Search Results

The Accufuser and Accufuser Plus systems are intended for general infusion use. Routes of infusion include intravenous, percutaneous, subcutaneous, intra-arterial and epidural, and into the intra-operative (soft tissue / body cavity) site. The Accufuser Plus is also intended for patient-controlled infusion using the integrated bolus button. General infusion uses include pain management for preoperative and postoperative and postoperative surgery.

The Accufuser and Accufuser Plus systems are 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 Accufuser/Accufuser Plus system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.

The Accufuser/Accufuser Plus system consists of a pump and an integrated administration set. The pump is a continuous silicone balloon type. The pump provides continuous fluid delivery with an attached, fixed rate administration set. The pumps are supplied as fixed flow rates. A silicone balloon is used as both the fluid reservoir of the device and the pressure (energy) source.

The Accufuser/Accufuser Plus pump and administration set are intended for single patient use.

The Accufuser Plus is the Accufuser with the addition of a Patient Medication Control Module (PCM). The PCM allows the patient to administer a bolus of a fixed volume with a fixed lockout (re-fill) time. The PCM in integrated into the administration set with a bolus button that allows the patient controlled administration of medication as needed.

The Standard Procedure Kit is substantially equivalent to the predicate devices. The kit includes various kit components such as catheter, needle, syringe, y adapter, dressing, tape, gauze and carry case.

This is a 510(k) premarket notification for an elastomeric infusion pump. There is no information in this document about a study that used a test set, human readers or ground truth as this is not applicable for this kind of device. The document mostly focuses on the substantial equivalence to predicate devices and the device's specifications.

Here's the relevant information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

• 1. 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.
• 2. 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.

Ask a specific question about this device