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The ITL SampLok® Luer Kit is intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests.

Luer Kit for use with blood collection systems for collecting blood samples from Y connectors.

This document details a Special 510(k) Summary for a medical device called the ITL SampLok® Luer Kit. A Special 510(k) is used for modifications to a manufacturer's own legally marketed device. In this case, the modification is the pre-attachment and co-packaging of two previously cleared devices: the SampLok® Needle Holder and the Nipro Luer Adaptor.

The core of a Special 510(k) relies on demonstrating that the modification does not introduce new risks or alter the fundamental safety and effectiveness of the device as previously cleared. Therefore, the "acceptance criteria" and "study" are not presented in the traditional sense of a de novo device submission with extensive clinical trials. Instead, the demonstration revolves around showing that the modified device's performance is either identical to or within the established safety and effectiveness parameters of its predicate components.

Here's the breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for ITL SampLok® Luer Kit

The provided document describes a Special 510(k) Summary for the ITL SampLok® Luer Kit. For a Special 510(k), the "acceptance criteria" and "device performance" are typically demonstrated by showing that the modified device's technical characteristics and intended use are identical or substantially equivalent to its legally marketed predicate components, and that the modification (pre-attachment and co-packaging) does not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not provide details on a specific test set, its sample size, or data provenance in the context of a performance study. For a Special 510(k) regarding the pre-attachment of two already cleared devices, the "proof" primarily relies on:

• The fact that the individual components have already been cleared and demonstrated safety and effectiveness (their "test sets" and data would have been part of their original 510(k)s).
• Justification that the act of pre-attaching and co-packaging does not alter the fundamental characteristics or introduce new risks. This typically involves engineering analysis, risk assessments, and perhaps basic functional testing if deemed necessary, rather than a large-scale performance study.

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

Not applicable. As noted above, there is no mention of a traditional "test set" requiring ground truth establishment by experts in this Special 510(k) summary. The reliance is on the prior clearance of the individual components.

4. Adjudication Method for the Test Set:

Not applicable. No test set or ground truth adjudication described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This type of study assesses human reader performance, typically with image interpretations or similar diagnostic tasks. The ITL SampLok® Luer Kit is a physical medical device for blood collection; therefore, an MRMC study is not relevant to its clearance.

6. Standalone Performance Study:

Not applicable in the traditional sense of an algorithm's standalone performance. The "standalone performance" of the ITL SampLok® Luer Kit is inherent in the demonstrated performance and clearance of its individual components (SampLok® Needle Holder and Nipro Luer Adaptor). The Special 510(k) argues that packaging them together does not diminish this performance.

7. Type of Ground Truth Used:

Not applicable. The clearance is based on the substantial equivalence of the components and the lack of new risks from the packaging modification, rather than performance against a specific "ground truth" derived from patient outcomes or pathology.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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