(293 days)
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
The Günther Tulip Vena Cava Filter Retrieval Set is composed of a retrieval loop system with a braided platinum wire loop, a coaxial retrieval sheath system, an entry needle, a wire guide, and a dilator. The outer sheath is provided with a radiopaque band on the distal tip to assist in positioning of the sheath. The Günther Tulip Vena Cava Filter Retrieval Set is intended to retrieve the implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter.
The Günther Tulip Vena Cava Filter Retrieval Set is a packaged, sterile device intended for single use.
The provided document is a 510(k) premarket notification for a medical device called the "Günther Tulip Vena Cava Filter Retrieval Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a specific performance claim (e.g., diagnostic accuracy for an AI device).
The document states that modifications were made to the predicate device, specifically a change in the dilator material and a change in the o-ring material. To demonstrate that these changes do not negatively impact safety and effectiveness, the manufacturer performed non-clinical performance tests.
Therefore, the information requested in your prompt regarding acceptance criteria, study design parameters (sample size, experts, ground truth, MRMC study, standalone performance), and training set details are not applicable (N/A) in the context of this specific 510(k) submission for a mechanical medical device. These types of details are typically required for AI/ML-based medical devices or devices making specific claims about diagnostic or predictive performance.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with BS EN ISO 10993-1:2009 for: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility | Materials and methods used to manufacture the subject device are non-toxic and met the acceptance criteria for their intended use. |
| Dimensional Verification | Testing performed. (Specific results not detailed, but implied to meet specifications for "reliable design and performance"). |
| Leakage Testing (Time Zero and 3-year Accelerated Aged) | Testing performed. (Specific results not detailed, but implied to meet specifications for "reliable design and performance"). |
| Tensile Testing | Testing performed. (Specific results not detailed, but implied to meet specifications for "reliable design and performance"). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A - This document describes non-clinical performance testing (biocompatibility, dimensional, leakage, tensile) of a mechanical device. There is no "test set" in the context of patient data, nor is there data provenance as would be relevant for clinical studies or AI/ML evaluation. These were laboratory-based physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
N/A - No human expert "ground truth" was established as this was non-clinical performance testing of a mechanical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - Adjudication methods are not applicable to the non-clinical performance testing described.
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
N/A - This device is a mechanical Vena Cava Filter Retrieval Set, not an AI-based system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A - This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A - For the non-clinical tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO 10993 for biocompatibility) against which the device's physical performance was measured. There is no biological or outcome-based ground truth mentioned.
8. The sample size for the training set
N/A - No "training set" is relevant for this type of mechanical device submission.
9. How the ground truth for the training set was established
N/A - See point 8.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).