(193 days)
The Next Generation Access Catheter is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
The Next Generation Access Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liguids through the system. The Next Generation Access Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Next Generation Access Catheter is visible under fluoroscopy. The Next Generation Access Catheter dimensions are included on the individual device label. The Next Generation Access Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Next Generation Access Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use only.
The provided text describes the 510(k) premarket notification for the "Next Generation Access Catheter" (K234074). This documentation focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a study involving human readers with or without AI assistance, or any specific AI component that would require a ground truth established by experts. Therefore, many of the requested sections related to AI performance, sample sizes for test/training sets, expert qualifications, and adjudication methods are not applicable here.
Here's a summary of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for each test but rather states whether the device "Passed" or "Met requirements." The "Test Method Summary" implicitly defines the criteria being evaluated.
| Test | Test Method Summary | Reported Device Performance (Results) |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity - MEM Elution | Tested in accordance with ISO 10993-5 | Pass (Considered non-cytotoxic) |
| Hemocompatibility - Hemolysis (Direct Contact & Extract Method) | Tested in accordance with ISO 10993-4 | Pass (Considered non-hemolytic) |
| Hemocompatibility - Complement Activation SC5b-9 Assay | Tested in accordance with ISO 10993-4 | Pass (Requirements met) |
| Hemocompatibility - Partial Thromboplastin Time (PTT) | Tested in accordance with ASTM F2382-18 | Pass (Requirements met) |
| Hemocompatibility – Blood Platelet and Leukocyte Count (PLC) | Tested in accordance with ASTM F2888-19 | Pass (Requirements met) |
| Hemocompatibility - Comparative Surface Assessment | Visually inspected at more than 40x magnification. | Pass (Requirements met) |
| Hemocompatibility - Thrombogenicity in a Canine Model | Tested in accordance with ISO 10993-4 | Pass (Performed similarly to comparator) |
| Pyrogenicity - Material-Mediated Rabbit Pyrogen | Tested in accordance with USP 151 | Pass (Requirements met) |
| Sensitization - Guinea Pig Maximization Sensitization | Tested in accordance with ISO 10993-10 | Pass (Did not elicit a sensitization response) |
| Systemic Toxicity - Acute Systemic Injection | Tested in accordance with ISO 10993-11 | Pass (Requirements met) |
| Irritation - Intracutaneous Reactivity | Tested in accordance with ISO 10993-23 | Pass (Requirements met) |
| Physical and Mechanical Performance | ||
| Dimensional Verification | Catheter outer diameter, inner diameter, usable length, tip length, and coating length were measured. | Pass |
| Surface Contamination | Visual inspection completed for surface defects. | Pass |
| Tensile Strength | Peak tensile force evaluated per ISO 10555-1 after preconditioning in a simulated use model. | Pass |
| Kink Resistance | Evaluated after preconditioning in a simulated use model. | Pass |
| Liquid Leakage | Exposed to liquid pressure for 30 seconds; inspected for leakage per ISO 10555-1. | Pass |
| Air Leakage | Tested for air leakage into the hub per ISO 10555-1. | Pass |
| Dynamic Burst | Verified ability to withstand internal liquid pressure under dynamic flow conditions with distal end open. | Pass |
| Torque Strength | Measured number of catheter rotations until failure after preconditioning in a simulated use model and compared to predicate. | Pass |
| Hub Validation Testing | Met established acceptance criteria per ISO 80369-7. | Pass |
| Particulate Matter | Underwent simulated use testing; particulate testing conducted including a reference device for comparison. | Pass |
| Tip Buckling | Maximum force to cause catheter tip buckling while constrained at varying distances was measured. | The tip stiffness was comparable to the predicate and other cleared catheters. |
| Corrosion | Tested per ISO 10555-1. | No evidence of corrosion and met requirements per ISO 10555-1. |
| Static Burst | Distal tip blocked, fluid injected at increasing pressure until burst (per ISO 10555-1); compared static burst pressure with maximum pressure generated with manual syringe injection. | Pass |
| Coating Integrity | Inspected before and after preconditioning through a simulated use model. | No evidence of surface damage or coating defects. |
| Saline and Contrast Exposure | After device use to deliver saline and contrast media, inspected for damage, and dimensional attributes measured. | No visual evidence of damage or dimensional changes. |
| Radiopacity (Visibility) | Tested to demonstrate acceptable radiopacity. | Marker radiopacity is comparable to the predicate. |
| Design Validation / Usability | Subject and predicate devices prepared per IFU and tested for usability in a clinically relevant anatomical model. | Device preparation, introduction, trackability, and retrieval were comparable to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test conducted. The provenance of the data is from Balt USA, LLC and describes non-clinical bench testing. There is no mention of human data, so concepts like "country of origin of the data" or "retrospective or prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The tests performed are engineering and biocompatibility tests on a physical medical device, not a diagnostic algorithm requiring ground truth established by medical experts.
4. Adjudication Method for the Test Set
This section is not applicable. There was no human interpretation or subjective assessment that would require an adjudication method.
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 section is not applicable. This submission is for a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This submission is for a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, USP) and the physical properties and performance characteristics of the device itself (e.g., directly measured dimensions, observed leakage, visual inspection for defects, comparison to a predicate device's performance).
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. There is no "training set" as this is not an AI/machine learning device.
§ 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).