(124 days)
The Socrates™ 38 Catheter is indicated for use in facilitating the insertion and guidance of an appropriate microcatheter or diagnostic agents into a selected blood vessel in the peripheral or neuro vasculature. The Socrates™ 38 Catheter is not intended for use in the coronary vasculature.
Scientia Vascular's Socrates™ 38 Catheter is a single lumen, variable stiffness, open-ended catheter designed to track through a guide catheter using a steerable guidewire and microcatheter. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Socrates™ 38 Catheter:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly state numerical acceptance criteria for each test. Instead, it indicates that all tests either "Pass" or that the "subject device met all acceptance criteria." The acceptance criteria are implicitly defined by the test methods referenced (e.g., ISO standards, comparison to predicate).
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1:2018; same design, components, materials, and manufacturing process as referenced device (K223913). | Pass |
| Functional Testing | ||
| Tensile and Elongation | Meet requirements of ISO-10555-1:2014 for peak tensile force and elongation. | Pass |
| Tip Stiffness | Meet defined cantilever bending stiffness requirements. | Pass |
| Kink Radius | Meet minimum kink radius requirements. | Pass |
| Liquid Leak and Static Burst | Meet requirements of ISO-10555-1:2014. | Pass |
| Dynamic Flow | Meet requirements of ISO-10555-1:2014 for dynamic flow rate. | Pass |
| Agent Compatibility | Maintain functionality after exposure to contrast media and saline. | Pass |
| Torque Turns to Failure | Comparable performance to predicate device in an anatomical model. | Pass |
| Visual and Dimensional Inspections | Meet requirements of ISO-10555-1:2014 and engineering drawings. | Pass |
| Flexural Fatigue | No damage after multiple flex cycles. | Pass |
| Air Ingress and Negative Collapse | Meet requirements for air ingress per ISO-10555-1:2014 and maintain lumen integrity under vacuum. | Pass |
| Model and Compatibility Testing | Successful performance with ancillary devices in a tortuous neurovasculature model. | Pass |
| Hub Luer Design Verification | Meet requirements of ISO-80369-7. | Pass |
| Usability and Radiopacity Validation | Physicians' positive evaluation of performance characteristics and radiopacity. | Pass |
| Lubricity and Durability | Maintain frictional force and coating integrity after simulated use. | Pass |
| Corrosion Resistance | Meet requirements of ISO-10555-1:2014. | Pass |
| Particulate Characterization | Comparable particle count to predicate device after simulated use. | Pass |
| Model and Product Compatibility Evaluation | Successful advancement through neurovascular model with ancillary devices, comparable to predicate. | Pass |
| Delivery and Retrieval Testing | Meet force requirements for delivery and retrieval in a tortuous pathway. | Pass |
| Coating Integrity | Maintain hydrophilic coating integrity after simulated use. | Pass |
| Sterilization, Shelf-Life, Residuals | Meet all acceptance criteria for shelf-life, packaging integrity, sterilization (EO, ECH residuals), and bacterial endotoxin levels. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the individual functional tests. It only states that "performance testing was conducted." The data provenance is non-clinical performance data, primarily from laboratory testing. It does not mention country of origin for the data, nor whether it's retrospective or prospective, as these are non-clinical studies. Many tests were "leveraged" from a previous submission (K223913) for a similar device, implying consistency in design and testing methodologies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
For the "Usability and Radiopacity Validation" test, it states "Physicians evaluated various performance characteristics...in a human cadaver."
- Number of experts: Not specified (plural "Physicians" implies more than one).
- Qualifications of experts: "Physicians" (likely interventional neuroradiologists or neurosurgeons given the device's indications) are mentioned, but specific qualifications (e.g., years of experience, subspecialty) are not provided.
- This specific test involved evaluation in a "human cadaver," which serves as a realistic test environment.
For all other functional tests, the "ground truth" (acceptance criteria) was established by engineering specifications, relevant ISO standards, and comparisons to the predicate device, not by expert consensus on a test set in the traditional sense of a clinical or image-based study.
4. Adjudication Method for the Test Set
For the "Usability and Radiopacity Validation" involving physicians, an adjudication method is not specified. For the other non-clinical functional tests, adjudication is not applicable as the results are quantitative measures against pre-defined engineering or standard-based acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Therefore, no clinical study was conducted." The device being reviewed is a physical medical device (catheter), not an AI or software device that would typically undergo MRMC studies to evaluate human-in-the-loop performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is a physical catheter, not an algorithm or software. Therefore, the concept of "algorithm only without human-in-the-loop performance" does not apply.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established through:
- Engineering specifications and design requirements: For dimensional, mechanical, and functional aspects.
- International Standards (ISO): Such as ISO 10555-1:2014 for catheters and ISO 80369-7 for luer connectors, which define test methods and performance requirements.
- Comparison to a legally marketed predicate device: Many tests established performance relative to the "Modified HD Guide Catheter (K133177)" or "Socrates Aspiration System (K223913)."
- Expert Observational Consensus: For the "Usability and Radiopacity Validation" test, physicians' evaluations (though specific methodology is not detailed).
- Leveraged Data: Much of the data was leveraged from the previous K223913 submission, indicating that the design, components, and manufacturing processes are sufficiently similar to pre-validate certain aspects.
8. The Sample Size for the Training Set
This question is not applicable. The Socrates™ 38 Catheter is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms, as no algorithm is being developed or trained.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above. There is no training set for this physical medical device.
§ 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).