(16 days)
ThromCat™ Thrombectomy Catheter System is indicated for mechanical removal of thrombus from synthetic hemodialysis access grafts and native vessel dialysis fistulae.
ThromCat™ Thrombectomy Catheter System is a single-use, disposable device that performs percutaneous maceration and removal of thrombus and restoration of blood flow. The device consists of a 5.5 Fr infusion/extraction catheter, a DC-powered infusion/extraction pump, and an extraction line and bag. The stainless steel helix is enclosed within a radiopaque, atraumatic flexible tip and shaft, preventing direct contact with the vessel wall. The integrated pumps, tubing, and 150cm length catheter provide an infusion flow to "wash" the vessel, while simultaneously providing an extraction flow to remove thrombus.
The provided document is a 510(k) summary for the ThromCat™ Thrombectomy Catheter System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain a study that proves the device meets specific acceptance criteria.
The "Non-Clinical Summary" section states: "Non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing. Results of this testing indicate that the ThromCat design meets all specifications and intended use." This is a general statement, but no specific acceptance criteria or detailed study results are provided.
Therefore, I cannot fulfill all parts of your request as the necessary information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "non-clinical verification has been verified through in-vitro bench testing and biocompatibility testing" and that "results of this testing indicate that the ThromCat design meets all specifications and intended use." However, it does not provide any specific acceptance criteria (e.g., "thrombus removal efficiency > 90%") or reported device performance metrics tied to those criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document only mentions "in-vitro bench testing" and "biocompatibility testing" but does not detail sample sizes, data provenance, or whether the testing was retrospective or prospective.
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)
- Not applicable / Cannot be provided. Since the studies mentioned are "in-vitro bench testing" and "biocompatibility testing," they are likely physical or chemical tests that do not involve human expert interpretation for establishing ground truth in the way a clinical image analysis study would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. As above, this is not relevant for the type of bench and biocompatibility 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
- No. The document does not describe any MRMC comparative effectiveness study, nor does it involve AI assistance. This device is a physical thrombectomy catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided definitively for "in-vitro bench testing." For "biocompatibility testing," the ground truth would typically be established by standardized toxicological and immunological assays against established safety limits or comparison to predicate device materials, rather than expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, this is not relevant for a physical medical device.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).