The CardioPerfect Workstation software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various diseases and/or treatment regimens. The CardioPerfect Workstation software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems.

The CardioPerfect Workstation and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

Stress Electrocardiograph - Intended Use: Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms.

Resting Electrocardiograph - Intended Use: The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician.

Spirometry - Intended Use: Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. The spirometer should only be used with patients able to understand the instructions for performing the test.

Ambulatory Blood Pressure - Intended Use: Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history.

Indications for Use:

Electrocardiograph - Indications for Use: Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

Spirometry - Indications for Use: Indications for spirometry include, but are not limited to, the following: Shortness of breath, Chronic cough, Occupational exposure to dust or chemicals, Assist in the diagnosis of Bronchitis, Assist in the diagnosis of Asthma, Wheezing, Assist in the monitoring of bronchodilator.

Ambulatory Blood Pressure - Indications for Use: Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21 :821-848, E. O'Brien et. at.) include, but are not limited to, the following: suspected "white coat" hypertension, Suspected nocturnal hypertension, To establish dipper status, Resistant hypertension, Elderly patient, To monitor antihypertensive drug treatment, Type 1 diabetes, Hypertension of pregnancy, Evaluations of hypotension, Autonomic failure, Masked hypertension.

Device Description

CardioPerfect Workstation software is used to create a computer platform on which ECG, ABP, & Spirometry applications can operate within inherent capabilities of an off-theshelf desktop or laptop personal computer utilizing a Windows operating system.

AI/ML Overview

The provided text describes the Welch Allyn CardioPerfect Workstation Software (CPWS) Version 1.6.2 and its comparison to a predicate device. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a detailed study proving device performance against those criteria.

The document states that the major difference between version 1.6.2 and the predicate version 1.5.0 is the inclusion of interpretive ECG software for pediatric patients through the PEDMEANS interpretive ECG algorithm. It then asserts that the performance of this algorithm in CPWS 1.6.2 is equivalent to its implementation in the CP 100™ and CP 200™ ECG devices (cleared under K072449).

Let's break down what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states:
"The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003, particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs."

This implies that the acceptance criteria for the MEANS algorithms (including PEDMEANS) are aligned with IEC 60601-2-51:2003. However, the document does not list specific performance metrics (e.g., sensitivity, specificity, accuracy for specific arrhythmias) or numerical thresholds that constitute the acceptance criteria from this standard. It only states that the algorithms were "consistent with" these requirements.

It also notes that "All requirements of the recognized and applicable standards are in compliance: EC11 (AAMI/ANSI), UL 60601-1. IEC 60601-1. IEC 60601-1-1. IEC 60601-1-2. IEC 60601-1-4 and IEC 60601-2-25." These are primarily safety and general electrical equipment standards, not direct clinical performance metrics.

Therefore, a table of specific acceptance criteria and reported numerical performance cannot be fully constructed from the provided text. The "reported device performance" is broadly stated as "equivalent" and "consistent with requirements."

Based on the available information, here's what can be provided:

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

Acceptance Criteria (Implied)	Reported Device Performance
Performance of MEANS algorithms (including PEDMEANS) for ECG interpretation	- Verified and found consistent with requirements of IEC 60601-2-51:2003 (particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs). - Implementation and performance of PEDMEANS in CPWS 1.6.2 is equivalent in every respect to its implementation in CP 100™ and CP 200™ ECG devices (cleared per K072449).
Compliance with recognized standards (General Safety/Electrical)	- In compliance with: EC11 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25.
Risk Management	- Activities conducted in accordance with ISO 14971 and comply with IEC 60601-1-4.

For the remaining points, the provided text contains limited to no information:

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

Not explicitly stated for the "verification" or "equivalence" studies. The document mentions the PEDMEANS algorithm was developed by P. Rijnbeek, 2007, in a thesis at Erasmus University Rotterdam, which might imply data from the Netherlands, but no specific test set details are given.

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):

Not explicitly stated. The document refers to "the requirements of IEC 60601-2-51:2003" and the "PEDMEANS Interpretive ECG algorithm developed by P. Rijnbeek" but does not detail how ground truth was established for their specific verification/equivalence study.

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

Not mentioned.

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 mentioned. The document focuses on the algorithm's performance against standards and its equivalence to a previously cleared implementation, not on human-AI collaboration.

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

This is the most likely scenario, given the mention of "interpretive algorithm" and "consistency with requirements" of a standard for recording and analyzing ECGs. The intended use states the algorithm provides "interpretive statements on an advisory basis," which are "presented for review and interpretation by the clinician." This implies a standalone algorithmic assessment, with the clinician in the loop for final diagnosis. However, the details of the standalone performance metrics are not provided.

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

Not explicitly stated for the verification or equivalence studies. For ECG interpretation, ground truth is typically established by expert cardiologists.

8. The sample size for the training set:

Not mentioned.

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

Not mentioned.

Summary of Study Information:

The document indicates that the device meets acceptance criteria through:

Verification of MEANS algorithms (including PEDMEANS) against IEC 60601-2-51:2003. This standard outlines requirements for the "safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs." The specific performance metrics within this standard that were met are not detailed in the submission.
Demonstration of "equivalence in every respect" of the PEDMEANS algorithm's implementation and performance in CPWS 1.6.2 to its previous clearance in CP 100™ and CP 200™ ECG devices (K072449). This implies that the prior clearance established the performance, and the current submission leverages that. No new, specific, detailed study results for CPWS 1.6.2 are provided beyond this statement of equivalence.
Compliance with various other safety and electrical standards (EC11, UL 60601-1, IEC 60601-1 series, IEC 60601-2-25) and risk management standards (ISO 14971).

In essence, the submission relies on standards compliance and a claim of equivalence to a previously cleared implementation of the same pediatric ECG interpretive algorithm, rather than presenting a new, detailed clinical performance study with specific metrics for CPWS 1.6.2 itself.

Summary

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510(k) Summary

Kof 2478

[As described in 21 CFR 807.92]

9 2009 MAR

Submitted by:

Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220

Contact Person:

John Sawyer Vice President, QA/RA Phone: (315) 685-4571 Fax: (315) 685-2532 E-mail: sawyerj@welchallyn.com

August 22, 2008 Date Prepared:

Trade Name:

CardioPerfect Workstation Software (CPWS) Version 1.6.2

Common Name:

Medical Device Software for interpretive and stress testing electrocardiographs and diagnostic spirometry.

Classification Reference: Class II, Diagnostic Spirometer (21 CFR 868.1840, Product Code BZG) and Cardiovascular (Product Code LOS).

Predicate Device:

CardioPerfect Workstation Software Version 1.5.0 (K052158)

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Description of the Device:

Intended Use:

Stress Electrocardiograph - Intended Use

Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms.

Resting Electrocardiograph - Intended Use

The same as defined for stress ECG plus the ability to use optional algorithms (MEANS) to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis. These are presented for review and interpretation by the clinician.

Spirometry - Intended Use

Using the optional spirometry module and associated accessories to acquire, view, store and print measures and waveforms of pulmonary function. The spirometer should only be used with patients able to understand the instructions for performing the test.

Ambulatory Blood Pressure - Intended Use

Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history.

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Indications for Use:

Electrocardiograph - Indications for Use

Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

Spirometry - Indications for Use

Indications for spirometry include, but are not limited to, the following:

Shortness of breath .
. Chronic cough
Occupational exposure to dust or chemicals .
Assist in the diagnosis of Bronchitis .
Assist in the diagnosis of Asthma .
. Wheezing
Assist in the monitoring of bronchodilator ●

Ambulatory Blood Pressure - Indications for Use

Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21 :821-848, E. O'Brien et. at.) include, but are not limited to, the following:

· suspected "white coat" hypertension
· Suspected nocturnal hypertension
To establish dipper status
· Resistant hypertension
· Elderly patient
· To monitor antihypertensive drug treatment
· Type 1 diabetes
· Hypertension of pregnancy
· Evaluations of hypotension
· Autonomic failure
· Masked hypertension

Technological Characteristics:

The Welch Allyn Electrocardiography and Spirometry Products are intended for use by trained operators in healthcare facilities.

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

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The optional spirometry module is indicated for use in clinical situation to assess a patient's pulmonary health status and evaluate symptoms, signs, or abnormal laboratory test results.

The CPWS version 1.6.2 is substantially equivalent to the previously released CPWS version 1.5.0 (K.052158). The major difference being the change to intended use. This submission intends to change the indications for use to include interpretive ECG software for the pediation. The previously marketed CPWS version 1.5.0 (K052158) did not provide interpretive software support for patients less than 16 years of age. The Pediatric Modular ECG PEDMEANS Interpretive ECG algorithm developed by P. Rijnbeek, 2007, in Analysis System thesis entitled 'Automatic Interpretation of Pediatric Electrocardiograms', Erasmus University Rotterdam. This PEDMEANS algorithm, is also used in our CP 100™ and CP 200™ ECG device cleared under K072449.

Summary of Effectiveness:

The Welch Allyn CPWS team has determined that the software "Level of Concern" is Moderate. (See section 10 for CPWS software Level of Concern)

The implementation of the PEDMEANS interpretive software in the CPWS 1.6.2 electrocardiograph device, and its performance, is equivalent in every respect to the implementation of this software in the CP 100™ and CP 200™ submitted to the agency by Welch Allyn and cleared per K072449.

The MEANS algorithms were verified and found to be consistent with the requirements of IEC 60601-2-51:2003, particular requirements for safety, including essential performance, of recording and analyzing single channel and multi-channel electrocardiographs.

All requirements of the recognized and applicable standards are in compliance: EC11 (AAMI/ANSI), UL 60601-1. IEC 60601-1. IEC 60601-1-1. IEC 60601-1-2. IEC 60601-1-4 and IEC 60601-2-25.

Additionally, risk management (risk, SFMEA and safety analysis) activities have been conducted in accordance with ISO 14971 Medical Devices - Application of risk management to medical devices and comply with IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2005

Welch Allyn, Inc. c/o Mr. John Sawyer Vice President QA/RA 4341 State Street Road Skaneateles Falls, NY 13153-0220

K082478 Re:

Trade/Device Name: Welch Allyn CardioPerfect Workstation Software (CPWS), Version 1.6.2 Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: Class II (Two) Product Code: BZG Dated: February 4, 2009 Received: March 5, 2009

Dear Mr. Sawyer:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. John Sawyer

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): 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

J. Atkin

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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Indications for Use Statement

KO82478 510(k) Number (if known):

Device Name: Welch Allyn CardioPerfect Workstation Software (CPWS) V 1.6.2

Intended Use:

Stress Electrocardiograph - Intended Use

Using the optional ECG module and associated accessories the user can acquire, view, store and print ECG waveforms.

Resting Electrocardiograph - Intended Use

Spirometry - Intended Use

Ambulatory Blood Pressure - Intended Use

Using the optional ABP module and associated accessories the user can acquire, retrieve, view, store and print patient ambulatory blood pressure history.

Atill Stein for B. Zuckerman

(Division Sign-Off) Division of Cardiovascular Device 510(k) Number KOS2478

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Indications for Use:

Electrocardiograph - Indications for Use

Indications for electrocardiography range from routine screening of cardiac health in the physician office environment to directed diagnostic differentiation in a hospital cardiology department.

Spirometry - Indications for Use

Indications for spirometry include, but are not limited to, the following:

Shortness of breath .
Chronic cough .
Occupational exposure to dust or chemicals ●
Assist in the diagnosis of Bronchitis .
Assist in the diagnosis of Asthma .
Wheezing ♥
Assist in the monitoring of bronchodilator .

Ambulatory Blood Pressure - Indications for Use

Indications for ambulatory blood pressure measurement (as listed in Journal of Hypertension 2003, 21 :821-848, E. O'Brien et. at.) include, but are not limited to, the following:

· suspected "white coat" hypertension
- · Suspected nocturnal hypertension
- To establish dipper status
- · Resistant hypertension
- · Elderly patient
- · To monitor antihypertensive drug treatment
- · Type 1 diabetes
- · Hypertension of pregnancy
- · Evaluations of hypotension
- · Autonomic failure
- · Masked hypertension

X AND/OR 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stittser for B Zuckerman

Mision Sign-Off) Division of Cardlovascular Device 510(k) Number

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).