Search Results
Found 1 results
510(k) Data Aggregation
(9 days)
The Abbott DataPort PC is an optional computer (PC) software accessory for use exclusively with the Abbott Plum A+ and A+3 Infusion Pumps in a biomedical technical service environment.
The indications for use are the indications for use of the parent devices belonging to the Abbott Plum A+ Infusion Pump family, which are the Abbott Plum A+ and Abbott Plum A+3 Infusion Pumps. Infusion pumps in the Abbott Plum A+ Infusion Pump Family are used in parenteral, enteral and epidural therapies and the administration of whole blood products. The Abbott Plum A+ and A+3 Infusion Pumps are designed to deliver infusions over a broad range of infusion rates from multiple container types.
The Abbott DataPort PC software supports data transfer between a single computer (PC) and up to 15 Abbott Plum A+ Infusion Pumps, or up to 4 Abbott Plum A 13 Infusion Pumps. Abbott DataPort PC allows authorized users to retrieve infuser alarm logs, event history logs, and biomedical settings from interfaced infusers, and to edit and send modified biomedical settings to the interfaced infusers from the PC.
The Abbott DataPort PC is an optional software accessory for use with Abbott Plum A+ and A+3 Infusion Pumps. Its primary function is to facilitate data transfer (retrieving alarm/event logs and biomedical settings, and sending modified biomedical settings) between a PC and the infusion pumps in a biomedical technical service environment.
Here's an analysis of the acceptance criteria and supporting study details based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The provided document describes the Abbott DataPort PC as substantially equivalent to existing Abbott Plum A+ and A+3 Infusion Pumps using interface software not supplied by Abbott. The acceptance criteria are framed in terms of substantial equivalence across various aspects, primarily demonstrating that the addition of the Abbott DataPort PC software does not negatively impact the established safety and effectiveness of the parent devices and offers enhanced functionality.
| Acceptance Criteria (Demonstrated by Substantial Equivalence) | Reported Device Performance (Summary of Similarities/Capabilities) |
|---|---|
| Intended Use Remains Unchanged: The device, with the new software, must have the same intended use as the predicate devices. | The Abbott DataPort PC supports the same intended use as the parent Abbott Plum A+ Infusion Pump family, which is for use in parenteral, enteral, and epidural therapies and the administration of whole blood products, used by licensed physicians or certified healthcare professionals. |
| Indications for Use Remain Unchanged: The specific indications for the use of the infusion pumps should be consistent. | The indications for use are identical to the parent devices (Abbott Plum A+ and A+3 Infusion Pumps), covering parenteral, enteral, and epidural therapies, and administration of whole blood and blood products. |
| Fundamental Scientific Technology is the Same: The core operating principle of the infusion pump itself should not change. | Both configurations (with and without Abbott DataPort PC) use the same fundamental scientific technology, operating principle (stepper motor with in-line cassette to meter IV fluids), administration sets, fluid contact materials, physical features, environmental features, and performance features (delivery rates, accuracy, modes, etc.). |
| No Degradation of Physical, Operational, and Performance Specifications: The addition of the software should not negatively impact the established specifications of the infusion pump. | The device maintains the same physical, operational, and performance specifications as the predicate devices, including delivery rates, VTBI range, dose units, and delivery accuracy. |
| Data Transfer Capability and Protocol Consistency: The software should utilize existing communication methods and protocols securely and effectively. | Both configurations (with Abbott DataPort PC and without) allow data transfer via the infuser data communication ports, use the same communication protocol, and the same accessory hardware for interfacing a PC to the infusers. It supports data transfer to up to 15 Abbott Plum A+ or 4 Abbott Plum A+3 pumps from a standalone PC. |
| Biomedical Technician Environment Focus: The software's functionality should be appropriate for its intended user environment. | Both configurations are intended for use in a biomedical technician environment. |
| Restriction on Therapy Programming and Remote Control: The software should not allow unauthorized programming of therapies or remote control of infusions. | Adherence to these restrictions is explicitly stated: "Both configurations do not allow users to program a new therapy into an infuser." and "Both configurations do not allow users to enter infuser keystrokes remotely." Also, "Both configurations do not allow users to monitor infusers that are actively infusing, priming, or being programmed for infusion." |
| No Hospital Information System/Network Interface: The software should not introduce network connectivity beyond its defined scope. | "Both configurations do not support Hospital Information System / Network interfaces." |
| New Capabilities without Adverse Impact: The new functionalities (retrieval/editing of BioMed settings) should be achieved without compromising safety or effectiveness. | The Abbott DataPort PC enables additional functionalities: retrieval, saving, and printing of BioMed configuration settings, and editing, saving, and sending modified BioMed configuration settings. These capabilities are not present in systems using non-Abbott supplied interface software but are presented as enhancements without adversely affecting the core safety and performance of the infusion pumps. The submission implicitly asserts these new capabilities are safe and effective through the substantial equivalence argument itself. |
| Overall Safety and Effectiveness: The device with the software must be as safe and effective as the predicate device without the software. | The "Statement of Safety and Effectiveness" explicitly states: "The Abbott Plum A+ Family of Infusion Pumps (V11.x) with Abbott DataPort PC software, meets the functional claims and intended use as described in the product labeling, and is as safe and effective as, the Abbott Plum A+ Family of Infusion Pumps without the Abbott DataPort PC software." |
2. Sample Size for Test Set and Data Provenance
The document does not specify a separate test set or sample size for the Abbott DataPort PC software itself. The submission is a Special 510(k) for a modification to a previously cleared device. The "study" for this submission focuses on demonstrating substantial equivalence to the predicate devices (existing Abbott Plum A+ and A+3 infusion pumps).
The data provenance for the underlying infusion pumps (K024084, K021350, K011442, K982159) is not detailed in this specific document, as those were previously cleared devices. The substantial equivalence argument relies on the inherent safety and efficacy of those predicate devices, with the new software being an accessory that does not alter these core characteristics.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for a test set related to the DataPort PC software. The submission focuses on design control and verification/validation activities demonstrating that the software performs its intended functions (e.g., correctly transfers data, retrieves logs, sends settings) in the biomedical technical service environment without introducing new risks or compromising existing safety features of the infusion pumps.
4. Adjudication Method
No adjudication method is described, as there is no explicit clinical or performance study with a test set requiring expert review or ground truth establishment in the traditional sense for this Special 510(k). The focus is on technical verification (e.g., does the data transfer work as designed?) rather than diagnostic accuracy or clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI is intended to assist in that interpretation. The Abbott DataPort PC is an accessory for an infusion pump, facilitating data management for biomedical technicians, not a diagnostic tool requiring human interpretation for clinical decision-making at the point of care.
6. Standalone (Algorithm Only) Performance Study
A standalone performance evaluation of the Abbott DataPort PC software itself was implicitly conducted through design validation and verification activities, as is standard for medical device software. However, the document does not describe specific metrics like sensitivity, specificity, accuracy, etc., as would be common for diagnostic algorithms. Instead, the "performance" is demonstrated by its ability to reliably retrieve, save, print, edit, and send the specified data (alarm logs, event history logs, and biomedical settings) correctly, without errors, and maintaining the integrity of the infuser's operation.
The "Statement of Safety and Effectiveness" indicates that the software "meets the functional claims and intended use as described in the product labeling." This implies internal testing was performed to verify these functional claims.
7. Type of Ground Truth Used
For the Abbott DataPort PC, the "ground truth" would be the expected and verified behavior of the software and the infusion pump hardware working together. This would involve:
- Functional Verification: Confirming that the software correctly retrieves the exact data (e.g., alarm codes, event timestamps, current biomedical settings) from the infuser.
- Data Integrity: Verifying that modified biomedical settings sent from the PC are accurately received and implemented by the infuser without corruption or unintended alterations.
- System Responsiveness: Ensuring the communication and data transfer occur within acceptable timeframes.
- Failure Mode Testing: Confirming that the system handles errors or disconnections gracefully without endangering patient safety or corrupting infuser settings.
This ground truth is typically established through engineering specifications, direct observation, and comparison against expected values or states during testing (e.g., comparing a retrieved log to the actual log stored in the infuser, or comparing a sent setting to the setting actually applied by the infuser).
8. Sample Size for the Training Set
The document does not specify a training set sample size. The Abbott DataPort PC is a software application for data transfer and configuration management, not a machine learning or AI algorithm that requires a training set in the typical sense. Its functionality is rules-based and deterministic, derived from programming rather than learned from data.
9. How Ground Truth for the Training Set Was Established
As there is no training set for this type of deterministic software, the concept of establishing ground truth for a training set is not applicable. The software's design and functionality are based on established communication protocols and the functional requirements of managing data for the Abbott Plum A+/A+3 Infusion Pumps.
Ask a specific question about this device
Page 1 of 1