(281 days)
No
The description of the Rothman Index calculation is based on "aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values," which suggests a statistical model, but not explicitly AI/ML. The document also explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a clinical decision support tool that displays and trends patient status information, and does not provide therapy or treatment.
No
The device displays and trends Rothman Index (RI) scores and warnings as an adjunct to clinical decision support, but it does not directly diagnose a condition. Instead, it provides a "patient status index" based on existing data.
Yes
The device description explicitly states that "PeraMobile and PeraWatch are software-only devices".
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: PeraMobile and PeraWatch are software applications that process and display existing patient data (vital signs, nursing assessments, and lab data) to calculate and present a patient status index (Rothman Index). They do not perform any tests on specimens taken from the body.
- Intended Use: The intended use is to provide a patient status index as an adjunct to clinical decision support and to support clinicians in surveilling patients. This is based on analyzing already collected data, not on performing diagnostic tests on biological samples.
The device utilizes data that may include results from IVD tests (lab data), but the device itself is not performing those tests. It's a data processing and display tool for clinical decision support.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MWI
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.
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
Adult and pediatric patients
Intended User / Care Setting
Healthcare professionals within the hospital. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff. 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.
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)
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."
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.
PeraTrend (K172959)
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.
AlertWatch:OB (K173715)
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 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
1
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:
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)
| 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 310 | |
| Charlotte, NC 28210 | |
| Contact: | Brad Coleman |
| Chief Information Officer | |
| bcoleman@perahealth.com | |
| Prepared by: | Donna-Bea Tillman, Ph.D. |
| Senior Consultant | |
| Biologics 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 arrhythmia |
| 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
4
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.
5
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.
6
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 | |||
| Regulation | 21 CFR 870.2300, Class II | 21 CFR 870.2300, Class II | Same |
| Product Code | MWI (Physiological Patient Monitor | ||
| (without arrhythmia detection or | |||
| alarms) | MWI (Physiological Patient Monitor | ||
| (without arrhythmia detection or alarms) | Same | ||
| Device Description | PeraServer collects specified | ||
| demographic and clinical data from the | |||
| EHR and ancillary systems. PeraServer | |||
| computes an Early Warning Score | |||
| called the Rothman Index (RI), | |||
| determines if RI scores and/or clinical | |||
| criteria meet configurable EWS | |||
| criteria; specified input data, and RI | |||
| score and warning states are stored for | |||
| analysis, remote viewing, and | |||
| interfacing. | |||
| PeraTrend provides a web-based user- | |||
| interface for trending and review of RI | |||
| scores and underlying data and warning | |||
| status. | |||
| PeraServer/PeraTrend also interface to | |||
| other medical automation systems such | |||
| as the Hospital Electronic Health | |||
| Record (EHR). | PeraWatch is a read-only web-based | ||
| graphical user interface for displaying | |||
| Rothman Index (RI) scores, trends and | |||
| configurable warnings. | |||
| PeraWatch reads data directly from the | |||
| PeraServer database. | |||
| PeraMobile is an interactive mobile | |||
| application that displays 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. | PeraTrend, PeraWatch, PeraMobile all run | ||
| from data supplied by PeraServer. | |||
| Functional differences: | |||
| Differences are primarily in the pushed | |||
| warning notifications to the PeraWatch and | |||
| PeraMobile. | |||
| PeraWatch array view provides a graph | |||
| header indicator to show patients with | |||
| recently changed warning states. | |||
| PeraMobile runs on a mobile device app, | |||
| supports out-of-app notifications of patients | |||
| changing warnings state, and the display of | |||
| data is modified for ease-of-use on smaller | |||
| 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 | |
| remote professional clinical surveillance | |||
| setting. | PeraTrend and PeraWatch are for use in the | ||
| hospital. | |||
| PeraMobile could be used in hospital or | |||
| remotely (e.g. in a centralized setting) for | |||
| surveilling patients who are in multiple | |||
| different facilities. It cannot be used in a | |||
| home use setting because it requires | |||
| connection to a hospital WiFi to operate. | |||
| Primary or Secondary | |||
| Monitoring | Only intended for secondary | ||
| 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 | ||
| notes or interventions. | PeraWatch does not allow user to enter notes | ||
| or interventions. | Ability to enter notes and select interventions | ||
| in PeraMobile does not impact the RI or RI- | |||
| warnings or how they are acted upon. | |||
| PeraMobile allows user to enter notes and | |||
| select intervention actions from a dropdown | |||
| menu. | The notes and intervention entry permit | ||
| activity tracking and reporting to be provided | |||
| to managers for quality and process | |||
| improvement purposes. | |||
| Warning States | Warnings states for patients are | ||
| calculated by PeraServer for use by | |||
| PeraTrend. | Warning states for patients are calculated by | ||
| PeraServer for use by PeraWatch and | |||
| PeraMobile | Same | ||
| Patient List View | No list view; does support multiple | ||
| patient graph view. | PeraWatch has no list view; does support | ||
| multiple patients graph view. | |||
| PeraMobile does have a text-based patient | |||
| list view. | Difference is in PeraMobile - screen real- | ||
| estate does not support a graph array view | |||
| and hence a text-based patient list view is | |||
| provided instead. | |||
| Primary Predicate | Subject Device | Discussion of Differences | |
| Watchlist View | No watchlist view available. | PeraWatch does not have a watchlist view | |
| available. | |||
| PeraMobile allows user to select patients to | |||
| go onto a custom "watchlist". | The PeraMobile "watchlist" is to support | ||
| mobile clinicians who have more limited | |||
| access to a computer and need a convenient | |||
| way to track patients of interest for follow-up | |||
| purposes. | |||
| Single Patient View | PeraTrend provides a patient specific | ||
| single-graph view of RI-scores trended | |||
| over time. | PeraWatch and PeraMobile provide a patient | ||
| specific single-graph view of RI-scores | |||
| trended over time. | |||
| PeraWatch graph header uses color to | |||
| indicate both patient's current warning status | |||
| and prior warning status if changed in the | |||
| last four hours. | Graph appearance and functionality is nearly | ||
| identical between PeraTrend and PeraWatch. | |||
| Array view | PeraTrend provides an array view of | ||
| multiple patients using small graph | |||
| icons. | PeraWatch array view is the same as | ||
| PeraTrend array view with the addition of | |||
| header color to indicate prior warning status | |||
| if changed in the last four hours. | |||
| PeraWatch also allows a "tile view" in which | |||
| graph thumbnails are replaced by squares | |||
| showing current RI score value and color | |||
| coded according to patient's current warning | |||
| state, if any. | |||
| PeraMobile includes a patient list view. | PeraWatch use of color to show prior | ||
| warning state if changed in last four hours is | |||
| an aid to PeraWatch users for identifying | |||
| patients getting better or worse (based on | |||
| warning state) given the very large number | |||
| of patients they are viewing. | |||
| The PeraWatch "tile" view is to facilitate | |||
| ease of viewing for large volume | |||
| surveillance (i.e. hundreds of patients) across | |||
| facilities. | |||
| PeraMobile difference is to make the multi- | |||
| patient viewing options more user-friendly | |||
| on a smaller device window (i.e. mobile | |||
| device). | |||
| Provides Clinical | |||
| Advisories | Clinical Advisories (warning states) are | ||
| generated by PeraServer which | |||
| computes RI scores and assigns | |||
| warning states based on configured | |||
| settings. | Clinical Advisories (warning states) are | ||
| generated by PeraServer which computes RI | |||
| scores and assigns warning states based on | |||
| configured settings. | No difference in how clinical advisories are | ||
| generated | |||
| Primary Predicate | Subject Device | Discussion of Differences | |
| Graph-based | |||
| indicator of Patient | |||
| Warning Status | PeraTrend graphs have a colored | ||
| header and text indicating patient | |||
| warning state. | PeraWatch and PeraMobile graphs have a | ||
| colored header and text indicating patient | |||
| warning state. | Same | ||
| In App Warning | |||
| Notifications | Users can see patient warning state by | ||
| viewing graphs within the PeraTrend | |||
| application. | Users can see patient warning state by | ||
| viewing graphs within the PeraWatch or | |||
| PeraMobile application. | |||
| PeraWatch and PeraMobile include a | |||
| notification list of patients with new | |||
| warnings. | |||
| PeraMobile can also display pop-up | |||
| notifications. | PeraTrend is intended for users to look at | ||
| small numbers of graphs, e.g. corresponding | |||
| to nurse or physician assignments, or a | |||
| nursing unit, where there is direct familiarity | |||
| with patients and it is easy to see patient | |||
| warning states. | |||
| PeraWatch is for oversight of large volumes | |||
| of patients, and it can be difficult to keep | |||
| track of who has recently escalated in | |||
| warning level - the notifications list provides | |||
| that information directly to the user. | |||
| PeraMobile is for mobile clinicians viewing | |||
| patients throughout the facility, and they may | |||
| not be accessing the EHR or otherwise | |||
| looking at patient RI graphs. The in-app | |||
| notification tracking allows them to easily | |||
| keep track of a patient on their list that has | |||
| escalated in warning level. | |||
| The use of In App Notifications is similar to | |||
| the reference device, AlertWatch:OB | |||
| (K173715), which also provides warning | |||
| alerts to mobile devices. | |||
| Out of App "pushed" | |||
| Warning Notifications | None | PeraMobile has an Out-of-App notification | |
| that identifies when a patient has a change to | |||
| a higher warning state. | PeraMobile is for mobile clinicians viewing | ||
| patients throughout the facility, and they may | |||
| not be accessing the EHR or otherwise | |||
| looking at patient RI graphs. The out-of-app | |||
| notifications allows them to easily know | |||
| when a patient on their list has escalated in | |||
| warning level. | |||
| Primary Predicate | Subject Device | Discussion of Differences | |
| Timeliness of | |||
| Warning (Alert) | |||
| Calculation | Calculated when data is available to | ||
| PeraServer from source system; | |||
| warning generation subject to data | |||
| entry delays. | Calculated when data is available to | ||
| PeraServer from source system; warning | |||
| generation subject to data entry delays. | Same | ||
| Timeliness of | |||
| Warning (Alert) | |||
| Availability | Once a warning is generated in | ||
| PeraServer, it is immediately available | |||
| via PeraTrend. | Once a warning is generated in PeraServer, it | ||
| is immediately available via PeraWatch and | |||
| PeraMobile. | |||
| The user will receive an out-of-app | |||
| notification in the case of PeraMobile. | Same | ||
| Material | Software only | Software only | Same |
| Hardware Platform | PC | PC, iPhone | PeraMobile runs on an iPhone platform to |
| support a mobile clinician. | |||
| Data Source | PeraTrend data comes from PeraServer | PeraWatch and PeraMobile data comes from | |
| PeraServer. | Same | ||
| Data Display | PeraTrend Web - a browser-based | ||
| display. | |||
| PeraTrend Kiosk - a browser-based | |||
| display configured for dedicated | |||
| monitors providing an always-up, auto- | |||
| refreshed display. | |||
| PeraTrend EHR – a browser-based | |||
| display accessed and viewed from | |||
| within the EHR. | PeraWatch - a browser-based display | ||
| configured for dedicated monitors providing | |||
| an always-up, auto-refreshed display. | |||
| PeraMobile – app-based display for use on | |||
| mobile hand-held devices. | PeraWatch and PeraTrend both display data | ||
| via a PC web browser. PeraMobile provides | |||
| display on a mobile device (iPhone | |||
| platform). | |||
| Ability to Trend | Yes | Yes | Same |
| Re-display of vital | |||
| sign 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.