(29 days)
The XableCath catheter is intended to be used to facilitate access to discrete regions of the peripheral vasculature in conjunction with steerable guidewires. This device may be used to facilitate placement and exchange of guidewires and other interventional devices.
Catheter, Percutaneous
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device Name: XableCath Support Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing quantitative acceptance criteria and then demonstrating performance against them in a tabular format. Instead, it details various tests and their successful completion, implying that "passing" each test constitutes meeting an implicit acceptance criterion.
However, based on the Performance Testing section and the Summary of non-clinical tests conducted, we can infer the acceptance criteria and reported performance:
| Acceptance Criteria (Inferred from tests conducted) | Reported Device Performance (Implied "Pass" or "Acceptable") |
|---|---|
| Visual & Technical Inspections | Equivalent to predicate |
| Dimensional Assessment & Comparisons | Equivalent to predicate |
| Luer Syringe Compatibility | Equivalent to predicate |
| Guidewire Compatibility | Equivalent to predicate |
| Sheath Compatibility | Equivalent to predicate |
| Leak Testing | Equivalent to predicate |
| Guidewire Retraction/Reinsertion | Equivalent to predicate |
| Catheter Kink-Resistance | Equivalent to predicate |
| Relative Radiopacity Comparison | Equivalent to predicate |
| Tensile Testing (proximal & distal) | Equivalent to predicate |
| Torque Transmission & Capability | Equivalent to predicate |
| Corrosion Testing | Equivalent to predicate |
| Simulated Use (iliac model) | Equivalent to predicate |
| General Packaging, Shelf-Life/Expiry | Successfully completed; configurational adequacy demonstrated |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous, Reactivity, Hemolysis, Systemic Toxicity (Acute), Complement Activation, Thromboresistance, Platelet and Leukocyte Count, Partial Thromboplastin Time, Materials Mediated Pyrogenicity) | All utilized materials and methods of construction/processing passed biocompatibility rigors (successfully performed in accord with product classification, under GLP rigors). |
| Packaging Integrity & Transport Challenge Testing | Successfully completed in accordance with established acceptance criteria |
| Clinical Safety (Intra-procedural complications) | No procedural complications attributable to the XableCath Support Catheter in 27 uses across 26 patients. No thrombosis, arterial rupture, or distal embolization. |
| Clinical Effectiveness (Performance as intended) | All arterial access sites and segments typically used for lower extremity angiography were used/traversed safely. The device performed as intended as an over-the-wire PAD catheter for guidewire and other interventional product exchange. (80 arterial segments traversed, no new questions of safety and effectiveness, no intra-procedural complications observed). |
| Post-procedure follow-up (6-8 weeks) | No complications noted at a mean follow-up of 53 days post-procedure office visit attributable to the XableCath Support Catheter. No XableCath Support Catheter related vessel perforation, major dissection, or distal debris embolization, nor abrasion tip post-procedural clinical sequelae were observed. |
| Infusion Pressure/Burst Strength | ≥300 psi (Stated as a characteristic, implies meeting a minimum) |
2. Sample size used for the test set and data provenance
- Sample Size for Clinical (In-vivo) Testing: 26 patients (20 male, 6 female), using 27 XableCath Support Catheters.
- Data Provenance: The study was a "real-world actual-use assessment" and "real-world validation study cohort" conducted as part of product design validation. The document does not explicitly state the country of origin, but given it's an FDA submission, it's highly likely to be U.S.-based or from a country adhering to similar regulatory standards. It is a prospective collection of data from actual patient procedures for validation purposes.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
- Number of Experts: One operating physician was responsible for medically observing patients in follow-up. It can be inferred that multiple experts (interventional cardiologists/radiologists) were involved in the procedures themselves, as the collective actions and observations during the "real-world actual-use assessment" formed the basis of the safety and performance evaluation. However, only one "operating physician" is explicitly mentioned for follow-up. Ground truth for device performance and complications during the procedure would be established by the proceduralists.
- Qualifications of Experts: The document refers to "operating physician(s)" and the context of procedures like angiography and PAD interventions implies that these are interventional cardiologists or radiologists with expertise in peripheral vascular interventions. Specific years of experience are not mentioned.
4. Adjudication method for the test set
The document does not explicitly state an adjudication method (like 2+1 or 3+1). The "operating physician" observed patients in follow-up, and findings during the procedure would have been documented by the medical team. The conclusions drawn are from "real-world actual-use assessment" and "real-world validation," suggesting that the medical community's standard practices for evaluating device performance and adverse events during and after such procedures would apply. This typically involves the proceduralist's assessment and follow-up clinical evaluation, but not a formal, independent adjudication panel as might be seen for subjective AI interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a physical medical instrument (a support catheter), not an AI algorithm for diagnostic imaging interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this is a physical medical device, not a standalone AI algorithm. The performance described is its standalone mechanical and functional operation.
7. The type of ground truth used
For the clinical study:
- Expert Clinical Assessment and Outcomes Data:
- Intra-procedural observations: Adequacy of passage, procedural complications (e.g., dissection, thrombosis, rupture, embolization) as observed by the operating physician(s) and documented during the angiography procedures.
- Post-procedural follow-up: Clinical sequelae (complications attributable to the device) observed at a mean of 53 days post-procedure office visit by the operating physician. This constitutes direct observation of patient outcomes.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device validation, not an AI/machine learning model that requires a training set. The "design validation" and "verification tests" relate to engineering principles and clinical observational assessments rather than model training.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
§ 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).