(102 days)
The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.
Based on an open-architecture design, DataCaptor is a data acquisition and distribution software, using ActiveX and the Distributed Component Object Model. This tool retrieves data from serial, network or analog devices and, via an ActiveX control, makes this data available over network or any other type of communication for use in software applications. We do not supply any hardware - our customers can buy cable and connect the devices directly to the COM port (we provide a wiring diagram that shows them pin configurations) or they can use a multiport box or card, an RS-232 to Ethernet converter is used if several devices need to be connected to the network and there are not necessarily computers next to each one. We don't recommend hardware suppliers.
This submission is a 510(k) premarket notification for the DataCaptor™ Data Acquisition and Distribution Software. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive studies with acceptance criteria and performance metrics typically seen for novel or higher-risk devices.
Therefore, the provided text does not contain the acceptance criteria or a study directly proving the device meets acceptance criteria in the format requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, I can extract the relevant information regarding the equivalence comparison, which serves as the basis for the FDA's decision to allow the device to market.
Summary of Device Equivalence and FDA Determination:
The DataCaptor™ Data Acquisition and Distribution Software's acceptance is based on its substantial equivalence to a legally marketed predicate device, the Hewlett-Packard M2376A DeviceLink System (K000635). The FDA determined that the device is substantially equivalent for the stated indications for use.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of quantitative performance thresholds that the device had to meet through a specific study. Instead, the "acceptance criteria" can be inferred from the comparison areas used to demonstrate equivalence to the predicate device. The device "performance" is implicitly deemed acceptable because it is "substantially equivalent" to a device already deemed safe and effective.
| Comparison Area | Predicate Device Performance / Characteristic (Hewlett-Packard M2376A DeviceLink System, K000635) | DataCaptor™ Reported Device Performance / Characteristic | Equivalence Conclusion (Implied Acceptance) |
|---|---|---|---|
| Indications for Use | Indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. Not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. | The DataCaptor™ System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor™ is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. | SAME (Substantially Equivalent) |
| Interfaces | Serial or network | SAME (Serial or network) | SAME (Substantially Equivalent) |
| Where used | Hospitals | SAME (Hospitals) | SAME (Substantially Equivalent) |
| Computer | Windows PC | SAME (Windows PC) | SAME (Substantially Equivalent) |
| Hardware | DeviceLink System (implies hardware component in the system) | Software only; no interconnection hardware is supplied. | Main Difference: Software Only. Still deemed substantially equivalent in safety and effectiveness. |
| Design | Not explicitly detailed, but implied to be effective for its function | Open-architecture design, uses ActiveX and Distributed Component Object Model for data acquisition and distribution. | Implied substantial equivalence, despite potential implementation differences. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not describe a test set or data provenance in the context of performance testing for acceptance criteria. The equivalence demonstration relies on a comparison of intended use, technological characteristics, and operational environment with a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There was no "ground truth" to establish for a test set in this type of submission. The ground truth for regulatory acceptance is the established safety and effectiveness of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication process is described in 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 is not an AI/CAD device. It is data collection software. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is data collection software, not an algorithm with performance metrics measured in a standalone fashion. Its function is to acquire and distribute data, not to make diagnostic or prognostic predictions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purpose of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device, the Hewlett-Packard M2376A DeviceLink System, K000635, as accepted by the FDA. The new device demonstrates substantial equivalence to this established "truth."
8. The sample size for the training set:
- Not Applicable. This submission does not describe a training set as it is not a machine learning or AI-driven device requiring model training.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth established for it.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).