(149 days)
The XO Cross is a support catheter intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
The XO Cross catheter is a single-lumen support catheter designed to support a quidewire during access of the peripheral vasculature, allowing for exchange of guidewires during vascular access procedures, and providing a conduit for the delivery of saline solutions or diagnostic contrast agents. The shaft and tip are both radiopaque to track the location of the XO Cross catheter within the vasculature, while under fluoroscopy. It is available in various lengths (90cm, 135cm, 150cm, 175cm) and ranges in diameter from 2 Fr (0.7 mm) to 4 Fr (1.35 mm) with a tapered polymer tip at its distal end.
The provided text is a 510(k) summary for the XO Cross Support Catheter. It outlines the device description, indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria, especially in the context of device performance metrics with numerical values or statistical analyses.
The document states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence" and "All data met pre-determined acceptance criteria" for functional tests, but it does not specify what those criteria are beyond general statements. It also doesn't describe the methodology of any studies that would demonstrate these criteria were met in a quantifiable way.
Therefore, I cannot populate the table or answer most of the specific questions as the required information is not present in the provided text.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Functional/Safety Testing: | |
| Biocompatibility (ISO 10993-1) | Met ISO 10993-1 requirements (Cytotoxicity, Irritation/Intracutaneous Toxicity, Sensitization, Systemic Injection, Material Mediated Pyrogenicity, Hemolysis Complete, Complement Activation, Thrombogenicity) |
| Design Verification (ISO 10555-1) | Met or exceeded Transit Scientific's in-house requirements and ISO 10555-1 requirements |
| Packaging integrity | Validated in conjunction with sterilization studies |
| Max Infusion Pressure | Tested for manual infusion, not for use with power injectors (No specific pressure limit given for manual infusion, implying it passed internal criteria for manual use) |
| Materials (similar to predicate) | Uses single Lumen metal alloy hypo-tube shaft with tapered tip and polymer jacket, different from predicate's SS braided shaft (This is a design difference, not a performance metric) |
| Dimensions (similar to predicate) | Various lengths (90cm, 135cm, 150cm, 175cm), diameters (2Fr to 4Fr), and distal tip profiles (1.6Fr, 1.9Fr, 3.2Fr), similar to, but not identical to, predicate (Again, a design spec, not a performance metric with specific acceptance criteria) |
| Visibility (radiopaque markers) | Radiopaque catheter body, 40% tungsten loaded polymer tip, different from predicate's 3 radiopaque markers (Design difference) |
| Guidewire Compatibility | 0.014", 0.018", 0.035" (Same as predicate) |
| Sheath/Introducer Compatibility | 4Fr (Predicate mentions 4Fr, 5Fr. Subject device is only 4Fr, but "same" is noted in the table) |
| Sterility (EO) | Sterile - EO (Same as predicate) |
Missing Information:
- Specific quantitative acceptance criteria for each functional test (e.g., maximum acceptable cytotoxicity index, specific force required for kink resistance in design verification).
- Quantitative results of the functional tests against the specific criteria.
- Any performance testing related to guidewire support strength, catheter trackability, pushability, or other in-use functional attributes beyond basic material and design verification.
2. Sample size used for the test set and the data provenance
- Missing. The document does not describe any specific "test set" in terms of patient data or clinical samples that would have a sample size or provenance. The "functional/safety testing" refers to laboratory-based verification, and no sample sizes for these tests are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This information would typically be relevant for studies involving qualitative assessments, such as image interpretation or clinical diagnosis. The described testing is primarily laboratory-based engineering and biocompatibility testing. No "ground truth" established by experts in this context is mentioned.
4. Adjudication method for the test set
- Not applicable. See point 3.
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 device (support catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the functional/safety testing, the "ground truth" would be the standards and specifications (e.g., ISO 10993, ISO 10555) that the device must meet, as well as the manufacturer's own internal design requirements. These are objective engineering and biological standards. There is no "expert consensus," "pathology," or "outcomes data" ground truth described for the tests mentioned.
8. The sample size for the training set
- Not applicable. This device is a physical medical device. There is no concept of a "training set" as there would be for AI/machine learning models.
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).