(155 days)
The Proxis Flow Control System controls the flow of fluids in the coronary and peripheral vasculature. This is achieved by temporary vessel occlusion to hold a column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control System is not indicated for use for embolic protection.
The Proxis System has five major components: the Evacuation Sheath Catheter, Inflation System, Infusion Catheter, Lip Seal, and an Aspiration syringe.
The Evacuation Sheath Catheter has one proximal low-pressure compliant sealing balloon that is inflated to occlude the arterial vessel. A radiopaque marker at the balloon site facilitation and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has a sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloon is inflated using the Inflation System.
Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloon is inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the evacuation sheath catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.
Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the evacuation sheath catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.
The Aspiration syringe is provided for the removal of stagnated fluid during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal of stagnated fluid.
The provided text is a 510(k) Summary for the Proxis Flow Control System and a subsequent FDA equivalency letter. It describes a medical device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for AI/algorithm performance studies.
This type of submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical safety and effectiveness through extensive clinical trials with specific performance endpoints.
Therefore, many of the requested items, particularly those related to algorithm performance, ground truth, expert adjudication, and comparative effectiveness studies with AI, are not applicable to this document. The "Test Summary" section explicitly states that no additional animal or clinical data was deemed necessary due to the scope of modifications and the substantial equivalence argument.
Here's a breakdown of the information that can be extracted based on the provided text, and where your requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the device must perform similarly to its predicate devices and meet specific verification tests. However, it does not provide quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) in the context of clinical performance or algorithm accuracy. Instead, the acceptance criteria are related to engineering and functional performance, and biocompatibility in comparison to the predicate devices.
- Reported Device Performance:
- Dimensional, Strength, Functional, Packaging, Sterilization, Biocompatibility, and Shelf Life tests: "Passed all verification criteria." (No specific numerical performance metrics are given for these tests, just a statement of compliance).
- Clinical Performance: "The device performs as intended without raising additional questions of safety and efficacy," based on substantial equivalence to predicate devices and the scope of modifications. No new clinical performance metrics are reported.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional/Design | Equivalent to predicate devices (K060651, K042117) | Identical in function, mechanism of action, intended use, and ability to control fluid flow to predicate devices. |
| Verification Tests | Pass criteria for dimensional, strength, functional, packaging, sterilization, biocompatibility, and shelf life. | Passed all verification criteria. |
| Clinical Efficacy | Performs as intended without raising new questions of safety and efficacy compared to predicate. | No new clinical data presented; substantial equivalence argument ensures performance. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No clinical test set data is described or analyzed in this 510(k) submission. The decision was made that "no additional animal or clinical data was deemed necessary." The "Test Summary" refers to engineering and functional verification tests, not clinical performance studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As there was no clinical test set requiring ground truth establishment, this information is not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set requiring adjudication.
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 catheter system, not an AI or algorithm-driven diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical ground truth was established for performance evaluation within this submission.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set of data.
9. How the ground truth for the training set was established
- Not Applicable. As there's no training set for an algorithm, this question is not relevant.
Summary of Device-Related Information from K063638:
- Device Name: Proxis Flow Control System
- Intended Use: Controls the flow of fluids in the coronary and peripheral vasculature for temporary vessel occlusion to hold a column of fluid stagnant (for visualization or local therapeutic solution delivery).
- Key Modification (from predicate): Decreased diameter of the catheter and sealing balloon.
- Key Similarities to Predicates: Identical in function, mechanism of action, and intended use as K042117 (rapid-exchange Proxis System). Has the same technological characteristics and flow control indication as K060651 (over-the-wire Proxis System).
- Key Distinction / Not Indicated For: Embolic protection (explicitly stated).
- Regulatory Conclusion: Substantially Equivalent to predicate devices K042117 and K060651.
In essence, this 510(k) demonstrates that the modified device is substantially equivalent to existing, legally marketed devices, and therefore does not require new comprehensive clinical studies or performance evaluations that would typically involve acceptance criteria and data sets as described in your prompt for AI/algorithm assessment.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).