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