Search Results

1. The Beeline system is intended for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management. The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous, percutaneous and epidural infusion of medications or fluids requiring continuous and/or intermittent delivery at controlled infusion rates. The Beeline system is suitable for use as an ambulatory device and is intended for use in the hospital, home environment, and alternative care sites.
2. The Beeline system is intended to provide 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. The Beeline system is also intended for patientcontrolled infusion using the integrated bolus device.
3. The Beeline system is 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 Beeline device consists of a spring-pressurized medication reservoir with a flowratecontrolling administration set. A spring applies force against a piston, pressurizing the medication. 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 prescribes for a patient a flow 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) or KVO (very low) flow. The bolus device consists of a dosage reservoir that is filled when activated manually. After the bolus device has been activated, 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 Beeline system.

The Beeline system is intended for single patient use.

The provided document is a 510(k) Summary for modifications to the McKinley Beeline System, an infusion pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically found for novel device approvals.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria, as it's not a study report. It describes modifications to an existing device and argues for its substantial equivalence to previously cleared devices.

Here's a breakdown of why the requested information is not available in the provided text, and what is present:

Information NOT available in the document:

• A table of acceptance criteria and the reported device performance: This document doesn't define explicit acceptance criteria for this specific submission. Instead, it relies on the predicate devices having already met such criteria. The "reported device performance" is not quantified in the way a clinical study report would present it (e.g., sensitivity, specificity, accuracy, etc., for a diagnostic device, or specific functional benchmarks for a therapeutic device).
• Sample size used for the test set and the data provenance: No clinical testing or formal "test set" is described for this 510(k) submission.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set or ground truth described in this submission.
• Adjudication method for the test set: Not applicable.
• 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. This device is an infusion pump, not an AI-assisted diagnostic or therapeutic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as there is no mention of a "training set" in the context of device development or machine learning.
• How the ground truth for the training set was established: Not applicable.

What the document does provide, related to its purpose:

• Device Description: It describes the Beeline system as a "spring-pressurized medication reservoir with a flow-rate controlling administration set" that dispenses medication continuously and/or intermittently. It also mentions variations in reservoir size, flow rates, and the addition of a bolus feature.
• Modifications: The submission is for modifications to an existing device, including "extension of the flow rate range, addition of medication reservoir volumes, addition of an indication for use, addition of bolus capability, and addition of intermittent flow capability."
• Predicate Devices: It lists several predicate devices (McKinley Beeline system K032642, McKinley's Accufuser K033039, I-Flow Elastomeric Pump K040337, Baxter Colleague Volumetric Pump K010566, and SIMS Deltec CADD-Prizm Model 6101 K000842) to establish substantial equivalence.
• Conclusion: The central argument is that "The modified Beeline system does not raise any new safety and efficacy concerns when compared to the original device that is already legally marketed. The Beeline system is substantially equivalent to the named predicate devices." This is the "proof" required for a 510(k) clearance – not a clinical trial proving specific performance against acceptance criteria, but a demonstration of equivalence to devices already proven safe and effective.
• Indications for Use: These are detailed, outlining the intended applications for continuous and/or intermittent infusion of medications (antibiotics, chemotherapy, pain management, local anesthetics) in various settings and routes (IV, IA, enteral, subcutaneous, percutaneous, epidural), including patient-controlled bolus.

In summary, this document is a regulatory submission for device modification based on substantial equivalence, not a clinical study report. Therefore, the specific details regarding acceptance criteria and performance metrics from a dedicated study are not present.

Ask a specific question about this device

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.

Ask a specific question about this device

The Beeline system is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates.

The Beeline system is also intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management.

The Beeline device consists of a spring-pressurized, syringe-like medication reservoir with a flowrate-controlling administration set. Medication is held between the barrel and piston of the infuser. A spring applies force against the piston, pressurizing the medication. 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 size of the reservoir and the amount of flow restriction are varied during manufacturing to yield a variety of product codes with differing infusion volumes and flowrates.

A procedure kit provides various components that facilitate setup and use of the Beeline system. Examples of kit components include items such as a prep tray, sterile drape, transfer syringe, medication/chart labels, catheter & introducer, dressing, tape, gauze, prep pads/wipes, carrying case, etc. Multiple kit product codes are made, with the contents varied as applicable for the particular procedure.

The Beeline system is intended for single patient use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the McKinley Beeline System, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria Interpretation: The document presents the device specifications as the intended performance targets which also serve as acceptance criteria for demonstrating substantial equivalence to predicate devices. There isn't a separate section explicitly labeled "acceptance criteria" distinct from the "device specifications" in this 510(k) summary; rather, the specifications are the criteria for this type of submission which relies on showing equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly detail a specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). It mentions that the submission is for modifications to an existing device (K990461) and relies on demonstrating substantial equivalence to predicate devices. This type of submission often involves internal testing against established specifications rather than a new clinical trial with a defined patient test set. The document outlines device specifications and how they compare to the predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This 510(k) summary does not mention the use of experts to establish ground truth for a test set. The evaluation of the device performance described (e.g., flow rate accuracy, residual volume) would typically be verified through engineering and bench testing, not expert consensus on clinical data for a "test set" in the way one might see for an AI diagnostic device.

4. Adjudication Method for the Test Set

As there is no mention of a "test set" requiring human adjudication, this information is not applicable and not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This type of study is usually conducted for diagnostic devices where human readers interpret medical images or data. The Beeline system is an infusion pump, and its performance evaluation focuses on engineering specifications rather than human interpretation.

6. Standalone Performance Study

The document describes the standalone performance of the algorithm (device in this case) in terms of its physical specifications and functionality. For example, "Flow rate accuracy is ±15% of nominal flow rate" and "Residual volume is 5 mL or less" are statements of the device's standalone performance. However, there isn't a separate, named "standalone study" document within this submission. The entire "Device Specifications" section (5.5.5) and "Device Safety Functions" section (5.5.6) discuss the algorithm/device's standalone performance characteristics.

7. Type of Ground Truth Used

The "ground truth" for the performance claims (e.g., flow rate, residual volume) is based on direct measurement and engineering specifications. For example, flow rate accuracy would be determined by precisely measuring the actual volume infused over time under controlled conditions and comparing it to the nominal flow rate. Similarly, residual volume would be measured directly. The ground truth for biocompatibility and sterilization is based on conformance to established international standards (ISO 10993-1, ISO 11135, ISO 11137) through testing and validation.

8. Sample Size for the Training Set

This information is not applicable and not provided. The Beeline system is a mechanical infusion pump, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Its design and performance are based on engineering principles and physical properties, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this device, this question is not applicable.

Ask a specific question about this device

The pump is indicated for intravenous, subcutaneous, arterial, enteral, and epidural infusion of antibiotics, analgesics, chemotherapeutic agents and other medications or fluids requiring precisely-controlled infusion rates.

Not Found

This is a 510(k) clearance letter for an infusion pump, which is a hardware device. The questions you're asking are typically relevant to AI/ML (Artificial Intelligence/Machine Learning) powered software as a medical device (SaMD) or AI/ML components of a medical device. This document does not contain information related to AI/ML algorithms, performance studies, or acceptance criteria in the context of AI.

Therefore, I cannot answer the questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document. The document pertains to the regulatory clearance of a physical medical device (infusion pump) based on substantial equivalence to a predicate device.

Ask a specific question about this device

The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.

McKinley SP Disposable Infusion Pump

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (McKinley SP Disposable Infusion Pump). It states that the device is substantially equivalent to a pre-amendment device but does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
3. Information about training sets or their ground truth establishment.

The document primarily focuses on regulatory approval and indications for use, without detailing the performance studies conducted to support the substantial equivalence claim.

Ask a specific question about this device

The OutBound DIP is indicated for intravenous, intra-arterial, subcutaneous, and The OutBound DIP is indicated for inturvenede, may will with the world in the successions of the controlled infusion rates. The OutBound pump is also intended to provide continuous infusion of a local The Outbound pump is also intracperative site for postoperative pain management.

Not Found

I am sorry, but the provided text from the FDA 510(k) letter for the "Outbound Disposable Syringe Infuser" does not contain the specific information you are requesting about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) letter primarily addresses the substantial equivalence determination for regulatory clearance to market the device. It focuses on:

• Device Identification: K982256, Outbound Disposable Syringe Infuser/Outbound II Disposable Infusion Pump.
• General Controls: Acknowledging compliance with general controls like annual registration, good manufacturing practice, labeling, etc.
• Indications for Use: Stating that the device is "indicated for intravenous, intra-arterial, subcutaneous, and epidural infusions at controlled infusion rates" and "for continuous infusion of a local anesthetic at an intraoperative site for postoperative pain management."

The letter does not include details regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed information would typically be found in the 510(k) submission document itself, which is a much larger and more comprehensive document than the clearance letter. The clearance letter confirms that the FDA reviewed those documents and made a determination, but it does not reproduce the detailed study results or acceptance criteria within its content.

Ask a specific question about this device

The McKinley OUTBOUND-2 is indicated for patients requiring intravenous, interarterial, subcutaneous, or enteral administration of medication. It is convenient for use by ambulatory patients.

Not Found

I am sorry, but the provided text from the FDA letter (K971844) is entirely administrative and concerns the substantial equivalence determination for the "McKinley Outbound-2 System" device. It does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

Ask a specific question about this device