(217 days)
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Unknown
The description mentions "aggregate statistical mortality risk associated with the values" and "compute a patient status index" based on data, which could potentially involve statistical modeling or machine learning, but the document does not explicitly state the use of AI or ML.
No
The device is described as an "adjunct to clinical decision support" that computes and displays a patient status index, but it does not directly treat or diagnose a disease or condition.
Yes
The device computes a patient status index and provides configurable warnings based on vital signs, nursing assessments, and lab data to aid in clinical decision support, indicating its use in diagnosing or assessing patient conditions.
Yes
The device description explicitly states that "PeraServer and PeraTrend are software-only devices that are installed on user-provided hardware."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The Rothman Index system, as described, takes existing patient data (vital signs, nursing assessments, lab values) that have already been collected, and processes them to compute a score. It does not perform any analysis on biological samples itself.
- The intended use is to compute and display a patient status index based on existing data. This is a form of clinical decision support based on aggregated patient information, not a diagnostic test performed on a biological specimen.
The device description and intended use clearly indicate that it's a software system that processes and displays data already collected from the patient, rather than performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes
MWI
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.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
The Rothman Index score is validated for use with neonatal, pediatric, and adult patients.
Intended User / Care Setting
Intended for use by healthcare providers.
Intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units).
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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).
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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.
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
1
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)
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.
| 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 310 | |
| Charlotte, NC 28210 | |
| Contact: | Joseph Beals, Ph.D. |
| Vice President, Informatics | |
| jbeals@perahealth.com | |
| Prepared by: | Donna-Bea Tillman, Ph.D. |
| Senior Consultant | |
| Biologics 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 arrhythmia |
| detection 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.
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."
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 Warning |
| System (BedsidePEWSTM) | ||
| Classification | ||
| Regulation | 21 CFR 870.2300, Class II | 21 CFR 870.2300, Class II |
| Product Code | MWI: Physiological Patient Monitor | |
| (without arrhythmia detection or | ||
| alarms) | MWI: Physiological Patient Monitor | |
| (without arrhythmia detection or | ||
| alarms) | ||
| 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). | BedsidePEWS is a web-based clinical | |
| decision-support tool that can also be | ||
| run as a standalone application for use | ||
| on computers running Microsoft | ||
| Software Operating features with a | ||
| local network connection, which access | ||
| medical data. It is also interfaces to | ||
| other medical automation systems such | ||
| as Hospital Information System (HIS), | ||
| Electronic Medical Record (EMR), and | ||
| Practice Management Software. | ||
| Subject Device | Predicate Device | |
| Indications for Use | 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. | The Bedside Paediatric Early Warning | |
| System (BedsidePEWS) is an | ||
| electronic documentation tool that is | ||
| designed to be used in conjunction with | ||
| multi-parameter patient monitoring. It | ||
| is indicated for use by healthcare | ||
| professionals with paediatric patients | ||
| between the ages of term newborn (>37 | ||
| weeks gestational age) and 18 years, | ||
| who are hospitalized with any medical | ||
| or surgical condition. | ||
| BedsidePEWS allows input by the | ||
| healthcare professional of commonly | ||
| recorded vital sign data and provides | ||
| clinician with a patient status index (the | ||
| "BedsidePEWS score") based on a | ||
| weighted average of seven vital signs | ||
| when entered by the clinician, namely | ||
| Heart Rate, Respiratory Rate, Blood | ||
| Pressure, Oxygen Saturation, Oxygen | ||
| Therapy, Respiratory Effort, and | ||
| Capillary Refill. The "BedsidePEWS | ||
| score" is a single measure of a patient's | ||
| condition and indicates the variation in | ||
| the patient's vital signs with respect to | ||
| normality. BedsidePEWS is an adjunct- | ||
| to and is not intended to replace vital | ||
| signs monitoring. | ||
| BedsidePEWS is intended for use in | ||
| wards and emergency rooms in | ||
| hospitals that provide care for children | ||
| between the ages of term newborn (>37 | ||
| weeks gestational age) and 18 years. It | ||
| is not intended for use in the Neonatal | ||
| Intensive Care Unit. | ||
| Intended users | Healthcare Professionals | Healthcare Professionals |
| Patient Population | Adult and pediatric patients | Pediatric patients between the ages of |
| term newborn (>37 weeks gestational | ||
| age) 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, Respiratory | |
| Rate, Blood Pressure, Oxygen | ||
| Saturation, Oxygen Therapy, | ||
| Respiratory Effort, and Capillary | ||
| Refill) | ||
| Subject Device | Predicate Device | |
| Score | Rothman Index (RI) and Pediatric RI | |
| (pRI) | BedsidePEWS score | |
| Material | Software only | Software only |
| Hardware Platform | PeraServer/PeraTrend require | |
| dedicated application and database | ||
| servers. | Windows PC or Tablet | |
| Data Source | Hospital EHR systems | Hospital EHR systems or manually |
| input | ||
| 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 | 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.