(270 days)
The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.
The provided text describes a medical device, the VasoPrep Vein Preparation Kit, and its 510(k) summary for FDA clearance. It details the device's intended use and substantial equivalence to predicate devices, along with mentions of performance and biocompatibility testing. However, the text does not include specific quantitative acceptance criteria or detailed study results that would typically be required to answer the questions about device performance in the requested format.
Therefore, I cannot populate the table or answer most of the specific questions about the study design as the information is not present in the provided document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Valve cracking pressure meets safety requirements | "Results of in-vitro testing, including valve cracking pressure... demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use." (Specific values not provided) |
| System leakage within acceptable limits | "Results of in-vitro testing, including... system leakage, demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use." (Specific values not provided) |
| Biocompatibility meets ISO 10993-1 | "The materials used in the VasoPrep Vein Preparation Kit meet the requirements of ISO 10993-1 in accordance with FDA Guidance Memo G-95." (No specific test results beyond compliance confirmation) |
Missing Information for Table: The document explicitly states that in-vitro testing was performed for "valve cracking pressure" and "system leakage" to demonstrate safety and effectiveness. However, it does not provide the specific numerical acceptance criteria for these parameters (e.g., "valve cracking pressure must be within X to Y mmHg") nor does it provide the numerical results (e.g., "valve cracking pressure was Z mmHg"). It only states that the device "demonstrates" safety and effectiveness.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified. The document mentions "in-vitro testing" but doesn't provide details on the number of samples or trials performed.
- Data provenance: "in-vitro testing" is stated, meaning it was conducted in a lab environment. No information on country of origin or whether it was retrospective/prospective is provided, as these are typically applicable to human or animal studies, not purely in-vitro device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the "test set" described is for in-vitro device performance (e.g., pressure and leakage), not for diagnostic accuracy or interpretation by experts. Ground truth in this context would likely be defined by engineering specifications and measurements.
4. Adjudication method for the test set
- This question is not applicable for the same reasons as #3. Adjudication methods are relevant for subjective interpretations, whereas these tests are objective measurements.
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 comparative effectiveness study was not done. This device is a physical medical kit used in surgery, not a diagnostic imaging or AI-assisted interpretation device, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical kit, not an algorithm or AI device.
7. The type of ground truth used
- The ground truth for the performance tests (valve cracking pressure, system leakage) would be based on engineering specifications and direct measurements. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its performance is evaluated through direct physical and material testing.
9. How the ground truth for the training set was established
- Not applicable for the same reason as #8.
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.