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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.

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The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

The EZ Huber Safety Infusion Set is used to access implanted septums for the purpose of drug and IV infusion. The Needle is constructed so that after patient use and upon needle removal, the needle can be removed and the safety mechanism will be activated. The product is designed so that the practitioner activates the safety mechanism during normal needle removal following typical removal procedures used for non-safety Huber needles. Upon activation of the safety mechanism, the total function of the EZ Huber Safety Infusion Set is complete and the unit is discarded in accordance with hospital protocol. Components will be assembled into standard configurations or configurations specified by the customer and packaged. Types of components that may be contained in a set include: Huber Housing, Huber Wing, Spring, Needle Cannula, Needle Sheath Tubing, PE lined Foam Pad, Pinch Clamp, Female Luer Dust Cap, Y-site, Swabable Y-site, Medegen.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EZ Huber Safety Infusion Set. This document is for a medical device (intravascular administration set) and primarily focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and statistical analysis.

Therefore, the information required to populate the requested table and answer the specific questions about acceptance criteria and study details for device performance is largely not present in the provided text. The document describes the device, its intended use, and biocompatibility, but it does not include a clinical study or performance testing with quantitative acceptance criteria.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the safety feature "aids in the prevention of accidental needle sticks" and that the device is "compatible with power injection procedures up to 300 psi." However, it does not provide specific quantitative acceptance criteria (e.g., a certain percentage of needle-stick prevention, or a specific performance metric for pressure) or the results of a study that objectively measured these performances against such criteria. The biocompatibility claim is a general statement, not a specific performance outcome against a numerical criterion.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not specified.
• Data provenance: Not specified. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No performance study with ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No performance study with 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. This device is not an AI-powered diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

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

7. The type of ground truth used

• Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable. As above, this is for a physical device, not a machine learning model.

Summary of what is present:

• Device Name: EZ Huber Safety Infusion Set
• Intended Use: Administer fluids to a patient's vascular system through an implanted port, with an active safety feature to prevent accidental needle sticks. Compatible with power injection up to 300 psi.
• Equivalency: The submission establishes substantial equivalence to existing predicate devices (PFM Medical, Inc. K040533 and CR Bard, Inc. K060812).
• Biocompatibility: Materials are "used in legally marketed devices under comparable conditions of use," suggesting reliance on prior art and established material safety rather than new biocompatibility testing for this specific device.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. While performance data may be submitted, the provided summary focuses on the descriptive aspects and regulatory classification rather than a detailed performance study with quantitative acceptance criteria.

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