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510(k) Data Aggregation
(30 days)
The Clari Vein IC is indicated for infusion of physician specified agents in the peripheral vasculature.
The ClariVein IC is a specialty infusion catheter with 360°rotatable fluid dispersion wire connected to a proximally located integral battery powered motor drive unit (MDU). The MDU includes the speed selector, handle grip and syringe support features which facilitate physician-controlled infusion of the selected agent. The ClariVein IC is introduced through a microintroducer. Utilizing vascular imaging, the coaxial catheter sheath with dispersion wire is navigated through the vasculature to the treatment site. Fluid delivered through the catheter assembly's infusion port, surrounds the dispersion wire and exits via an opening at the distal end of the catheter. The Clari Vein IC has no user serviceable parts or capital equipment. It is provided to the user sterile, for single patient use and is fully disposable.
The provided document is a 510(k) Premarket Notification for the ClariVein IC device. This type of FDA submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials.
The document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., on a clinical dataset. Instead, it describes non-clinical testing to demonstrate that the device functions as intended and is safe for its indicated use, relying heavily on its similarity to a predicate device.
Therefore, I cannot populate the requested table and answer the questions related to acceptance criteria, AI/ML performance, sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided for this specific device's 510(k) submission.
The document explicitly states:
"H. Clinical Testing: Not applicable."
"I. Animal Testing: Not applicable."
This signifies that the FDA's substantial equivalence determination for this device did not require human or animal clinical studies to demonstrate its performance against specific clinical acceptance criteria in the way you've outlined for an AI/ML device.
The "Performance Data" section (G) focuses on:
- Compliance with Industry Standards: (ISO, ISTA, IEC) related to the physical characteristics, safety, and manufacturing processes of medical devices.
- Biocompatibility Testing: To ensure the materials used in the device are safe for contact with human tissue.
- Nonclinical Performance Testing: Mechanical and functional tests (e.g., tensile strength, leak tests, wire rotation speed, torque force, simulated use) to verify the device's physical integrity and functional parameters.
Summary of Device Performance (based on provided text, not an AI/ML context):
| Acceptance Criteria (Non-Clinical/Functional) | Reported Device Performance (as per "Summary of Nonclinical Tests") |
|---|---|
| Biocompatibility | |
| Hemocompatibility - Hemolysis | Meets requirements |
| Hemocompatibility - Coagulation | Meets requirements |
| Cytotoxicity | Meets requirements |
| Direct/Indirect Contact | Meets requirements |
| Unactivated Partial Thromboplastin Time | Meets requirements |
| L929 Natural Red Uptake | Meets requirements |
| Irritation/Sensitization | Meets requirements |
| Thrombogenicity | Meets requirements |
| Kligman Maximization | Meets requirements |
| Intracutaneous Reactivity | Meets requirements |
| Systemic Toxicity (acute) | Meets requirements |
| Materials Mediated Rabbit Pyrogen | Meets requirements |
| Performance Testing | |
| Visual Quality (no extraneous materials) | Test demonstrates no extraneous materials |
| Corrosion (no signs of corrosion) | Test demonstrates no signs of corrosion |
| Labeling Nominals (meets unit expressions) | Test demonstrates that labeling meets unit expressions |
| Peak Tensile Tests (all joints meet req.) | Test demonstrates that all joints meet requirements |
| Dispersion Wire Tests (all joints meet req.) | Test demonstrates that all joints meet requirements |
| Simulated Use (functionality in fixture) | Test demonstrates functionality in a simulated fixture |
| Liquid leak under pressure | Test demonstrates no leakage |
| Wire rotation Speed (required rotation speed) | Test demonstrates required rotation speed |
| Torque Force to drive train (torque req.) | Test demonstrates torque requirements |
| Syringe and check valve functionality | Test demonstrates compatible functionality |
Reasons why the other requested information cannot be provided from this document:
- Sample sized used for the test set and data provenance: No clinical test set. The non-clinical tests typically involve a sample of devices tested under laboratory conditions, but specific sample sizes for these engineering tests are not detailed here. Data provenance (country, retrospective/prospective) is not relevant for non-clinical lab tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no clinical test set requiring expert ground truth for diagnostic or prognostic performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (no clinical test set).
- 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 (not an AI/ML device; no MRMC study).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI/ML device).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical ground truth established for performance metrics). The "ground truth" for the non-clinical tests would be the pre-defined engineering specifications and standards.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (not an AI/ML device).
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