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The TERUMO® Surshield® Safety I.V. Catheter (18G × 51mm and 20G × 51mm catheter sizes) is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length) are devices consisting of an over-the needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub that is inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the catheter is placed in the vascular system. The sharp end of the inner needle is covered by the steel guard as the needle is withdrawn from catheter's hub to aid in the prevention of needle stick injuries. This is a passive safety mechanism.

The provided text describes a Special 510(k) submission for a medical device, the TERUMO® Surshield® Safety I.V. Catheter (51mm catheter length). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and performance metrics against a medical condition.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth generation is not applicable to this document because it describes a 510(k) submission for a modified device, which focuses on demonstrating substantial equivalence to a predicate device rather than on novel performance validation.

Here's a breakdown based on the provided text, indicating why certain information is not present:

Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence)

This submission relies on demonstrating substantial equivalence to a predicate device (K082362 TERUMO® Surshield® SAFETY I.V. CATHETER). The "performance" section states: "All performance testing conducted on the TERUMO® Surshield® SAFETY IV CATHETER (51mm sizes length) manufactured by Terumo Corporation determined that the modified device was substantially equivalent to the predicate."

Therefore, there are no explicit acceptance criteria or direct performance metrics against a disease condition as would be found in a study for a novel device. The criteria for acceptance are that the new device performs equivalently to the predicate.

Study Details (Not Applicable - Substantial Equivalence)

The filing for a Special 510(k) for a modified device doesn't typically involve new clinical studies that establish de novo performance against a medical condition. The focus is on ensuring the changes to the device do not raise new issues of safety or effectiveness compared to the predicate.

Therefore, the following information is not available in the provided text:

• Sample size used for the test set and the data provenance: No new test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a new test set with expert-established ground truth is not part of this type of submission.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this device does not involve an algorithm.
• Type of ground truth used: Not applicable.

Training Set Information (Not Applicable - Substantial Equivalence)

• Sample size for the training set: Not applicable, as this device is not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of Device Information from Text:

The provided document is a 510(k) summary for a TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter length).

• Proprietary Name: TERUMO® Surshield® SAFETY I.V. CATHETER (51mm catheter)
• Classification Name: Intravascular Catheter (880.5200)
• Product Code: FOZ
• Classification: Class II
• Predicate Device: K082362 TERUMO® Surshield® SAFETY I.V. CATHETER
• Intended Use: Inserted into the patient's vascular system for short term (<30 days) use to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment. The needle shield feature aids in the prevention of needle stick injuries.
• Description: Over-the-needle, peripheral catheter made of a slender, flexible, radio-opaque, plastic catheter with a hub. Stainless steel cannula for rigidity. Passive safety mechanism for needle stick injury prevention.
• Principle of Operation: Manually operated.
• Materials: Same as the predicate device (K082362).
• Performance: All performance testing determined the modified device was substantially equivalent to the predicate. The differences do not raise any new issues of safety or effectiveness.

Key takeaway: This document does not describe a study to prove a device meets specific acceptance criteria in the sense of a clinical trial for a novel product. Instead, it demonstrates substantial equivalence of a modified device to a previously cleared predicate and that the modifications do not alter its safety or effectiveness.

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