(20 days)
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
The Abbott Plum A+ Infusion Pump is an electromechanical infusion pump that uses a stepper motor in conjunction with an in-line cassette to meter IV fluids through a dedicated intravenous administration set that is also manufactured and distributed by Abbott Laboratories.
The subject and predicate devices have identical indications for use. Abbott proposes to modify the predicate device through software changes, minor changes to mechanical parts and labeling changes.
The featured software changes include: providing users with a choice to select the manufacturer's recommended units of measure for drug administration, updating the drug list, adding a confirmation screen before allowing therapy to begin, including a standby function and adding a password protected keypad.
These proposed changes along with the updated drug list are intended to potentially aid in medication error reduction by highlighting the drug to be infused and the units of measure for drug administration as shown in the manufacturer's package insert.
The user interface of the infusion pump allows the healthcare practitioner to program fluid delivery through a variety of weight and medication based units such as micrograms/kq/hour, grams/hr and other delivery specifications.
Like the predicate device. the proposed device includes: a nurse call function, a computer data port, a druq list, and a bar code wand. The display on the pump provides visible indication of several functions including active pump operations, alarm and program status and the parameters of fluid flow for one or both incoming fluid lines.
Both the predicate and the proposed devices can be used for standard, piggyback, or concurrent fluid delivery.
The provided text from the 510(k) submission for the Abbott Plum A+® Infusion Pump (K024084) describes a device modification and its substantial equivalence to a predicate device. However, it does not contain the detailed information requested for acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, or detailed study designs like MRMC or standalone performance.
The document is a summary for a Special 510(k) submission, which typically focuses on demonstrating that modifications do not raise new issues of safety or effectiveness. The information regarding studies is very general.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implicit Acceptance Criteria: | General Statement: |
| No new issues of safety and effectiveness raised by the modifications. | "The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device. There are no new issues of safety or effectiveness raised by the Plum A+® with version 11.3 software." (Section 9, Page 3) |
| Device performance equivalent to the predicate device. | "Both pumps use the same software lanquage. The proposed pump has similar design, materials of construction, components, labeling and manufacturing processes as the currently marketed Abbott Plum A+® Infusion Pump. These differences do not raise new issues of safety and effectiveness nor do they alter the fundamental technology of the predicate device." (Section 8, Page 2) |
| Software changes (choice of units, drug list update, confirmation screen, standby function, password-protected keypad) function as intended. | "The featured software changes include: providing users with a choice to select the manufacturer's recommended units of measure for drug administration, updating the drug list, adding a confirmation screen before allowing therapy to begin, including a standby function and adding a password protected keypad... These proposed changes along with the updated drug list are intended to potentially aid in medication error reduction by highlighting the drug to be infused and the units of measure for drug administration..." (Section 6, Pages 1-2) |
Missing Information: Specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, alarm response time within Y seconds) and the specific, measured performance values from the tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "Data regarding the functional performance of the proposed Abbott Plum A+ Infusion Pump has been generated and reviewed." There is no indication of the number of devices, tests, or data points used.
- Data Provenance: Not specified. It can be inferred that the testing was conducted by Abbott Laboratories, a U.S.-based company, but the specific location or nature (retrospective/prospective) of the data collection is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. The document describes functional and design verification/validation, which typically does not involve "ground truth" establishment by experts in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not applicable in the context of this device's testing as described. The testing appears to be engineering verification and validation against performance specifications, not human interpretation of data requiring adjudication.
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
- No MRMC study was done or mentioned. This type of study is relevant for AI-assisted diagnostic devices, which this infusion pump is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This concept is not directly applicable to a modified infusion pump. The "algorithm" (software) is integral to the pump's function. The functional performance tests described are inherently a standalone evaluation of the device's operation. No "human-in-the-loop" performance impact is discussed as it's a device modification, not a diagnostic aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The concept of "ground truth" as typically applied in AI/diagnostic device studies is not applicable here. The "ground truth" for an infusion pump's performance would be its adherence to engineering specifications and safe operation, as validated through various functional and safety tests.
8. The sample size for the training set
- This information is not provided. As this is a software modification to an existing electromechanical device, and not an AI or machine learning algorithm in the typical sense, there would not be a "training set" in the context of fitting a model to data. The "training" for the software would involve traditional software development, coding, and debugging.
9. How the ground truth for the training set was established
- This information is not provided and is not applicable for the reasons stated in point 8.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).