(25 days)
The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.
The dual port line of Infusors are a modification of Baxter's currently marketed Infusor line of elastomeric infusion devices. The modification consists of adding a "Y" fitting and an additional section of administration set tubing resulting in a bifurcated tubing. This allows solution flow through two ports. There are no new materials or technology associated with the modification. In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps. Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices.
The provided text describes a 510(k) premarket notification for a medical device, the Baxter Dual Port Infusor. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria in the manner one would expect for a new, non-equivalent device. Therefore, many of the requested categories of information are not explicitly available in this type of submission.
Here's an analysis based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria and reported device performance in a quantitative table format. This type of 510(k) submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the Infusor SV and LV Elastomeric Infusion Device). The primary 'performance' aspect highlighted is that the "range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices."
- Acceptance Criteria (Inferred from Substantial Equivalence Claim): The flow rates of the Dual Port Infusor (single and combined ports) must be equivalent to or within the established range of the predicate Infusor SV and LV devices.
- Reported Device Performance: The document states that the flow rates "are within the current range of flow rates available in the single port Infusor devices."
- Technological Characteristics: The document explicitly states, "The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices." This implies that other performance aspects (e.g., material compatibility, pressure resistance, etc.) are also considered to be equivalent.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Flow rates (single & combined ports) within predicate device range | "range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices." |
| Identical technological characteristics to predicate device | "The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices." |
| No new materials or technology | "There are no new materials or technology associated with the modification." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a "test set" in the context of a new performance study. As this is a 510(k) for a modification to an existing device where the "modification consists of adding a 'Y' fitting and an additional section of administration set tubing," the testing likely involved engineering verification/validation, rather than a large-scale clinical study with a "test set" as typically understood for AI or diagnostic devices. There is no mention of country of origin or whether data was retrospective or prospective, as these are not relevant for the type of comparison being made.
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 section is not applicable to this submission. The device is a physical medical device (an elastomeric infusion pump), not a diagnostic or AI system requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable to this submission for the same reasons as point 3.
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
This section is not applicable. The device is an infusion pump, not an AI system or diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable for the same reasons as point 5.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This section is not applicable as the device is not a diagnostic tool requiring such ground truth. The "ground truth" equivalent here would be the established performance specifications and characteristics of the predicate devices, which serve as the benchmark for substantial equivalence.
8. The sample size for the training set
This section is not applicable. The document does not describe the development of an algorithm or AI model, thus there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reasons as point 8.
Summary of the Study / Basis for Substantial Equivalence:
The "study" or basis for this 510(k) submission is a technical comparison to legally marketed predicate devices (Infusor SV and LV Elastomeric Infusion Device).
- Rationale: The device is a modification of an existing device. The modification consists solely of "adding a 'Y' fitting and an additional section of administration set tubing" to create a bifurcated flow path.
- Key Argument for Equivalence:
- "There are no new materials or technology associated with the modification."
- "In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps."
- "Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices."
- The "technological characteristics... are identical" to the predicate.
- Evidence: While not detailed in the provided text, the submission implicitly relies on engineering verification and validation testing to confirm that the modification does not alter the fundamental performance characteristics (especially flow rates) outside the established parameters of the predicate devices. The focus is on demonstrating that the device remains functionally equivalent despite the addition of the second port.
- Conclusion: The FDA reviewed the submission and determined that the device is "substantially equivalent" to the predicate devices, allowing it to be marketed. A contraindication for intravenous, intra-arterial, and epidural use was added to the labeling for the Dual Port Infusors.
§ 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).