(14 days)
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- The I-Flow Elastomeric Pump with Bolus 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, subcutaneous, intramuscular and epidural.
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- The I-Flow Elastomeric Pump with Bolus is also intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/c close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural or percutaneous.
This special 510(k) proposes a new optional component for the I-Flow Elastomeric Pump that incorporates a bolus component. The bolus component offers the additional ability to deliver fixed bolus volumes of medication at fixed time intervals instead of just a continuous infusion rate.
The provided text is a 510(k) summary for the I-Flow Elastomeric Pump with Bolus. This document does not contain the detailed acceptance criteria and study information typically found in a clinical trial report or a comprehensive device validation study.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to an existing legally marketed device (the I-Flow Elastomeric Pump without the bolus component). The key argument is that the new bolus component "utilizes the same technology for dispensing medication as the existing unmodified design," implying that the safety and effectiveness are comparable and, therefore, extensive new performance studies (as outlined in your request) are not required for this type of submission.
Therefore, I cannot provide the information requested in your numbered list directly from the provided text because it's not present. The document explicitly states:
- "Conclusion: The I-Flow Elastomeric Pump with Bolus is substantially equivalent to the existing I-Flow Elastomeric Pump."
- "Technology Comparison: The new Bolus Component utilizes the same technology for dispensing medication as the existing unmodified design."
This type of submission relies on the predicate device's established performance rather than new, extensive studies for the modified device, particularly since the modification is described as an "optional component" that adds a specific function (bolus delivery) but uses the same fundamental technology.
§ 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).