The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

noninvasive blood pressure,
pulse rate.
noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight <11 Kg) during sleep and resting condition.

The Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that require cardiac monitoring.

This ECG module can be used on adult and pediatric patients.

The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient's physiological parameters for the following:

· ECG

· ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole
· Impedance respiration

Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to Welch Allyn 3.5V instruments.

This product is available for sale only upon the order of a physician or licensed health care professional.

Device Description

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

NIBP Module provides measurements of noninvasive blood pressure and pulse rate,
SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin,
The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa),
. The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
. The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement.
The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k)

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

AI/ML Overview

This document is a 510(k) premarket notification for the Welch Allyn Connex® Vital Signs Monitor 6000 Series, specifically addressing the integration and display of signals from the Global Instruments ECG module. The filing asserts substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study report as would be typical for proving performance de novo.

Therefore, the information traditionally found under "acceptance criteria and the study that proves the device meets the acceptance criteria" (as per new device development) is not explicitly present in the provided text. Instead, the document focuses on demonstrating that the modified device (CVSM with integrated ECG module) remains as safe and effective as its predicate devices.

However, I can extract the closest equivalents to the requested information based on the provided text, particularly from the "Non-Clinical Tests" and "Device Comparison Table" sections.

Acceptance Criteria and Device Performance (based on "Non-Clinical Tests" and "Device Comparison Table"):

Given that this is a 510(k) submission for a software modification to integrate an already cleared ECG module into an already cleared vital signs monitor, the "acceptance criteria" are primarily related to maintaining the safety and effectiveness of the existing device and ensuring proper integration of the new module, without introducing new risks or compromising existing performance. The "performance" is demonstrated through compliance with recognized standards and successful completion of various engineering and functional tests.

Here's a table summarizing the "acceptance criteria" (implied through standards compliance and comparative performance) and "reported device performance" (via test results and stated equivalence):

Acceptance Criteria Category (Implied)	Reported Device Performance (as stated in the document)
General Safety and Performance	Passed (per IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 62366, IEC 60601-2-49, IEC 60601-1-8 (Alarms), IEC 62304 (Software Life Cycle), IEC 80601-2-30 (NIBP), ISO 80601-2-55 (Respiratory Gas), ISO 80601-2-56 (Thermometers), ISO 80601-2-61 (Pulse Oximeter), EN/ISO 14971 (Risk Management)). Specific non-clinical tests all "Pass".
ECG Module Integration	Verified that the ECG module functions when integrated into the platform device (Report 60072154). Fidelity of data transfers tested in design control process. ECG module operates with the CVSM via USB communications using the same software communication format as other modules.
ECG Specific Performance (from Predicate)	Respiration Rate: 6 to 45 breaths per minute (±4% or ±1.5 breaths per minute, whichever is greater). Heart Rate: 30 to 170 beats per minute (±4% or ±5 beats per minute, whichever is greater). Detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation. Display of 3-5 Lead ECG. (Stated as "Same as cleared by Global Instruments in K152701").
Known Vital Signs Performance (from Predicate)	NIBP: Systolic: Adult 30-260 mmHg, Pediatric 30-260 mmHg, Neonate 20-120 mmHg. Diastolic: Adult 20-220 mmHg, Pediatric 20-220 mmHg, Neonate 10-110 mmHg. Pulse Rate: Adult 30-200 bpm, Pediatric 30-200 bpm, Neonate 35-220 bpm. Pulse Rate Accuracy: ±3 bpm. (Same as predicate, NIBP module not modified).
	Thermometer: Temp Range: 80-110°F. Predictive or Direct Mode. Oral, axillary, rectal. (Same as predicate, Thermometer module not modified).
	SpO2: Masimo/Nellcor Sensor. SpO2 saturation percentage, pulse amplitude display, perfusion index, Sat Seconds. Pulse Rate Range/Accuracy: 20-250 +/- 3bpm (Nellcor), 25-240 +/- 3bpm (Masimo). O2 Saturation Range/Accuracy: +/- 3 digits between 70-100% (Nellcor), +/- 2.0% between 70-100% (Masimo). Total Hemoglobin: 0-25 g/dL, Adults/Infants/Pediatrics 8-17 g/dL + 1 g/dL. Acoustic Respiration Rate: 4-70 +/- 1 breath per minute (adults >30kg). (Same as predicate, SpO2 modules not modified).
	Capnography (CO2): CO2 accuracy: 0-38 mmHg: ±2 mmHg; 39-150 mmHg: ±2 (5% of reading + 0.08% for every 1 mmHg above 38 mmHg). Flow rate: 50 (42.5 ≤ flow ≤ 65) ml/min. Initialization time: 40 seconds. System response time: 2.9 seconds. (Same as predicate, CO2 module not modified).
	EarlySense Module: Continuous measurement of respiration rate, heart rate and movement. Movement (% time moving): 0 (0%), L (up to 40%), M (40-60%), H (60-80%), EH (80-100%). (Same as predicate).

Detailed Study Information:

It's important to reiterate that this is a 510(k) submission, relying on substantial equivalence to existing devices. As such, it does not describe a de novo clinical study proving the ECG module's performance, but rather the integration of an already cleared module.

A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" are implied by compliance with various IEC/ISO standards and the claimed substantial equivalence to predicate devices, meaning the new configuration must perform "as well as" the existing cleared devices. The "reported device performance" is documented as "Pass" for all listed non-clinical tests and as "Same" when compared to the performance characteristics of the predicate devices for each vital sign parameter.
Sample sizes used for the test set and the data provenance:
The document does not specify "sample sizes" in terms of patient data for clinical studies, as "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (page 12). The testing mentioned (e.g., thermal shock, functional drop, abuse testing) are engineering and bench tests performed on the device itself.
- Data Provenance: Not applicable as no clinical study data is presented. The tests are non-clinical/bench tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies with expert-adjudicated ground truth were performed for this submission. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies requiring expert adjudication were performed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done, nor is AI assistance mentioned as a feature of this device. This device is a vital signs monitor, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document does not describe standalone algorithm performance in the context of this 510(k). The ECG module itself (Global Instruments ECG module, K152701) would have had its own performance data for its 510(k) clearance, but that data is not detailed here, only referenced. The current submission focuses on integrating this cleared module into another cleared system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical bench testing, the "ground truth" would be the established engineering specifications, design requirements, and the pass/fail criteria derived from the referenced IEC and ISO standards. For the performance characteristics of the various vital sign modules, the "ground truth" refers to the validated performance of the predicate devices to which the current device claims substantial equivalence.
The sample size for the training set:
Not applicable. The device is not an AI/ML device that requires a training set in the conventional sense. The "training" in this context would be the engineering and software development process leading to the integration of the ECG module.
How the ground truth for the training set was established:
Not applicable. See point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2017

Welch Allyn, Inc. Mark Alsberge Lead Engineer, Regulatory Affairs 4341 State Street Road Skaneateles Falls, New York 13153

Re: K171621

Trade/Device Name: Welch Allyn Connex Vital Signs Monitor 6000 Series, Welch Allyn Connex Integrated Wall System 80000 Series, 901060 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MHX, MWI Dated: May 31, 2017 Received: June 2, 2017

Dear Mark Alsberge:

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Hillebrand

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171621

Device Name

Welch Allyn Connex® Vital Signs Monitor 6000 Series Welch Allyn Connex® Integrated Wall System 80000 Series 901060 Vital Signs Monitor

Indications for Use (Describe)

The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

noninvasive blood pressure,
pulse rate.
noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that require cardiac monitoring.

This ECG module can be used on adult and pediatric patients.

The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient's physiological parameters for the following:

· ECG

· ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole
· Impedance respiration

Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to Welch Allyn 3.5V instruments.

This product is available for sale only upon the order of a physician or licensed health care professional.

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)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn". The logo is simple and modern.

K171621 Page 1 of 19

Special 510(k) Premarket Notification Connex® Vital Signs Monitor 6000 Series

510(k) Summary

[As described in 21 CFR 807.92]

Submitted by:	Welch Allyn Inc.
	4341 State Street Road
	Skaneateles Falls, NY 13153-0220
Contact Person:	Mark AlsbergeLead Regulatory Affairs EngineerPhone: (315) 685-4471Fax: (315) 685-2532E-mail: Mark.Alsberge@welchallyn.com
Date Prepared:	May 19, 2017
Trade Name:	Connex® Vital Signs Monitor 6000 SeriesConnex® Integrated Wall System 80000 Series901060 Vital Signs Monitor
Common Name:	monitor, physiological, patient(with arrhythmia detection or alarms)
Classification Reference:	Class II, monitor, physiological, patient(with arrhythmia detection or alarms)(21 CFR 870.1025, Product Code MHX)
Predicate Device:	Connex® Vital Signs Monitor 6000 Series510(k) Number: K132808monitor,physiological,patient(without arrhythmia detection or alarms), 21 CFR870.2300Class II, MWIMatrix Mini ECG Monitor510(k) Number: K152701Arrhythmia Detector and Alarm (Including ST-Segment Measurementand Alarm), 21 CFR 870.1025Class II, DSL, DRT, BZO

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Image /page/4/Picture/8 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text reads "Hill-Rom."

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Image /page/5/Picture/0 description: The image shows the logo for Welch Allyn. The text "Welch Allyn" is displayed in a combination of green and blue colors. The word "Welch" is in green, while "Allyn" is in blue, with a registered trademark symbol next to it.

Description of the Device:

NIBP Module provides measurements of noninvasive blood pressure and pulse rate,
SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin,
The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa),
. The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
. The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement.
The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k)

Indications for Use:

The Connex® Vital Signs Monitor 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

noninvasive blood pressure, -
pulse rate,
noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for patients and their caregivers.

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Image /page/6/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol next to the word "Allyn". The logo is simple and clean.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition.

The optional ECG/Impedance Respiration System is intended for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tibrillation in general medical and surgical floors, general hospital and professional healthcare facilities. The system is indicated for use in pediativ and adult patients.

This product is available for sale only upon the order of a physician or licensed health care professional.

Contraindications:

This system (all configurations) is not intended to be used:

· on patients connected to heart/lung machines
on patients being transported outside a healthcare facility
· within the controlled access area of MRI equipment
· in a hyperbaric chamber
· in the presence of flammable anesthetics
· in the presence of electrocauterization devices

Systems configured with EarlySense are not intended to be used:

on patients for whom proper positioning cannot be achieved or maintained
· on patients who do not meet the weight limits tested or specified

Systems configured with a GI ECG module are not intended to be used:

· The Welch Allyn ECG/Impedance Respiration module is not intended for infants weighing less than 10 Kg (22 lbs) or neonatal patients.
4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Fnhancing outcomes for patients and their caregivers

Image /page/6/Picture/26 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text is the company name, "Hill-Rom."

Section 11 510(k) Summary (per 21 CFR 807.92)

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· This module is not designed for direct cardiac application.
· This module is not suitable for transport.
· Computer-assisted ECG data acquisition and interpretation is a valuable tool when used properly. However, no automated interpretation is completely reliable. Interpretations should be reviewed by a qualified physician before treatment, or non-treatment, of any patient.

Technological Characteristics:

The fundamental hardware and mechanical aspects of the CVSM itself remain the same as the predicate CVSM device cleared under K132808 and Global Instruments ECG module cleared under K152701. As noted above, this special 510(k) is for minor software modifications to integrate and display signals from the cleared Global Instruments ECG module on the CVSM system. No changes were made to the Global Instruments ECG technology as cleared; the only changes that are the subject of this submission are the modifications to the CVSM to accommodate integration of the Global Instruments ECG module.

Non-Clinical Tests:

The Welch Allyn Connex® Vital Signs Monitor 6000 Series was tested to evaluate its safety and effectiveness based on the following standards:

Standard	Version	Title
IEC 60601-1	2012	Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance
EN/IEC 60601-1-2	2007	Medical Electrical Equipment – Part 1-2: General Requirements forBasic Safety and Essential Performance – Collateral Standard:Electromagnetic Compatibility – Requirements and Tests
IEC 60601-1-6	2010 (3.1 Edition) +A1:2013	Medical electrical equipment Part 1-6General requirements for safety - Collateral Standard: Usability
IEC 62366	2007 (FirstEdition) +A1: 2014	Medical devices – Application of usability engineering to medical devices

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for patients and their caregivers

Image /page/7/Picture/13 description: The image shows the Hill-Rom logo. The logo is white text on a blue rounded rectangle. The text reads "Hill-Rom."

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Image /page/8/Picture/0 description: The image shows the Welch Allyn logo. The words "Welch" is in green and "Allyn" is in blue. There is a registered trademark symbol next to the word "Allyn".

Connex® Vital Signs Monitor 6000 Series

IEC 60601-2-49	2011 (2ndEdition)	Medical electrical equipment Part 2-49: Particular requirements for thebasic safety and essential performance of multifunction patient monitoringequipment
IEC 60601-1- 8	2006 (SecondEdition) +Am.1: 2012	Medical electrical equipment General requirements for basic safety andessential performance - Collateral standard: General requirements, testsand guidance for alarm systems in medical electrical equipment andmedical electrical systems
IEC 62304	2006 (FirstEdition) +A1:2015	Medical Device Software - Software Life Cycle Processes
IEC 60601-2-27	2011 (ThirdEdition)	Medical electrical equipment Part 2-27: Particular Requirements for theSafety, Including Essential Performance of ElectrocardiographicMonitoring Equipment
IEC 80601-2-30	2009/AMD1:2013	Medical Electrical Equipment - Part 2-30: Particular Requirements ForThe Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers
ISO 80601-2-55	2011 (FirstEdition)	Medical Electrical Equipment - Part 2-55: Particular Requirements ForThe Basic Safety And Essential Performance Of Respiratory GasMonitors
ISO 80601-2-56	2009 (FirstEdition)	Medical Electrical Equipment - Part 2-56: Particular Requirements ForBasic Safety And Essential Performance Of Clinical Thermometers ForBody Temperature Measurement.
ISO 80601-2-61	2011 (FirstEdition)	Medical electrical equipment - Part 2-61: Particular requirements forbasic safety and essential performance of pulse oximeter equipment
EN/ISO 14971	2007 / (R)2010	Medical Devices - Application of Risk Management to Medical Devices

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for
patients and their caregivers:

Image /page/8/Picture/7 description: The image shows the Hill-Rom logo. The logo consists of the words "Hill-Rom" in white text on a blue, rounded rectangle. The text is in a sans-serif font and is centered within the rectangle.

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Additional performance Bench Testing:

Report --- Description	Objective of the Test	Conclusions
60077449Safety Test - CVSM/CIWSConnex Vital Signs Monitor /Connex Integrated Wall System	Test the device per requirements of 60601-1 GeneralStandard, along with associated Collateral and ParticularStandards to ensure that the device meets the requirementsfor Electrical Medical Device Safety	Pass
60082806Electromagnetic Compatibility testCVSMConnex Vital Signs Monitor	Test the device per 60601-1-2 to ensure that the devicemeets the requirements for Electromagnetic Compatibility	Pass
600829806Electromagnetic Compatibility testCIWSConnex Integrated Wall System	Test the device per 60601-1-2 to ensure that the devicemeets the requirements for Electromagnetic Compatibility	Pass
60072154 CVSM-CIWS ECGInterface Test.	To verify the ECG module functions when integrated intothe platform device.This test is also used to verify ECG Module functions afterthe system is exposed to the various test conditions belowand appears in the criteria column when repeated	PASS
60054591Mobile Stand Threshold	The purpose of this test is to verify that the product iscapable of withstanding the stresses caused by roughhandling as defined by IEC 60601-1)	Pass
60056145Mobile Stand Tilt	The purpose of this test is to verify that the product is stableon a stand as defined by IEC 60601-1	Pass
60056145 Shock and Vibration Test	To verify product safety and performance after exposure toshock and vibration.	Pass
60056405Thermal Shock Test	To verify product performance after the thermal shockconditions specified in Applied standards.	Pass
60056431Operating Environmental Test(Temperature and Humidity)	To verify product safety and performance within thespecified temperature and humidity environment.	Pass
60056898Ambient Characterization Test	The purpose of this test is ensure that the module levelcomponents do not exceed each of their operatingtemperatures when integrated into the Platform Device andexposed to the operating temperature limits of that device.	Pass
60056476Functional Drop	To verify product safety and performance after exposure tofree fall.	Pass
60056426VVP Device Weight Test	To verify the configured Platform device weight.	Pass
60056945Device Ship Test	Ensure device, enclosed in the selected shipping container,meets specifications.	Pass
60042214Battery Use Cycles Per Charge-Continuous Monitoring	Verify that the battery shall operate for a minimum of 2hours under the continuous monitoring use case conditionsspecified in PMP PAS 60028508 Section 4.4.	Pass
60072092 2 ECG ModuleConnected to CVSM - Misuse	The purpose of the test is to investigate the behavior of thedevice after two ECG modules are connected to it.Misuse Testing - reasonably foreseeable misuse use by theoperator in a way not intended by the manufacturer butwhich can result from readily predictable human behavior.	Pass
60082302CVSM-CIWS ECG Patient Cableshorting	The purpose of the test is to investigate the behavior of thedevice, connected to an ECG module via USB, when thepatient cables are all shorted together. This is a commontrouble shooting technique with other ECG products toensure that the patient cable leads are intact.Abuse Testing - reasonably foreseeable abusive use by theoperator in a way not intended by the manufacturer butwhich can result from readily predictable human behavior.	Pass
60042215PMP BOM Verification	The objective of this test is to verify that the releasedCVSM-ECG BOM includes the specified componentsidentified within the requirements being tested section ofthis test. This is not a functional test, it is intended as adevice inventory to ensure models can be built that willsupport the features indicated.	Pass
60047144 Thermal Shock - 25cycle	To identify design flaws or behaviors that may occur as aresult of the device being exposed to stimulus beyond whatis specified within the device thermal shock requirements.	Pass
60082307CIWS ECG Patient Cable Abuse	The purpose of the test is to investigate the behavior of thedevice, connected to an ECG module via USB, when cablesconnected to the ECG module are pulled with a force.Abuse Testing - reasonably foreseeable abusive use by theoperator in a way not intended by the manufacturer butwhich can result from readily predictable human behavior.
VVR 60082325 For 60072367CVSM ECG USB and Patient CableAbuse	The purpose of the test is to investigate the behavior of thedevice, connected to an ECG module via USB, when cablesconnected to the ECG module are pulled with a force.Abuse Testing - reasonably foreseeable abusive use by theoperator in a way not intended by the manufacturer butwhich can result from readily predictable human behavior.
60082350 for 60072546 ECGDevice List	This protocol verifies that WAST (WelchAllyn ServiceTool) lists the ECG device with CVSM connected via USB,and updates when any device is added or removed
VVR 60082506 For 60082431CVSM ECG ACM MountReliability Test.	Test the Reliability of ECG module mounting to repeateduse

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

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K171621 Page 8 of 19

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

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Section 11 510(k) Summary (per 21 CFR 807.92)

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Clinical Performance Data:

No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.

Device Comparison Table:

The Welch Allyn Connex® Vital Signs Monitor 6000 Series is substantially equivalent in operation and performance to the Welch Allyn Vital Signs Monitor 6000 Series monitor (K121013).

Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
Device Name	Connex® VSM 6000 SeriesandMatrix Mini ECG Monitor	Connex® VSM 6000 Series	SameAdded ECGModule
Manufacturer	Welch Allyn, Inc.,andGlobal Instrumentation ,LLC	Welch Allyn, Inc.,	Same - WelchAllyn will bedistributor ofECG Module
510(k) Number	K132808 K152701	N/A	N/A
Product Code	MWIDSI, DRT, BZQ	MHX	Update withaddition ofECG module
Regulation Name	870.2300 - Cardiac monitor(includingcardiotachometer and ratealarm)870.1025 - ArrhythmiaDetector and Alarm(Including ST-SegmentMeasurementand Alarm)	870.1025 – monitor,physiological, patient(witharrhythmia detection oralarms)	Update withaddition ofECG module
Indications For Use	Welch Allyn Connex ® VSM6000 SeriesThe VSM 6000 series ofmonitors is intended to beused by clinicians andmedically qualified personnelfor monitoring of neonatal,pediatric, and adult patients	Welch Allyn Connex ® VSM6000 SeriesThe VSM 6000 series ofmonitors is intended to beused by clinicians andmedically qualified personnelfor monitoring of neonatal,pediatric, and adult patients
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	for:	for:
	- noninvasive blood pressure,	- noninvasive blood pressure,
	- pulse rate,	- pulse rate,
	- noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2), and	- noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2), and
	- body temperature in normaland axillary modes.	- body temperature in normaland axillary modes.
	The most likely locations forpatients to be monitored aregeneral medical and surgicalfloors, general hospital, andalternate care environments.	The most likely locations forpatients to be monitored aregeneral medical and surgicalfloors, general hospital, andalternate care environments.
	The optional MasimoRainbow SET® Pulse CO-Oximeter and accessories areindicated for the continuousnoninvasive monitoring offunctional oxygen saturationof arterial hemoglobin (SpO2),pulse rate, total hemoglobinconcentration (SpHb), and/orrespiration rate (RRa). TheMasimo Rainbow SET®Radical 7R Pulse CO-Oximeter and accessories areindicated for use with adult,pediatric, and neonatalpatients during both motionand no motion conditions, andfor patients who are well orpoorly perfused in hospitalsand hospital-type facilities.	The optional MasimoRainbow SET® Pulse CO-Oximeter and accessories areindicated for the continuousnoninvasive monitoring offunctional oxygen saturationof arterial hemoglobin (SpO2),pulse rate, total hemoglobinconcentration (SpHb), and/orrespiration rate (RRa). TheMasimo Rainbow SET®Radical 7R Pulse CO-Oximeter and accessories areindicated for use with adult,pediatric, and neonatalpatients during both motionand no motion conditions, andfor patients who are well orpoorly perfused in hospitalsand hospital-type facilities.
	The optional Oridion moduleand accessories are intendedfor the continuous non-invasive measurement andmonitoring of carbon dioxideconcentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal, pediatric,	The optional Oridion moduleand accessories are intendedfor the continuous non-invasive measurement andmonitoring of carbon dioxideconcentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal,	Same
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	and hospital type facilities.concentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal,pediatric, and adult patients inhospitals and hospital typefacilities.	hospitals and hospital typefacilities. concentration of theexpired and inspired breathand respiration rate. It isintended for use withneonatal, pediatric, and adultpatients in hospitals andhospital type facilities.
	The optional Oridion modulealso provides the clinicianwith an integrated pulmonaryindex (IPI). The IPI is basedon four parameters providedby the monitor: end tidalcarbon dioxide, respirationrate, oxygen saturation andpulse rate. The IPI is a singleindex of an adult or pediatricpatient's ventilatory statusdisplayed on a scale of 1 - 10,where 10 indicates optimalpulmonary status. IPImonitoring displays a singlevalue that represents thepatient's pulmonaryparameters and alertsclinicians to changes in thepatient's pulmonary status.	The optional Oridion modulealso provides the clinicianwith an integrated pulmonaryindex (IPI). The IPI is basedon four parameters providedby the monitor: end tidalcarbon dioxide, respirationrate, oxygen saturation andpulse rate. The IPI is a singleindex of an adult or pediatricpatient's ventilatory statusdisplayed on a scale of 1 - 10,where 10 indicates optimalpulmonary status. IPImonitoring displays a singlevalue that represents thepatient's pulmonaryparameters and alertsclinicians to changes in thepatient's pulmonary status.
	The IPI is an adjunct to, and isnot intended to replace, vitalsign monitoring.	The IPI is an adjunct to, and isnot intended to replace, vitalsign monitoring.	Same (Thebase intended
	Optional compatible weightscales (e.g.,Health o meter®)can be used for height, weight,and BMI input.	Optional compatible weightscales (e.g.,Health o meter®)can be used for height, weight,and BMI input.	use remainsthe monitoringof patient vitalsigns. As with
	The Welch Allyn Connex®Vital Signs Monitor (CVSM)6000 Series also contains theWelch Allyn ApplicationsFramework ("Framework").The Framework is generalpurpose software that allowsmedical device and non-medical device softwareapplications to be run on the	The Welch Allyn Connex®Vital Signs Monitor (CVSM)6000 Series also contains theWelch Allyn ApplicationsFramework ("Framework").The Framework is generalpurpose software that allowsmedical device and non-medical device softwareapplications to be run on the	previoussubmissions,the GlobalInstrumentsModule'sclearedindications foruse statementis appendedunchanged
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	CVSM independently of, andisolated from, the CVSM'svital signs monitoringfunctionality. All suchapplications are intended to beused on the CVSM by trainedprofessionals in a health caresetting.	CVSM independently of, andisolated from, the CVSM'svital signs monitoringfunctionality. All suchapplications are intended to beused on the CVSM by trainedprofessionals in a health caresetting.	CVSM'sclearedindications foruse statement,as shown bythe bold text inthe column tothe left. TheGlobalInstruments
	The optional EarlySense®(Everon) System is intendedfor continuous measurementof respiration rate, heart rate,and movement in an automaticcontact-less manner, in ahospital or clinic setting. Thesystem is indicated for use inchildren, adolescents, andadults. The operation of theEarlySense has been studied inchildren (weight $≥$ 10 Kg) andadults (weight <111 Kg)during sleep and restingcondition.	The optional EarlySense®(Everon) System is intendedfor continuous measurementof respiration rate, heart rate,and movement in anautomatic contact-lessmanner, in a hospital or clinicsetting. The system isindicated for use in children,adolescents, and adults. Theoperation of the EarlySensehas been studied in children(weight $≥$ 10 Kg) and adults(weight <111 Kg) duringsleep and resting condition.	Instrumentsmodule waspreviouslycleared inGlobalInstrumentsmodule510(k)K152701).
	This product is available forsale only upon the order of aphysician or licensed healthcare professional.	The optionalECG/ImpedanceRespiration System isintended for continuousmeasurement of respirationrate, heart rate anddetection of cardiacstandstill (asystole),ventricular tachycardia andventricular fibrillation ingeneral medical and surgicalfloors, general hospitaland professional healthcarefacilities. The system isindicated for use in pediatricand adult patients.
		This product is available forsale only upon the order of a
	Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
		physician or licensed healthcare professional.
Basic Description	The Welch Allyn Connex®Vital Signs Monitor 6000Series is designed to provide ascalable, modular system ofcomponents that could beconfigured to address the needsfor vitals signs spot check andmonitoring.The CVSM 6000 Series ofmonitors are intended to beused by clinicians andmedically qualified personnelfor monitoring of noninvasiveblood pressure, pulse rate,noninvasive functional oxygensaturation of arteriolarhemoglobin (SpO2), and bodytemperature in normal andaxillary modes of neonatal,pediatric, and adult patients.Electronic transmission of datefrom external accessorydevices is supported includingtemperature, Weight, Height,and BMI. When equippedwith Masimo Rainbow SET®Pulse Co-oximeter andaccessories may be used forcontinuous noninvasivemonitoring of totalhemoglobin concentration andacoustic respiration rate(RRa). Patient monitorsequipped with Oridioncapnography are also capableof carbon dioxide (CO2),respiration rate (RR) andcalculation of IntegratedPulmonary Index (IPI).Patient monitors equippedwith the EarlySense Modulecan measure respirationrate, heart rate, and	The Welch Allyn Connex®Vital Signs Monitor 6000Series is designed to provide ascalable, modular system ofcomponents that could beconfigured to address theneeds for vitals signs spotcheck and monitoring.The CVSM 6000 Series ofmonitors are intended to beused by clinicians andmedically qualified personnelfor monitoring of noninvasiveblood pressure, pulse rate,noninvasive functionaloxygen saturation of arteriolarhemoglobin (SpO2), and bodytemperature in normal andaxillary modes of neonatal,pediatric, and adult patients.Electronic transmission ofdate from external accessorydevices is supported includingtemperature, Weight, Height,and BMI. When equippedwith Masimo Rainbow SET®Pulse Co-oximeter andaccessories may be used forcontinuous noninvasivemonitoring of totalhemoglobin concentration andacoustic respiration rate(RRa). Patient monitorsequipped with Oridioncapnography are also capableof carbon dioxide (CO2),respiration rate (RR) andcalculation of IntegratedPulmonary Index (IPI).Patient monitors equippedwith the EarlySense Modulecan measure respiration rate,heart rate, and movement in	ECG Moduleadded
	can measure respirationrate, heart rate, andmovement in an automatic	can measure respiration rate,heart rate, and movement inan automatic contact-less
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	contact-less manner usingEarlySense sensors.	manner using EarlySensesensors.The optionalECG/ImpedanceRespiration System isintended for continuousmeasurement of respirationrate, heart rate anddetection of cardiacstandstill (asystole),ventricular tachycardia andventricular fibrillation.
Target Population	Neonatal, Pediatric, andAdult Patients of anygender.	Neonatal, Pediatric, and AdultPatients of any gender.	Same
Where Used	The product is intended foruse in a clinical environmentgeneral medical and surgicalfloors, general hospital, andalternate care environments.	The product is intended foruse in a clinical environmentgeneral medical and surgicalfloors, general hospital, andalternate care environments.	Same
Design/Technology	Modular	Modular	Same
Alarms	• Can configure, observe,and respond to an alarmcondition.	• Can configure, observe,and respond to an alarmcondition.	Same
Nurse Call(wired)	• Can connect to customernurse call system. ProvidesNO/NC relay.	• Can connect to customernurse call system. ProvidesNO/NC relay.	Same
Patient datamanagement	• Change patient type (adult,pediatric, neonate)• View and enter manualparameters (height, weight,pain, respiration)• Manage patient vitalsrecord• Assign patient and clinicianID to readings• Automated data input ofweight, height, and BMI• Connectivity to ElectronicRecords Managementsystems for transfer ofpatient data.• Connectivity to Central	• Change patient type (adult,pediatric, neonate)• View and enter manualparameters (height, weight,pain, respiration)• Manage patient vitalsrecord• Assign patient and clinicianID to readings• Automated data input ofweight, height, and BMI• Connectivity to ElectronicRecords Managementsystems for transfer ofpatient data.• Connectivity to Central	Same
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	patient monitoring anddistributed alarms	patient monitoring anddistributed alarms
Memory	• Save patient data to devicememory - (300) readings	• Save patient data to devicememory - (300) readings	Same
Printer	Yes - 57mm Internal Thermal	Yes - 57mm Internal Thermal	Same
Non-InvasiveBlood Pressure(NIBP)	• Display systolic, diastolic,and MAP measurements• Manual and automatic NIBPmeasurements• Can measure blood pressureas the cuff is inflating• Can measure blood pressureas the cuff is deflating	• Display systolic, diastolic,and MAP measurements• Manual and automatic NIBPmeasurements• Can measure blood pressureas the cuff is inflating• Can measure blood pressureas the cuff is deflating	Same - theNIBP modulehas not beenmodified
Algorithm	• Oscillatory BP Algorithm• Fast BP Algorithm	• Oscillatory BP Algorithm• Fast BP Algorithm	Same
Systolic range	• Adult: 30 to 260 mmHg• Pediatric: 30 to 260 mmHg• Neonate: 20 to 120 mmHg	• Adult: 30 to 260 mmHg• Pediatric: 30 to 260 mmHg• Neonate: 20 to 120 mmHg	Same
Diastolic range	• Adult: 20 to 220 mmHg• Pediatric: 20 to 220 mmHg• Neonate: 10 to 110 mmHg	• Adult: 20 to 220 mmHg• Pediatric: 20 to 220 mmHg• Neonate: 10 to 110 mmHg	Same
Pulse rate rangeusing BP	• Adult: 30 to 200 bpm• Pediatric: 30 to 200 bpm• Neonate: 35 to 220 bpm	• Adult: 30 to 200 bpm• Pediatric: 30 to 200 bpm• Neonate: 35 to 220 bpm	Same
Pulse rate accuracy	• ±3 bpm	• ±3 bpm	Same
Thermometer(Thermister probe)	• Welch Allyn SureTemp Plustechnology• Temperature range: 80 -110°F• Either the Predictive(Normal) or Direct (Monitor)Mode• °C or °F• Oral, axillary, rectal	• Welch Allyn SureTemp Plustechnology• Temperature range: 80 -110°F• Either the Predictive(Normal) or Direct(Monitor) Mode• °C or °F• Oral, axillary, rectal	Same - theThermometermodule hasnot beenmodified
SpO2	• Masimo Sensor• Nellcor Sensor• SpO2 saturation percentageand the pulse amplitudedisplay• Perfusion index• Sat Seconds	• Masimo Sensor• Nellcor Sensor• SpO2 saturation percentageand the pulse amplitudedisplay• Perfusion index• Sat Seconds	Same - theSpO2 moduleshave not beenmodified
Pulse rate Rangeand accuracy using	• 20 - 250 +/- 3bpm, basedwith Nellcor SpO2parameter	• 20 - 250 +/- 3bpm, basedwith Nellcor SpO2parameter	Same
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
SpO2 determination	• 25 - 240 +/- 3bpm, based onMasimo SpO2 parameter	• 25 - 240 +/- 3bpm, based onMasimo SpO2 parameter
O2 SaturationRange andaccuracy	• Nellcor O2 sat (%) valuesshall be +/- 3 digits betweenthe range of 70 - 100%• Masimo O2 sat (%) valuesshall be +/- 2.0% of thevalues set between the rangeof 70 - 100%	• Nellcor O2 sat (%) valuesshall be +/- 3 digits betweenthe range of 70 - 100%• Masimo O₂ sat (%) valuesshall be +/- 2.0% of thevalues set between the rangeof 70 - 100%	Same
Total Hemoglobinrange and accuracy(SpHb g/dL)	• Masimo Sensor only –Range 0 – 25 g/dLAdults/Infants/Pediatrics 8-17 g/dL + 1 g/dL	• Masimo Sensor only –Range 0 – 25 g/dLAdults/Infants/Pediatrics 8-17 g/dL + 1 g/dL	Same
AcousticRespiration Rate(RRa)	Masimo hardware providedand software enabled• 4 – 70 +/- 1 breath perminute, adults (>30kg)	Masimo hardware providedand software enabled• 4 – 70 +/- 1 breath perminute, adults (>30kg)	Same
Capnography forcarbon dioxide(CO2), respirationrate (RR)measurements andcalculation ofIntegratedPulmonary Index(IPI).	CO2 accuracy:	CO2 accuracy:	Same – theCO2 modulehas not beenmodified
	0 to 38 mmHg: ±2 mmHg39 to 150 mmHg: ±2 ( 5% ofreading + 0.08% for every 1mmHg above 38 mmHg)	0 to 38 mmHg: ±2 mmHg39 to 150 mmHg: ±2 ( 5% ofreading + 0.08% for every 1mmHg above 38 mmHg)
	Flow rate:	Flow rate:
	50 (42.5 ≤ flow ≤ 65) ml/min,flow measured by volume	50 (42.5 ≤ flow ≤ 65) ml/min,flow measured by volume
	Initialization time:	Initialization time:
	40 seconds (typical, includespower-up andinitialization time)	40 seconds (typical, includespower-up andinitialization time)
	System response time:	System response time:
	2.9 seconds	2.9 seconds
	Compensation:	Compensation:
	BTPS (standard correctionused by Microstreamcapnography during allmeasurement procedures for	BTPS (standard correctionused by Microstreamcapnography during allmeasurement procedures for
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	body temperature, pressure, and saturation)	body temperature, pressure, and saturation)
EarlySense Module	Yes	Yes	Same
Respiration rate	Also provided by Early Sense, Masimo and Oridion Modules	6 to 45 breaths per minute(±4% or ±1.5 breaths per minute, whichever is greater)	Same ascleared byGlobalInstrumentsImpedanceRespiration inK152701.
Heart Rate	Also provided by Early Sense, Masimo and Oridion Modules	30 to 170 beats per minute(±4% or ±5 beats per minute, whichever is greater)	Same ascleared byGlobalInstrumentsImpedanceRespiration inK152701.
Display of ECG	N/A	3 - 5 Lead ECG added byGlobal Instruments Module	Same ascleared byGlobalInstruments inK152701.
Detect abnormalECG's	N/A	detection of cardiacstandstill (asystole),ventricular tachycardia andventricular fibrillation.	Same ascleared byGlobalInstruments inK152701
Patient Movement	Movement during definedperiod (percent of timemoving in1.5 minutes)0 = 0%	Movement during definedperiod (percent of timemoving in1.5 minutes)0 = 0%	Same.
	L = Up to 40%	L = Up to 40%
	M = 40% to 60%H = 60% to 80%EH = 80% to 100%(Adult:	M = 40% to 60%H = 60% to 80%EH = 80% to 100%(Adult:
	0 = 100%, L = 100%, M =81%, H = 100%, EH = 96%	0 = 100%, L = 100%, M =81%, H = 100%, EH = 96%
Subject Device and Predicate Device Comparison
Characteristic	Predicate Devices	Subject Device	Differences
	Pediatric:0 = 100%, L = 100%, M =81%, H = 86%, EH = 94%).	Pediatric:0 = 100%, L = 100%, M =81%, H = 86%, EH = 94%)
External DeviceCommunicationProtocol	WACP	WACP	Same
Communicationwith electronicrecord systems foralarming andremote monitoring(e.g., centralstation)	Patient date uploadedepisodically to electronicrecord systems.SpO2 and Pulse Ratecontinuous monitoring andinterval measurements ofNIBP and Temperature	Patient date uploadedepisodically to electronicrecord systems.SpO2 and Pulse Ratecontinuous monitoring andinterval measurements ofNIBP and Temperature.Interface also allows clinicianto manually enter Patientnotes.	Same.
Display type	LCDTouch Screen	LCDTouch Screen	Same
Barcode scanner	YesThe monitor enables thescanning of patients' and/orclinicians' barcodes to enteridentification information. Thebarcode scanner supportslinear and 2D barcodes.	YesThe monitor enables thescanning of patients' and/orclinicians' barcodes to enteridentification information.The barcode scanner supportslinear and 2D barcodes.	Same
Sterility	Device not supplied Sterile	Device not supplied Sterile	Same
Power source	100 -240 V ac 50/60 Hz	100 -240 V ac 50/60 Hz	Same
Battery Power	• Yes• Level of Charge indicator• Lithium ion	• Yes• Level of Charge indicator• Lithium ion	Same

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Enhancing outcomes for patients and their caregivers?

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Section 11 510(k) Summary (per 21 CFR 807.92)

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Image /page/17/Picture/0 description: The image shows the Welch Allyn logo. The word "Welch" is in green, and the word "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn". The logo is simple and professional.

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Section 11 510(k) Summary (per 21 CFR 807.92)

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Conclusion

Based on the information presented in this 510(k) premarket notification the Connex® Vital Signs Monitor 6000 Series(CVSM) is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices (K132808 and K152701) citied in this submission. The differences noted between the CVSM and the predicate devices do not impact safety or effectiveness based on the successfully conducted testing of the

4341 State Street Road, P.O. Box 220, Skaneateles Falls, NY 13153-0220 www.welchallyn.com

Section 11 510(k) Summary (per 21 CFR 807.92)

This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

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Enhancing outcomes for patients and their caregivers?

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Connex® Vital Signs Monitor 6000 Series

modified device. The hardware, software, and mechanical aspects of the CVSM itself remain the same as the cleared device (Vital Signs Monitor - VSM 6000 Series, K132808, S.E. date November 30, 2012) except as described below. The modification is to make the Global Instruments ECG module (K152701) available on the CVSM to provide ECG monitoring. The software of the CVSM has been modified to enable display of the Global Instruments ECG measurements, which are received by CVSM via the same USB communications used to receive data from the currently available modules. It follows the same software communication format as our currently available modules. The fidelity of these data transfers were tested in our design control process. Like the predicate CVSM device, this version of the CVSM can transfer acquired data electronically via USB, wired Ethernet, or wireless communications to other locations. Like the CVSM cleared in K132808, this version of the CVSM can transmit data continuously for secondary remote viewing and alarming (e.g., central station, NCE).

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Enhancing outcomes for patients and their caregivers?

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Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.