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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.

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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.

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.

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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

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