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510(k) Data Aggregation
(4 days)
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER
The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.
The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F Catheter and an Accessory Kit. The 7F Catheter is a 65 - 100 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.
The provided documents are for a 510(k) submission for the Cordis 7F Hydrolyser Thrombectomy Catheter. This is a medical device, not an AI or software device, so many of the requested fields regarding AI/ML device performance and ground truth establishment are not applicable.
Based on the provided text, here's what can be extracted:
- Device Name: Cordis 7F Hydrolyser Thrombectomy Catheter
- Predicate Device: Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length)
- Indications for Use: The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.
Acceptance Criteria and Study for Cordis 7F Hydrolyser Thrombectomy Catheter
For this medical device, the acceptance criteria are generally focused on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. The "study" in this context refers to the pre-clinical testing mentioned to confirm equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance / Method of Confirmation |
|---|---|---|
| Substantial Equivalence | Device performs in a manner similar to or better than the predicate device for its indicated use. | Confirmed through pre-clinical testing, demonstrating equivalence to the Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length). The 510(k) was a "Line Extension," indicating modifications (e.g., increased length to 100 cm) did not alter fundamental function or safety. |
| Biocompatibility | All materials in contact with body fluids must be biocompatible. | All materials used are biocompatible (stated in the Summary of Safety and Effectiveness). |
| Functional Performance | Ability to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts. | Verified by pre-clinical testing (implied by "equivalence confirmed through pre-clinical testing"). Specific metrics like thrombus removal efficiency, time, or complete removal percentage are not detailed in these summary documents but would have been part of the underlying test reports. |
| Safety | No new safety concerns compared to the predicate device. | Verified by pre-clinical testing and biocompatibility assessments. The FDA's substantial equivalence determination implies acceptable safety. |
| Design and Materials | Catheter design (dual lumen, injection/exhaust lumen) and materials meet specifications and are consistent with the predicate device or justified modifications. | Device described as a "7F Catheter," "dual lumen," with an "injection lumen" and "exhaust lumen," consistent with the Hydrolyser technology. "All materials used... are biocompatible." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided documents. "Pre-clinical testing" typically involves a series of in-vitro and/or in-vivo studies with a defined number of test articles and possibly animal models, but the exact sample sizes are not detailed here.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing would have been conducted by the manufacturer (Cordis Corp.) or its designated testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of medical device submission. "Ground truth" in the context of AI/ML or diagnostic imaging studies refers to verifiable clinical truth, established by experts. For a physical medical device like a thrombectomy catheter, "ground truth" relates to physical and functional performance measurements obtained through engineering tests and biological assessments. Testing would be performed by qualified engineers, technicians, and potentially veterinarians/surgeons (for animal studies), but the "number of experts" for ground truth establishment as defined for AI is not relevant.
4. Adjudication method for the test set
Not applicable for this type of medical device. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple human readers when establishing ground truth for diagnostic studies; this is not relevant for the performance testing of a thrombectomy catheter.
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
Not applicable. This device is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an AI algorithm.
7. The type of ground truth used
For this device, the "ground truth" would be established through a combination of:
- Engineering Measurements: Quantifiable physical properties and performance characteristics (e.g., flow rates, force measurements, material properties, catheter flexibility, thrombus removal efficiency in in-vitro models).
- Biological Assessments: Biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies as per ISO 10993 standards).
- Pre-clinical In-vivo Studies (if conducted): Performance and safety observations in animal models to simulate thrombus removal, with "truth" established by direct observation, pathological analysis of tissues, or imaging results.
The documents state "The equivalence was confirmed through pre-clinical testing," which broadly covers these types of ground truth.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(140 days)
7F HYDROLYSER THROMBECTOMY CATHETER
The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.
The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F Catheter and an Accessory Kit.
The 7F Catheter is a 65 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.
This is a 510(k) premarket notification for the Cordis 7F Hydrolyser Thrombectomy Catheter, which received substantial equivalence on February 26, 1999. The device is indicated for the percutaneous removal of soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.
While the document confirms the device's substantial equivalence to predicate devices and mentions "pre-clinical and clinical testing" to confirm this equivalence, it does not provide detailed acceptance criteria or the specific results of those studies. Therefore, I cannot construct a table of acceptance criteria and reported device performance, nor can I answer the questions about sample sizes, ground truth establishment, or specific study designs (MRMC, standalone).
The document is a regulatory approval letter and a summary of safety and effectiveness, which typically provides high-level information rather than detailed study protocols and results.
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