PeraMobile and PeraWatch

K183370 · Perahealth, Inc. · MWI · Sep 11, 2019 · Cardiovascular

Device Facts

• Record ID: K183370
• Device Name: PeraMobile and PeraWatch
• Applicant: Perahealth, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Sep 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing support to bed-side clinicians. PeraWatch is indicated for use by healthcare providers whenever there is need within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.

Device Story

Software-only system; displays Rothman Index (RI) scores, trends, and configurable warning states. Inputs: vital signs, nursing assessments, lab data from EHR via PeraServer. PeraMobile: mobile app for clinicians; supports patient watchlists, intervention documentation, and out-of-app push notifications for warning state changes. PeraWatch: web-based interface for centralized/remote clinical surveillance; provides tile/array views for large-volume patient monitoring. Used by Rapid Response Teams, bedside clinicians, and surveillance staff. Output: visual dashboard of patient physiologic status. Effect: aids clinical decision-making by providing secondary monitoring and timely awareness of patient deterioration; does not replace primary care.

Clinical Evidence

No clinical data. Bench testing only; software verification and validation conducted per FDA guidance.

Technological Characteristics

Software-only; runs on user-provided hardware (PC, iPhone). Connectivity: IEEE 802.11b/ac. Data source: PeraServer (previously cleared). Architecture: Web-based GUI (PeraWatch) and mobile application (PeraMobile).

Indications for Use

Indicated for adult and pediatric patients in hospital settings. Used by healthcare providers to display/trend Rothman Index (RI) scores and warning states as an adjunct to clinical decision support. Not intended to replace primary care measures.

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

• PeraTrend (K172959)

Reference Devices

• AlertWatch:OB (K173715)

Submission Summary (Full Text)

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PeraHealth, Inc. % Donna-Bea Tillman Senior Consultant Biologics Consulting Group 1555 King Street, Suite 300 Alexandria, Virginia 22314

Re: K183370

Trade/Device Name: PeraMobile and PeraWatch System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: July 25, 2019 Received: July 26, 2019

Dear Donna-Bea Tillman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Stephen Browning Acting 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

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## Indications for Use

510(k) Number (if known) K183370

Device Name PeraMobile and PeraWatch System

### Indications for Use (Describe)

PeraMobile Indications for Use:

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values. PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing support to bed-

side clinicians.

PeraWatch Indications for Use:

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values.

PeraWatch is indicated for use by healthcare providers whenever there is need within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support.

PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.

Type of Use (Select one or both, as applicable)

| <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## 510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the PeraMobile and PeraWatch System is provided below:

| Device Common Name: | Adjunct to Multiparameter Patient Monitor |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | PeraMobile and PeraWatch System |
| Applicant: | PeraHealth, Inc.<br>6302 Fairview Road, Suite 310<br>Charlotte, NC 28210 |
| Contact: | Brad Coleman<br>Chief Information Officer<br>[e-mail] |
| Prepared by: | Donna-Bea Tillman, Ph.D.<br>Senior Consultant<br>Biologics Consulting Group, Inc.<br>[e-mail] |
| Date Prepared: | December 4, 2018 |
| Classification Regulation: | 21 CFR 870.2300 (Class II) |
| Regulation Description: | Cardiac Monitor (including Cardiotachometer and Rate Alarm) |
| Panel: | Cardiovascular |
| Product Code: | MWI |
| Product Code Description: | Physiological Patient Monitor (without arrhythmia<br>detection or alarms) |
| Predicate Device: | PeraTrend (K172959) |
| Reference Device: | AlertWatch:OB (K173715) |

#### INDICATIONS FOR USE: 1.

The indications for use for PeraMobile are the following:

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's

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physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values.

PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support.

PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing supplemental support to bed-side clinicians.

The indications for use for PeraWatch are the following:

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values.

PeraWatch is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support.

PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.

#### 2. DEVICE DESCRIPTION:

PeraMobile is an interactive mobile application that provides an interface to display RI scores, trends, and configurable warnings for selected groups of patients within the hospital. PeraMobile reads and writes data directly to and from the PeraServer database. Designed for mobile clinicians, PeraMobile functionality also allows end-users to document both pre-defined interventions and free text notes that are stored in PeraServer and accessible through the user interface within PeraMobile. PeraServer was previously cleared in K172969.

PeraWatch is a read-only, web-based graphical user interface for displaying Rothman Index scores, trends and configurable warnings. PeraWatch reads data directly from the PeraServer database.

PeraMobile and PeraWatch are software-only devices that are installed on user-provided hardware that supports IEEE 802.11b or higher (802.11ac is recommended). PeraHealth has conducted load tests to determine expected payload sizes and acceptable response times. Throughput is calculated based on the default 5 second refresh rate, which is configurable by hospital IT administration. Based on the 1.33 Gbit/s specification of 802.11ac, PeraMobile will support 346MM simultaneous patient updates. In other words, a typical 500 bed hospital will only use .0014% of available bandwidth. 802.11ac will support distances of up to 400 feet with minimal data degradation. Most hospitals strive for 100 feet between access points.

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#### 3. SOFTWARE:

Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

#### SUBSTANTIAL EQUIVALENCE: 4.

#### 4.1. Cited Predicate Device:

The cited predicate device is PeraTrend, cleared under K172959.

#### 4.2. Comparison of Intended Use:

Both the subject PeraWatch and PeraMobile devices and the predicate PeraTrend device rely on PeraServer to calculate an RI score. The subject and predicate devices are both secondary patient monitoring devices intended for displaying and trending the RI score and associated warnings as an adjunct to clinical decision support for healthcare professionals throughout the hospital setting.

PeraWatch and PeraMobile are also indicated for use by healthcare professionals working in a professional care setting to augment and support bedside clinicians by providing a second pair of eyes on the evolving patient condition. PeraWatch and PeraMobile are not intended to replace or substitute for any of the usual care measures provided by primary or direct care givers working in the facility and at the bedside. The functionality provided by PeraWatch and PeraMobile can only augment, but not detract from, existing care standards, and the use of these products does not introduce new risks. Therefore, the differences in indications for use do not constitute a new intended use, and PeraTrend can be used as a primary predicate device for PeraWatch and PeraMobile.

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#### 4.3. Comparison of Technological Characteristics:

| | Primary Predicate | Subject Device | Discussion of Differences |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K172959 | K183370 | N/A |
| Manufacturer | PeraHealth, Inc. | PeraHealth, Inc. | Same |
| Device Name | PeraServer and PeraTrend System | PeraWatch and PeraMobile Systems | N/A |
| Classification<br>Regulation | 21 CFR 870.2300, Class II | 21 CFR 870.2300, Class II | Same |
| Product Code | MWI (Physiological Patient Monitor<br>(without arrhythmia detection or<br>alarms) | MWI (Physiological Patient Monitor<br>(without arrhythmia detection or alarms) | Same |
| Device Description | PeraServer collects specified<br>demographic and clinical data from the<br>EHR and ancillary systems. PeraServer<br>computes an Early Warning Score<br>called the Rothman Index (RI),<br>determines if RI scores and/or clinical<br>criteria meet configurable EWS<br>criteria; specified input data, and RI<br>score and warning states are stored for<br>analysis, remote viewing, and<br>interfacing.<br>PeraTrend provides a web-based user-<br>interface for trending and review of RI<br>scores and underlying data and warning<br>status.<br>PeraServer/PeraTrend also interface to<br>other medical automation systems such<br>as the Hospital Electronic Health<br>Record (EHR). | PeraWatch is a read-only web-based<br>graphical user interface for displaying<br>Rothman Index (RI) scores, trends and<br>configurable warnings.<br>PeraWatch reads data directly from the<br>PeraServer database.<br>PeraMobile is an interactive mobile<br>application that displays RI scores, trends<br>and configurable warnings for selected<br>groups of patients within the hospital.<br>PeraMobile reads and writes data directly to<br>and from the PeraServer database. | PeraTrend, PeraWatch, PeraMobile all run<br>from data supplied by PeraServer.<br>Functional differences:<br>Differences are primarily in the pushed<br>warning notifications to the PeraWatch and<br>PeraMobile.<br>PeraWatch array view provides a graph<br>header indicator to show patients with<br>recently changed warning states.<br>PeraMobile runs on a mobile device app,<br>supports out-of-app notifications of patients<br>changing warnings state, and the display of<br>data is modified for ease-of-use on smaller<br>screens. |
| Intended users | Healthcare Professionals | Healthcare Professionals | Same |
| | Primary Predicate | Subject Device | Discussion of Differences |
| Patient Population | Adult and pediatric patients | Adult and pediatric patients | Same |
| Use environment | Hospital | Throughout Hospital and centralized and/or<br>remote professional clinical surveillance<br>setting. | PeraTrend and PeraWatch are for use in the<br>hospital. |
| | | | PeraMobile could be used in hospital or<br>remotely (e.g. in a centralized setting) for<br>surveilling patients who are in multiple<br>different facilities. It cannot be used in a<br>home use setting because it requires<br>connection to a hospital WiFi to operate. |
| Primary or Secondary<br>Monitoring | Only intended for secondary<br>monitoring. | Only intended for secondary monitoring. | Same |
| RI score calculation | RI score is calculated by PeraServer | RI score is calculated by PeraServer | Same |
| Notes/Interventions | PeraTrend does not allow user to enter<br>notes or interventions. | PeraWatch does not allow user to enter notes<br>or interventions. | Ability to enter notes and select interventions<br>in PeraMobile does not impact the RI or RI-<br>warnings or how they are acted upon. |
| | | PeraMobile allows user to enter notes and<br>select intervention actions from a dropdown<br>menu. | The notes and intervention entry permit<br>activity tracking and reporting to be provided<br>to managers for quality and process<br>improvement purposes. |
| Warning States | Warnings states for patients are<br>calculated by PeraServer for use by<br>PeraTrend. | Warning states for patients are calculated by<br>PeraServer for use by PeraWatch and<br>PeraMobile | Same |
| Patient List View | No list view; does support multiple<br>patient graph view. | PeraWatch has no list view; does support<br>multiple patients graph view.<br>PeraMobile does have a text-based patient<br>list view. | Difference is in PeraMobile - screen real-<br>estate does not support a graph array view<br>and hence a text-based patient list view is<br>provided instead. |
| | Primary Predicate | Subject Device | Discussion of Differences |
| Watchlist View | No watchlist view available. | PeraWatch does not have a watchlist view<br>available.<br>PeraMobile allows user to select patients to<br>go onto a custom "watchlist". | The PeraMobile "watchlist" is to support<br>mobile clinicians who have more limited<br>access to a computer and need a convenient<br>way to track patients of interest for follow-up<br>purposes. |
| Single Patient View | PeraTrend provides a patient specific<br>single-graph view of RI-scores trended<br>over time. | PeraWatch and PeraMobile provide a patient<br>specific single-graph view of RI-scores<br>trended over time.<br>PeraWatch graph header uses color to<br>indicate both patient's current warning status<br>and prior warning status if changed in the<br>last four hours. | Graph appearance and functionality is nearly<br>identical between PeraTrend and PeraWatch. |
| Array view | PeraTrend provides an array view of<br>multiple patients using small graph<br>icons. | PeraWatch array view is the same as<br>PeraTrend array view with the addition of<br>header color to indicate prior warning status<br>if changed in the last four hours.<br>PeraWatch also allows a "tile view" in which<br>graph thumbnails are replaced by squares<br>showing current RI score value and color<br>coded according to patient's current warning<br>state, if any.<br>PeraMobile includes a patient list view. | PeraWatch use of color to show prior<br>warning state if changed in last four hours is<br>an aid to PeraWatch users for identifying<br>patients getting better or worse (based on<br>warning state) given the very large number<br>of patients they are viewing.<br>The PeraWatch "tile" view is to facilitate<br>ease of viewing for large volume<br>surveillance (i.e. hundreds of patients) across<br>facilities.<br>PeraMobile difference is to make the multi-<br>patient viewing options more user-friendly<br>on a smaller device window (i.e. mobile<br>device). |
| Provides Clinical<br>Advisories | Clinical Advisories (warning states) are<br>generated by PeraServer which<br>computes RI scores and assigns<br>warning states based on configured<br>settings. | Clinical Advisories (warning states) are<br>generated by PeraServer which computes RI<br>scores and assigns warning states based on<br>configured settings. | No difference in how clinical advisories are<br>generated |
| | Primary Predicate | Subject Device | Discussion of Differences |
| Graph-based<br>indicator of Patient<br>Warning Status | PeraTrend graphs have a colored<br>header and text indicating patient<br>warning state. | PeraWatch and PeraMobile graphs have a<br>colored header and text indicating patient<br>warning state. | Same |
| In App Warning<br>Notifications | Users can see patient warning state by<br>viewing graphs within the PeraTrend<br>application. | Users can see patient warning state by<br>viewing graphs within the PeraWatch or<br>PeraMobile application.<br>PeraWatch and PeraMobile include a<br>notification list of patients with new<br>warnings.<br>PeraMobile can also display pop-up<br>notifications. | PeraTrend is intended for users to look at<br>small numbers of graphs, e.g. corresponding<br>to nurse or physician assignments, or a<br>nursing unit, where there is direct familiarity<br>with patients and it is easy to see patient<br>warning states.<br>PeraWatch is for oversight of large volumes<br>of patients, and it can be difficult to keep<br>track of who has recently escalated in<br>warning level - the notifications list provides<br>that information directly to the user.<br>PeraMobile is for mobile clinicians viewing<br>patients throughout the facility, and they may<br>not be accessing the EHR or otherwise<br>looking at patient RI graphs. The in-app<br>notification tracking allows them to easily<br>keep track of a patient on their list that has<br>escalated in warning level.<br>The use of In App Notifications is similar to<br>the reference device, AlertWatch:OB<br>(K173715), which also provides warning<br>alerts to mobile devices. |
| Out of App "pushed"<br>Warning Notifications | None | PeraMobile has an Out-of-App notification<br>that identifies when a patient has a change to<br>a higher warning state. | PeraMobile is for mobile clinicians viewing<br>patients throughout the facility, and they may<br>not be accessing the EHR or otherwise<br>looking at patient RI graphs. The out-of-app<br>notifications allows them to easily know<br>when a patient on their list has escalated in<br>warning level. |
| | Primary Predicate | Subject Device | Discussion of Differences |
| Timeliness of<br>Warning (Alert)<br>Calculation | Calculated when data is available to<br>PeraServer from source system;<br>warning generation subject to data<br>entry delays. | Calculated when data is available to<br>PeraServer from source system; warning<br>generation subject to data entry delays. | Same…