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510(k) Data Aggregation
(82 days)
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
| Feature/Parameter | Acceptance Criteria (from device specifications) | Reported Device Performance (from device specifications) |
|---|---|---|
| Accuracy | ||
| 60 ml Reservoir | +/- 10% of nominal flow rate at 95% confidence interval | +/- 10% of nominal flow rate at 95% confidence interval |
| 100 ml Reservoir | +/- 10% of nominal flow rate at 95% confidence interval | +/- 10% of nominal flow rate at 95% confidence interval |
| 275 ml Reservoir | +/- 15% of nominal flow rate at 95% confidence interval | +/- 15% of nominal flow rate at 95% confidence interval |
| 550 ml Reservoir | +/- 15% of nominal flow rate at 95% confidence interval | +/- 15% of nominal flow rate at 95% confidence interval |
| Operating Pressure | Not explicitly stated as acceptance criteria, but a characteristic of the device. | 5 to 6 psi |
| System Residual Volume |
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