Search Results

Clicky Cros™ is indicated for fluid flow control and for providing access port(s) for administration of solutions in a limited contact duration (24 hours or less). Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids.

Clicky Cross™ is indicated for fluid flow control and for providing access port(s) for administration of solutions. Typical uses include pressure monitoring, intravenous fluid administration, transfusion and infusion of nutritive or medicinal fluids. Yomura Clicky Cross™ is a new medical device using as flow control switch and is developed by Yomura Technologies Inc. Click-release process via one-handed operation Less leakage issue than currently commercial products Stopcock system for I.V. set and other application Suitable for all current pressure infusion system There are two types of fitting end (Barb /Luer) for normal I.V. infusion sets. In order to meet the requirement of I.V. infusion set, here we provide two different types of fitting end (Barb/Luer).

The provided FDA 510(k) summary for the Clicky Cross™ device details its substantial equivalence to a predicate device, the Safeport Manifold™ (K111016). It primarily focuses on demonstrating that the new device is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of "acceptance criteria" in a typical quantitative format for algorithmic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device by meeting established performance and safety standards for medical devices of this type.

The reported device performance is indicated by its compliance with various ISO and ASTM standards relevant to infusion equipment and biocompatibility.

Ask a specific question about this device

The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

The Yomura Safety I.V. Catheter consists of a catheter connected to a standard conical fitting, and a safety mechanism. Upon activation of the safety mechanism the needle guard covers the entire length of the needle. Therefore, the risks of needle stick injuries can be reduced.
The YOMURA Safety I.V. Catheter consists of an over needle peripheral catheter made of polyurethane material with radiopaque stripes. The stainless steel needle is placed in the catheter to maintain rigidity and to facilitate venipuncture. A safety mechanism constitutes a needle guard is built inside the device. Upon insertion and threading of the catheter, the needle guard extends to full length and locks into place to encapsulate the entire length of the needle. Thus adds in the prevention of accidental needle stick injuries.

The provided text is a 510(k) Pre-market Notification for a medical device, the YOMURA Safety I.V. Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel performance or clinical efficacy through new studies with specific acceptance criteria as you've outlined. Therefore, much of the requested information regarding detailed study design, sample sizes for test and training sets, expert qualifications, and AI-related metrics is not applicable to this document.

The document primarily focuses on bench testing to show that the device meets functional and performance requirements and is safe for its intended use, largely by demonstrating compliance with established international standards and FDA guidance.

Here's a breakdown of the available information based on your request, with an explanation of why certain criteria are not met by this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the way one might expect for a clinical study evaluating a diagnostic device. Instead, it refers to compliance with established standards.

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

• Sample Size: The document does not specify the sample size for the bench tests performed. Typically, for compliance with ISO standards, specific numbers of units are tested, but these details are not provided in this summary.
• Data Provenance: The tests were performed by the manufacturer, YOMURA Technologies Inc., based in Linkou District, Taipei, TAIWAN. The tests are "bench tests," meaning they were conducted in a laboratory setting, not on human subjects. They are inherently "retrospective" in the sense that they are conducted on manufactured devices as part of the validation process.

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

• Not Applicable. This device is an I.V. catheter with a safety mechanism, not an AI-driven diagnostic device. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant here. The ground truth for these tests is defined by the technical specifications of the device and the requirements of the standards (e.g., successful activation of safety mechanism, material strength, biocompatibility).

4. Adjudication Method for the Test Set

• Not Applicable. As this involves bench testing against predefined standards, there is no need for expert adjudication in the manner described (e.g., 2+1 review for medical imaging). The results of the physical and material tests are objectively measured against the criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance

• Not Applicable. This is a physical medical device, not an AI-based diagnostic tool. No human readers or AI assistance are involved in its primary function or the safety tests described.

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

• Not Applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the performance and safety tests is based on technical specifications, established international standards (ISO 10993, ISO 10555.1, ISO 10555.5), and specific FDA guidance document requirements. For example:
  • For biocompatibility: Whether the material passes the tests outlined in ISO 10993.
  • For functional performance: Whether the catheter meets the physical and leakage requirements of ISO 10555.
  • For the safety mechanism: Whether the needle guard fully covers the needle and locks as intended, as per FDA guidance.
    Pathology or outcomes data are not used as ground truth for these specific bench tests.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

Ask a specific question about this device