professionals and lay-users | Healthcare professionals | Healthcare professionals |
| Devices it | |||
| communicates | |||
| with | The Zyter RPM supported devices | ||
| include: | The BoxView SAI provides an interface | ||
| with physiological patient monitoring | |||
| systems. Specific medical devices or | |||
| parameters the primary predicate | |||
| supports are not referenced in their | |||
| publicly available 510(k) summary. | The secondary predicate communicates | ||
| with EarlySense Bedside monitoring | |||
| devices (K131379 and K120465). The | |||
| transmitted information from Bedside | |||
| Unit to CDS and backwards includes | |||
| alert information and physiological | |||
| parameters (such as patient in / out of | |||
| bed status, heart rate, respiration rate, | |||
| motion rate and SpO2, if monitored at | |||
| bedside unit, as well as room and bed | |||
| number, etc.). | |||
| Blood pressure | |||
| Monitoring BodyTrace Blood Pressure | |||
| Monitor iHealth BP Monitor Weighing scale BodyTrace Weighing Scale iHealth Weighing Scale Glucometer Smart Meter iGlucose Blood | |||
| Glucose Monitor Starter Kit iHealth Blood Glucose Thermometer iHealth Thermometer PT3 Pulse oximeter iHealth Air Pulse Oximeter Nonin Pulse Oximeter Health kit & wearables Apple Health Kit Tablet | |||
| o Samsung Android Tablet | |||
| Alert/Alarm | |||
| Interface | Transports alert signals to display | ||
| devices provided by compatible third- | |||
| party mobile device companies | Transports alarm signals to display | ||
| devices provided by compatible third- | |||
| party mobile device companies | Transports alarm signals from | ||
| EarlySense Bedside monitoring devices | |||
| to a central remote screen (EarlySense | |||
| CDS). | |||
| Configurations | Web browser-based application | ||
| configured to send alert notifications to | |||
| specific | |||
| Users. Parameters can be adjusted, e.g., | |||
| change settable parameters like alert | |||
| thresholds depending on patient. | Web browser-based application | ||
| configured to send alert notifications to | |||
| specific | |||
| users | Software application is installed on | ||
| standard off-the-shelf PC computer with | |||
| computer screen. Bedside unit's | |||
| parameters can be adjusted, e.g., change | |||
| settable parameters like alert thresholds. | |||
| Hardware | |||
| Requirements | Processor and RAM requirements: | ||
| Processor - Single-core 1Ghz or higher | |||
| (Minimum); 4GB RAM. | |||
| Operating Systems: | |||
| Ubuntu 16.04 | |||
| macOS X with macOS 10.9, Windows | |||
| 10, Windows 8 or 8.1 | |||
| Browser: | |||
| Chrome 63, FireFox 57 | |||
| Network: | |||
| Broadband wired or wireless (3G or | |||
| 4G/LTE) | |||
| High-level hardware components needed | |||
| include: Standard PC with monitor, | |||
| keyboard, mouse, screen | Minimum Specs for | ||
| Server: 64-bit | |||
| (x64) processor, two | |||
| core; 8GB Ram; 40GB | |||
| Hard Drive; Linux OS - | |||
| CentOS 8 or Later | |||
| (CentOS is a version of | |||
| Linux); Google Chrome | |||
| 54.0 or later browser; | |||
| Network - 100MB. | High-level hardware components needed | ||
| include: Standard PC with monitor, | |||
| keyboard, mouse, screen | |||
| Communications | |||
| Operation | Communication performed through | ||
| HTTPS/WSS protocol, Wireless | |||
| communications platform, WiFi, hospital | |||
| infrastructure and BLE or LTE for | |||
| devices | Wireless communications platform, | ||
| WiFi, paging technology, hospital | |||
| infrastructure. | Communication performed through | ||
| TCP/IP protocol, wireless | |||
| communication, wired, external | |||
| communication devices e.g. pagers | |||
| Administration | |||
| User ID and Password required to enter | |||
| the configuration manager | User ID and Password required to enter | ||
| the configuration manager | Not referenced in publicly available | ||
| 510(k). | |||
| Connection to | |||
| Network | Cloud based application connected | ||
| through site to-site internet connection | Message integration to hardware on-site | ||
| via wired Ethernet connections; or Cloud | |||
| based application connected through site | |||
| to-site internet connection | Communication performed through | ||
| TCP/IP protocol, via standard wired or | |||
| wireless LAN | |||
| Logging | Zyter RPM stores messages (encrypted), | ||
| alerts, RPM Notes, Device readings. | Stores messages, alarms, faults, | ||
| input/output activities. | Not referenced in publicly available | ||
| 510(k). | |||
| User Interface | Cloud based application with the user | ||
| dashboard, where users can view alert | |||
| messages and reading values, add notes | |||
| and set parameters, such as alert | |||
| thresholds. | Accept or reject messages if busy – | ||
| automatically redirect to | |||
| another caregiver. | Users can access user interface of | ||
| individual bedside units via the CDS's | |||
| screen and view or adjust bedside unit's | |||
| parameters, e.g. change settable | |||
| parameters, such as alert thresholds. | |||
| Remote view of the CDS screen from a | |||
| tablet or additional PC computer is also | |||
| possible. | |||
| Alarm | |||
| Configuration | Filter to provide specific alert signals to | ||
| specific providers | Filter to provide specific alarm signals to | ||
| specific caregivers | Not referenced in publicly available | ||
| 510(k). | |||
| Performance | |||
| Testing | Performance testing of the Zyter RPM | ||
| included: |
- Risk Analysis
- Software verification and
validation - Performance bench testing
Performance testing done on number of
concurrent transaction (readings from
device or alerts generated from a
reading) APIs can handle within a
stipulated interval. The transactions are
stimulated through auto scripts to the test
the server capacity to identify when the
application performance begins to
degrade | The bench performance test for Smart
Alarm Interface involves simulating
alert/alarm messages from concurrent
alert/alarm sources to validate that below
and at server capacity the alarm
messages filter correctly and that
notifications send to caregiver devices
when applicable. Another bench
performance test will involve simulating
alert/alarm messages over server
capacity to identify when the application
performance begins to degrade. | Performance testing of the EarlySense
CDS included: - Risk Analysis
- Software verification and
validation - Performance bench testing |
9
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Not Applicable (Standalone Software)
Biocompatibility Testing
Not Applicable (Standalone Software)
Electrical safety and electromagnetic compatibility (EMC)
Not Applicable (Passive Device)
Software Verification and Validation Testing
Software verification and validation testing was conducted in compliance with ANSI/AAMI/IEC 62304:2006/A1:2016 Medical device software -Software life cycle processes, and the following FDA Guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- । Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
- Guidance for Industry and Food and Drug Administration Staff, Content of Premarket — Submissions for Management of Cybersecurity in Medical Devices
- Guidance for Industry and Food and Drug Administration Staff Postmarket | Management of Cybersecurity in Medical Devices
Human Factors Testing
A summative human factors study was conducted to evaluated the usability of the subject device by the intended users. The usability studies were conducted in compliance with ANSI/AAMI/EC 62366-1:2015/A1:2020, and the following FDA Guidance document:
- Guidance for Industry and Food and Drug Administration Staff Applying Human Factors and Usability Engineering to Medical Devices
Animal Study
Animal performance testing was not required to demonstrate substantial equivalence of the device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the substantial equivalence of the device.
VIII. CONCLUSIONS
The Zyter RPM is substantially equivalent to the identified predicates in terms of design features, fundamental scientific technology, and intended use. Substantial equivalence has been demonstrated with non-clinical performance testing. The verification and validation results provided in this 510(k) premarket notification demonstrate that the subject device, Zyter RPM, is substantially equivalent to the identified predicate devices.