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:

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 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).

AI/ML Overview

The provided text does not contain detailed information about a specific study proving the device meets acceptance criteria, nor does it present a table of acceptance criteria and reported device performance. The document is a 510(k) summary for the PeraMobile and PeraWatch System, focusing on establishing substantial equivalence to a predicate device (PeraTrend).

However, I can extract information related to the device's functionality and the general approach to validation mentioned in the document.

Here's an attempt to answer your questions based on the available text, highlighting what is present and what is missing:

Device: PeraMobile and PeraWatch System

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the document. The document describes the core functionality of the device (displaying and trending Rothman Index scores and warning states) and compares its technological characteristics to a predicate device, but it does not specify quantitative acceptance criteria or report measured device performance against such criteria. The closest related statement is that "the results of software testing demonstrate that the PeraMobile and PeraWatch systems perform in accordance with specifications and meets user needs and intended uses."

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "Software verification and validation testing was conducted." However, it does not specify the sample size used for the test set (e.g., number of patients, records, or cases).
Data Provenance: The Rothman Index (RI) uses "commonly recorded vital sign, nursing assessment, and lab data." This data comes from an "EHR and ancillary systems" via PeraServer. The document does not specify the country of origin of the data or explicitly state whether the data used for testing was retrospective or prospective. It implies the use of existing clinical data within hospital systems.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications.
The Rothman Index (RI) itself is described as "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." This suggests that the ground truth for the Rothman Index itself is derived from a statistical model based on patient outcomes (mortality risk), rather than expert consensus on individual cases for the purpose of this specific device's validation. The device then displays this calculated RI score and warning states.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test set. Given that the device calculates a score based on a defined algorithm, formal adjudication by experts for each case's "ground truth" (e.g., as in image interpretation studies) is likely not applicable in the same way.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted or described in this document. The device is an "adjunct to clinical decision support" displaying calculated scores, not an AI for interpreting medical images by human readers.
The document states: "the subject devices to provide a warning list in the case of PeraWatch, and an out-of-app warning notification in the case of PeraMobile, assists end users in having a more timely awareness of warnings than was the case in the predicate device, which required users to access and review patient RI graphs to determine if the patient was in a warning state." This suggests an improvement in workflow and awareness, but it is not presented as a formal MRMC study effect size.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The document does not explicitly describe a standalone performance study of the algorithm itself. It states that "The RI score algorithm has not changed since the previous submission, therefore the algorithm testing provided in the predicate submission (K172979) is relevant to this submission." This implies that the algorithm's performance was assessed during the predicate device's clearance. The current submission focuses on the display and notification capabilities of PeraMobile and PeraWatch, which are essentially interfaces to the existing RI calculation from PeraServer.

7. Type of Ground Truth Used:

The core "ground truth" for the Rothman Index is based on "aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values." This indicates historical outcomes data (mortality) was used to train or establish the underlying Rothman Index algorithm. For the PeraMobile and PeraWatch devices, the ground truth relative to their function (displaying RI scores and warning states) is simply the correct calculation and display of these values from the PeraServer.

8. Sample Size for the Training Set:

The document does not specify the sample size for the training set for the Rothman Index algorithm. It refers back to the predicate device submission (K172959) for details on the RI score algorithm testing.

9. How the Ground Truth for the Training Set Was Established:

For the Rothman Index algorithm itself, the ground truth was established by correlating patient data (vital signs, nursing assessments, labs) with "aggregate statistical mortality risk." This implies a data-driven, statistical approach based on historical patient outcomes (mortality) to quantify the physiologic condition and risk. The specifics of this process are not described in the current document but were presumably part of the K172959 submission.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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:

side clinicians.

PeraWatch Indications for Use:

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

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.6302 Fairview Road, Suite 310Charlotte, NC 28210
Contact:	Brad ColemanChief Information Officerbcoleman@perahealth.com
Prepared by:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting Group, Inc.dtillman@biologicsconsulting.com
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 arrhythmiadetection 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:

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.

2. DEVICE DESCRIPTION:

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
ClassificationRegulation	21 CFR 870.2300, Class II	21 CFR 870.2300, Class II	Same
Product Code	MWI (Physiological Patient Monitor(without arrhythmia detection oralarms)	MWI (Physiological Patient Monitor(without arrhythmia detection or alarms)	Same
Device Description	PeraServer collects specifieddemographic and clinical data from theEHR and ancillary systems. PeraServercomputes an Early Warning Scorecalled the Rothman Index (RI),determines if RI scores and/or clinicalcriteria meet configurable EWScriteria; specified input data, and RIscore and warning states are stored foranalysis, remote viewing, andinterfacing.PeraTrend provides a web-based user-interface for trending and review of RIscores and underlying data and warningstatus.PeraServer/PeraTrend also interface toother medical automation systems suchas the Hospital Electronic HealthRecord (EHR).	PeraWatch is a read-only web-basedgraphical user interface for displayingRothman Index (RI) scores, trends andconfigurable warnings.PeraWatch reads data directly from thePeraServer database.PeraMobile is an interactive mobileapplication that displays RI scores, trendsand configurable warnings for selectedgroups of patients within the hospital.PeraMobile reads and writes data directly toand from the PeraServer database.	PeraTrend, PeraWatch, PeraMobile all runfrom data supplied by PeraServer.Functional differences:Differences are primarily in the pushedwarning notifications to the PeraWatch andPeraMobile.PeraWatch array view provides a graphheader indicator to show patients withrecently changed warning states.PeraMobile runs on a mobile device app,supports out-of-app notifications of patientschanging warnings state, and the display ofdata is modified for ease-of-use on smallerscreens.
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/orremote professional clinical surveillancesetting.	PeraTrend and PeraWatch are for use in thehospital.
			PeraMobile could be used in hospital orremotely (e.g. in a centralized setting) forsurveilling patients who are in multipledifferent facilities. It cannot be used in ahome use setting because it requiresconnection to a hospital WiFi to operate.
Primary or SecondaryMonitoring	Only intended for secondarymonitoring.	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 enternotes or interventions.	PeraWatch does not allow user to enter notesor interventions.	Ability to enter notes and select interventionsin PeraMobile does not impact the RI or RI-warnings or how they are acted upon.
		PeraMobile allows user to enter notes andselect intervention actions from a dropdownmenu.	The notes and intervention entry permitactivity tracking and reporting to be providedto managers for quality and processimprovement purposes.
Warning States	Warnings states for patients arecalculated by PeraServer for use byPeraTrend.	Warning states for patients are calculated byPeraServer for use by PeraWatch andPeraMobile	Same
Patient List View	No list view; does support multiplepatient graph view.	PeraWatch has no list view; does supportmultiple patients graph view.PeraMobile does have a text-based patientlist view.	Difference is in PeraMobile - screen real-estate does not support a graph array viewand hence a text-based patient list view isprovided instead.
	Primary Predicate	Subject Device	Discussion of Differences
Watchlist View	No watchlist view available.	PeraWatch does not have a watchlist viewavailable.PeraMobile allows user to select patients togo onto a custom "watchlist".	The PeraMobile "watchlist" is to supportmobile clinicians who have more limitedaccess to a computer and need a convenientway to track patients of interest for follow-uppurposes.
Single Patient View	PeraTrend provides a patient specificsingle-graph view of RI-scores trendedover time.	PeraWatch and PeraMobile provide a patientspecific single-graph view of RI-scorestrended over time.PeraWatch graph header uses color toindicate both patient's current warning statusand prior warning status if changed in thelast four hours.	Graph appearance and functionality is nearlyidentical between PeraTrend and PeraWatch.
Array view	PeraTrend provides an array view ofmultiple patients using small graphicons.	PeraWatch array view is the same asPeraTrend array view with the addition ofheader color to indicate prior warning statusif changed in the last four hours.PeraWatch also allows a "tile view" in whichgraph thumbnails are replaced by squaresshowing current RI score value and colorcoded according to patient's current warningstate, if any.PeraMobile includes a patient list view.	PeraWatch use of color to show priorwarning state if changed in last four hours isan aid to PeraWatch users for identifyingpatients getting better or worse (based onwarning state) given the very large numberof patients they are viewing.The PeraWatch "tile" view is to facilitateease of viewing for large volumesurveillance (i.e. hundreds of patients) acrossfacilities.PeraMobile difference is to make the multi-patient viewing options more user-friendlyon a smaller device window (i.e. mobiledevice).
Provides ClinicalAdvisories	Clinical Advisories (warning states) aregenerated by PeraServer whichcomputes RI scores and assignswarning states based on configuredsettings.	Clinical Advisories (warning states) aregenerated by PeraServer which computes RIscores and assigns warning states based onconfigured settings.	No difference in how clinical advisories aregenerated
	Primary Predicate	Subject Device	Discussion of Differences
Graph-basedindicator of PatientWarning Status	PeraTrend graphs have a coloredheader and text indicating patientwarning state.	PeraWatch and PeraMobile graphs have acolored header and text indicating patientwarning state.	Same
In App WarningNotifications	Users can see patient warning state byviewing graphs within the PeraTrendapplication.	Users can see patient warning state byviewing graphs within the PeraWatch orPeraMobile application.PeraWatch and PeraMobile include anotification list of patients with newwarnings.PeraMobile can also display pop-upnotifications.	PeraTrend is intended for users to look atsmall numbers of graphs, e.g. correspondingto nurse or physician assignments, or anursing unit, where there is direct familiaritywith patients and it is easy to see patientwarning states.PeraWatch is for oversight of large volumesof patients, and it can be difficult to keeptrack of who has recently escalated inwarning level - the notifications list providesthat information directly to the user.PeraMobile is for mobile clinicians viewingpatients throughout the facility, and they maynot be accessing the EHR or otherwiselooking at patient RI graphs. The in-appnotification tracking allows them to easilykeep track of a patient on their list that hasescalated in warning level.The use of In App Notifications is similar tothe reference device, AlertWatch:OB(K173715), which also provides warningalerts to mobile devices.
Out of App "pushed"Warning Notifications	None	PeraMobile has an Out-of-App notificationthat identifies when a patient has a change toa higher warning state.	PeraMobile is for mobile clinicians viewingpatients throughout the facility, and they maynot be accessing the EHR or otherwiselooking at patient RI graphs. The out-of-appnotifications allows them to easily knowwhen a patient on their list has escalated inwarning level.
	Primary Predicate	Subject Device	Discussion of Differences
Timeliness ofWarning (Alert)Calculation	Calculated when data is available toPeraServer from source system;warning generation subject to dataentry delays.	Calculated when data is available toPeraServer from source system; warninggeneration subject to data entry delays.	Same
Timeliness ofWarning (Alert)Availability	Once a warning is generated inPeraServer, it is immediately availablevia PeraTrend.	Once a warning is generated in PeraServer, itis immediately available via PeraWatch andPeraMobile.The user will receive an out-of-appnotification in the case of PeraMobile.	Same
Material	Software only	Software only	Same
Hardware Platform	PC	PC, iPhone	PeraMobile runs on an iPhone platform tosupport a mobile clinician.
Data Source	PeraTrend data comes from PeraServer	PeraWatch and PeraMobile data comes fromPeraServer.	Same
Data Display	PeraTrend Web - a browser-baseddisplay.PeraTrend Kiosk - a browser-baseddisplay configured for dedicatedmonitors providing an always-up, auto-refreshed display.PeraTrend EHR – a browser-baseddisplay accessed and viewed fromwithin the EHR.	PeraWatch - a browser-based displayconfigured for dedicated monitors providingan always-up, auto-refreshed display.PeraMobile – app-based display for use onmobile hand-held devices.	PeraWatch and PeraTrend both display datavia a PC web browser. PeraMobile providesdisplay on a mobile device (iPhoneplatform).
Ability to Trend	Yes	Yes	Same
Re-display of vitalsign data	Re-displays vital sign data from EHR	Re-displays vital sign data from EHR	Same

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Image /page/11/Figure/1 description: The image compares the PeraTrend and PeraWatch array views, single graph views, and the PeraMobile single graph view. The PeraTrend array view shows a dashboard with multiple graphs and data points. The PeraWatch array view displays a similar dashboard, but with a slightly different layout. The PeraMobile single graph view shows a graph of a patient's data over time, with options to view different time ranges.

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Both the subject device and the predicate device rely on the same PeraServer system for data. PeraServer generates the RI score. The RI score algorithm has not changed since the previous submission, therefore the algorithm testing provided in the predicate submission (K172979) is relevant to this submission.

The timeliness of data and warnings in both subject and predicate devices has some dependency on the timeliness of data entry into the source (e.g. EHR systems). The extent and impact of delayed data entry on the generation of scores and warnings was explained in detail in the predicate device submission (K172959). As a result, the timeliness of warning generation and availability to the end user in the predicate device and the subject devices is identical.

Furthermore, the capability of the subject devices to provide a warning list in the case of PeraWatch, and an out-of-app warning notification in the case of PeraMobile, assists end users in having a more timely awareness of warnings than was the case in the predicate device, which required users to access and review patient RI graphs to determine if the patient was in a warning state.

CONCLUSION: న్.

The subject PeraMobile and PeraWatch systems and the predicate PeraTrend have the same intended use, which is to provide healthcare providers with a patient status index that reflects the underlying patient condition. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the results of software testing demonstrate that the PeraMobile and PeraWatch systems perform in accordance with specifications and meets user needs and intended uses. Therefore, the PeraMobile and PeraWatch systems have been demonstrated to be substantially equivalent to the predicate PeraTrend.

Regulation Number and Section

§ 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).