(102 days)
The Merit Majestik® Shielded Angiography Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates a safety mechanism to help minimize needlestick injuries after use.
The Merit Majestik Shielded Angiography Needle is a safety-engineered angiography needle that is used for providing a puncture site in blood vessels for the introduction of vascular access devices. The needle incorporates an integral, user-activated needle shield (safety feature) that is activated once a conventional vessel puncture procedure has concluded. The Majestik Shielded Angiography Needle will provide clinicians with a safety version of the legally marketed pre-amendment Majestik Angiography Needle (or equivalent) currently used during Cardiology and Radiology procedures. The Majestik Shielded Angiography Needle incorporates a clear standard female luer locking connector for immediate bleedback visualization and is color coded for needle gauge identification. A one-piece, color coded folding needle shield, linked with "living hinges" is bonded to the female luer locking connector. The needle shield is color coded to match the luer connector for immediate needle gauge identification. The Majestik Shielded Angiography Needle is offered with the needle shield in two orientations: 1) oriented vertically to the ground bevel side of the needle; or 2) oriented 90 degrees to the ground bevel side of the needle. The Majestik Shielded Angiography Needle is a single use device supplied sterile and non-pyrogenic.
The Merit Medical Systems, Inc. Majestik® Shielded Angiography Needle received 510(k) clearance (K022117) by demonstrating substantial equivalence to predicate devices and meeting acceptance criteria through a series of bench and simulated use tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not list specific numerical acceptance criteria for each test performed. Instead, it states that the device "met all acceptance criteria of the tests performed." The tests conducted and the reported performance are summarized below:
| Acceptance Criteria Category (Implied) | Specific Test Conducted | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Dimensions | Met all acceptance criteria |
| Structural Integrity | Strength of bonds and hinges | Met all acceptance criteria |
| Safety Feature Functionality | Force to activate the safety feature | Met all acceptance criteria |
| Puncture Prevention | Puncture resistance of shield or sheath: the force to failure (puncture) | Met all acceptance criteria |
| Material Compatibility | Biocompatibility | Met all acceptance criteria |
| Clinical Simulation | Simulated Clinical Use | Met all acceptance criteria |
| Overall Safety Assessment | FMEA (Failure Mode and Effects Analysis) | Risks associated with use were found acceptable |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test or the "test set" in terms of a patient cohort. The tests were "bench and simulated use tests."
- Sample Size for Test Set: Not explicitly stated. The nature of bench and simulated use tests typically involves testing a statistically significant number of device units.
- Data Provenance: The tests were conducted "in-house" according to "in-house test protocols" and “recognized standards.” The information provided does not indicate the country of origin of the data or whether it was retrospective or prospective, as these terms are generally applicable to clinical studies involving human subjects, which this was not.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable to this submission. The "ground truth" for the performance tests of this medical device (a needle) was established through engineering specifications, recognized standards, and in-house protocols for physical and functional performance. It did not involve expert consensus on medical images, pathology, or clinical diagnosis.
4. Adjudication Method for Test Set:
This section is not applicable as the "test set" refers to bench and simulated use tests focused on engineering and functional performance, not clinical data requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This section is not applicable. The device is an angiography needle with a safety feature, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. Standalone (Algorithm Only) Performance Study:
This section is not applicable. The device is a physical medical instrument, not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance was based on:
- Engineering specifications and design requirements: For aspects like dimensions, strength of bonds, and force to activate the safety feature.
- Recognized standards: The document explicitly mentions following "FDA's Supplementary Guidance On The Content Of Premarket Notification [510(k)] Submissions For Medical Devices With Sharps Injury Prevention Features, dated March 1995" and "various recognized standards."
- In-house test protocols: For evaluating various performance aspects of the device.
8. Sample Size for the Training Set:
This section is not applicable. The device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI models. The development process would have involved design, prototyping, and iterative testing, but not a formally defined "training set" like in AI.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the same reasons as point 8. The development relied on established engineering principles, design specifications, and recognized safety and performance standards for medical devices.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.