(36 days)
- The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotherapy and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
- The 1-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of local anesthetics or narcotics to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia. Routes of administration may be intraoperative, perineural or percutaneous.
- The I-Flow Elastomeric Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.
The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. The current device has an optional Y-adapter that splits the administration line into two delivery sites. This special 510(k) proposes a multi-Y adapter that can provide 3 or more integrated administration lines for multi-site delivery.
The provided text describes a Special 510(k) submission (K052117) for a modification to the I-Flow Elastomeric Pump. This submission focuses on a design change, specifically the addition of a multi-Y adapter to allow for 3 or more integrated administration lines, as an extension of an existing product line (K040337).
Crucially, the provided document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.
Instead, it's a declaration of substantial equivalence to a previously cleared device. The rationale is that the new multi-Y adapter utilizes the same technology as the existing unmodified design, and therefore, no new issues of safety or effectiveness are believed to arise from this change.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
Here's why and what information would typically be needed if a study were conducted:
1. A table of acceptance criteria and the reported device performance
- Missing Information: The document does not define any specific acceptance criteria (e.g., flow rate accuracy, pressure stability, material compatibility, bacterial ingress prevention) for the new multi-Y adapter, nor does it report any performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing Information: No test set is mentioned because no study was conducted for this specific submission to demonstrate performance against new criteria.
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)
- Missing Information: Not applicable, as no study requiring ground truth establishment was conducted for this submission. This type of information is usually relevant for studies evaluating diagnostic or AI-driven devices, not a simple accessory modification like this.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing Information: Not applicable, as no study requiring adjudication was conducted.
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
- Missing Information: Not applicable. This type of study is for evaluating AI performance in diagnostic imaging, which is completely unrelated to an elastomeric pump accessory.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing Information: Not applicable. This device does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing Information: Not applicable, as no study requiring ground truth was conducted.
8. The sample size for the training set
- Missing Information: Not applicable. This device does not involve a training set as there is no AI/ML component.
9. How the ground truth for the training set was established
- Missing Information: Not applicable, as there is no training set mentioned.
Conclusion from the provided text:
The submission K052117 is a "Special 510(k)" which indicates a modification to an already cleared device (K040337). The nature of the change (adding more "Y" splices to an existing administration line) is deemed minor enough by the submitter and the FDA to not require new performance studies. The core argument is based on technological equivalence to the predicate device, implying that the established safety and effectiveness of the original pump apply to this modified version. The FDA letter confirms the determination of "substantial equivalence" based on this premise, allowing the device to be marketed without new clinical or performance studies.
§ 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).