(259 days)
The XO Cross is a support catheter intended to 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 Support Catheter is identical to the predicate device in that it is a single-lumen support catheter designed to support a guidewire 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 Support Catheter within the vasculature, while under fluoroscopy. The distal end of the subject catheter is also coated with a hydrophilic coating to reduce surface friction. It is available in various lengths (90cm, 135cm, 15cm) 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 describes the submission for a 510(k) premarket notification for the XO Cross Support Catheter, which is a revised version of a previously cleared device. The document primarily focuses on demonstrating substantial equivalence to the predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with corresponding performance statistics for the device in terms of clinical outcomes or diagnostic accuracy. Instead, it details that "Verification & Validation activities were performed on the subject XO Cross Support Catheter to demonstrate substantial equivalence to the predicate device."
The closest the document comes to "acceptance criteria" and "reported performance" is in the context of the functional/safety testing and biocompatibility testing. For these, the acceptance criteria are generally "passed" or "met/exceeded" internal requirements and ISO standards.
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-1) | Passed (per the same protocol as predicate) |
| Sensitization (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Irritation/Intracutaneous Toxicity (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Acute Systemic Toxicity (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Material Mediated Pyrogenicity (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Hemolysis Assay (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Complement Activation (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| LAL Pyrogenicity (ISO 10993-1) | Passed (per the same protocol as predicate) | |
| Design Verification | Radiopacity Acceptability (Polymer Tip Extrusion) | Met or exceeded Transit Scientific's in-house requirements |
| Tip ID Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Tip Tensile Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Biocompatibility Testing (Hydrophilic Coating) | Passed | |
| Catheter OD Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Coating Lubricity Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Coating Durability Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Distal Catheter Tensile | Met or exceeded Transit Scientific's in-house requirements | |
| Coating Particulate Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Simulated Use | Met or exceeded Transit Scientific's in-house requirements | |
| Coating Integrity | Met or exceeded Transit Scientific's in-house requirements | |
| Coaxial Testing | Met or exceeded Transit Scientific's in-house requirements | |
| Overall Design Verification (ISO 10555-1 requirements) | All models met or exceeded requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a 'test set' in the context of clinical data or patient outcomes. The testing described is primarily pre-clinical (biocompatibility, engineering design verification). Therefore, information on sample size and data provenance for a clinical test set is not available.
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)
This information is not applicable to the provided document. The submission is for a medical device (support catheter), not an AI/diagnostic software. Ground truth, in the sense of expert consensus on imaging or pathology, is not part of this type of submission. The "ground truth" for the engineering and biocompatibility tests would be the established scientific methods and standards (e.g., ISO 10993-1, ISO 10555-1) and internal specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no clinical 'test set' involving human interpretation or adjudication for this device submission.
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
This information is not applicable. The device is a physical support catheter and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical support catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the evaluations performed is based on:
- International Standards: ISO 10993-1 for biocompatibility and ISO 10555-1 for catheter design verification.
- Internal Requirements: Transit Scientific's in-house specifications for design verification tests (e.g., radiopacity, tip ID, tensile, lubricity, durability, particulate, integrity, coaxial).
8. The sample size for the training set
This information is not applicable. The document does not describe the development of an AI algorithm with a training set. The descriptions relate to physical device design and manufacturing.
9. How the ground truth for the training set was established
This information is not applicable. As there is no AI algorithm or training set discussed, this question is not relevant to the provided content.
§ 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).