(195 days)
The intended use of the DIB-RA Infusor is similar to that of other legally marketed elastomeric infusion pumps.
The DIB-RA Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon.
This document, "Attachment F: Summary of Safety and Effectiveness for the DIB-RA Infusor," describes the manufacturing, testing procedures, prior in-vitro tests, and clinical experience of the DIB-RA Infusor. However, it does not explicitly state specific acceptance criteria or provide a study that directly proves the device meets those acceptance criteria in the format requested.
Here's an analysis based on the provided text, highlighting what's missing and what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicitly Stated | |
| Silicone balloons tested to internal pressure of 110+5 mmHg. | 100% of silicone balloons are tested to an internal pressure of 110+5 mmHg. |
| Conformity to AMMI Draft Infusion Device Standard (implicit functional performance). | The DIB-RA Infusor will conform to the AMMI Draft Infusion Device Standard. (This is a future commitment, not a demonstrated performance result). |
| Biocompatible materials (implicit safety). | Utilizes all biocompatible materials, including a medical grade silicone shaft and silicone balloon. |
| Manufacturing in Class 10,000 clean room and according to GMP regulations (implicit quality control). | All manufacturing operations performed in a class 10,000 clean room in accordance with GMP regulations. |
| Normal clinical operating pressure (implicit functional range). | Normal clinical operating pressure has been measured at approximately 70 mmHg. |
| Full traceability of production lots (implicit quality control). | Full traceability of production lots will be maintained. |
| Inferred from "Intended Use" and "Prior In-Vitro Tests" | |
| Similar function to other legally marketed elastomeric infusion pumps (flow rate, drug delivery accuracy). | Intended use similar to other legally marketed elastomeric infusion pumps. Studies (A.Y. Susuki, M.D., et al. and Dept of Biomedical Engineering, Univ of Utah) mention "Laboratory Evaluation" and "flow study," suggesting these would assess performance metrics like flow stability and accuracy. However, specific acceptance criteria (e.g., flow rate deviation within X%) and the actual performance data against these criteria are not provided. |
| Efficacy in specific clinical applications (e.g., obstetrical analgesia, post operative pain, chronic pain, intravenous infusions). | Legally marketed DIB pumps have been used clinically in the USA for these applications. Clinical experience (outside USA) also cited for continuous epidural block and postoperative pain relief. However, this section describes existing use and experience with similar devices, not a study proving the DIB-RA Infusor meets specific efficacy acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
- For the "100% testing of silicone balloons to 110+5 mmHg": The sample size is the entire production lot ("100% tested"). The provenance is internal manufacturing data.
- For the in-vitro tests (Susuki et al. and University of Utah flow study): Not specified. We know they are "in-vitro" tests and likely conducted in Canada (Susuki) and the USA (University of Utah). These studies are attached to the original Premarket Notification (K930404), suggesting they are retrospective to the DIB-RA Infusor's submission. Specific test set sizes (e.g., number of devices tested, number of flow measurements) are not detailed.
- For "Clinical Experience": The document refers to "legally marketed DIB pumps" and citations of clinical studies from Japan. These are retrospective (already published studies with other DIB pumps) and involve patient data. The "sample size" here refers to the patient cohorts in those studies, which are not specified in this summary. These studies serve as evidence of the utility of similar technology, not necessarily a direct test set for the DIB-RA Infusor itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable / Not specified. The document describes engineering tests (pressure, flow) and general clinical experience. It does not mention a "test set" that requires expert-established ground truth in the context of diagnostic or interpretive tasks. The clinical experience section refers to published medical studies, where the "ground truth" would be the clinical outcomes and observations made by the treating physicians, but this is reported for other devices, not directly for a specific "test set" of the DIB-RA Infusor requiring an independent expert panel.
4. Adjudication Method:
- Not applicable / Not specified. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This document describes a medical device, not an AI or diagnostic imaging tool that would typically involve an MRMC study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an elastomeric infusion pump, not an algorithm. Its performance is inherent in its mechanics.
7. The Type of Ground Truth Used:
- For pressure testing: The ground truth is the measured internal pressure of the silicone balloons against a defined specification (110+5 mmHg).
- For flow studies (inferred): The ground truth would be the measured flow rate against a calibrated standard (e.g., gravimetric measurement, volumetric displacement).
- For clinical experience (inferred from cited studies): The ground truth would be clinical outcomes data (e.g., pain relief scores, duration of analgesia, adverse events for the specific conditions studied). However, this is for similar devices, not a direct ground truth for the DIB-RA Infusor's specific performance in a clinical trial.
8. The Sample Size for the Training Set:
- Not applicable / Not specified. This summary does not describe any machine learning models or algorithms that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not specified. See point 8.
In summary:
This document provides a summary of safety and effectiveness for a medical device (infusion pump), focusing on manufacturing controls, material biocompatibility, and referencing in-vitro tests and clinical experience with similar devices. It functions more as regulatory submission content demonstrating a commitment to standards and drawing upon existing knowledge base for analogous technologies, rather than a detailed report of a single, comprehensive study proving specific acceptance criteria for the DIB-RA Infusor itself. The document implicitly asserts safety and effectiveness based on adherence to manufacturing standards, use of biocompatible materials, and the established clinical history of elastomeric infusion pumps.
§ 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).