(160 days)
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.
| Acceptance Criteria (Inferred from Standards & Guidance) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Compliance with ISO 10993 for communicating, circulating blood, prolonged exposure (external devices). | "Material biocompatibility is verified by performing all required tests specified by ISO 10993..." |
| Functional and Performance: Compliance with ISO 10555.1 and ISO 10555.5 for over-needle peripheral catheters. | "Functional and performance tests were also carried out according to ISO 10555.1 and 10555.5." |
| Safety Feature (Needle Stick Injury Prevention): Compliance with requirements in FDA guidance document "Medical devices with sharps injury prevention features" (August 9, 2005). | "Safety feature was tested according to requirements provided by a guidance document issued by US FDA 'Medical devices with sharps injury prevention features'..." |
| Mechanical Integrity/Design: The needle guard covers the entire length of the needle upon activation. | "Upon activation of the safety mechanism the needle guard covers the entire length of the needle." |
| Ease of Use/Functionality: Needle guard extends to full length and locks into place to encapsulate the entire length of the needle upon insertion and threading of the catheter. | "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." |
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.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).