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The NIPRO® Safetouch II Gamma is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharps safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

The NIPRO® SafeTouch II Gamma is a sterile, single use, safety AVF needle. It includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length. The NIPRO® SafeTouch II Gamma includes an arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (nonimplanted blood access device) as described in 21 CFR 876.5540. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks into place. The only difference being the material used for the protector which has changed from a frosted to a transparent component, making it easier to confirm blood flash black. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

This document describes the NIPRO® SafeTouch II Gamma, a sterile, single-use safety AVF needle, and compares it to a legally marketed substantial equivalent device, the NIPRO® SafeTouch Safety AVF Needle (K032777).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the performance is demonstrated through a comparison of technological characteristics and non-clinical tests, concluding substantial equivalence to the predicate device.

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

The document does not explicitly state the sample size used for the test set of the NIPRO® SafeTouch II Gamma. It refers generally to "performance testing" and "biocompatibility data." The data provenance is not specified beyond indicating that "Those reports along with associated data are included in this submission." It is implied that these are prospective tests performed on the NIPRO® SafeTouch II Gamma, as part of its premarket notification.

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

This information is not provided in the document. As this is a medical device submission focused on substantial equivalence based on non-clinical testing and comparison to a predicate, the "ground truth" for the test set largely comes from established scientific and engineering principles for material safety and device functionality, rather than human expert interpretation of clinical data on the device itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on observations (e.g., image interpretation). This document focuses on the results of non-clinical testing and material property comparisons.

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

An MRMC comparative effectiveness study was not done and is not applicable to this device. This is a medical device for blood access, not an AI-driven diagnostic or interpretative tool. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

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

A standalone performance study, as typically understood for an algorithm without human intervention, was not done and is not applicable. This is a physical medical device, not a software algorithm. Its performance is intrinsic to its design and materials.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• Established scientific and engineering standards: For biocompatibility (e.g., ISO standards for cytotoxicity, sensitization, etc.).
• Performance specifications: For the mechanical functionality of the safety feature and the needle itself (e.g., strength, sharpness, ease of activation).
• Predicate device characteristics: The NIPRO® SafeTouch Safety AVF Needle (K032777) serves as the primary reference for "ground truth" regarding acceptable performance and characteristics for this type of device.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The NIPRO® SafeTouch II Gamma is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable and therefore not provided. As there is no AI model or training set, there is no ground truth for a training set to be established.

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