The Connex Spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments.

Device Description

The Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable monitor designed to facilitate the workflows of its users. The Welch Allyn Connex® Spot 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 technology integrated into the base unit including; NIBP, provides measurements of noninvasive blood pressure and pulse rate, SpO2 , provides pulse rate and noninvasive functional oxygen saturation of arteriolar hemoglobin, Thermometer measures temperature, e.g., in neonatal, pediatric, and adult patients. The Custom Scores option provides custom calculations based on patient vital sign values and modifiers determined by the user. The CSM 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, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications including Bluetooth, for example, to electronic record systems and for remote display and alarming (e.g., central station).

AI/ML Overview

The Welch Allyn Connex® Spot Monitor (CSM) has undergone various tests to demonstrate its safety and effectiveness, leading to its classification as substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes several non-clinical tests performed on the Welch Allyn Connex® Spot Monitor. The acceptance criteria are implicitly defined by the standards and guidance documents against which the device was tested. The reported device performance for these tests is simply "Pass."

Test Category	Specific Test / Standard	Acceptance Criteria / Objective	Reported Device Performance
General Safety & Performance	IEC 60601-1 (3ED 2005, AMD 1 2012)	Medical electrical equipment - part 1: general requirements for basic safety and essential performance	Pass
Electromagnetic Compatibility	IEC 60601-1-2 (3 ED 2007)	Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests	Pass
Alarm Systems	IEC 60601-1-8 (2nd edition 2006)	Medical electrical equipment - part 1-8: general requirements for basic safety and essential performance - collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems	Pass
NIBP	IEC 80601-2-30 (1ED 2009, COR 1 2010)	Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers	Pass
SpO2	ISO 80601-2-61 (1ED 2011) and FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff, March 4, 2013	Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment. Ensure the accuracy and communication of the OEM FDA cleared SpO2 technologies per the FDA SpO2 guidance.	Pass
Temperature	ISO 80601-2-56 (2009 First edition)	Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.	Pass
Risk Management	EN/ISO 14971 (2007)	Medical devices - application of risk management to medical devices	Pass
Shipping Performance	Device Ship Test ISTA-2A and ISTA 1A	Ensure device, enclosed in the selected shipping container, meets ISTA 2A 2011 specifications.	Pass
Wireless Communication	Wireless radio communication	Ensure device can communicate via wireless radio in its intended environment.	Pass
Bluetooth Communication	Bluetooth radio communication	Ensure device can communicate via Bluetooth radio in its intended environment.	Pass
Usability	Formative Usability Testing	Ensure device meets the user needs.	Pass
Biocompatibility	ISO-10993 (for accessories)	The CSM itself does not contact the patient. Accessories used with the CSM have been cleared under previous 510(k)'s and have been tested in accordance with ISO-10993. Therefore, the acceptance criteria are met by proxy through the predicate device's cleared accessories.	Pass
Software	Software Verification and Validation Testing	Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software was considered a "major" level of concern.	Documentation Provided

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of units tested for shipping, number of subjects for SpO2 accuracy). It refers to testing against established standards and guidance documents, which typically dictate sample size requirements.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective, as the studies are described as non-clinical and bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the non-clinical tests described. These tests primarily rely on established engineering standards and technical measurements rather than expert human interpretation. For the SpO2 Functional Accuracy testing, the ground truth would be against a reference oximeter or validated physiological measurements as per the FDA guidance. For Formative Usability Testing, user feedback would be gathered, but the number and qualifications of "experts" are not detailed.

4. Adjudication Method for the Test Set

No adjudication method is described, as the tests are non-clinical and the results are performance against established metrics or standards (resulting in a "Pass").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No MRMC study was done. The document explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence." This is a device for measuring vital signs, and the substantial equivalence is primarily based on technological similarity and non-clinical performance to an existing predicate device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance tests described are inherently standalone in nature, as they evaluate the device's technical specifications and adherence to standards (e.g., accuracy of NIBP, SpO2, Temperature, communication capabilities). There isn't an "algorithm only" component presented distinctly from the device's integrated functionality. The software verification and validation would fall under this category as an evaluation of the device's core processing independent of human interaction during the test.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is based on:

Established engineering standards and regulatory guidance: For safety (IEC 60601-1), EMC (IEC 60601-1-2), alarm systems (IEC 60601-1-8), specific vital sign measurements (IEC 80601-2-30 for NIBP, ISO 80601-2-61 for SpO2, ISO 80601-2-56 for temperature), and risk management (EN/ISO 14971).
Reference measurements/equipment: For functional accuracy of SpO2, it would be compared against a 'gold standard' or reference pulse oximeter as per FDA guidance.
Specifications: For wireless/Bluetooth communication, the ground truth is successful communication within defined parameters.
User feedback: For formative usability testing, user needs and expectations serve as a form of ground truth.

8. The Sample Size for the Training Set

The document does not mention a "training set" as it relates to machine learning or AI algorithms. The device's vital sign algorithms (NIBP, SpO2, Temperature) are stated to be "unchanged from CVSM" (the predicate device). Therefore, any "training" (if applicable to these types of algorithms, which often rely on established physiological models rather than machine learning training sets) would have been conducted for the predicate device. For this submission, no new training data or process is described.

9. How the Ground Truth for the Training Set Was Established

Since no training set for new algorithms is described for the CSM (as the algorithms are carried over from the predicate device), the method for establishing ground truth for a training set is not applicable to this submission.

Summary

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

December 19, 2014

Welch Allyn, Inc. Kevin Crossen Director Regulatory Affairs 4341 State St. Rd. P.O. Box 220 Skaneateles Falls, New York 13153-0220

Re: K142356

Trade/Device Name: Connex Spot Monitor, 901058 Vital Signs Monitor Core Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: December 2, 2014 Received: December 3, 2014

Dear Kevin Crossen,

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 device

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related adverse events) (21 CFR 803): good 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.

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 yours,

Melissa A. Torres -S

For

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

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Traditional 510(k) Premarket Notification CSM

Indications for Use

510(k) Number (if known): K

Device Name: Welch Allyn Connex® Spot Monitor

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Traditional 510(k) Premarket Notification for Connex® Spot Monitor Section 07

510(k) Summary (per 21 CFR 807.92)

510(k) Summary

[As described in 21 CFR 807.92]

Section 07 510(k) Summary (per 21 CFR 807.92)

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

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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 professional.

Submitted by:	Welch Allyn Inc.
	4341 State Street Road
	Skaneateles Falls, NY 13153-0220
Contact Person:	Kevin Crossen
	Director Regulatory Affairs
	Phone: (315) 685-2609
	Fax: (315) 685-2532
	E-mail: Kevin.Crossen@welchallyn.com
Date Prepared:	August 20, 2014
Trade Name:	Connex® Spot Monitor
	901058 Vital Signs Monitor Core
Common Name:	Monitor, physiological, patient (without arrhythmia detection or alarms)
Classification Reference:	Class II, monitor, physiological, patient (without arrhythmia detection or alarms) (21 CFR 870.2300, Product Code: MWI)
Predicate Device:	Connex® Vital Signs Monitor 6000 Series
	510(k) Number: K132808
	Cardiovascular, 21 CFR 870.2300
	Class II, MWI

Description of the Device:

The Welch Allyn Connex® Spot Monitor (CSM) is an integrated, configurable monitor designed to facilitate the workflows of its users.

The Welch Allyn Connex® Spot 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 technology integrated into the base unit including;

. NIBP, provides measurements of noninvasive blood pressure and pulse rate,
. SpO2 , provides pulse rate and noninvasive functional oxygen saturation of arteriolar hemoglobin,
. Thermometer measures temperature, e.g., in neonatal, pediatric, and adult patients.

Section 07 510(k) Summary (per 21 CFR 807.92)

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

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Image /page/5/Picture/0 description: The image shows the logo for Welch Allyn. The text "Welch" is in green, and the text "Allyn" is in blue. There is a registered trademark symbol to the right of the word "Allyn".

. The Custom Scores option provides custom calculations based on patient vital sign values and modifiers determined by the user.
The CSM 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, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications including Bluetooth, for example, to electronic record systems and for remote display and alarming (e.g., central station).

Indications for Use:

The Connex Spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive function of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments.

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

Contraindications:

This system is not intended to be used:

· on patients connected to heart/lung machines
· on patients being transported outside a healthcare facility
near an MRI machine
in a hyperbaric chamber
near flammable anesthetics
· near electro-cauterization devices

For contraindications of SpO2 sensors, consult the sensor manufacturer's directions for use.

Technological Characteristics:

The CSM is essentially the same device as the CVSM offering utilizing a subset of Spot check only sensors in a slightly different form factor. There are three main technological differences from the predicate CVSM. Instead of utilizing interchangeable modules, the CSM integrates many of the vital sign features into the device. In addition, the CSM and the CVSM utilize different operating systems. Finally, the CSM adds the option of having wireless Bluetooth capability in addition to wireless radio. CSM can be configured to have custom scoring that is determined by the customer.

Performance Data:

Biocompatibility testing

The CSM does not contact the patient. The accessories used with the CSM have been cleared under previous 510(k)'s and have been tested in accordance with ISO-10993.

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Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Animal Study

No animal studies were conducted as part of submission to prove substantial equivalence. .

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence.

Non-Clinical Tests:

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

Standard	Version	Title
IEC 60601-1	3ED 2005,AMD 1 2012	Medical electrical equipment - part 1: general requirements for basic safety andessential performance
IEC 60601-1-2	3 ED 2007	Medical electrical equipment - part 1-2: general requirements for basic safetyand essential performance - collateral standard: electromagnetic compatibility -requirements and tests
IEC 60601-1-8	2nd edition2006	Medical electrical equipment - part 1-8: general requirements for basic safety andessential performance - collateral standard: general requirements, tests and guidance foralarm systems in medical electrical equipment and medical electrical systems
IEC 80601-2-30	1ED 2009COR 1 2010	Medical electrical equipment - part 2-30: particular requirements for the basicsafety and essential performance of automated non-invasivesphygmomanometers
ISO 80601-2-61	1ED 2011	Medical electrical equipment - part 2-61: particular requirements for basicsafety and essential performance of pulse oximeter equipment
ISO 80601-2-56	2009 Firstedition	Medical electrical equipment - part 2-56: particular requirements for basicsafety and essential performance of clinical thermometers for body temperaturemeasurement.
EN/ISO 14971	2007	Medical devices - application of risk management to medical devices

Standards, Electrical Safety and Electromagnetic Compatibility (EMC)

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Report DIR ---Description	Objective of the Test	Conclusions
Device Ship Test ISTA-2Aand ISTA 1A	Ensure device, enclosed in the selected shipping container,meets ISTA 2A 2011 specifications.	Pass
SpO2 Functional Accuracytesting	Ensure the accuracy and communication of the OEM FDAcleared SpO2 technologies per the FDA SpO2 guidance; PulseOximeters-Premarket Notification Submissions Guidance forIndustry and Food and Drug Staff, March 4, 2013.	Pass
Wireless radio communication	Ensure device can communicate via wireless radio in itsintended environment	Pass
Bluetooth radiocommunication	Ensure device can communicate via Bluetooth radio in itsintended environment	Pass
Formative Usability Testing	Ensure device meets the user needs	Pass

Additional performance Bench Testing:

Device Comparison

The Welch Allyn Connex® Spot Monitor is substantially equivalent to the Welch Allyn Vital Signs Monitor 6000 Series monitor (K132808) The indications for use of the indications for use of the indications for use of the CVSM. The CSM is able to capture the vital sign measurements of SpO2, blood pressure and temperature. The algorithms for these vital signs measurement are unchanged from CVSM. The CSM vital signs technologies are integrated into the device. The CSM can be configured with custom scores, wireless radio and Bluetooth. The CSM provides three SpO2 options compared to two in the CVSM.

Similarities between the subject device and the predicate device. The subject device and the predicate device have the same :

. NIBP Technology
. SpO2 Technology (Masimo, Covidien)
. Temperature Technology
Wireless radio communication
. LCD touch screen

Differences between the subject device and the predicate device. The subject device has the following:

Linux operating system
Integrated technology

Section 07 510(k) Summary (per 21 CFR 807.92) This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.

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. Nonin additional SpO2 option
Additional battery power source
. Bluetooth capability

Conclusion

Based on the information presented in this 510(k) premarket notification the Connex® Spot Monitor (CSM) is considered substantially equivalent. The CSM is as safe and effective as the currently marketed CVSM predicate device (K132808). The differences between the hardware, software, and mechanical aspects of the CSM and the predicate CVSM device were successfully tested with the relevant standards and FDA guidance, and does not affect equivalent safety and effectiveness or raise new questions of safety or effectiveness.

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).