(189 days)
The VersaD™ Delivery Catheter is intended for use with compatible guide catheters in facilitating the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.
The VersaD™ Delivery Catheter is a single-lumen, variable stiffness catheter with a long, tapered tip delineated by radiopaque markers. The proximal end has a luer hub, and the distal portion has a hydrophilic coating to reduce friction. The delivery catheter is designed specifically for use with compatible catheters.
The provided text describes the acceptance criteria and the study that proves the Unity Medical VersaD™ Delivery Catheter meets these criteria. It applies to a medical device, not an AI/ML product, so some of the requested information (like multi-reader multi-case studies, expert ground truth for AI, training sets, etc.) is not applicable and thus cannot be provided from this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are primarily defined by successful completion of various performance tests, biocompatibility tests, and sterilization/shelf-life validations. The "Conclusion" column in the tables below indicates whether the device met these criteria.
Performance Testing - Bench
| Test | Test Method Summary | Acceptance Criteria (Implicit) | Reported Device Performance (Conclusion) |
|---|---|---|---|
| Surface Integrity | The surface of the catheter was evaluated for surface defects. | No surface defects present. | The device met the established criteria. |
| Coating Uniformity | The surface of the catheter was evaluated for coating defects and voids. | No coating defects or voids present. | The device met the established criteria. |
| Device Compatibility | A full-length silicone neurovascular model was used to simulate use. The procedure included using a test catheter with worst-case ancillary devices. | Compatible with ancillary devices in simulated use. | The device was found to be compatible with ancillary devices. |
| Push/Track | Simulated use was performed, and the catheter was tracked through a challenge neurovascular model to determine the deliverability of the subject catheter and compatibility with ancillary devices. | Performed as intended under simulated use conditions. | The device performed as intended under simulated use conditions. |
| Torque Response | The catheter was constrained, torqued, and evaluated. | Maintained integrity and functionality under torque. | The device met the established criteria. |
| Particulate | The catheter was tracked through the tortuous neurovascular model with ancillary devices, and particulate generation was measured. | Particle generation similar to predicate device. | Device particulate generation was similar to the predicate device. |
| Coating Adhesion | The surface of the catheter was evaluated for coating voids after simulated use. | No coating voids after simulated use. | The device met the established criteria. |
| Tip Inspection | The distal tip of the catheter was evaluated. | Distal tip met design specifications. | The device met the established criteria. |
| Dimensional Verification | The catheter dimensional attributes were evaluated and measured. | Dimensions met specified requirements. | The device met the established criteria. |
| Kink Resistance | The proximal and distal sections of the catheter were evaluated using a radius apparatus. | Resistant to kinking under specified conditions. | The device met the established criteria. |
| Liquid Leak Under Pressure | The catheter was evaluated by holding hydrostatic pressure. | No liquid leak under pressure. | The device met the established criteria. |
| Air Leak Under Aspiration | The catheter was evaluated for air leakage into the hub assembly during aspiration. | No air leakage into the hub assembly during aspiration. | The device met the established criteria. |
| Burst Strength | The catheter was pressurized to burst with fluid. | Withstood pressure without bursting up to a specified limit. | The device met the established criteria. |
| Tip Stiffness | The tip buckling force of the catheter was evaluated in comparison with the predicate. | Tip buckling force similar to the predicate. | The tip buckling force was similar to the predicate. |
| Tensile Strength (Tip, Mid Joints, and Hub) | The force required to separate the joints in the catheter was evaluated. | Joints maintained integrity under specified tensile force. | The device met the established criteria. |
| Corrosion | The catheter was evaluated for corrosion. | No corrosion observed. | No corrosion was noted on the catheter. |
| Radiopacity | The catheter marker bands visibility were evaluated under fluoroscopy. | Marker bands visible under fluoroscopy. | The device was visible under fluoroscopy. |
| Delivery and Retrieval Force | The forces to deliver and retrieve the catheter within a neurovascular model were measured. | Delivery and retrieval forces comparable to predicate device. | Delivery and retrieval forces were comparable to the predicate device. |
Biocompatibility
| Test Category | Method | Acceptance Criteria (Implicit) | Result (Reported Device Performance) |
|---|---|---|---|
| Cytotoxicity | MEM Elution with L-929 Cells (ISO 10993-5) | No cytotoxic effects. | Non-Cytotoxic |
| Irritation | Intracutaneous Reactivity Test (ISO 10993-23) | No irritant reaction. | Non-Irritant |
| Sensitization | Guinea Pig Maximization Sensitization Test (ISO 10993-10) | No sensitizing reaction. | Non-Sensitizing |
| Systemic Toxicity | Acute Systemic Injection Test (ISO 10993-11) | No evidence of acute systemic toxicity. | No evidence of Acute Systemic Toxicity |
| Material-Mediated Pyrogenicity | Rabbit Pyrogen test (USP ) | Non-pyrogenic. | Non-Pyrogenic |
| Complement Activation | SC5b-9 Assay (with comparator control) | No complement activation. | Non- Activator |
| Thrombogenicity - In Vitro Blood Flow Loop Assay | In vitro blood flow loop (ISO 10993-4) | Thromboresistant. | Thromboresistant |
| Thrombogenicity - Coagulation | Partial Thromboplastin Time (PTT) Assay Human Blood | No significant effect on PTT. | No effect on the PTT |
| Thrombogenicity - Platelet Leukocyte | Direct contact Platelet Leukocyte Count Test | No significant effect on platelet and leukocyte count. | No effect on the platelet and leukocyte count |
| Hemolysis | Hemolysis Test (ASTM F756) | Non-hemolytic. | Non- Hemolytic |
Sterilization and Shelf Life
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sterilization | Minimum sterility assurance level (SAL) of 10⁻⁶. | EO sterilized to achieve a minimum sterility assurance level (SAL) of 10⁻⁶. |
| Shelf Life (12-month) | Product and packaging remain functional and sterile. | Product and packaging remain functional and sterile for 12 months. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test or biocompatibility test. It indicates that testing was performed to demonstrate substantial equivalence.
Regarding data provenance:
- Country of Origin: Not specified. Standard medical device testing labs and animal models would typically be used.
- Retrospective or Prospective: All testing described is prospective bench and lab testing conducted specifically for this 510(k) submission. It's not based on retrospective clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical catheter, not an AI/ML product requiring expert annotation for ground truth. The "ground truth" for this device is defined by passing established engineering specifications, biocompatibility standards, and sterility validations.
4. Adjudication Method for the Test Set
This is not applicable for a physical medical device. Testing results are typically quantitatively measured or visually assessed against predefined acceptance criteria by qualified personnel, not "adjudicated" by multiple experts in a consensus manner as would be done for image annotation in AI/ML.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not conducted because this is a physical delivery catheter, not an AI-assisted diagnostic device. The study described focuses on the physical and biological performance of the catheter itself, demonstrating substantial equivalence to a predicate device through bench, biocompatibility, and sterility testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance refers to the engineering and biological performance of the catheter independent of human user skill in the tests performed (e.g., measuring burst strength of the catheter itself).
7. The Type of Ground Truth Used
The "ground truth" for this medical device is established by:
- Engineering Specifications/Standards: The device must meet predefined dimensional tolerances, mechanical strength requirements (e.g., tensile strength, burst strength), and functional performance (e.g., push/track, torque response, liquid/air leak).
- Biocompatibility Standards (ISO 10993): Adherence to established biological safety profiles (e.g., non-cytotoxic, non-irritant, non-sensitizing).
- Sterilization Standards: Achieving a specified sterility assurance level.
- Comparison to Predicate Device: Many tests (e.g., particulate generation, tip stiffness, delivery/retrieval force) compare the subject device's performance to that of the legally marketed predicate device to demonstrate substantial equivalence.
It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as it's a delivery catheter.
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device, not an AI/ML system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for a physical medical device, the concept of establishing ground truth for it does not apply.
§ 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).