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PeraMobile and PeraWatch

PeraHealth, Inc. • Cardiovascular • 09/11/2019

510(k)IEC 62304 Class C
FDA Summary PDF

Device Purpose

The PeraMobile and PeraWatch System provides healthcare professionals with tools to monitor patient physiological status using the Rothman Index, a score derived from vital signs, nursing assessments, and lab data. This system, comprising a mobile application (PeraMobile) and a web interface (PeraWatch), aims to enhance clinical decision support and patient surveillance through real-time data display, trend analysis, and configurable warnings, leveraging the PeraServer for core data processing.

Summary

The PeraMobile and PeraWatch System is designed to assist healthcare providers by displaying and trending Rothman Index (RI) scores and associated configurable warning states as an adjunct to clinical decision support. The Rothman Index itself is a single, comprehensive measure of a patient's physiological condition, calculated using commonly recorded vital signs, nursing assessments, and laboratory data, reflecting the aggregate statistical mortality risk associated with these values. PeraMobile is an interactive mobile application intended for hospital-based healthcare providers, such as Rapid Response Teams, to proactively round on patients of concern and provide supplemental support to bedside clinicians. PeraWatch is a read-only, web-based interface designed to support clinicians in surveilling patients throughout various hospital settings (e.g., emergency department, wards, ICUs) and can be used for centralized or remote professional clinical surveillance across multiple hospitals. Both PeraMobile and PeraWatch are software-only devices that operate on user-provided hardware supporting standard hospital Wi-Fi (IEEE 802.11b or higher). They interface directly with the PeraServer database, which is responsible for calculating the RI scores; PeraMobile can read and write data (allowing users to document interventions and notes), while PeraWatch only reads data. The systems provide configurable warnings and, in the case of PeraMobile, offer out-of-app push notifications for changes in patient warning states to enhance timely awareness. PeraWatch also includes features like a notification list for new warnings and different patient viewing modes (graph array, tile view) to facilitate surveillance of large patient volumes. The timeliness of the RI score and associated warnings is dependent on the data entry into source systems like EHRs, but the notification features aim to improve end-user awareness.

AI Regulatory Concerns

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Keywords

Rothman IndexClinical Decision SupportPatient MonitoringPhysiological StatusMortality RiskMobile ApplicationWeb InterfacePeraServerConfigurable WarningsHealthcare Surveillance

Device Metadata

Submission Number
K183370
Company
PeraHealth, Inc.
Panel
Cardiovascular
Product Code
N/A
Data Type
Signals
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. How does the integration of PeraMobile's note-taking and intervention documentation capabilities with PeraServer influence workflow efficiency and the quality of care coordination for Rapid Response Teams?; What specific vital signs, nursing assessments, and lab values contribute to the Rothman Index, and what is the weighting or statistical model used to aggregate them into a single score representing mortality risk?; Beyond displaying trends and warnings, what evidence exists regarding the impact of the PeraMobile and PeraWatch systems on specific patient outcomes, such as length of stay, ICU admission rates, or code blue events, when used as an adjunct to clinical decision support?; How do the configurable warning states in PeraMobile and PeraWatch adapt to different patient populations (e.g., adult vs. pediatric) or varying acuity levels within different hospital units (e.g., ICU vs. general ward)?; What are the data security and privacy measures implemented within the PeraMobile and PeraWatch systems, especially considering PeraMobile's use on mobile devices and PeraWatch's potential for remote surveillance across multiple hospitals?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score45/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment✓ Detected in Summary
Postmarket Plan✓ Detected in Summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials
- Not detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server, remote)
✓ Detected
HBOMHardware Bill of Materials(hardware)
✓ Detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of SaaSBOM, HBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Not detected in AI-generated device summary: SBOM, ML-BOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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PeraMobile and PeraWatch - PeraHealth, Inc. | ESL FDA AI Device Intelligence