(16 days)
The EP-WorkMate® with an EP-3 (K935590) or EP-4 (K041442) stimulator is intended to be used for diagnostic electrical stimulation of the heart for the purpose of refractory measurements, initiation and termination of tachy-arrhythmias measurements of electrical conduction. The addition of NurseMate™ does not change intended use of the EP-WorkMate®.
Indications for Use Statement
EP-WorkMate® is indicated for use during clinical electrophysiology procedures. The addition of NurseMate™ does not change the indications for use.
NurseMateTM is indicated for use during clinical electrophysiology procedures.
This application describes a modification to the EP-WorkMate® computer that will be offered as an option to customers under the name NurseMate™. NurseMate™ is a PC (Personal Computer) workstation that when connected to the EP-WorkMate® system can be used for real-time patient charting, physiologic monitoring, and data analysis during electrophysiology (EP) studies.
The provided 510(k) summary for K063113 describes the NurseMate™, a modification to the EP-WorkMate® system. This document is focused on demonstrating substantial equivalence to a predicate device (EP-WorkMate® K994011) rather than a de novo submission. As such, the study described is primarily a comparison of functionalities and specifications to show that the new device, NurseMate™, does not introduce new safety or effectiveness concerns.
Therefore, the typical acceptance criteria and detailed study design (sample size, ground truth, expert adjudication, MRMC, standalone performance) that would be expected for a de novo submission or a device with new clinical claims are not explicitly present or elaborated upon in this 510(k) summary. The summary emphasizes that the addition of NurseMate™ does not change the intended use or indications for use of the EP-WorkMate®.
Summary of Information based on K063113:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a modification to an existing device (EP-WorkMate®) and the claim is that the NurseMate™ does not change intended use, the "acceptance criteria" revolve around demonstrating that the new functionalities of NurseMate™ do not negatively impact the safety and effectiveness established for the predicate device. The performance reported is primarily functional comparison.
| Acceptance Criteria (Implied) | Reported Device Performance (NurseMate™) |
|---|---|
| Maintain existing intended use and indications for use. | NurseMate™ does not change the intended use or indications for use of the EP-WorkMate®. |
| Display real-time physiologic data (HR, BP, ECG waveforms). | NurseMate™ displays HR, BP (Figure 3), and intracardiac ECG waveforms (from Amp/SCU via PC-to-Amp/SCU connection). |
| Allow patient charting (event titles, medications, comments). | NurseMate™ users can independently enter tabular data; stored on EP-WorkMate® patient file. |
| Control start/stop data recording on EP-WorkMate®. | NurseMate™ can issue commands to the EP-WorkMate® to start/stop data recording. |
| Not control cardiac stimulator. | NurseMate™ does not control the cardiac stimulator. |
| Data received from EP-WorkMate® cannot be modified/deleted. | NurseMate™ users can only view clinical data; this data cannot be modified or deleted. |
| Hardware and software compatibility with EP-WorkMate®. | Software is a modified version of EP-WorkMate® C++ code; hardware uses similar PC technology; dedicated interconnections (CAT 5, TCP/IP, Packet Driver). |
| Maintain safety and effectiveness of the parent system. | Implied by substantial equivalence claim and no change in intended use/indications. |
2. Sample size used for the test set and the data provenance
- Not explicitly stated. The document describes the system's function and a functional comparison. It doesn't detail a specific "test set" in terms of subject data for performance claims. The comparison is primarily against the established functionalities and components of the predicate EP-WorkMate®.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not explicitly stated. This type of information is typically required for studies demonstrating clinical diagnostic accuracy through expert interpretation of medical images or data. For a functional modification to a diagnostic computer that maintains its original intended use, expert-established ground truth on a test set is not detailed in this 510(k) summary. The demonstration relies on functional validation and comparison to the predicate.
4. Adjudication method for the test set
- Not applicable / Not explicitly stated. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC study is not mentioned. Such studies are typically performed to assess the impact of AI on human reader performance for diagnostic tasks, which is not the primary claim of this submission. The NurseMate™ acts as an additional workstation for charting and monitoring, not as a diagnostic aid that enhances physician interpretation in an MRMC context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Implicitly, "yes," in terms of functional validation. The NurseMate™ software (modified EP-WorkMate® application) and hardware components are described as functioning independently as a workstation, receiving data and allowing input. However, "standalone performance" in the context of diagnostic accuracy (e.g., sensitivity/specificity) is not applicable as the NurseMate™ is not an independent diagnostic algorithm. Its function is to display data and record charting information, with the diagnostic function residing with the physician and the main EP-WorkMate® system. The key functional performance described is its ability to display accurate physiological data and to record patient charting information without error.
7. The type of ground truth used
- Functional Specification/Predicate Device Comparison. The "ground truth" for this submission are the functional specifications of the NurseMate™ and the established performance of the predicate EP-WorkMate®. The NurseMate™ is intended to accurately display data transmitted from the Amp/SCU and the EP-WorkMate®, and to accurately record user input as patient charting data on the EP-WorkMate®. The ground truth for this would be that the displayed data matches the source data, and the recorded data matches the input data, both validated through internal testing and verification activities against the device's design specifications.
8. The sample size for the training set
- Not applicable / Not explicitly stated. There is no mention of a "training set" in the context of machine learning or AI models, as this device is a software modification and hardware addition for data display and charting, not a learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).