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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.

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.

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.

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