(69 days)
The Welch Allyn Printing Electrocardiography and Spirometry Products (Subject Devices) are intended for use by trained operators in health facilities. The subject Devices will provide the following diagnostic functions:
- Acquiring, viewing, storing and printing ECG waveforms patients using ECG . Front End modules and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
- Using optional algorithms to generate measurements, data presentations, . graphical presentations and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
- Using the optional Spirometry module and associated accessories 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 able to understand the instructions for performing the test, such as with children greater than three (3) years of age.
The Welch Allyn Multi-Channel Electrocardiographs, the low cost CP 100 or full-featured CP200. Both feature full alphanumeric keyboards for easy and fast entry of patient demographics, user-programmable report formats printed on patient chart size thermal paper, ECG measurement, advanced filters for optimal ECG trace quality and battery or AC operation.
Here's a breakdown of the acceptance criteria and study information for the Welch Allyn CP 100/200 Electrocardiography and Spirometry Products, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it describes the intended functions of the device. Since specific numerical targets are not mentioned, I will infer the performance criteria from the device's stated functions.
| Performance Characteristic | Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance |
|---|---|---|
| ECG Functionality | Acquiring, viewing, storing, and printing ECG waveforms for up to twelve (12) leads. | The device provides these functions, as stated in its intended use. |
| ECG Interpretation (Optional Algorithm) | Generating measurements, data presentations, graphical presentations, and advisory interpretive statements for patients 16 years and older. These are for review and interpretation by a clinician. | The device offers these algorithmic capabilities as an option, with the caveat that they are advisory and require clinical review. |
| Spirometry Functionality (Optional Module) | Acquiring, viewing, storing, and printing measures and waveforms of pulmonary function (e.g., maximal volume and flow of air). | The device provides these functions as an optional module. |
| Spirometry Patient Age Range | Usable with patients able to understand instructions (e.g., children > 3 years old). Interpretive results are not calculated for children under six. | The device adheres to these age limitations for spirometry testing and interpretations. |
Study Information
The provided 510(k) premarket notification does not contain details of a specific performance study (e.g., clinical trials, bench testing with detailed results) that "proves" the device meets acceptance criteria.
Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means that the device's design, intended use, technology, and performance are sufficiently similar to approved devices that it raises no new questions of safety or effectiveness. The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the devices... are substantially equivalent."
Therefore, many of the specific study-related questions cannot be directly answered from the provided text.
- Sample size used for the test set and the data provenance: Not mentioned in the provided text, as a specific "test set" for a new performance study is not described. The substantial equivalence determination would have involved a comparison of design and functional specifications, potentially using literature or prior predicate device data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no specific ground truth establishment for a new test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned, as no specific test set or adjudication process is described.
- 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. This type of study is typically done for AI-driven diagnostic aids. While the device includes an "optional algorithm to generate measurements, data presentations, graphical presentations and interpretive statements on an advisory basis," the document does not suggest a new MRMC study was conducted to evaluate its impact on human readers. Such a study might have been conducted for the predicate device's interpretive algorithm or would be part of a separate submission if the algorithm itself was novel and required performance validation.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned. For the interpretive algorithm, its "advisory basis" implies it's not strictly standalone for diagnosis. The 510(k) process for substantial equivalence often means that the algorithm's performance is either comparable to or directly inherited from the predicate device's validated algorithm, or its performance is evaluated in a non-clinical context against established standards rather than a formal standalone clinical study described here.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For substantial equivalence, ground truth for comparing device characteristics is often based on engineering specifications, recognized standards, and the performance characteristics of the predicate devices.
- The sample size for the training set: Not mentioned. Training sets are relevant for machine learning algorithms. While an "optional algorithm" is mentioned, details about its development (including training data) are not part of this 510(k) summary, which focuses on substantial equivalence rather than novel algorithm validation.
- How the ground truth for the training set was established: Not mentioned.
Summary of Substantial Equivalence:
The core of this 510(k) submission is the claim of substantial equivalence to two predicate devices:
- PageWriter Trim Series Cardiograph (K031422) for electrocardiography.
- Spirometer System (Medikro D9 Spirometer) (K971336) for spirometry.
The FDA's approval indicates they found no new questions of safety or effectiveness compared to these legally marketed devices, implying that the Welch Allyn CP 100/200 meets an acceptable level of performance based on comparison to its predicates, rather than through a new, detailed clinical performance study described within this document.
§ 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).