Search Results
Found 2 results
510(k) Data Aggregation
(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).
Ask a specific question about this device
(245 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.
The XableCath Support Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt tip design. The catheter is offered in a product family configuration, with size models as outlined in the table below:
| Catalog Number Blunt Tip (B) | French Size | Working Length (cm) | Recommended Guidewire Inches (mm) |
|---|---|---|---|
| XC-014-065B | 5Fr | 65 | 0.014" (0.36 mm) |
| XC-014-090B | 5Fr | 90 | 0.014" (0.36 mm) |
| XC-014-145B | 5Fr | 145 | 0.014" (0.36 mm) |
| XC-018-065B | 6Fr | 65 | 0.018" (0.46 mm) |
| XC-018-090B | 6Fr | 90 | 0.018" (0.46 mm) |
| XC-018-145B | 6Fr | 145 | 0.018" (0.46 mm) |
| XC-035-065B | 7Fr | 65 | 0.035" (0.89 mm) |
| XC-035-090B | 7Fr | 90 | 0.035" (0.89 mm) |
| XC-035-145B | 7Fr | 145 | 0.035" (0.89 mm) |
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopaque cobalt chromiumtungsten-nickel distal tip. The proximal portion is comprised of an olefin strain relief and polycarbonate hub, which includes a female luer connection with the catheter lumen. The catheter pass-through lumen is used to advance the catheter over an appropriately sized guidewire for intravascular advancement to the target site. Component connections are ensured through inter-mechanical locks and utilization of medical grade adhesives. Catheter quidewire compatibility size/length are declared on the XableCath Support Catheter strain relief. All provided family member models are compatible with >=4Fr introducer sheaths. All configurations are provided sterile, single-use only.
The document describes the XableCath Support Catheter and its substantial equivalence determination to a predicate device, the Merit Medical SureCross® Catheter (K123311). This is a 510(k) premarket notification, which relies on demonstrating substantial equivalence rather than independent proof of safety and effectiveness through clinical trials like a PMA.
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical (bench) testing performed to demonstrate that the XableCath Support Catheter is as safe and effective as the predicate device. There is no mention of an AI-powered device or a study involving human readers or expert ground truth for image interpretation.
Here's a breakdown based on the provided text, focusing on the device's performance relative to the predicate rather than AI-specific criteria:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with specific quantitative thresholds. Instead, it describes various non-clinical (bench) tests and states that the subject device was found to be "substantially equivalent" to the predicate in these areas. The performance is assessed comparatively.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Direct Product Bench In-vitro Comparison Testing | ||
| Visual & Technical Inspections | Comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Luer Syringe Compatibility | Compatible with standard luer syringes, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Sheath Compatibility | Compatible with introducer sheaths, comparable to predicate. All models compatible with ≥4Fr introducer sheaths. | Subject & predicate products shown to be substantially equivalent. All provided family member models are compatible with ≥4Fr introducer sheaths. |
| Guidewire Retraction/Reinsertion | Smooth and effective, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Relative Radiopacity Comparison | Adequate visibility under fluoroscopy, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Torque Transmission & Capability | Effective torque transmission, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Simulated Use (Iliac model) | Effective performance in simulated use, comparable to predicate. Ease of insertion and tracking yields equivalent product delivery performance. | Subject & predicate products shown to be substantially equivalent. |
| Dimensional Assessment & Comparisons | Within acceptable variations, comparable to predicate. | "Similarly offered working lengths, and identical dimensional guidewire compatibility (i.e., 0.014", and 0.035")." Subject & predicate products shown to be substantially equivalent. Outer Diameters vary by model but are compared. |
| Leak Testing | No leaks, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Catheter Kink-Resistance | Resistant to kinking, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Tensile Testing (proximal & distal) | Adequate tensile strength, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| Corrosion Testing | No significant corrosion, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. |
| General Packaging, Shelf-life/Expiry | Stable and effective packaging over shelf-life, comparable to predicate. | Subject & predicate products shown to be substantially equivalent. Packaging integrity, transport challenge testing, and shelf-life testing were applied and successfully completed in accordance with established acceptance criteria demonstrating configurational adequacy. |
| Infusion Pressure/Burst Strength | ≥300 psi burst strength. | Reported: ≥300 psi, matching predicate. |
| Biocompatibility | Meet GLP rigors for biocompatibility (e.g., non-cytotoxic, non-irritating). | Full panel biocompatibility successfully performed under GLP rigors, demonstrating all utilized materials and methods of construction/processing passed biocompatibility rigors. (Specific tests: Cytotoxicity, Irritation/Intracutaneous Reactivity, Hemolysis, Complement Activation, Platelet and Leukocyte Count, Sensitization, Systemic Toxicity (Acute), Thromboresistance, Partial Thromboplastin Time, Materials Mediated Pyrogenicity). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of catheters) used for each bench test. The provenance is internal laboratory testing ("bench in-vitro comparison testing") likely conducted by the manufacturer, XableCath, Inc., to support their 510(k) submission. The data is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device clearance based on substantial equivalence to a predicate, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests comes from objective physical measurements and established biological safety testing protocols (e.g., ISO standards, GLP practices).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an imaging study requiring human adjudication of interpretations.
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 medical catheter, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests would be established by:
- Physical standards and measurements: e.g., using calipers for dimensional checks, force gauges for tensile strength, calibrated pressure sensors for burst strength.
- Standardized test methods/protocols: e.g., ISO 10555-1 for intravascular catheters, and GLP (Good Laboratory Practice) guidelines for biocompatibility tests.
- Analytical chemistry/biology results: For biocompatibility, results from established lab assays (e.g., cell culture for cytotoxicity, animal models for systemic toxicity).
- Comparison to predicate: A key "ground truth" in a 510(k) is often the performance of the predicate device, with the new device needing to demonstrate comparable performance.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
Ask a specific question about this device
Page 1 of 1