Search Results

PowerLoc™ Max Power Injectable Infusion Set:

The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.

For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.

The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.

SafeStep™ Huber Needle Set:

The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

These devices may be used in any patient population with an implanted vascular port.

Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

This document describes the premarket notification for the "PowerLoc™ Max Power Injectable Infusion Set" and "SafeStep™ Huber Needle Set". The study presented focuses on demonstrating substantial equivalence to a predicate device (K171735) through performance testing, rather than a standalone clinical study to establish new acceptance criteria. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and training data is not applicable in this context.

Here's a breakdown of the available and applicable information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implied by the "All testing passed the predetermined acceptance criteria" statement. Specific quantitative acceptance criteria or detailed performance results are not provided in this summary. Instead, the document lists the type of test conducted and the standard it references, indicating compliance.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "All testing passed the predetermined acceptance criteria."
• Data Provenance: The studies were conducted "by or for Bard Access Systems (BD)". The data is presumably from laboratory testing, not patient data (retrospective or prospective), given the nature of the device and the tests performed. The country of origin for the data is not specified, but the applicant's address is in Salt Lake City, Utah, USA.

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

This information is not applicable. The device's substantial equivalence was established through engineering and performance testing against recognized standards, not through clinical trials requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not applicable, as no clinical study with human observers or adjudication committees was performed.

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

This is not applicable. This is a medical device (infusion set and Huber needle set), not an AI-powered diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests would be the established requirements and limits defined by the referenced ISO standards, USP standards, and internal protocols for a device of this type. For example, for "Assembly Burst," the ground truth is that the device must withstand a certain pressure without bursting, as defined by ISO 10555-1.

8. The Sample Size for the Training Set

This is not applicable. There is no AI component or training set involved in the assessment of this physical medical device.

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

This is not applicable as there is no training set. The "ground truth" for the device's acceptable performance is derived from established international and national standards for medical devices and internal quality control protocols.

Ask a specific question about this device

The PowerLoc MAX® Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports.

The PowerLoc MAX® Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.

When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.

The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

The PowerLoc MAX® Power-Injectable Infusion Set is a standard non-coring intravascular administration set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling. The PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc MAX® Power-Injectable Infusion Set is offered with and without a Y-site.

The SafeStep® Huber Needle Set is a standard right angle Huber needle and administration set with a needlestick prevention feature, designed for use with a vascular access infusion system. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site.

The stabilization device is intended for use as an accessory to the subject PowerLoc MAX® and SafeStep® infusion sets, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization device is lifted off of the needle. The stabilization device is then discarded per hospital protocol.

The provided document is a 510(k) summary for medical devices (PowerLoc MAX® Power-Injectable Infusion Set and SafeStep® Huber Needle Set). It details the regulatory clearance for these devices. However, the document does not contain information about acceptance criteria and studies proving the device meets these criteria in the context of an AI/algorithm-driven device.

The "Performance Tests" section details a series of tests conducted to ensure the device's physical and functional performance, materials, and safety in relation to its intended use as an intravascular administration set. These tests include:

• Slide Force testing (to ensure easy needle slide within the stabilization device).
• Stabilization Device Removal Force testing (to ensure easy removal of the stabilization device).
• Acceptability of the Stabilization Device (clinical acceptability of placement).
• Acceptability of GuardIVa® with Stabilization Device (validation of antimicrobial dressing use).
• Various ISO standards compliance (e.g., sharps injury protection, infusion equipment, biocompatibility, sterilization, packaging, luer fittings, needle tubing, intravascular catheters, and hypodermic needles).
• FDA Guidance compliance (e.g., sharps injury prevention features, MR compatibility).
• Risk management (FMEA) in accordance with BS EN ISO 14971:2012.

The document states: "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices."

Therefore, it is not possible to extract the requested information (sample size for test/training set, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, type of ground truth) because the supplied document describes the regulatory approval of a physical medical device (infusion set/needle) and not an AI/algorithm-driven device.

The questions posed relate to the validation of AI/ML-based medical devices, which involve different types of studies (e.g., diagnostic accuracy, reader studies) and data considerations than those detailed for this hardware device.

Ask a specific question about this device