(8 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.
This submission is intended to notify the Food and Drug Administration that McKinley, Inc. intends to market a modification to an existing device (K023098) called the Accufuser/Accufuser Plus system. The modification to the existing device is the addition of procedure kits containing different accessories.
Standard Procedure Kits will have an optional multi-port catheter with a longer fenestrated length for wetting a larger area. The current kits have a standard epidural catheter with a small number of fenestrations over a short length.
Standard Procedure Kits will have an optional fixed-hub catheter. The current kits have catheters that utilize a Tuohy-Borst adapter or alligator clip-style adapter.
Standard Procedure Kits will have an optional break-away introducer needle, allowing use of a fixed-hub catheter. The current kits have a non-break-away introducer needle that requires use of a catheter with separate connector (i.e., Tuohy-Borst or alligator clip style adapter).
Standard Procedure Kits will have an optional fill port cover, inhibiting access to the fill port once the cover is attached.
This document, K033039, is a 510(k) summary for modifications to the McKinley Accufuser, Accufuser Plus & Standard Procedure Kit. It describes changes to an existing device, rather than a new device requiring extensive performance studies. Therefore, much of the requested information regarding acceptance criteria, study designs, sample sizes, and ground truth establishment, which are typical for studies validating AI/ML-based devices or devices requiring clinical performance data, is not present or applicable here.
The core of this submission is to demonstrate "substantial equivalence" of the modified device to a legally marketed predicate device (K023098) by ensuring the modifications do not raise new safety and efficacy concerns.
Here's a breakdown of the available information in response to your request, indicating where information is not applicable (N/A) or not provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for modifications to an existing device, specific quantitative "acceptance criteria" and "reported device performance" in the context of a new efficacy study are not presented in the same way as for a novel device. The primary "acceptance criteria" for this type of submission is demonstrating that the modifications do not negatively impact the safety and effectiveness of the device compared to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Modifications do not raise new safety and efficacy concerns. | "The new optional accessories for the Standard Procedure Kit do not raise any new safety and efficacy concerns when compared to the original Accufuser device that is already legally marketed." |
| Modified device is substantially equivalent to the predicate device. | "The Accufuser Plus, and Standard Procedure Kit is substantially equivalent to the named predicate device (K023098)." |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical data for performance evaluation. The evaluation is based on engineering and design changes and their impact on the existing device's safety and efficacy.
- Sample size used for the test set: Not applicable (N/A) – No clinical test set described for performance evaluation.
- Data provenance: Not applicable (N/A) – No clinical data in the traditional sense is presented for performance evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable (N/A). This document does not refer to a test set requiring expert-established ground truth for performance evaluation. The "ground truth" here is the established safety and efficacy of the predicate device.
4. Adjudication Method for the Test Set
Not applicable (N/A). No test set requiring expert adjudication is described.
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
Not applicable (N/A). This device is an elastomeric infusion pump system and does not involve AI or human readers in its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable (N/A). This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the predicate device (K023098). The modifications are assessed against this existing baseline. No new clinical outcomes data or pathology results are explicitly generated to establish a new ground truth for the modified components themselves in this summary.
8. The Sample Size for the Training Set
Not applicable (N/A). There is no "training set" as this is not an AI/ML device or a device requiring a training phase with clinical data.
9. How the Ground Truth for the Training Set Was Established
Not applicable (N/A). There is no "training set" or corresponding ground truth establishment process described in the document.
§ 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).