The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.

The Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for:

adult and pediatric patients 12 years and older,
hospital and clinic use only.

Device Description

The Welch Allyn CP150™ Electrocardiograph with Spirometry Option is an electrocardiograph used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart and it provides an optional interface to a pulmonary function device that allows the user to acquire, view, store, and print measures and waveforms of pulmonary function. Its features include a 7" color touch screen display for ECG and Spirometry preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power.

Communication of ECG and spirometry data with a central data-management system is optional.

The CP150™ Electrocardiograph with Spirometry is able to connect via USB cable or via wired ethernet (RJ45 connector) across the ethernet network, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The USB port can also be used to connect other accessory devices.

The CP150™ Electrocardiograph is specifically intended for acquiring and printing ECG signals from adults and pediatric patients. It will be used in clinical settings by trained healthcare providers.

The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.

The CP 150™ spirometry option allows the user to acquire, view, store, and print measures and waveforms of pulmonary function including, but not limited to, maximal volume and flow of air that can be moved in and out of a patient's lungs. These measures are used in the diagnosis and monitoring of lung diseases and interventions for the treatment of certain lung diseases. The spirometer should only be used with patients who are able to understand the instructions for performing the test.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Welch Allyn CP150™ Electrocardiograph with Spirometry Option. While it lists various standards the device was tested against for safety and effectiveness, it does not explicitly state specific acceptance criteria or provide a study demonstrating the device meets quantitative performance metrics for either the ECG or spirometry functions.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K131573 for the Electrocardiograph and K133428 for the Spirometer component) by detailing software and hardware modifications made to integrate the spirometry option. The non-clinical tests mentioned are predominantly related to compliance with general medical device standards (risk management, electrical safety, EMC, software lifecycle, and specific standards for electrocardiographs and spirometry).

Therefore, based solely on the provided text, a table of acceptance criteria and reported device performance, information about sample sizes, ground truth establishment, expert involvement, and MRMC/standalone study details cannot be fully extracted.

However, I can describe what is mentioned regarding testing and equivalence:

Acceptance Criteria and Device Performance (Based on available information):

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from standards/description)	Reported Device Performance (Implied by equivalence claim)
General Safety & Effectiveness	Compliance with recognized industry standards (e.g., ISO 14971, IEC 60601-1, IEC 62304).	Device tested for safety and effectiveness based on listed standards. Modifications maintain safety and effectiveness as predicate.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Device tested to IEC 60601-1-2 standards.
Electrocardiograph Performance	Compliance with IEC 60601-2-25 and ANSI/AAMI EC11 for basic safety and essential performance of ECGS.	Device provides ECG signals for adults and pediatric patients, with optional interpretation algorithm (guidance only). Substantially equivalent to predicate K131573.
Spirometry Performance	Compliance with ATS/ERS 2005 for standardization of spirometry.	Measures lung air volume and airflow rate, providing spirometric indices. Substantially equivalent to predicate K133428 (Medikro Spirometer).
Software Functionality	Software accurately receives, converts, displays, prints, and saves spirometry data. Software changes allow user configuration and test conduct.	Software modifications described for integrating spirometry data functionality.
Hardware Interface	Creation of connectors between Medikro Spirometer and CP150 Spiro.	Hardware interface created.

Further Specifics Not Explicitly Stated in the Provided Text:

Sample sizes used for the test set and data provenance: Not mentioned. The document primarily refers to compliance with standards rather than specific performance studies with human or simulated data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- An "optional interpretation algorithm" for ECG is mentioned, but no MRMC study or its results are detailed. The algorithm provides "computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information." This implies it is an assistive tool, but its impact on human reader performance is not quantified here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The ECG interpretation algorithm is presented as a component providing "guidance for qualified physicians" and "must not be relied upon as diagnoses." This suggests its performance is not intended to be standalone for diagnosis, and no standalone performance metrics are provided.
The type of ground truth used: Not mentioned for any specific performance validation studies. The general context implies that ground truth for ECG interpretation would eventually be clinical diagnosis confirmed by a physician, and for spirometry, accurate physical measurements.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary of Study Type:

The submission K141582 is a Special 510(k) Premarket Notification. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device, especially when modifications do not affect the fundamental scientific technology or intended use (as described in section 3.2.1 of the FDA's "Guidance for Industry and FDA Staff: The 510(k) Program").

In this case, the study presented is a demonstration of compliance with recognized performance and safety standards and a comparison of technological characteristics to existing predicate devices (Welch Allyn CP150 Electrocardiograph K131573 and Medikro Spirometer K133428). The "study" proving the device meets acceptance criteria primarily consists of:

Engineering analysis and documentation of hardware and software modifications.
Verification and Validation (V&V) activities to ensure these modifications support the intended functionality and maintain safety and effectiveness.
Compliance testing against the listed international and national standards (e.g., ISO 14971, IEC 60601 series, IEC 62304, ANSI/AAMI EC11, ATS/ERS 2005).

The submission does not provide details of a clinical performance study using patient data to derive performance metrics like sensitivity, specificity, accuracy, or reader agreement. Instead, it relies on the established safety and performance of its predicate devices, asserting that the implemented changes maintain this level of performance.

Summary

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JUL 1 1 2014

K141582

Page 1 of 5

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:

Kevin Crossen

Director Regulatory Affairs

Phone: (315) 685-2609

Fax: (315) 685-2532

E-mail: Kevin.Crossen@welchallyn.com

June 11, 2014 Date Prepared: ・・ Welch Allyn CP150™ Electrocardiograph with Spirometry Option Trade Name: 901049 Electrocardiograph Common Name: Electrocardiograph and Diagnostic Spirometer Class II, Electrocardiograph (21 CFR 870.2340, Product Code DPS) Classification Reference:

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K141582

Page 2 of 5

Class II, Diagnostic Spirometer (21 CFR 870.1840, Product Code BZG)

Predicate Device:

Welch Allyn CP150™ Electrocardiograph 510(k) Number: K131573 Electrocardiograph, 21 CFR 870.2340 Class II, DPS

Description of the Device:

Communication of ECG and spirometry data with a central data-management system is optional.

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Indications for Use:

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and measure patient cardiac function.

adult and pediatric patients 12 years and older, .
. hospital and clinic use only.

Contraindications (specific to Spirometry)

Relative contraindications to performing spirometry:

. hemoptysis of unknown origin (forced expiratory maneuver may aggravate the underlying condition)
pneumothorax .

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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)
. presence of an acute disease process that might interfere with test performance (e.g., nausea, vomiting)
recent eye (for example, cataract), thoracic and abdominal surgery .
. chest and abdominal pain

The electrocardiograph has no known contraindications.

Technological Characteristics:

The subject device has the same technological characteristics and indications for use as the predicate. The hardware, software, and mechanical aspects of the CP150 have been updated to current technology equivalent to the cleared devices (CP150™ Electrocardiographs, K131573, S.E. dated July 3, 2013 and Medikro Spirometer, K133428, S.E. dated May 21, 2014) as described below. Modifications were made to the CP150 in order to provide an interface to receive, convert, and display measurements from the optional Medikro Spirometer. The modifications include:

· Hardware Interface
- Creation of connectors between Medikro Spirometer and CP150 Spiro
Software Interface .
- O Software changes to receive flow data
- o Software changes to enable conversion of flow data to parameter measurements (e.g., FVC, FEV1, PEF, etc.)
- o Software changes to allow user setting the spirometer configurations and conduct the spirometry tests.
- O Software changes to display the parameter measurements of spirometry test
- Software changes to allow for printing and saving spirometry tests

Non-Clinical Tests:

The Welch Allyn CP150™ Electrocardiograph with Spirometry Option was tested to evaluate its safety and effectiveness based on the following standards:

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K141582

and the comments of the comments of the comments of

Page 5 of 5

Standard	Version	Title
ISO 14971	2007/2007	Medical Devices – Application of Risk Management to Medical Devices
IEC 60601-1	3rd Edition2005	Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance
IEC 60601-1-2	2007	Medical Electrical Equipment - Part 1-2: General Requirements for BasicSafety and Essential Performance – Collateral Standard: ElectromagneticCompatibility - Requirements and Tests
IEC 62304	2006	Medical Device Software - Software Life Cycle Processes
IEC 60601-2-25	2nd Edition2011-10	Medical electrical equipment - Part 2-25: Particular requirements for the basicsafety and essential performance of electrocardiographs
ANSI/AAMI EC11	1991 (R2007)	Diagnostic electrocardiographic devices
ATS/ERS	2005	ATS/ERS Task Force Standardisation of Lung Function Testing: Standardisationof spirometry

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Public Health Service

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

Image /page/5/Picture/3 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three wavy lines representing its body and wings. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

July 11, 2014

Welch Allyn c/o Mr. Kevin Crossen Director, Regulatory Affairs 4341 State Street Road P.O. Box 220 Skaneateles Falls, New York 13153

K141582 Re:

Trade/Device Name: Welch Allyn CP150 Electrocardiograph with Spirometry Option Regulation Number: 21 CFR 870.2340 and 21 CFR 870.1840 Regulation Name: Electrocardiograph And Diagnostic Spirometer Regulatory Class: Class II Product Code: DPS and BZG Dated: June 11, 2014 Received: June 13, 2014

Dear Mr. 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 and of Federal statutes and regulations administered by other Federal agencies. You must comply

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Page 2 - Mr. Kevin Crossen

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/6 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, blocky appearance. The logo is black and white and appears to be a low-resolution image.

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

Enclosure

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WelchAllyn

Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph with Spirometry Option

K141582

Indications for Use

510(k) Number (if known): K141582

Device Name: Welch Allyn CP150™ Electrocardiograph with Spirometry Option

Indications for Use:

The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.

. adult and pediatric patients 12 years and older,
hospital and clinic use only. .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date:
2014.07.11
07.40.08 -04'00'

Page 7-1

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).