(8 days)
- The I-Flow Elastomeric Pump is intended for continuous and/or intermittent infusion of medications for general infusion use, including antibiotic delivery, chemotheraly and pain management. Routes of administration include the following: intravenous, intra-arterial, subcutaneous, intramuscular and epidural.
- The I-Flow Elastomeric Pump is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
The I-Flow Elastomeric Pump consists of an elastomeric pressure source with an integrated administration line. This special 510(k) proposes a change from latex to polyisoprene for the outer bladder. The outer bladder is not in contact with the fluid path and thus does not require biocompatibility. The inner bladder will remain the same and thus drug compatibility will not be affected.
The provided document is a 510(k) submission for a change in material for the I-Flow Elastomeric Pump, specifically switching the outer bladder from latex to polyisoprene. This is a "Special 510(k)," which indicates a modification to an existing device where the design control activities are sufficient to demonstrate substantial equivalence.
Given the nature of a Special 510(k) for a material change that does not contact the fluid path and where drug compatibility is not affected, the submission focuses on demonstrating that the new material (polyisoprene) has similar properties to the existing material (latex) and that the device still performs as intended. Therefore, the "acceptance criteria" and "study" are not presented as a traditional performance study with accuracy metrics, but rather as a demonstration of material equivalence and continued device functionality.
Here's the breakdown based on the provided information:
1. A table of acceptance criteria and the reported device performance
The document doesn't present explicit numerical acceptance criteria and a performance table in the typical sense of accuracy or precision. Instead, the acceptance criterion is implicitly that the device with the new material remains substantially equivalent to the predicate device. The performance is summarized by stating the two materials have "similar properties" and that the material change does not impact drug compatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device with latex bladder | The new polyisoprene bladder and the existing latex bladder are "two different types of elastomers with similar properties." The outer bladder is not in contact with the fluid path, and the inner bladder remains the same, so "drug compatibility will not be affected." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not provide information on a specific test set sample size or data provenance for a performance study. As this is a material change for a non-fluid-contact component, the "study" appears to be more focused on material characterization and engineering assessment rather than a clinical or performance testing study with
patient samples.
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 applicable and not provided. The context is a material change for a medical device's component. There's no "ground truth" to be established by experts in the sense of diagnostic accuracy or clinical outcomes. The assessment is likely performed by engineers and material scientists from the manufacturer.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided. There's no mention of an adjudication process as there is no "test set" in the context of diagnostic interpretation.
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 information is not applicable and not provided. The device is an elastomeric infusion pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is an elastomeric infusion pump, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable and not provided. There is no "ground truth" in the clinical sense mentioned, as the study pertains to material properties and substantial equivalence, not clinical diagnosis or outcomes.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As there's no training set, there's no ground truth establishment for it.
In summary, this 510(k) submission is for a material change that is considered minor because it does not affect device performance or patient contact. The "study" referenced is the demonstration that the new material is functionally equivalent to the old material and does not impact critical device features like drug compatibility. The typical metrics and study designs for diagnostic devices or AI systems are not relevant here.
§ 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).