(131 days)
The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries.
The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It incorporates a safety mechanism/quard to minimize needlestick injuries. The needle consists of a stainless steel one wall cannula and a clear standard female Luer lock hub for immediate bleed-back visualization. The hub of this introducer needle is designed with an ergonomic feel for ease of handling and is offered with a standard hub or a Seldinger shield. The needles are available in 18 gauge and 21 gauge with a usable length of 7 cm. The safety mechanism is color coded for needle gauge identification. The design of the Merit Safety Device Introducer Needle allows clinicians to easily activate the safety mechanism by advancing it to the end of the needle to shield the needle bevel after use. The safety mechanism automatically senses the end of the needle and locks the safety mechanism covering the needle tip which reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile, and audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The safety mechanism cannot be deactivated and remains protective through disposal into a sharps container. The safety mechanism can be activated over quide wires. The Merit Safety Introducer Needle is a single use device that is supplied sterile and non-pyrogenic for use in the adult population.
The Merit Safety Introducer Needle's acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document is a 510(k) summary for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Merit Safety Introducer Needle were based on a risk analysis and compliance with various recognized and unrecognized international standards and FDA guidance documents. These standards cover aspects like device dimensions, material properties, safety mechanism function, biocompatibility, and sterilization. The document reports that the subject device "meets the requirements that are considered essential for its intended use."
The table below summarizes the performance tests conducted, which implicitly define the acceptance criteria for each aspect. The exact quantitative acceptance limits for each test are not provided in this summary, but the general outcome of meeting the requirements is stated.
| Acceptance Criteria (Implicitly defined by test) | Reported Device Performance |
|---|---|
| Bench Performance: | |
| Dimensions | Meets requirements |
| Puncture Resistance | Meets requirements |
| Force to Defeat Safety Mechanism | Meets requirements |
| Force to Activate Safety Mechanism | Meets requirements |
| Hub to Cannula Bond Strength | Meets requirements |
| Visual Inspection | Meets requirements |
| Luer Gauging | Meets requirements |
| Luer Liquid Leak Test | Meets requirements |
| Luer Air Aspiration Leak Test | Meets requirements |
| Luer Separation Force | Meets requirements |
| Luer Unscrewing Torque Test | Meets requirements |
| Luer Ease of Assembly | Meets requirements |
| Luer Resistance to Overriding | Meets requirements |
| Luer Stress Cracking | Meets requirements |
| Needle Penetration | Meets requirements |
| Guide Wire Compatibility | Meets requirements |
| Corrosion Resistance | Meets requirements |
| Simulated Use | Meets requirements |
| Biocompatibility: | |
| Cytotoxicity | Meets requirements |
| Sensitization | Meets requirements |
| Irritation | Meets requirements |
| Acute Systemic Toxicity | Meets requirements |
| Pyrogenicity | Meets requirements |
| Hematology | Meets requirements |
| Coagulation | Meets requirements |
| Hemolysis | Meets requirements |
| Chemical Characterization | Meets requirements |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual performance test (bench or biocompatibility). The testing was conducted by the manufacturer, Merit Medical Systems, Inc. The data provenance is internal to the manufacturer and would be considered prospective for the purpose of demonstrating substantial equivalence. There is no information regarding country of origin of the data beyond the manufacturer's location in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (introducer needle) does not typically involve human expert interpretation for "ground truth" in the same way an imaging AI device would. The "ground truth" for the performance tests would be defined by the specifications of the device and the standards against which it is tested. For example, for "dimensions," the ground truth is the specified dimension range. For "biocompatibility," the ground truth is the pass/fail criteria for the specific biological tests outlined in ISO 10993. Therefore, no external "experts" were used to establish a subjective ground truth on a test set as would be the case for diagnostic AI.
4. Adjudication Method for the Test Set
Given the nature of the device and the testing performed (bench and biocompatibility), there was no adjudication method (e.g., 2+1, 3+1) involving human readers or interpretation. The performance tests are objective measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or is applicable for this device. This device is an introducer needle with a safety mechanism, not an AI-assisted diagnostic or decision-making tool that would involve human readers interpreting cases.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This question is not applicable. The Merit Safety Introducer Needle is a physical medical device, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm without human interaction. The safety mechanism is an integral part of the physical device's design.
7. Type of Ground Truth Used
The ground truth used for performance validation was based on:
- Engineering specifications and design requirements: For bench tests like dimensions, bond strength, Luer connections, and forces.
- Recognized international standards and FDA guidance documents: For both bench performance (e.g., ISO for needles, Luer fittings, catheters) and biocompatibility (e.g., ISO 10993 series, USP pyrogenicity). These standards define the specific test methods and acceptance criteria.
8. Sample Size for the Training Set
This question is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).