(169 days)
The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic agents.
The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.
The provided text is a 510(k) Premarket Notification from the FDA regarding the Okami Medical SENDERO Microcatheter. It discusses the device's substantial equivalence to predicate devices based on non-clinical performance testing.
However, the document does not contain the kind of detailed information typically associated with Acceptance Criteria and Study Proof for a device like an AI/ML algorithm or software. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for metrics like sensitivity, specificity, or image quality (as would be seen for an AI diagnostic device).
- Details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. This submission is for a medical device (microcatheter), not a software or AI product.
- The type of ground truth used as this applies to diagnostic/AI devices, not typically a physical catheter.
The document primarily focuses on demonstrating the physical and functional equivalence of the SENDERO Microcatheter to existing, legally marketed predicate devices through non-clinical performance testing. The acceptance criteria for this type of device are related to its physical properties, material compatibility, and functional performance, rather than diagnostic accuracy metrics.
Here's a summary of what is available in the document, framed in the context of device acceptance, even if not precisely what the prompt asked for regarding AI/ML:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):
The acceptance criteria for the SENDERO Microcatheter are implicitly defined by the successful completion of various non-clinical performance tests, demonstrating its suitability for its intended use and substantial equivalence to predicate devices. The "reported device performance" is a statement that the device met these criteria.
| Acceptance Criteria Category (Test per standard or internal protocol) | Reported Device Performance (as stated in the document) |
|---|---|
| Dimensional/Visual Inspection | Met suitability for intended use |
| Coating Thickness and Lubricity | Met suitability for intended use |
| Simulated Use Testing | Met suitability for intended use |
| Catheter Coating Integrity | Met suitability for intended use |
| Compatibility Testing | Met suitability for intended use |
| Burst Pressure Testing (per ISO 10555-1) | Met suitability for intended use |
| Catheter Tensile Strength (per ISO 10555-1) | Met suitability for intended use |
| Kink Diameter Testing | Met suitability for intended use |
| Torque Testing | Met suitability for intended use |
| Hub Testing (per ISO 594-1/2) | Met suitability for intended use |
| Particulate Testing | Met suitability for intended use |
| Flowrate Testing (per ISO 10555-1) | Met suitability for intended use |
| Radiopacity Testing (per ASTM F640) | Met suitability for intended use |
| Packaging Validation | Met suitability for intended use |
| Biocompatibility Testing (per ISO 10993-1): | |
| - Cytotoxicity | Met suitability for intended use |
| - Sensitization | Met suitability for intended use |
| - Irritation | Met suitability for intended use |
| - Acute Systemic Toxicity | Met suitability for intended use |
| - Material-Mediated Pyrogenicity | Met suitability for intended use |
| - Hemocompatibility | Met suitability for intended use |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the comprehensive Non-clinical Performance Testing regimen described. The document states: "The results of the testing indicate that the SENDERO Microcatheter is substantially equivalent to the predicate device." And "The non-clinical performance data submitted in this premarket notification clearly supports the substantial equivalence of the SENDERO Microcatheter to the predicate, and demonstrates the subject device should perform as intended when used as instructed."
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each non-clinical test. These tests are typically conducted on a defined number of device units (e.g., a certain number of catheters for burst pressure, tensile strength, etc.) according to recognized standards (like ISO or ASTM) or internal validated protocols.
- Data provenance: This is a physical medical device. The data comes from laboratory testing of manufactured devices, not from patient data, so concepts like "country of origin of the data" or "retrospective/prospective" patient studies are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the tests are for physical properties and biocompatibility. Ground truth is established by validated measurement techniques and adherence to engineering and scientific standards, not expert adjudication of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic interpretation or clinical data review study.
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 is a physical medical device (microcatheter), not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" relates to the physical and chemical properties meeting predefined specifications and standards (e.g., a specific tensile strength value, a certain flow rate, absence of cytotoxicity). It is established through validated laboratory methods and measurements.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).