The Welch Allyn® Diagnostic Cardiology Suite™ is a prescription device intended for use by physicians, other licensed health care practitioners, and trained personnel who are acting on the orders of a physician. Welch Allyn Diagnostic Cardiology Suite is intended for use in medical clinics, physician offices and hospital settings to acquire, analyze, display, transmit and print certain physiological signals identified below and provide the data for consideration by a physician.

Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic resting ECG and diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.

Welch Allyn Diagnostic Cardiology Suite is not intended to be used as a physiological vital signs monitor, not intended to be used in a mobile medical environment (e.g. ambulance, helicopter), in magnetic resonance (MR) environments, in operating theaters, nor in conjunction with high frequency surgical equipment.

Indications for Welch Allyn Diagnostic Cardiology Suite ECG range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department. Welch Allyn Diagnostic Cardiology Suite ECG is indicated for patients of all ages. There are no known contraindications for resting ECG.

Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

Device Description

The Welch Allyn Diagnostic Cardiology Suite is a PC-based software device. Section 16 details the software technology including its requirements, architecture, detailed design, development environment, verification and validation and lifecycle management plan. Medical device software development and management is characterized in IEC 62304 Medical device software – Software life cycle processes.

The technology of the hardware accessories are:

For diagnostic ECG, the technology involves applying surface electrodes to the patient's skin to obtain signals of the heart's electrical activity. The electrical signals are then amplified, analyzed (VERITAS algorithms) and displayed on Welch Allyn Diagnostic Cardiology Suite ECG module user interface. Clinical Users can evaluate these ECGs, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic ECG technology is characterized in IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is being cited herein as a reference device.
For diagnostic Spirometry, a pneumotach air flow sensor obtains signals of a patient's forced expiratory breathing maneuvers, called "efforts", that are then analyzed against norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module. Patient breathing efforts are displayed on the Welch Allyn Diagnostic Cardiology Suite Spirometry user interface. Clinical Users can evaluate these Spirometry efforts, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic Spirometry technology is characterized in ISO 26782 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and follows ATS 2005 Standardization of Spirometry quidelines.

AI/ML Overview

This document describes the regulatory submission for the Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM (K191013). This submission aims to demonstrate substantial equivalence to a predicate device, Welch Allyn CardioPerfect®Workstation Software™ (CPWS) 901047 (K082478), with the addition of diagnostic spirometry capabilities.

Based on the provided information, no specific acceptance criteria or detailed study results for the device's performance are explicitly stated in terms of metrics like sensitivity, specificity, or accuracy thresholds. The submission focuses on demonstrating substantial equivalence primarily through non-clinical performance data and comparison to a predicate device and a reference device (Welch Allyn® RScribe™ K120865) that shares the same ECG algorithms.

Here's an analysis of the provided information regarding acceptance criteria and performance studies, addressing each of your points:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported numerical performance data from a clinical study for the subject device. The clearance is based on:

Substantial Equivalence: The primary "acceptance criteria" here is satisfying the FDA's "substantial equivalence" requirements. This means demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Non-Clinical Performance Data: The reported performance is implicitly covered by successful adherence to various international and national standards for medical devices, particularly for electrical safety, software lifecycle, usability, and specific requirements for electrocardiographs and spirometers. The document states: "Non-clinical performance tests were conducted and submitted to demonstrate that the Welch Allyn Diagnostic Cardiology Suite performs similarly to the predicate."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical studies were utilized for the purpose of showing substantial equivalence." Therefore, there is no clinical test set sample size, data provenance, or information on retrospective/prospective data for a clinical performance study of the subject device itself. The evidence relies on:

Predicate Device Performance (K082478): The predicate device has established performance.
Reference Device Performance (K120865): The shared VERITAS algorithms with the reference device, which has been in clinical use since 2012, serve as indirect evidence of performance for the ECG component.
Non-clinical testing: This includes compliance with standards (e.g., ISO 26782 for spirometers, IEC 60601-2-25 for ECGs). The sample sizes for these engineering or bench tests are not specified here but would typically involve controlled testing environments rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed for this submission to show substantial equivalence, there were no experts establishing ground truth for a clinical test set in the context of a new performance study. The existing "ground truth" is implied by the predicate device's established performance and the established standards for spirometry and ECG interpretation (e.g., ATS 2005 Standardization of Spirometry guidelines, VERITAS algorithms).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring ground truth adjudication was used for this submission.

5. 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

Not applicable. This submission does not mention an MRMC study or any AI components that assist human readers requiring a comparative effectiveness study. The device is a "CARDIOPULMONARY ECG SYSTEM" and a "Diagnostic Spirometer" which acquires, analyzes, displays, transmits, and prints physiological signals, and offers "VERITAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician." This suggests an algorithmic interpretation, but not necessarily one that assists a human reader in an MRMC comparative study context.

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

The device incorporates algorithms ("VERITAS™ resting ECG algorithm" and analysis against "norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module"). The performance of these algorithms is implicitly demonstrated through the non-clinical testing against relevant standards (e.g., IEC 60601-2-25 for ECG, ISO 26782 and ATS 2005 for spirometry) and the substantial equivalence argument to predicate/reference devices that also use such algorithms. However, a separate, specific standalone performance study (e.g., reporting sensitivity/specificity of the algorithm diagnosis) is not presented in this document. The description implies that the algorithm generates "measurements and advisory statements for review and interpretation by the physician," indicating a human-in-the-loop for final interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance and substantial equivalence argument, the "ground truth" for the device's function is established by:

Adherence to recognized standards: ISO 26782 (Spirometers), ATS 2005 Standardization of Spirometry, IEC 60601-2-25 (Electrocardiographs). These standards define acceptable levels of performance and accuracy in a controlled, non-clinical environment.
Comparison to predicate/reference devices: The predicate (K082478) and reference (K120865) devices have already been found substantially equivalent to establish their safety and effectiveness. The current submission argues that the new device performs similarly.

8. The sample size for the training set

Not applicable. Since no new clinical performance study was conducted for this submission (which would typically involve machine learning or AI models with training sets), there is no specified training set for the subject device. The VERITAS algorithm is pre-existing and its development "training" data is not discussed in this document.

9. How the ground truth for the training set was established

Not applicable, as no new training set or associated ground truth establishment is described in this document. The "VERITAS algorithms" are mentioned as existing technology, implying their ground truth was established during their initial development and clearance.

Summary

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September 10, 2019

Welch Allyn, Inc. Megan Pellenz Regulatory Engineer 7865 North 86th St. Milwaukee, Wisconsin 53224

Re: K191013

Trade/Device Name: Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic spirometer Regulatory Class: Class II Product Code: BZG, DPS Dated: August 22, 2019 Received: August 23, 2019

Dear Megan Pellenz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachana Visaria, Ph.D. Assistant Director (Acting) DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191013

Device Name

Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM

Indications for Use (Describe)

Welch Allyn Diagnostic Cardiology Suite utilizes a software platform to support 12-lead diagnostic Spirometry applications and is designed to operate within the inherent capabilities of an off-the-shelf laptop or PC Windows operating system. Welch Allyn Diagnostic Cardiology Suite also provides functions related to patient data management including communication with electronic medical records systems. Welch Allyn Diagnostic Cardiology Suite Resting ECG's are intended to be taken with the patient in the supine position and offer VERTAS™ resting ECG algorithm to generate measurements and advisory statements for review and interpretation by the physician.

Welch Allyn Diagnostic Cardiology Suite Spirometry is inction testing, providing forced expiratory flowvolume and time measurements. The device is intended to be a general assessment tool assisting the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shorthess of breath and wheezing; disorders such as interstitial lung disease, bronchitis, ashma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Welch Allyn® Diagnostic Cardiology Suite™

510(k) SUMMARY [As described in 21 CFR 807.92]

Submitted by Manufacturer: Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA

Establishment Reqistration: 2183461

Primary Contact Person: Megan Pellenz, Regulatory Affairs Engineer

Secondary Contact Person: Mark Elliott, Quality Assurance Director, QMR

Date Updated: September 9th, 2019

Device Trade Name: Welch Allyn® Diagnostic Cardiology Suite™ 2.X.X with Spirometry option 901128 CARDIOPULMONARY ECG SYSTEM Common Name: Diagnostic Spirometer

Regulation Number: 868.1840

Device Class: Il

Product Code: BZG

Secondary Product code, and Regulation: DPS, 870.2340

Predicate Device: Welch Allyn CardioPerfect®Workstation Software™ (CPWS) 901047 CARDIOPULMONAY ECG SYSTEM (K082478)

Reference Device: Welch Allyn® RScribe™ (K120865) 901127 ELECTROCARDIOGRAPH

Background

The Welch Allyn® Diagnostic Cardiology Suite™ is a modification to Welch Allyn's current legally marketed RScribe cleared by FDA under K120865 and since branded "Connex Cardio". Welch Allyn's interpretation of when to submit a 510(k) for a change to an existing device and our planned device modification, the addition of indications for diagnostic spirometry, led us to the determination that the

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RScribe/Connex Cardio is being significantly modified and therefore this 510(k) submission is appropriate.

Indications for Use

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COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

Contraindications for diagnostic spirometry:

hemoptysis of unknown origin (forced expiratory maneuver may ● aggravate the underlying condition)
pneumothorax ●
unstable cardiovascular status (forced expiratory maneuver may worsen ● angina or cause changes in blood pressure) or recent myocardial infarction or pulmonary embolus
. thoracic, abdominal, or cerebral aneurysms (danger of rupture due to increased thoracic pressure)
Recent eye surgery (e.g., cataract);
presence of an acute disease process that might interfere with test ● performance (e.g., nausea, vomiting) Recent surgery of thorax or abdomen.

Technoloqical Characteristics

The technology of the hardware accessories are:

cited herein as a reference device.

. For diagnostic ECG, the technology involves applying surface electrodes to the patient's skin to obtain signals of the heart's electrical activity. The electrical signals are then amplified, analyzed (VERITAS algorithms) and displayed on Welch Allyn Diagnostic Cardiology Suite ECG module user interface. Clinical Users can evaluate these ECGs, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic ECG technology is characterized in IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is being
For diagnostic Spirometry, a pneumotach air flow sensor obtains signals ● of a patient's forced expiratory breathing maneuvers, called "efforts", that are then analyzed against norms contained within Welch Allyn Diagnostic Cardiology Suite Spirometry module. Patient breathing efforts are

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displayed on the Welch Allyn Diagnostic Cardiology Suite Spirometry user interface. Clinical Users can evaluate these Spirometry efforts, store them, save them or send them via the technological characteristics provided by the Welch Allyn Diagnostic Cardiology Suite. The diagnostic Spirometry technology is characterized in ISO 26782 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans and follows ATS 2005 Standardization of Spirometry quidelines.

Device Comparison

It is of the opinion of Welch Allyn, Inc. that Welch Allyn Diagnostic Cardiology Suite is substantially equivalent to the predicate device. Welch Allyn CardioPerfect Workstation Software (K082478) as they share similar fundamental technical characteristics, intended use including indications for use, target population and use environment, detailed in the device comparison table below. The Welch Allyn® RScribe™ K120865 utilizes the same VERITAS algorithms as Welch Allyn Diagnostic Cardiology Suite ECG and therefore is presented as a Reference device.

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Characteristic	Reference Device	Subject Device	Predicate Device
Trade Name	Welch Allyn® RScribe™K120865	Welch Allyn® DiagnosticCardiology Suite™	Welch Allyn® CardioPerfectWorkstation Software™ (CPWS)V1.6.2 K082478
Model Identifier	901127ELECTROCARDIOGRAPH	901128CARDIOPULMONARY ECG SYSTEM	901047CARDIOPULMONARY ECG SYSTEM
Manufacturer	Welch Allyn, Inc.	Welch Allyn, Inc.	Welch Allyn, Inc.
510(k) Number	K120865	K082478	K082478
Product Code	DPS	BZG	BZG
ClassificationName	Electrocardiograph, Class II	Diagnostic Spirometer, Class II	Diagnostic Spirometer, Class II
RegulationNumber	21 CFR 870.2340	21 CFR 868.1840	21 CFR 868.1840
Indications for Use	The RScribe Electrocardiograph is amulti-channel electrocardiographproduct used for acquiring, analyzing,displaying and printing resting ECG's.The RScribe is a 12-channeldiagnostic electrocardiograph intendedfor recording and printing ECG's ofadult and pediatric patients. Theacquired ECG will be displayed forquality check purpose, analyzed usingthe Mortara VERITAS restinginterpretation, optionally printed, storedand/or transmitted to a ECGManagement System or HospitalInformation System. The device is notintended to be used as a vital signsphysiological monitor.It is a system comprised of a MortaraECG amplifier (Wireless AcquisitionModule [WAM] or AM12 PatientCable) and an off-the-shelf personalcomputer with Mortara softwareapplication that allows clinicians tocollect ECGs on patients during	The Welch Allyn® Diagnostic CardiologySuite™ is a prescription device intendedfor use by physicians, other licensedhealth care practitioners, and trainedpersonnel who are acting on the ordersof a physician. Welch Allyn DiagnosticCardiology Suite is intended for use inmedical clinics, physician offices andhospital settings to acquire, analyze,display, transmit and print certainphysiological signals identified belowand provide the data for considerationby a physician. Welch Allyn DiagnosticCardiology Suite utilizes a softwareplatform to support 12-lead diagnosticresting ECG and diagnostic Spirometryapplications and is designed to operatewithin the inherent capabilities of an off-the-shelf laptop or PC Windowsoperating system. Welch AllynDiagnostic Cardiology Suite alsoprovides functions related to patientdata management includingcommunication with electronic medical	The Welch Allyn® CardioPerfectWorkstation Software™ (CPWS) andassociated accessories are indicatedfor the acquisition, analysis, formatting,display, printing and storage of certainphysiologic signals, as identifiedbelow, for the purpose of assisting theclinician in the diagnosis andmonitoring of various diseases and/ortreatment regimens. TheCardioPerfect Workstation softwarealso provides non-diagnostic functionssuch as patient management, datasecurity, search tools for patient and/ortest records and support for exportingdata to Electronic Medical Recordsystems.The CardioPerfect WorkstationSoftware and associated accessoriesare intended for use by or on the orderof a physician in a hospital or clinicsetting. The product is designed foruse on both adult and pediatricpatients as included in the cleared
Characteristic	Reference Device	Subject Device	Predicate Device
	routine visits. The patient populationsfor which the device will be used maybe healthy or diseased of any age.ECG's are taken with the patient in thesupine position. The RScribe is intendedto be used by a licensed health carepractitioner in a hospital, medical clinicand offices of any size, including ClinicalResearch Organizations.	records systems. Welch AllynDiagnostic Cardiology Suite RestingECG's are intended to be taken with thepatient in the supine position and offerVERITAS™ resting ECG algorithm togenerate measurements and advisorystatements for review and interpretationby the physician.	indications for use listed below, subjectto any specific contraindicationsidentified below.
	The RScribe electrocardiograph is anon-invasive prescription device.The device is indicated for useto acquire, analyze, display,transmit and printelectrocardiograms. The device is indicated for useto provide interpretation of thedata for consideration by aphysician. The device is indicated for usein a clinical setting, by aphysician or by trainedpersonnel who are acting onthe orders of a licensedphysician. It is not intended asa sole means of diagnosis. The interpretations of ECGoffered by the device are onlysignificant when used inconjunction with a physicianover-read as well asconsideration of all otherrelevant patient data. The device is indicated for useon adult and pediatricpopulations. The device is not intended tobe used as a vital signsphysiological monitor. The device is not designed forout of hospital transport.	Welch Allyn Diagnostic Cardiology Suiteis not intended to be used as aphysiological vital signs monitor, notintended to be used in a mobile medicalenvironment (e.g. ambulance,helicopter), in magnetic resonance (MR)environments, in operating theaters, norin conjunction with high frequencysurgical equipment.Indications for Welch Allyn DiagnosticCardiology Suite ECG range fromroutine screening of cardiac health inthe physician office environment todirected diagnostic differentiation in ahospital cardiology department. WelchAllyn Diagnostic Cardiology Suite ECGis indicated for patients of all ages.Welch Allyn Diagnostic Cardiology SuiteSpirometry is indicated for pulmonaryfunction testing, providing forcedexpiratory flow-volume and timemeasurements. The device is intendedto be a general assessment toolassisting the clinician in the diagnosis ofpulmonary function. These devices arecommonly used on patients withoccupational exposure to dust orchemicals; presenting with symptomssuch as chronic cough, shortness ofbreath and wheezing; disorders such asinterstitial lung disease, bronchitis,asthma, and COPD; or other patients	Electrocardiograph - Indications forUseIndications for electrocardiographyrange from routine screening ofcardiac health in the physician officeenvironment to directed diagnosticdifferentiation in a hospital cardiologydepartment.Spirometry - Indications for UseIndications for Spirometry include, butare not limited to, the following:Shortness of breath Chronic cough Occupational exposure to dustor chemicals Assist in the diagnosis ofBronchitis Assist in the diagnosis ofAsthma Wheezing Assist in the monitoring ofbronchodilatorAmbulatory Blood Pressure -Indications for UseIndications for ambulatory bloodpressure measurement (as listed inJournal of Hypertension 2003, 21:821-848, E. O'Brien et. at.) include, but arenot limited to, the following:Suspected "white coat"hypertension Suspected nocturnalhypertension To establish dipper status Resistant hypertension Elderly patient
Characteristic	Reference Device	Subject Device	Predicate Device
	use in highly invasive environments, such as an operating theatre.	where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite with Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.	To monitor antihypertensive drug treatment Type 1 diabetes Hypertension of pregnancy Evaluations of hypotension Autonomic failure Masked hypertension

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Non-clinical Performance Data

Non-clinical data was utilized in this submission. The non-clinical standards and tests that were submitted. referenced or relied upon to support a determination of substantial equivalence are:

ISO 14971 Medical devices - Application of risk management to medical devices (2007)

ANSI/AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (2005+A1:2012)

IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

ANSI/AAMI IEC 62304 Medical device software - Software life cycle processes (2006)

IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (2015)

AAMI/ANSI HE75 Human Factors Engineering – Design of Medical Devices (2009 R2013)

IEC 60601-1-6 General requirements for basic safety and essential performance -Collateral standard: Usability (2010+A1:2013)

IEC 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs (2011)

ISO 26782 Anaesthetic and respiratory equipment -- Spirometers intended for the measurement of time forced expired volumes in humans (2009)

ATS 2005 Standardization of Spirometry

ISO 10993-1 (2009+Cor.1:2010) Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The spirometry patientcontacting materials are identical or equivalent to the materials cleared in K133428. The ECG patient-contacting materials are identical to the materials cleared in K120865.

Clinical Performance Data

No clinical studies were utilized for the purpose of showing substantial equivalence.

Conclusion

The Welch Allyn Diagnostic Cardiology Suite subject device and its predicate, the Welch Allyn CardioPerfect Workstation Software (CPWS) K082478 share the same intended use, the same modular software design, the same installation environment, the same general operating principles, the same basic technology and share similar performance claims and labeling. The Welch Allyn RScribe K120865 utilizes the same VERITAS algorithms as the subject device and has been in clinical use since 2012. Minor differences between the devices do not raise concerns of differences in safety. efficacy or intended use. Non-clinical performance tests were conducted and submitted to demonstrate that the Welch Allyn Diagnostic Cardiology Suite performs similarly to the predicate. It is Welch Allyn's opinion that the Welch Allyn Diagnostic Cardiology

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Suite subject device is substantially equivalent to its predicate, the Welch Allyn CardioPerfect Workstation Software (CPWS) cleared through K082478.

Regulation Number and Section

§ 868.1840 Diagnostic spirometer.

(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).