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This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.

The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent in accidental needlesticks. This device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.

The NIPRO SafeTouch Huber Infusion Set is a safety intravascular administration set designed for fluid and drug administration or blood sampling through surgically implanted vascular ports. It also incorporates a safety mechanism to protect against accidental needlestick injuries and associated bloodborne pathogen exposure.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a distinct "test set" sample size in the context of a clinical study with human subjects. The evaluation primarily relies on non-clinical testing and comparison to a predicate device.
• Data Provenance: The document does not mention any human clinical data or its provenance (e.g., country of origin, retrospective/prospective). The study is described as non-clinical.

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

• This question is not applicable as the provided documentation describes a non-clinical study for substantial equivalence rather than a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

• This question is not applicable as the provided documentation describes a non-clinical study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not conducted. The submission focuses on substantial equivalence based on non-clinical testing and comparison to a predicate device, not on comparing human reader performance with or without AI assistance.

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

• This question is not applicable as the device is a physical medical device (Huber Infusion Set) and not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is primarily established through:
  • Predicate Device Equivalence: The performance and characteristics of the legally marketed EXEL SecureTouch Safety Huber Infusion Set serve as the benchmark for "ground truth" regarding safety and effectiveness for this device type.
  • Engineering Specifications and Standards: The "ground truth" for dimensional, mechanical, performance, and biocompatibility testing would be adherence to established engineering specifications and relevant industry standards for medical devices of this class.

8. The Sample Size for the Training Set

• This question is not applicable as the device is a physical medical device and not an AI/machine learning system that requires a "training set."

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

• This question is not applicable for the same reason as above (not an AI/machine learning system).

Summary of the Study and Device Performance:

The NIPRO SafeTouch Huber Infusion Set underwent a premarket notification (510(k)) process, which primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, the EXEL SecureTouch Safety Huber Infusion Set.

The study presented in the 510(k) summary consisted of:

• Non-clinical tests: Dimensional, Mechanical, Performance, and Biocompatibility testing were performed. The specifics of these tests (e.g., sample sizes for each test, exact methodologies, quantitative results) are not detailed in the summary but are stated to have been included in the full submission.
• Comparison of technological characteristics: The NIPRO SafeTouch Huber Infusion Set was compared to the predicate device in terms of design, physical characteristics, basic scientific technology, and intended use.

The conclusion drawn from these tests and comparisons was that the NIPRO SafeTouch Huber Infusion Set performs equivalently to the predicate device and is safe and effective when used as intended. The FDA's issuance of the 510(k) clearance confirms this finding of substantial equivalence. The "acceptance criteria" were met by demonstrating that the device's characteristics and performance are comparable to a known safe and effective predicate device, as evidenced by the non-clinical testing.

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