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(1) The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for dialysis. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

(2) The K-Shield Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles

(3) The K-Shield Phlebotomy Set with Antineedle Stick Protector is a single use, sterile set designed for vascular access for blood withdrawal. The antineedle stick device is an integral, active safety device intended to minimize accidental needles stick injuries when used to shield needles

Name: Kawasumi A.V. Fistula Set

Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery.

Name: Kawasumi Laboratory Blood Drawing Kit

Intended Use: This is a therapeutic device used to access a patient's vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Name: Kawasumi Laboratories Phlebotomy Set

Intended Use: This device is intended to be used to access a patient's vein and as a monduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, K-Shield Blood Drawing Kit with Antineedle Stick Protector, and K-Shield Phlebotomy Set with Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's vascular system for dialysis and blood withdrawal. The K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector and K-Shield Phlebotomy Set with Antineedle Stick Protector devices are comprised of a needle and wing assembly with tubing and a female luer connector. The K-Shield Blood Drawing Kit is comprised of a needle and wing assembly, tubing and a blood collection bag. The devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.

The provided document describes modifications to existing devices (K-Shield Arterial Venous Fistula Set, K-Shield Blood Drawing Kit, and K-Shield Phlebotomy Set with Antineedle Stick Protector) and their substantial equivalence to predicate devices, rather than an AI/ML device that requires performance metrics like accuracy, sensitivity, and specificity against specific acceptance criteria.

The document focuses on non-clinical testing for safety and effectiveness, particularly related to the anti-needle stick protector mechanism. Therefore, much of the requested information regarding AI/ML device performance, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable or available in this document.

However, I can extract the relevant acceptance criteria and results from the non-clinical testing described.

Acceptance Criteria and Reported Device Performance

Non-Applicable Information for this Device (as per the provided document):

The following information is typically relevant for AI/ML device studies, but is not provided or not applicable to this 510(k) submission which describes a modification to a medical device with an anti-needle stick protector:

• Sample size used for the test set and the data provenance: Not specified for the internal tests. The "simulated use study" doesn't provide a quantitative sample size for users. No mention of data provenance (country, retrospective/prospective) for these types of engineering tests.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is defined by the physical function of the device (e.g., whether the wing activates, deactivates, or the locking mechanism can be defeated).
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for these engineering tests.
• 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 as this is not an AI/ML diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the "PASS" results is based on the device's mechanical function meeting design specifications. For the simulated use study, the ground truth was the absence of needle sticks and user feedback.
• The sample size for the training set: Not applicable. No AI/ML model.
• How the ground truth for the training set was established: Not applicable. No AI/ML model.

Summary of the Study:

The study described is a series of non-clinical bench tests and a simulated use study to ensure the modified anti-needle stick protector functions correctly and does not introduce new safety concerns. The "study" aims to demonstrate substantial equivalence to predicate devices, focusing on the mechanical and safety features of the device rather than diagnostic accuracy or human performance improvement.

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