The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute 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.

PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings.

PeraTrend is indicated for use by healthcare providers whenever there is need for displaying and/or trending RI scores and displaying associated configurable warning states as an adjunct to clinical decision support.

PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units).

The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct-to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.

Device Description

The subject of this submission is the PeraServer and PeraTrend System, consisting of:

PeraServer a backend hardware/software platform that imports electronic health record ● (EHR) data, which are used to compute and store Rothman Index (RI) scores and related measures
PeraTrend – the frontend web-based user interfaces for displaying RI scores and related measures, as well as simple manipulations of the display (i.e., graphical representations over time, comparison of Rothman Index scores and input measures)

PeraServer and PeraTrend are software-only devices that are installed on user-provided hardware.

AI/ML Overview

The PeraServer™ and PeraTrend™ System calculates a patient's physiologic condition using the Rothman Index (RI) based on vital signs, nursing assessments, and lab data. The system is intended for use by healthcare providers as an adjunct to clinical decision support in various hospital settings across neonatal, pediatric, and adult patients, but not in the Neonatal Intensive Care Unit.

The submission references three retrospective studies to demonstrate the validity of the RI score and establish substantial equivalence to the predicate device, BedsidePEWS (K124038).

Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it refers to three studies that "demonstrate that the performance of the PeraServer and PeraTrend System is equivalent to that of the predicate device for both pediatric and adult populations." The studies likely showed the RI score's accuracy or efficacy in reflecting patient condition and predicting outcomes.

Key information extracted from the provided text:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format within the given document. The document states that the performance of the PeraServer and PeraTrend System has been validated and demonstrated to be equivalent to the predicate device through the described studies.
Sample sizes used for the test set and data provenance:
- The document refers to three retrospective studies:
  - Rothman et. al (2013) for the adult RI score.
  - Finlay et. al (2014) for a comparison between RI scores and MEWS.
  - Rothman et. al (2017) for the pediatric RI score.
- Specific sample sizes for the test sets are not provided in this document.
- Data Provenance: The studies are described as retrospective, implying the data was collected from past patient records. The country of origin of the data is not specified.
Number of experts used to establish the ground truth for the test set and their qualifications: This information is not provided in the document.
Adjudication method for the test set: This information is not provided in the document.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: An MRMC study is not explicitly mentioned as having been performed. The studies focus on validating the Rothman Index score itself, not on comparing human reader performance with and without AI assistance.
Standalone (algorithm-only) performance study: Yes, the described studies appear to be evaluating the standalone performance of the Rothman Index algorithm. The document emphasizes the validation of the RI score itself.
Type of ground truth used:
- The Rothman Index 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 used for validation in the studies would likely be patient outcomes data, such as mortality, or other clinically validated indicators of patient deterioration that the RI score is designed to predict or reflect. However, the exact nature of the ground truth (e.g., pathology, expert consensus) is not explicitly stated.
Sample size for the training set: This information is not provided in the document.
How the ground truth for the training set was established: This information is not provided in the document. The document only mentions "the mechanics and validation" of the RI score in the context of the retrospective studies.

Summary

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May 1. 2018

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

Re: K172959

Trade/Device Name: PeraServer™ and PeraTrend™ System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: March 29, 2018 Received: March 29, 2018

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

M.A. Wilhelmsen

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172959

Device Name PeraServer and PeraTrend System

Indications for Use (Describe)

PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings.

PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units).

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 PeraServer and PeraTrend System is provided below:

Device Common Name:	Adjunct to Multiparameter Patient Monitor
Device Trade Name:	PeraServerTM and PeraTrendTM System
Applicant:	PeraHealth, Inc.6302 Fairview Road, Suite 310Charlotte, NC 28210
Contact:	Joseph Beals, Ph.D.Vice President, Informaticsjbeals@perahealth.com
Prepared by:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting Group, Inc.dtillman@biologicsconsulting.com
Date Prepared:	April 26, 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:	BedsidePEWS (K124038)

1. INDICATIONS FOR USE:

The indications for use for the PeraServer and PeraTrend System are the following:

"The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute 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.

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PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings.

PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units).

2. DEVICE DESCRIPTION:

The subject of this submission is the PeraServer and PeraTrend System, consisting of:

PeraServer a backend hardware/software platform that imports electronic health record ● (EHR) data, which are used to compute and store Rothman Index (RI) scores and related measures
PeraTrend – the frontend web-based user interfaces for displaying RI scores and related measures, as well as simple manipulations of the display (i.e., graphical representations over time, comparison of Rothman Index scores and input measures)

PeraServer and PeraTrend are software-only devices that are installed on user-provided hardware.

SOFTWARE: 3.

Documentation has been provided in the submission commensurate with a Moderate Level of Concern.

SUBSTANTIAL EQUIVALENCE: 4.

4.1. Cited Predicate Device:

The cited predicate device is the Bedside Clinical Systems Bedside Paediatric Early Warning System (BedsidePEWS), cleared under K124038.

Comparison of Intended Use: 4.2.

The PeraServer and PeraTrend System and the predicate BedsidePEWS have the same intended use, namely to provide healthcare providers with a patient status index that reflects the underlying patient condition. Both devices acquire their inputs from the hospital Electronic Medical Record System and are intended to be an adjunct to vital signs monitoring. Both devices are intended to be used by healthcare professionals in the clinical care environment. The intended patient population of BedsidePEWS is the pediatric population, while the PeraServer

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and PeraTrend System is intended for both pediatric and adult populations. This difference in indications does not raise different questions of safety and effectiveness.

Comparison of Technological Characteristics: 4.3.

	Subject Device	Predicate Device
Manufacturer	PeraHealth, Inc.	Bedside Clinical Systems, Inc.
Device Name	PeraServerTM and PeraTrendTM System	Bedside Paediatric Early WarningSystem (BedsidePEWSTM)
ClassificationRegulation	21 CFR 870.2300, Class II	21 CFR 870.2300, Class II
Product Code	MWI: Physiological Patient Monitor(without arrhythmia detection oralarms)	MWI: Physiological Patient Monitor(without arrhythmia detection oralarms)
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 andwarning status.PeraServer/PeraTrend also interface toother medical automation systems suchas the Hospital Electronic HealthRecord (EHR).	BedsidePEWS is a web-based clinicaldecision-support tool that can also berun as a standalone application for useon computers running MicrosoftSoftware Operating features with alocal network connection, which accessmedical data. It is also interfaces toother medical automation systems suchas Hospital Information System (HIS),Electronic Medical Record (EMR), andPractice Management Software.
	Subject Device	Predicate Device
Indications for Use	The Rothman Index uses commonlyrecorded vital sign, nursingassessment, and lab data to compute apatient status index. The RothmanIndex is a single measure of a patient'sphysiologic condition based on theaggregate statistical mortality riskassociated with the values of thepatient's vital signs, nursingassessments, and selected lab values.PeraServer is indicated for usewherever there is interest in generatingRothman Index (RI) scores and/orassociated configurable warnings.PeraTrend is indicated for use byhealthcare providers whenever there isneed for displaying and/or trending RIscores and displaying associatedconfigurable warning states as anadjunct to clinical decision support.PeraServer/PeraTrend is intended forthe care of patients throughout thehospital setting (e.g. in the emergencydepartment, on the wards, in intensivecare units).The Rothman Index score is validatedfor use with neonatal, pediatric, andadult patients. It is an adjunct-to and isnot intended to replace vital signsmonitoring and is not intended for usein the Neonatal Intensive Care Unit.	The Bedside Paediatric Early WarningSystem (BedsidePEWS) is anelectronic documentation tool that isdesigned to be used in conjunction withmulti-parameter patient monitoring. Itis indicated for use by healthcareprofessionals with paediatric patientsbetween the ages of term newborn (>37weeks gestational age) and 18 years,who are hospitalized with any medicalor surgical condition.BedsidePEWS allows input by thehealthcare professional of commonlyrecorded vital sign data and providesclinician with a patient status index (the"BedsidePEWS score") based on aweighted average of seven vital signswhen entered by the clinician, namelyHeart Rate, Respiratory Rate, BloodPressure, Oxygen Saturation, OxygenTherapy, Respiratory Effort, andCapillary Refill. The "BedsidePEWSscore" is a single measure of a patient'scondition and indicates the variation inthe patient's vital signs with respect tonormality. BedsidePEWS is an adjunct-to and is not intended to replace vitalsigns monitoring.BedsidePEWS is intended for use inwards and emergency rooms inhospitals that provide care for childrenbetween the ages of term newborn (>37weeks gestational age) and 18 years. Itis not intended for use in the NeonatalIntensive Care Unit.
Intended users	Healthcare Professionals	Healthcare Professionals
Patient Population	Adult and pediatric patients	Pediatric patients between the ages ofterm newborn (>37 weeks gestationalage) and 18 years
Use environment	Hospital	Hospital
Parameters	Vital signs (Temp, Sys. BP, Dias. BP,HR, RR) Pulse-ox, heart rhythm*,nursing assessments, Braden score,selected labs (potassium, sodium,creatinine, chloride, WBC, BUN,HGB)	Vital signs (Heart Rate, RespiratoryRate, Blood Pressure, OxygenSaturation, Oxygen Therapy,Respiratory Effort, and CapillaryRefill)
	Subject Device	Predicate Device
Score	Rothman Index (RI) and Pediatric RI(pRI)	BedsidePEWS score
Material	Software only	Software only
Hardware Platform	PeraServer/PeraTrend requirededicated application and databaseservers.	Windows PC or Tablet
Data Source	Hospital EHR systems	Hospital EHR systems or manuallyinput
Data Display	PeraTrend Web – a browser baseddisplayPeraTrend Kiosk – a browser baseddisplay configured for dedicatedmonitors providing an always-up,auto-refreshed displayPeraTrend EHR – a browser baseddisplay accessed and viewed fromwithin the EHR	Browser based display
Ability to trend	Yes	Yes
Real-time display	Yes	Yes
Privacy	HIPPA compliant	HIPPA compliant

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*Note: Although the PeraServer and PeraTrend System uses heart rhythm as one of its inputs, this information is obtained from the EHR and therefore the PeraServer and PeraTrend System is not performing arrhythmia detection.

PERFORMANCE TESTING: 5.

To demonstrate the validity of the RI score, three retrospective studies are described in the submission:

Rothman et. al (2013), to describe the mechanics and validation of the adult RI score ●
Finlay et. al (2014), to provide a comparison between RI scores and MEWS ●
Rothman et. al (2017), to describe the mechanics and validation of the pediatric RI score ●

These studies demonstrate that the performance of the PeraServer and PeraTrend System is equivalent to that of the predicate device for both pediatric and adult populations.

CONCLUSION: 6.

The subject PeraServer and PeraTrend System and the predicate BedsidePEWS have the same intended use, which is to provide healthcare providers with a patient status index that reflects the

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underlying patient condition. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the results of performance testing demonstrate that the PeraServer and PeraTrend System performs in accordance with specifications and meets user needs and intended uses. The software testing provided in the submission verifies the functionality of the software, and the studies provided in the submission validate the Rothman Index score. Therefore, the PeraServer and PeraTrend System has been demonstrated to be substantially equivalent to the predicate BedsidePEWS.

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).