(185 days)
The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.
The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.
The provided text describes the non-clinical testing performed on the "6F Wallaby Long Sheath" to demonstrate substantial equivalence to a predicate device, the "Neuron MAX System." This document does not describe the evaluation of an AI/ML powered medical device. Therefore, the information requested in the prompt related to AI/ML device evaluations (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or available in this document.
However, I can extract the acceptance criteria and reported device performance from the Design Verification Testing - Bench and Biocompatibility sections as they relate to a medical device in general.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document often states that the device "met all pre-defined acceptance criteria" or "demonstrated similar results to the predicate," rather than providing specific numerical acceptance thresholds. Where quantitative results are provided, they are included.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| Visual Inspection | Visual inspection requirements met. | The device met all pre-defined acceptance criteria. |
| Dimensional Inspection (ID, OD, overall length, working length, coating length) | Dimensional requirements met. | The subject device met all pre-defined acceptance criteria. |
| Simulated Use | Device performs as intended with compatibility with 6F and 8F catheters, RHV, guidewire, and stent retriever. | The device performed as intended. |
| Physician Validation | Device performs as intended and is comparable to predicate for preparation, ease of assembly, 8F short sheath interaction, RHV Luer connection interaction, dilator interaction, compatibility with guidewire, guide and aspiration catheters, and kink resistance. | The subject device performed as intended. |
| Delivery and Retrieval Forces | Similar forces to predicate required to deliver and retrieve with ancillary devices. | Demonstrated similar forces to the predicate device. |
| Tip Stiffness | Similar tip stiffness to predicate. | Tip stiffness is similar to the predicate. |
| Tensile Strength (distal shaft, proximal hub) | Met minimum tensile requirement. | Met the minimum tensile requirement. |
| Elongation to Failure (shaft) | Met pre-defined acceptance criteria. | Met all pre-defined acceptance criteria. |
| Torque Strength | Similar torque strength to predicate. | Torque strength is similar to the predicate device. |
| Coating Integrity | No visible defects or irregularity after particulate testing. | No visible defects or sign of irregularity were observed. |
| Coating Lubricity | Similar frictional forces to predicate. | Demonstrated similar results between the subject device and the predicate device. |
| Catheter Dynamic/Static Burst, Leak (Liquid/Air) | Compatible with accessories per ISO 10555-1. | Compatible with accessories per ISO 10555-1. |
| Kink Resistance | Met acceptance criteria for resistance to kinking around bends with clinically relevant radii at specific locations. | Met the acceptance criteria. |
| Particulate | Comparable number of particulates to predicate; met acceptance criteria. | The number of particulates was comparable to the predicate. The device met the acceptance criteria. |
| Corrosion Resistance | Met acceptance criteria per ISO 10555-1. | Met the acceptance criteria. |
| Insertion and Retrieval Forces (with dilator) | Similar forces to predicate. | Demonstrated similar forces for the subject device and the predicate device. |
| Radiopacity | Marker band visible under fluoroscopy; similar to predicate. | Demonstrated results similar to the predicate device. |
| Sterilization & Shelf Life | ||
| Sterility Assurance Level (SAL) | 10^-6 | SAL of 10^-6 achieved in accordance with ISO 11135:2014. |
| Shelf Life | Device and packaging functional for 12 months with packaging integrity, seal strength, and device functionality maintained. | Established that the device and its packaging remains functional for the 12-month shelf life, meeting acceptance criteria. |
| Biocompatibility (Sheath - 100 cm model) | ||
| MTT – L-929 Cytotoxicity Study | Viability ≥ 70%. | Viability ≥ 70%; 80-91%. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses not greater than "0". | Test and control animals' responses are not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| Complement Activation - SC5b-9 Assays | Results within acceptable range compared to comparator device. | Results within acceptable range as compared to the comparator device. (Similar complement activation to comparator) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.4, 0.1. (Non-hemolytic) |
| Platelet and Leukocyte counts | Counts within acceptable ranges and comparable to Control Device. | Ranges/levels within acceptable range and comparable to Control Device. |
| Partial Thromboplastin Time (PTT) | Similar performance to predicate devices. | Test and predicate devices have similar performance. (Not an activator of intrinsic coagulation) |
| Thromboresistance Evaluation | No adverse effects or clinical signs; no thrombus score > 3 for test or control device. | No adverse effects/clinical signs, no thrombus score > 3. (Thrombogenic risk similar to control) |
| Biocompatibility (Dilator) | ||
| MTT – L-929 Cytotoxicity Study | Viability ≥ 70%. | Viability ≥ 70%; 79.8%. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' responses not greater than "0". | Test and control animals' responses not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| Complement Activation - SC5b-9 Assays | Results within acceptable range compared to negative reference material. | Results within acceptable range as compared to the negative reference material. (Non-activator of complement system) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.3, 0.5. (Non-hemolytic) |
| Thromboresistance Evaluation | No adverse effects or clinical signs during test period; no thrombus score > 3 for test or control device. | No adverse effects/clinical signs, no thrombus score > 3. (Thrombogenic risk similar to control device) |
| Biocompatibility (RHV) | ||
| Cytotoxicity MEM Elution | Cytotoxic Score: 0; 0% Cell Lysis. | Percent Cell Lysis: 0%; Cytotoxic Score: 0. (Non-cytotoxic) |
| ISO Intracutaneous Irritation | Difference between average scores of test article extract and vehicle control is 0. | Difference between average scores is 0. (Non-irritant) |
| ISO Guinea Pig Maximization Sensitization | Test and control animals' response not greater than "0". | Test and control animals' response not greater than "0". (Non-sensitizing) |
| ISO Acute Systemic Toxicity | No abnormal clinical signs indicative of toxicity for 72 hours; all animals alive at 72 hours; body weight changes within acceptable parameters. | No abnormal clinical signs, all animals alive, body weight changes within acceptable parameters. (Non-toxic) |
| ISO Material Mediated Rabbit Pyrogen | No rabbit temperature rise ≥ 0.5°C. | No rabbit temperature rise ≥ 0.5°C. (Non-pyrogenic) |
| ASTM Hemolysis - Direct Contact and Extract Method | Hemolytic index below threshold for non-hemolytic. | Blank corrected Hemolytic index: 0.0, 0.1. (Non-hemolytic) |
For the following points, the information is not applicable to this document as it details the clearance of a non-active, surgically invasive device (a vascular catheter), not an AI/ML powered device.
- Sample size used for the test set and the data provenance: Not applicable. Data provenance is not relevant for bench and biological testing of this type of device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Physician Validation" involved physicians but their exact number or role in "ground truth" establishment (which is an AI/ML concept) is not detailed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth as typically defined for AI/ML evaluations is not relevant here. The ground truth for device performance is based on established engineering principles, ISO standards, and comparison to a legally marketed predicate device.
- The sample size for the training set: Not applicable. There is no AI/ML training set.
- How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.
§ 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).