(11 days)
Intended for single use by a trained physician to assist in vessel cannulation.
The MC3 Vascular Access Kit consists of component devices that are already cleared by FDA, as well as various sized dilator devices. The subject devices include dilators that are 13, 16, 20, 24, 26, and 28 French (FR). These dilators are all made of Colorite PVC, 9566M-RAD14. The MC3 logo and size indicator are legibly printed at the hub end of the dilator using NAZDAR VF111 Black Ink with NAZDAR VF190 Ink Thinner. These dilators are packaged together in the MC3 Vascular Access Kit with other devices already cleared by FDA in accordance with the FDA convenience kit guidance. All kit contents are sterile (EtO), nonpyrogenic, and single use only. The current FDA cleared devices of the kit include a stainless steel Guidewire; a Stepped Dilator, starting at 8Fr. on the tip transitioning to 10Fr.; a singlewall introducer needle, with protector, that is designed to introduce up to a 0.038" guidewire into the vasculature; a long handle, disposable #11 safety scalpel used for incisions during operational procedures; and a 10ml silicone double seal stopper syringe with luer slip. Peripheral access to the vein is gained using the needle, syringe, and scalpel. The guidewire is then inserted into the vessel through the needle is removed. A dilator is then chosen by the physician and inserted over the guidewire into the vessel. The dilator is then removed and the next sized dilator is inserted in the same manner until the desired dilation is achieved. The single-use devices are then disposed after use.
The provided document describes the predicate device and the studies conducted to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. The device in question is the "MC3 Vascular Access Kit 21030," which consists of physical components like dilators, guidewires, needles, and scalpels for vessel cannulation. It is not an AI/ML device.
Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable to this physical medical device submission.
However, I can extract the relevant information regarding the acceptance criteria and the performance for this device based on the non-clinical testing performed.
Updated Information based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Test | Description (Acceptance Criteria Implicit in Description) | Reported Device Performance |
|---|---|---|
| Dilator Buckling | Dilator body strength testing with objective acceptance criteria. (Implicitly, the device should not buckle under expected forces.) | All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application. |
| Dilator Tensile Strength | Pull test with objective acceptance criteria. (Implicitly, the device should withstand pulling forces without breaking or deforming excessively.) | All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application. |
| Guidewire Fit | 0.038" guidewire fits through dilator. (Implicitly, the internal lumen of the dilator must be patent and of sufficient size for the specified guidewire.) | All test articles met acceptance criteria. |
| Tip Cracking/Kinking | Splitting or cracking testing with objective acceptance criteria. (Implicitly, the dilator tip should not split or kink during use.) | All test articles met acceptance criteria. |
| Biocompatibility | Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours. (Implicitly, the materials should not cause adverse biological reactions.) | Under conditions of the study, the dilator materials are not cytotoxic, are not a sensitizer and not an irritant. |
| Packaging Integrity | Not explicitly described, but generally involves ensuring the sterile barrier and physical protection of the device. | "Verification and validation testing was used to establish the performance characteristics... Packaging Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Transportation Integrity | Not explicitly described, but generally involves ensuring the device's integrity after transportation simulations. | "Verification and validation testing was used to establish the performance characteristics... Transportation Integrity" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Sterilization Validation | Not explicitly described, but generally involves confirming the efficacy of the sterilization process. | "Verification and validation testing was used to establish the performance characteristics... Sterilization Validation" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
| Functional Testing | Not explicitly described, but generally involves testing the device's ability to perform its intended function. | "Verification and validation testing was used to establish the performance characteristics... Functional Testing" - Results implicitly met acceptance criteria as it was used to support substantial equivalence. |
2. Sample size used for the test set and the data provenance:
For the non-clinical tests (Buckling, Tensile Strength, Guidewire Fit, Tip Cracking/Kinking, Biocompatibility), the document states "All test articles met acceptance criteria." This implies a sample size was used for each test, but the exact number for each specific test is not explicitly stated in the provided text.
The data provenance is from non-clinical laboratory testing conducted by the manufacturer, MC3 Incorporated. It is not patient data (retrospective or prospective) from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This criterion is not applicable as the studies were in-vitro/lab-based non-clinical tests, not involving expert interpretation of data or images.
4. Adjudication method for the test set:
Not applicable for these types of non-clinical tests.
5. If a multi-reader multicase (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:
Not applicable as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable as this is not an AI/ML device.
7. The type of ground truth used:
For the mechanical and physical tests, the "ground truth" was established by objective engineering specifications and measurement standards. For biocompatibility, it was based on internationally recognized standards (ISO-10993).
8. The sample size for the training set:
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.
§ 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).