Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states "Not Found" for mentions of AI, DNN, or ML, and the scoring mechanism is described as a "weighted average" of vital signs, which is a deterministic algorithm, not AI/ML.

Therapeutic

No
The device is a clinical decision-support tool that calculates a patient status index (BedsidePEWS™ score) based on vital signs; it is an adjunct tool and not intended to directly diagnose, treat, or prevent a disease or condition.

Diagnostic

No

The device is described as an "electronic documentation tool" and a "web-based clinical decision-support tool" that provides a patient status index ("BedsidePEWS™ score") based on entered vital sign data. While it helps identify patients at risk, it is explicitly stated that "BedsidePEWS™ is an adjunct to and is not intended to replace vital signs monitoring" and it provides "actionable information, such as recommended follow-up and/or guideline for further and subsequent clinical assessments", rather than providing a definitive diagnosis itself.

SaMD (Software as a Medical Device)

Yes

The device is described as a "web-based clinical decision-support tool" and a "standalone application" that runs on computers. It interfaces with existing medical automation systems and uses a database for patient information and data input. While it relies on input from multi-parameter patient monitoring and interfaces with other systems, the device itself is presented as software that processes and displays data, without including any hardware components as part of its defined scope. The mention of "Ability to display multimodality images: Yes" refers to a software capability, not a hardware component included in the device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Bedside Paediatric Early Warning System (BedsidePEWS™) is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
BedsidePEWS™ Function: BedsidePEWS™ is a software tool that processes vital sign data (Heart Rate, Respiratory Rate, Blood Pressure, etc.) which are obtained through patient monitoring, not from the examination of specimens in vitro. It uses this data to calculate a score and provide clinical decision support.
Intended Use: The intended use clearly states it's an "electronic documentation tool" used "in conjunction with multi-parameter patient monitoring" and is an "adjunct to and is not intended to replace vital signs monitoring." This reinforces its role in processing in vivo data.

Therefore, BedsidePEWS™ falls under the category of a clinical decision support software or a medical device that processes physiological data, rather than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

MWI

Device Description

The product 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.

The software device consists of a SQL compatible database that provides access to the patient specific information and allows clinicians to input patient data (i.e. heart rate, respiratory rate, blood pressure, oxygen saturation, oxygen therapy, respiratory effort, and capillary refill time) to deliver actionable information, such as recommended follow-up and/or guideline for further and subsequent clinical assessments, and analytics of patients through real-time vital signs monitoring algorithm.

The software is installed on a network connected server with the following minimum requirements:

For server installation:

Java Runtime Environment 1.6 or higher .

For end users:

Mozilla FireFox 3.6 or higher; Google Chrome 4.0 or higher; Safari 4.0 or higher; Opera 10.5 or higher, with JavaScript enabled
1024 x 768 screen resolution or higher. .

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

Between the ages of term newborn (>37 weeks gestational age) and 18 years

Intended User / Care Setting

Healthcare professionals; wards and the emergency rooms in hospitals that provide care for children

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)

Clinical evaluation of the BedsidePEWS was performed to ensure that the BedsidePEWS software was clinically useful, and would be accepted by the clinical users.

The validation of the Bedside PEWS score using the 7-item score successfully quantified severity of illness in routinely monitored hospitalized children and identified critically ill children with at least one hours notice. Overall, the results support that the device can be used to identify a pediatric patient at risk while undergoing routine monitoring in the hospital.

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.

K053112

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.

Not Found

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

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).

Summary

0

K124038

510(k) Summary

JUN 2 1 2013

1. Submission Sponsor

·

Bedside Clinical Systems 101 College Street, # 402 Toronto, Ontario Canada M5G 1L7 Phone: 647-258-4299 Fax: 647.260.7870 Contact: Rajesh Sharma, RRT RRCP

2. Submission Correspondent

Emergo Group 816 Congress Avenue Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Dr. Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com

3. Date Prepared

June 20th, 2013

4. Device Identification

Trade/Proprietary Name:	Bedside Paediatric Early Warning System (BedsidePEWSTM)
Common/Usual Name:	Accessory to multi-parameter patient monitor (bedside or
ambulatory)
Classification Name:	Physiological Patient Monitor (without arrhythmia detection or
alarms)
Classification Regulation:	870.2300
Product Code:	MWI
Device Class:	Class II
Classification Panel:	Cardiovascular

5. Predicate Devices

K053112 – BioSign (Oxford BioSignals Ltd)

6. Device Description

The product 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

1

automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), and Practice Management Software.

The software device consists of a SQL compatible database that provides access to the patient specific information and allows clinicians to input patient data (i.e. heart rate, respiratory rate, blood pressure, oxygen saturation, oxygen therapy, respiratory effort, and capillary refill time) to deliver actionable information, such as recommended follow-up and/or guideline for further and subsequent clinical assessments, and analytics of patients through real-time vital signs monitoring algorithm.

The software is installed on a network connected server with the following minimum requirements:

For server installation:

Java Runtime Environment 1.6 or higher .
For end users:
Mozilla FireFox 3.6 or higher; Google Chrome 4.0 or higher; Safari 4.0 or higher; Opera 10.5 or higher, with JavaScript enabled
1024 x 768 screen resolution or higher. .

7. Intended Use

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 the 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.

8. Comparison of Technological Characteristics

The following table compares the Bedside Paediatric Early Warning System (BedsidePEWS™) to the predicate device with respect to intended use, technological

2

characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	OBS Medical	Bedside Clinical System Inc.
Trade Name	Predicate
BioSignTM	New Device
Bedside Paediatric Early Warning
System (BedsidePEWSTM)
510(k) Number	K053112	Not assigned
Product Code	MWI	MWI
Regulation Number	870.2300	870.2300
Regulation Name	Physiological Patient Monitor
(without arrhythmia detection or alarms)	Physiological Patient Monitor
(without arrhythmia detection or alarms)
Indications for Use	BioSignTM is an accessory to multi-parameter patient monitors (bedside or ambulatory) or clinical information systems and is indicated for use by health care professionals with those non-pediatric high dependency care patients for whom multi-parameter patient monitoring has been routine.
BioSignTM provides the clinician with a patient status index based on a weighted average of five vital signs namely heart rate, respiration rate, temperature, oxygen saturation and blood pressure. The patient status index is a single measure of a patient's condition and represents how different the patient's vital signs are with respect to normality. BioSignTM is an adjunct to and is not intended to replace vital sign monitoring and as such does not contain alarms, but alerts the physician to changes in the patient's physiological status.	The Bedside Paediatric Early Warning System (BedsidePEWSTM) 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.

BedsidePEWSTM allows input by the healthcare professional of commonly recorded vital sign data and provides clinician with a patient status index (the "BedsidePEWSTM 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 "BedsidePEWSTM score" is a single measure of a patient's condition and indicates the variation in the patient's vital signs with respect to normality. BedsidePEWSTM is an adjunct to and is not intended to replace vital signs monitoring.

Table 5A – Comparison of Characteristics

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K124038

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Bedside Clinical Systems' BedsidePEWS clinical decision support system is a medical device and has similar indications for use statement as the predicate device. The differences do not alter the intended decision support -both devices have essentially the same intended use.

The device also has similar technological characteristics as the predicate device. Both devices use software to process the condition scores. Both clinical decision support systems are statistically derived. While the details of the process are different, the basic technology is the same. Since the comparison of the descriptive characteristics of the proposed and predicate devices may not be sufficiently precise to assure equivalence, performance data are provided from the published literature. The results of the performance testing demonstrate substantial equivalence.

9. Non-Clinical Performance Data

The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The BedsidePEWS device passed all testing and supports the claims of substantial equivalence and safe operation.

10. Clinical Testing

Clinical evaluation of the BedsidePEWS was performed to ensure that the BedsidePEWS software was clinically useful, and would be accepted by the clinical users.

The validation of the Bedside PEWS score using the 7-item score successfully quantified severity of illness in routinely monitored hospitalized children and identified critically ill children with at least one hours notice. Overall, the results support that the device can be used to identify a pediatric patient at risk while undergoing routine monitoring in the hospital.

11. Statement of Substantial Equivalence

The Bedside Paediatric Early Warning System (BedsidePEWS™) has similar intended use as the predicate device and that any technological differences between the Bedside Paediatric Early Warning System (BedsidePEWS'") software and the predicate device do not raise any questions regarding Bedside Paediatric Early Warning System (BedsidePEWS™)'s safety and effectiveness.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 21, 2013

Bedside Clinical Systems Inc Diane Sudduth 611 West 5th Street, Third Floor Austin, TX 78701 US

K124038 Re:

Trade/Device Name: Bedside Paediatric Early Warning System (BedsidePEWS) Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MWI Dated: May 28, 2013 Received: May 29, 2013

Dear Diane Sudduth:

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 (reporting of medical

6

Page 2 - Diane Sudduth

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Owen P. Faris -S

for

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

7

Section 4 - Indications for Use Statement

510(k) Number (if known): K124038

Device Name: Bedside Paediatric Early Warning System (BedsidePEWS™)

Indications for Use:

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.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Prescription Use______________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.06.21
15:11:18 -04'00'