(30 days)
The MicroTaper™ Needle Introducer Set is used for percutaneous introduction of a guidewire into the peripheral vasculature. The MicroTaper needle incorporates a blunting mechanism to reduce the risk of accidental needle stick injury.
The Summit Access Needle Introducer Set consists of: 1 - 0.018 inch (0.46 mm) / 0.035 inch (0.89 mm) Tapered Guidewire, Angled, Nitinol 1 - 21G (0.9 mm) Tapered Needle, 18G (1.27 mm) Max Outside Diameter, Echogenic The tapered needle consists of a stainless steel cannula with expansion feature and a translucent standard female luer lock hub. Needle is available in lengths of 3. 4. 7. 10. and 15 cm. The needle is used to gain percutaneous access to the vein or artery. The 0.018 inch tapered segment of the guidewire is advanced through the needle allowing confirmation of guidewire placement in the vasculature. The pass-through blunting mechanism is then actuated by twisting hub to needle main body, expanding the needle distal end. An audible confirmation of the actuation and locking confirms the blunting mechanism advances beyond the tip of the needle. The 0.035 inch segment of the guidewire is then advanced through the needle to desired placement. The needle is withdrawn, leaving the guidewire in place.
The provided FDA 510(k) document for the MicroTaper Needle Introducer Set (K151076) does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in a clinical or AI performance context.
This document is a premarket notification for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than a clinical trial report or an evaluation of an AI-powered device. Therefore, most of the requested information (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training sets) is not applicable to this type of regulatory submission.
However, I can extract information regarding the non-clinical performance tests conducted to support the substantial equivalence claim, which serve as a form of acceptance criteria for the device's functional and safety aspects.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI or clinical performance study, the "acceptance criteria" here refer to the successful completion of various non-clinical performance, packaging/labeling, sterilization, and biocompatibility tests. The "reported device performance" is indicated by the statement of "successful completion" of these tests.
| Acceptance Criterion (Test Category) | Reported Device Performance |
|---|---|
| Performance Tests | Successful completion |
| - Surface Inspection | (Implied) |
| - Dimensional Inspection | (Implied) |
| - Hub / Needle Bond Strength | (Implied) |
| - Hub / Blunting Cannula Bond Strength | (Implied) |
| - Protective Sheath Puncture | (Implied) |
| - Needle Penetration | (Implied) |
| - Conical Fittings (Luer Taper) | (Implied) |
| - Guidewire Fracture, Flexing, and Peak Tensile Force | (Implied) |
| - Guidewire Compatibility | (Implied) |
| - Corrosion Resistance | (Implied) |
| - Guidewire Torque Strength, Torqueability, and Tip Flexibility | (Implied) |
| - Sharps Injury Protection Indication | (Implied) |
| - Sharps Injury Protection Activation | (Implied) |
| - Sharps Injury Protection Locking Mechanism Challenge | (Implied) |
| - Access To The Sharp In Safe Mode | (Implied) |
| - Other Capabilities (Needle Echogenicity and Guidewire Radiopacity) | (Implied) |
| - Simulated Use | (Implied) |
| Packaging/Labelling Tests | Successful completion |
| - Environmental Conditioning and Distribution Simulation | (Implied) |
| - Package Integrity (Visual Inspection, Bubble Leak Test, Seal Strength Test) | (Implied) |
| - Stability Testing (Accelerated Aging Visual Inspection, Bubble Leak, Seal Strength) | (Implied) |
| - Symbols to be used with medical device labels | (Implied) |
| Sterilization Tests | Successful completion |
| - Electron Beam Irradiation Sterilization Qualification using Dose Substantiation Method VDmax25 | (Implied) |
| - Bacterial Endotoxins - LAL Test | (Implied) |
| Biocompatibility Tests | Successful completion |
| - Cytotoxicity | (Implied) |
| - Sensitization | (Implied) |
| - Irritation or Intracutaneous Reactivity | (Implied) |
| - System Toxicity (Acute) | (Implied) |
| - Genotoxicity | (Implied) |
| - Hemocompatibility | (Implied) |
| - Pyrogenicity | (Implied) |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes non-clinical engineering and biological tests, not a clinical study on a patient test set. The tests would likely involve a statistically appropriate number of device units or components, but specific sample sizes for each test are not provided in this summary. Data provenance is not specified as these are internal manufacturer tests based on recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of expert consensus is not relevant here as it's not a diagnostic AI device or a clinical outcome study. The "ground truth" for these non-clinical tests would be the established scientific and engineering principles, and the pass/fail criteria defined by the relevant standards (e.g., ISO, FDA guidance). The experts involved would be engineers, microbiologists, and other technical specialists conducting the tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert labeling or diagnoses, which is not relevant to non-clinical device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done. This device is not an AI-powered diagnostic tool, but a medical instrument (needle introducer set).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device performance is standalone (i.e., the physical device itself is tested), but in a non-clinical context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-clinical test standards and specifications. The "ground truth" for these tests are the pre-defined pass/fail criteria established by international standards (e.g., ISO 10993-1 for biocompatibility, ISO 23908 for sharps injury protection) and internal engineering specifications, based on physical and chemical properties and functional requirements of the device.
8. The sample size for the training set:
- Not applicable. This is not an AI device, so there is no training set in this context.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set.
Summary Statement regarding the study:
The study proving the device meets its "acceptance criteria" is a series of non-clinical performance and biological evaluations. As stated in the "CONCLUSION OF SAFETY AND EFFECTIVENESS" section: "The successful completion of performance tests; compliance to biological standard ISO 10993-1; and comparison of similarities and differences with predicate device; demonstrate that the Summit Access MicroTaper Needle Introducer Set is as safe, as effective, and performs as well as or better than the legally marketed predicate device NMI Coaxial Microintroducer Set."
The document also explicitly states: "No clinical studies were performed to demonstrate substantial equivalence." (Page 7). This confirms that the evidence presented is based entirely on non-clinical testing and comparison to a predicate device, rather than patient data or trials.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).