(48 days)
The XableCath Catheter is intended for use with a guidewire to access discrete regions of the peripheral vasculature. The XableCath™ Crossing Catheter is intended for use to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
The XableCath Crossing Catheter device is an over-the-wire (OTW) single-lumen catheter, with blunt and abrasion tip design. The catheter is offered in a product family configuration, with size models as outlined below:
Catalog Number: AbrasionTip (A), Blunt Tip (B)
Dimensions: Working Length (cm), Recommended Guidewire Inches (mm)
XC-014-065A, XC-014-065B, 65, 0.014" (0.36 mm)
XC-014-090A, XC-014-090B, 90, 0.014" (0.36 mm)
XC-014-145A, XC-014-145B, 145, 0.014" (0.36 mm)
XC-018-065A, XC-018-065B, 65, 0.018" (0.46 mm)
XC-018-090A, XC-018-090B, 90, 0.018" (0.46 mm)
XC-018-145A, XC-018-145B, 145, 0.018" (0.46 mm)
XC-035-065A, XC-035-065B, 65, 0.035" (0.89 mm)
XC-035-090A, XC-035-090B, 90, 0.035" (0.89 mm)
XC-035-145A, XC-035-145B, 145, 0.035" (0.89 mm)
The catheter shaft consists of a cortically reinforced co-polymeric material blend, with radiopague cobalt chromiumtunqsten-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 Crossing Catheter strain relief. All provided family member models are compatible with ≥4Fr introducer sheaths. All product configurations are provided sterile, single-use only.
Here's a breakdown of the acceptance criteria and study information for the XableCath Crossing Catheter, based on the provided document:
Acceptance Criteria and Device Performance
The document does not present a formal table of distinct, quantitative acceptance criteria for device performance. Instead, it details various non-clinical and clinical tests performed and states that the device was deemed "substantially equivalent" to a predicate device, and that specific endpoints were met in the clinical assessment.
However, based on the narrative, we can infer some key performance achievements:
| Acceptance Criteria (Inferred from study outcomes) | Reported Device Performance |
|---|---|
| Non-Clinical Performance: | |
| Substantially equivalent to predicate device in various physical and functional areas. | Direct product bench in-vitro comparison testing showed the subject & predicate products to be substantially equivalent in areas such as visual & technical inspections, dimensional assessment, luer syringe compatibility, guidewire compatibility, sheath compatibility, leak testing, guidewire retraction/reinsertion, catheter kink-resistance, relative radiopacity comparison, tensile testing, torque transmission & capability, corrosion testing, simulated use (iliac model), and general packaging/shelf-life. |
| Biocompatibility | Full panel biocompatibility successfully performed under GLP rigors, demonstrating all materials and construction methods passed biocompatibility (including cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, hemolysis, thromboresistance, complement activation, partial thromboplastin time, platelet and leukocyte count, and materials mediated pyrogenicity). |
| Packaging integrity and transport challenge | Applied and successfully completed in accordance with established acceptance criteria demonstrating configurational adequacy. |
| Clinical Performance (Real-world assessment): | |
| Primary Endpoint: Successful passage within the target lesion, enabling subsequent therapy (angioplasty and/or stenting). | 98% primary endpoint achievement with successful PTA/Stenting & technical success with lesion/claudication crossing. |
| Secondary Endpoint: Absence of major adverse event attributable to XableCath Catheter product use (perforation, thrombosis, or distal embolization). | 100% secondary endpoint achievement. (Routine minor dissection in 10% of treatment subjects experiencing an access site complication, both successfully treated with standard remedial maneuvers, without any residual clinical sequelae at 30-45 day post-treatment follow-up.) No recorded minor adverse events were caused by or attributable to the XableCath Crossing Catheter deployment. |
| Human factors engineering and usability | Assessments performed to ensure subject product features could be safely and effectively used. |
Study Details
This submission describes a pre-market notification (510(k)) for the XableCath Crossing Catheter, leveraging substantial equivalence to a predicate device (eV3/Medtronic Viance Crossing® Catheter (K120533)). The study components include non-clinical (bench) testing and a real-world clinical assessment.
1. A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are largely inferred from the successful completion of various tests and the achievement of primary and secondary endpoints in the clinical assessment.
2. Sample sized used for the test set and the data provenance:
- Non-Clinical Test Set: The document does not specify exact sample sizes for each non-clinical bench test but indicates that "Direct product bench in-vitro comparison testing" was performed on the subject and predicate devices. No specific number of devices tested is provided.
- Clinical Test Set:
- Sample Size: 49 patients underwent lesion modifying therapeutic intravascular treatment with XableCath Catheters.
- Data Provenance: This was a "real-world assessment," implying prospective data collection in clinical settings where the device was used. No specific country of origin is mentioned, but the sponsoring company location (Salt Lake City, Utah) suggests US-based or international clinical sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Non-Clinical: Not specified. Testing would typically involve qualified engineers and lab personnel.
- Clinical: The "real-world assessment" involved "physicians" administering the treatment and assessing outcomes. While their specific qualifications (e.g., interventional cardiologists, radiologists) are not detailed, it can be assumed they are qualified medical professionals experienced in peripheral arterial disease re-canalization and intervention. The document mentions "clinical outcomes," which would be determined by these treating physicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Non-Clinical: Not applicable in the context of expert adjudication. Bench testing results are typically based on objective measurements and established test protocols.
- Clinical: No formal external adjudication method (like 2+1 or 3+1 expert review) is mentioned for the clinical outcomes. The outcomes (primary and secondary endpoints, adverse events) were reported from the real-world treatment context, presumably as recorded and assessed by the treating clinicians.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical catheter, not an AI or imaging software, so MRMC studies involving human readers and AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical catheter, not an algorithm. Its standalone performance is demonstrated through the non-clinical and clinical studies where it is used as a tool by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Non-Clinical: The "ground truth" for non-clinical tests was based on objective measurements, adherence to ISO standards (ISO 10555-1, ISO 10993), and engineering performance criteria.
- Clinical: The "ground truth" for the clinical study was based on patient outcomes data, specifically:
- Successful passage within the target lesion and enablement of subsequent therapy (angioplasty and/or stenting).
- Absence of major adverse events attributed to the device (perforation, thrombosis, distal embolization).
- Resolution of minor adverse events without residual clinical sequelae.
8. The sample size for the training set:
- Not applicable. This submission describes a medical device, not an AI model, so there is no "training set" in the context of machine learning. The non-clinical and clinical data serve as validation/verification of the device's performance.
9. How the ground truth for the training set was established:
- Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment in the machine learning sense. The device's design and manufacturing are based on engineering principles and preclinical testing, and its clinical efficacy is evaluated through the real-world patient outcomes mentioned above.
§ 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).