(27 days)
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
| Acceptance Criteria (Target) | Reported Device Performance |
|---|---|
| Flow Rate Accuracy: ±15% of nominal flow rate, for all product codes | Flow Rate Accuracy: ±15% of nominal flow rate, for all product codes |
| Residual Volume: 5 mL or less | Residual Volume: 5 mL or less |
| Nominal Fill Volume: 100 mL (small infuser) or 275 mL (large infuser) | Nominal Fill Volume: 100 mL (small infuser) or 275 mL (large infuser) |
| Nominal Flow Rate Range: 0.4 to 10 mL/hr | Nominal Flow Rate Range: 0.4 to 10 mL/hr |
| Operating Pressure: Approximately 6 psi | Operating Pressure: Averages approximately 6 psi |
| Fluid path materials biocompatibility: Conformance with ISO 10993-1 | Fluid path materials biocompatibility: All fluid path materials are in conformance with ISO 10993-1 biocompatibility standards |
| Sterilization validation (EtO): ISO 11135, residuals ISO 10993-7 | Sterilization validation (EtO): EtO cycle validated per ISO 11135 and residuals validated per ISO 10993-7 |
| Sterilization validation (Gamma): ISO 11137 | Sterilization validation (Gamma): Sterilization dose validated per ISO 11137 |
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.
§ 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).