(20 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, perioperative, 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 and Accufuser Plus systems are 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 Accufuser device consists of an elastomeric balloon medication reservoir with a flow rate-controlling administration set. The pressure that pumps the fluid is derived from the strain energy of the elastomeric membrane that is forced to expand when the pump is filled. The administration set includes a flow restrictor component with controlled internal diameter and length. The flow rate at which medication is dispensed from the system is a function of the pressure applied to the medication and the dimensions of the flow restrictor component. The medication may be dispensed from the system continuously and/or intermittently.
The size of the reservoir and the amount of flow restriction are determined to yield a variety of product codes with differing infusion volumes and flow rates. The physician variety of product on thow rate and reservoir size based on the individual patient needs.
Administration sets may incorporate a bolus feature, which may be used alone or in conjunction with basal (continuous) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been rctivated, the bolus volume is infused at a controlled flow rate. The bolus device is integrated into the administration set and allows patient-controlled administration of medication as needed.
A procedure kit option provides various components that facilitate setup and use of the Accufuser system.
The Accufuser system is intended for single patient use.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for modifications to an existing device, the McKinley Accufuser, Accufuser Plus, and Standard Procedure Kit.
The key points of this document are:
- Device: McKinley Accufuser, Accufuser Plus, and Standard Procedure Kit.
- Modification: Addition of an indication for use.
- Claim: The added indication states that the Accufuser and Accufuser Plus systems are intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves, compared with narcotic-only pain management.
- Basis for Clearance: Substantial equivalence to previously cleared devices (K003915, K023098, K033039) and predicate devices (McKinley's beeLINE system & standard procedure kit (K042228) and the I-Flow Elastomeric Pump (K040337)).
- Conclusion: The modified system "does not raise any new safety and efficacy concerns" and is "substantially equivalent to the named predicate devices."
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details of any specific study (like a clinical trial or performance study) designed to prove the new indication for use, including sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on ground truth types or how ground truth was established for any test or training sets.
- Sample sizes for training sets.
The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than requiring new clinical studies for every modification, especially if the modification is related to an indication for use that is generally accepted for similar devices. In this case, the claim of decreasing narcotic use and pain might be considered a clinical benefit inferred from the mechanism of action (delivering local anesthetics) and comparison to existing devices with similar functionalities, rather than requiring a dedicated, new clinical trial for this specific 510(k) submission.
§ 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).