(30 days)
- The carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.
- The size 8 French Shunt is intended for use on those patients whose vasculature is too small to accommodate a size 9 French Shunt.
The Next Generation Pruitt Carotid Shunt is designed to serve as a temporary blood conduit connecting one section of a vessel to a second area of the same vessel. This allows blood to continuously flow to the patient's brain during an endarterectomy procedure. The device is manufactured using a clear, plastic, sterile conduit, which is held in place by a stabilization technique on both ends of the conduit.
The Next Generation Pruitt Carotid Shunt is a multi-lumen device with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. An external safety balloon, located on the inflation arm that is inserted into the internal carotid artery, acts as a mechanism to relieve pressure on the internal carotid balloon in the event it is inflated above a predetermined pressure. The external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage.
The provided text describes a 510(k) submission for a medical device, the "Next Generation Pruitt-Inahara Outlying Carotid Shunt." This submission focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance evaluations against a set of complex acceptance criteria typically associated with AI/ML devices. Therefore, much of the requested information regarding AI/ML-specific study design (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable to this 510(k) summary.
However, I can extract the relevant information regarding performance data and acceptance criteria as presented for this specific type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "The safety and effectiveness of the Next Generation Pruitt-Inahara Outlying Carotid Shunt has been demonstrated through data collected from bench tests and analyses." While specific quantitative acceptance criteria or detailed performance metrics are not explicitly listed in this summary, the core acceptance criterion for a 510(k) device is substantial equivalence to an existing predicate device. This is assessed across various characteristics.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | "The Pruitt-Inahara Outlying Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries." This matches the predicate device's intended use. |
| Design, Materials, Method of Delivery Equivalence | "The design, materials, method of delivery and intended use features of Next Generation Pruitt-Inahara Outlying Carotid with 10.5F diameter is substantially equivalent with reqard to these features in the predicate device, the Pruitt-Inahara Outlying Carotid Shunt (K960715, September 9, 1996)." |
| Technological Characteristics Equivalence | "Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging of the proposed device are substantially equivalent to the currently marketed predicate devices." This is supported by "bench tests and analyses." |
| Safety (Demonstrated via Bench Tests & Analyses) | The device includes an "external safety balloon feature reduces the possibility of balloon over-inflation and resultant vessel damage." This design element addresses potential safety concerns. General safety is affirmed by "bench tests and analyses" establishing substantial equivalence. |
| Effectiveness (Demonstrated via Bench Tests & Analyses) | Effectiveness, in the context of a temporary conduit for blood flow, is supported by "bench tests and analyses" demonstrating that the device functions as intended and is substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific bench tests in this summary. The "tests and analyses" would typically involve a certain number of units or simulated conditions, but these details are not provided.
- Data Provenance: The data is from "bench tests and analyses." This implies laboratory-based testing conducted by the manufacturer, LeMaitre Vascular, Inc., in the USA (their address is Burlington, MA). The data would be retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This 510(k) summary does not involve human expert ground truth for evaluating AI/ML results. The "ground truth" for this device's performance would be established by engineering specifications, validated test methods, and comparison against the known performance of the predicate device.
4. Adjudication method for the test set
Not applicable. There is no human expert adjudication process described, as this is not an AI/ML device evaluating complex medical images or data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of AI/ML systems on human reader performance, which is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI/ML device. The "performance" refers to the physical device's characteristics.
7. The type of ground truth used
The "ground truth" for this device's performance relies on:
- Engineering Specifications: Adherence of the device to its physical, mechanical, and material specifications.
- Validated Test Methods: Results from standardized or validated bench tests (e.g., pressure resistance, flow rates, material compatibility, balloon inflation/deflation characteristics, dimensional accuracy).
- Predicate Device Performance: The established performance and safety profile of the legally marketed predicate device (Pruitt-Inahara Outlying Carotid Shunt, K960715) serves as the benchmark against which substantial equivalence is claimed.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).