(83 days)
Export XT & Export AP Catheters indications for use include:
- Removal/aspiration of embolic material (thrombus/debris) from vessels of the arterial system, and
- To sub selectively infuse/deliver diagnostics or therapeutics agents with or without vessel occlusion.
The Export XT & Export AP Catheters are dual lumen catheters used for the aspiration of thrombus and/or debris from a vascular site. The Export XT & Export AP Catheters may also be used for the infusion of diagnostic or therapeutic agents to a desired vascular site.
The provided text is a 510(k) summary for the Medtronic Vascular Export XT and Export AP Catheters, which are embolectomy catheters. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new, novel device. Therefore, the document does not contain the detailed acceptance criteria and a study proving the device meets those criteria in the way one might expect for a new device requiring de novo authorization or a PMA.
However, based on the information provided, I can infer the "acceptance criteria" were related to demonstrating that a material change (PFOA-Free emulsifier for PTFE resin in microlumen tubing) did not negatively impact the device's performance compared to its predicate. The "study" was a series of non-clinical (bench and biocompatibility) tests.
Here's an attempt to structure the information based on your request, even though some points cannot be directly answered as the document is a 510(k) summary, not a detailed study report:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The device in question, the Medtronic Vascular Export XT and Export AP Catheters, underwent a 510(k) submission (K120808) due to a material change: replacing a PFOA emulsifier with a PFOA-Free emulsifier for the PTFE resin in the microlumen tubing. The "acceptance criteria" and "study" described below are focused on demonstrating that this material change did not alter the fundamental safety and effectiveness of the device compared to its legally marketed predicate devices, thereby establishing substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Standard (Inferred) | Reported Device Performance |
|---|---|---|---|
| Material Performance | Shaft Stiffness Test | Performance similar to predicate devices (K061958, K081573) | Met acceptance criteria and performed similarly. |
| Microlumen Wire Pull Through Test | Performance similar to predicate devices (K061958, K081573) | Met acceptance criteria and performed similarly. | |
| Biocompatibility | Cytotoxicity | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. |
| In vitro Hemolysis | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| Systemic Toxicity | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| Sensitization | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| C3a Complement Activation | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| Sc5b9 Complement Activation | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| ISO Intracutaneous Reactivity | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| USP Material Mediated Pyrogen Study | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. | |
| In vivo Thromboresistance | Compliant with ISO 10993-1:2009 and 21 CFR 58 | Full biocompatibility testing performed; no new safety issues. |
Summary Conclusion from Data: The bench testing qualification and biocompatibility testing demonstrated that the proposed Export XT & Export AP Catheters devices are substantially equivalent to the predicate devices. No new safety or effectiveness issues were raised during the testing.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for the bench or biocompatibility tests. It only states that testing was "performed specific to the material change" and "full biocompatibility testing on the proposed device."
- Data Provenance: Not specified in the document. Given it's a submission to the US FDA, the testing was likely conducted in compliance with US regulatory requirements, but the physical location of the labs is not noted. The nature of the tests (bench/biocompatibility) implies prospective testing for the current device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided in a 510(k) summary for a device like an embolectomy catheter, especially when demonstrating substantial equivalence for a material change through non-clinical testing. "Ground truth" in this context would be defined by validated test methods and established standards (e.g., ISO 10993-1, 21 CFR 58), rather than expert consensus on cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable to bench and biocompatibility testing of a medical device's physical properties and material safety. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation of images or patient outcomes, often in the context of diagnostic AI.
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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical investigation has been performed for these devices." This being a material change within an already cleared device, such a study would not typically be required. Furthermore, this device is a physical catheter, not an AI-powered diagnostic tool, so the concept of "human readers improve with AI" is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical catheter and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical tests conducted (bench and biocompatibility), the "ground truth" is established by adherence to recognized international standards and regulatory guidelines.
- Bench Testing: Engineering specifications and performance metrics derived from the predicate devices.
- Biocompatibility Testing: Standards such as ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) and 21 CFR 58 (Good Laboratory Practice for Nonclinical Laboratory Studies).
8. The sample size for the training set
- Not applicable. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
§ 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).