(149 days)
The CEREBASE DA Guide Sheath is indicated for the introduction of interventional devices into the neuro vasculature.
The CEREBASE DA Guide Sheath is a single lumen, stainless steel braided catheter of variable stiffness with a large non-tapered lumen that facilitates the intravascular passage of interventional devices. The guide sheath is a straight shaped catheter that comes in four lengths; 70 cm, 80 cm, 90 cm, and 95 cm. The lubricious PTFE-lined inner lumen is designed to facilitate delivery of the interventional devices. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The guide sheath has an outer hydrophilic coating at the distal end that reduces friction during use. A hemostasis valve and a dilator are provided with the CEREBASE DA Guide Sheath within its sterile packaging. The dilator is a single lumen radiopaque catheter with a tapered distal end and a luer hub at the proximal end. The dilator is compatible with the CEREBASE DA Guide Sheath and up to 0.038 inch diagnostic guidewires. The hemostasis valve with side port is an off the shelf component used for flushing and insertion of catheters.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for the CEREBASE DA Guide Sheath. This is a medical device, and the study in question is a premarket notification for substantial equivalence to an existing predicate device, not a typical AI/ML performance study. Therefore, some of the requested information regarding AI/ML specific criteria (like human-in-the-loop, training set details, or multiple expert ground truth) is not applicable or not provided in this document.
Here's the breakdown of the acceptance criteria and performance as presented:
Acceptance Criteria and Device Performance for CEREBASE DA Guide Sheath
The acceptance criteria for the CEREBASE DA Guide Sheath are primarily based on non-clinical performance testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (Neuron MAX System).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria were established through various tests designed to ensure the device meets predefined requirements (design inputs) and industry standards (e.g., ISO 10555-1, ISO 11070). The reported performance for all tests was "Pass," indicating that the samples met the established acceptance criteria.
| Test | Acceptance Criteria Summary | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Tests | ||
| Visual Inspection | Meets visual requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Catheter Internal Diameter (ID) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Catheter Outer Diameter (OD) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Catheter Working Length | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Distal Tip Length | Distance of distal marker band edge to tip meets requirements. | Pass. Samples passed established acceptance criteria. |
| Hub Luer Taper | Fits standard luer fittings using a taper device. | Pass. Samples passed established acceptance criteria. |
| Air Leak Test | No air leaks into the hub subassembly (no air bubbles). | Pass. Samples passed established acceptance criteria. |
| Liquid Leak Test | Joint strength meets freedom from leakage requirements (liquid during pressurization) of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Static Burst | Maximum hydrostatic pressure meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Hub Pull Testing | Strength of the catheter hub meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Shaft Tensile Strength | Strength of the catheter shaft meets requirements of ISO 10555-1. | Pass. Samples passed established acceptance criteria. |
| Particulate Count | Quantifies particulate count generated by simulated use. | Pass. Samples passed established acceptance criteria. |
| Coating Lubricity | Measures lubricity; frictional force meets requirements. | Pass. Samples passed established acceptance criteria. |
| Coating Durability | Measures durability of lubricious coating layer. | Pass. Samples passed established acceptance criteria. |
| Coating Length | Hydrophilic coating length meets design requirement. | Pass. Samples passed established acceptance criteria. |
| Kink Resistance | Confirms catheter stability and no kinking during use. | Pass. Samples passed established acceptance criteria. |
| Delamination of PTFE Liner | PTFE appropriately adhered to inner lumen with braid reinforcement. | Pass. Samples passed established acceptance criteria. |
| Backup Support | Measures stability while advancing other interventional devices; force at which catheter support failed meets requirements. | Pass. Samples passed established acceptance criteria. |
| Tip Linear Stiffness | Evaluates flexibility relative to other devices of similar design. | Pass. Samples passed established acceptance criteria. |
| Dilator Visual Inspection | Free of extraneous matter per ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Dilator Inner Diameter (ID) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Hub Luer Taper | Fits standard luer fittings using a tapered device. | Pass. Samples passed established acceptance criteria. |
| Insertion Forces | Measures forces required to insert dilator and catheter into a simulated model. | Pass. Samples passed established acceptance criteria. |
| Dilator Outer Diameter (OD) | Meets requirements. | Pass. Samples passed established acceptance criteria. |
| Dilator Working Length (WL) | Ensures compatibility with the catheter. | Pass. Samples passed established acceptance criteria. |
| Dilator Tensile Strength | Meets requirements of ISO 11070. | Pass. Samples passed established acceptance criteria. |
| Torque (Turns to Failure) | Counts number of turns catheter can withstand without separating. | Pass. Samples passed established acceptance criteria. |
| Trackability | Measures force required to advance catheter through a simulated vascular model. | Pass. Samples passed established acceptance criteria. |
| In Vitro Modeling and In Vivo Testing | Ensures design outputs meet customer requirements (conducted in a porcine model). | Pass. Samples passed established acceptance criteria. |
| Packaging Qualification | ||
| Visual Inspection (Packaging) | Meets visual criteria. | PASS |
| Dye Leak Penetration | No dye penetration. | PASS |
| Seal Strength | Meets strength requirements. | PASS |
| Shelf Life (Packaging) | Confirmed for at least one year through accelerated aging and package integrity testing per ISTA 3A:2018 and EN ISO 11607-1:2009. | PASS (1 year demonstrated). |
| Biocompatibility Testing | (Reference ISO 10993-1, FDA Guidance for Industry and FDA Staff: Use of International Standard ISO-10993) | |
| Cytotoxicity - ISO Elution Method | No discrete intracytoplasmic granules, no cell lysis, no reduction of cell growth; reactivity grade = 0 per ISO 10993-5. | PASS: Non-cytotoxic |
| Sensitization - ISO Guinea Pig Maximization Sensitization | No abnormal dermal reactions and no sensitization observed. | PASS: Non-sensitizing |
| ISO Intracutaneous Reactivity Study | Injection sites appear normal; no difference in erythema and edema scores from control. | PASS: Non-irritating |
| ISO Acute Systemic Toxicity in Mice | Animals appear clinically normal; no deaths; no significant changes in body weight. | PASS: Non-toxic |
| USP Rabbit Material-Mediated Pyrogenicity | No single animal shows total temperature rise of ≥ 0.5 °C, within USP requirements. | PASS: Non-pyrogenic |
| ASTM Hemolysis | Hemolysis % not higher than control (direct contact or extracted samples). | PASS: Non-hemolytic |
| SC5b-9 Complement Activation Assay | SC5b-9 concentration of test article samples not statistically higher than negative control and activated normal human serum (NHS) controls. | PASS: Not a potential activator of the complement system |
| In Vivo Thromboresistance Study | Thrombus formation comparable to control article in similar animal vasculature. | PASS: Acceptable Thromboresistance |
| Sterilization | Sterility assurance level (SAL) of 10^-6 per ISO 11135-1:2014; EO residuals per EN ISO 10993-7:2009. The device and accessories are for single use only. | The device meets these requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document consistently states "Samples passed established acceptance criteria" for the performance tests. However, the specific number of samples tested for each criterion ("sample size") is not explicitly provided in the given text for the non-clinical tests. The document only mentions "test samples" or "samples."
For the In Vitro Modeling and In Vivo Testing, it states "In Vivo testing in a porcine model," indicating animal data.
For Biocompatibility, specific animal numbers are mentioned for certain tests:
- ISO Guinea Pig Maximization Sensitization (Guinea Pigs)
- ISO Acute Systemic Toxicity in Mice (Mice)
- USP Rabbit Material-Mediated Pyrogenicity (3 animals in Pyrogenicity test)
- In Vivo Thromboresistance Study (Implies animal model, potentially porcine as mentioned above for in vivo testing).
The data provenance is from non-clinical testing (bench testing, in vitro, and in vivo animal studies) and laboratory evaluations. The location/country of these studies is not specified, but the submission is from Medos International SARL in Switzerland to the U.S. FDA. The data is prospective as it was collected for the purpose of demonstrating device performance for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for a medical device's performance in a 510(k) submission is established by meeting predefined engineering specifications, adherence to international standards (e.g., ISO), and successful outcomes in validated physical, chemical, and biological tests. There are no human "experts" in the sense of clinicians establishing ground truth from patient data, as this is not an AI/ML diagnostic or prognostic device study.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human-read interpretations of clinical data, typically in studies involving multiple human readers or AI algorithms. The testing here is objective, based on physical and chemical measurements and biological responses.
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 submission is for a percutaneous catheter, not an AI/ML-driven diagnostic or assistive device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or more accurately, the demonstration of acceptable performance) is based on:
- Engineering specifications and design inputs: The device was tested against its own design requirements.
- International standards: Adherence to established standards like ISO 10555-1, ISO 11070, ISO 10993 series, ISO 11135-1, EN ISO 11607-1, and USP requirements.
- Bench testing results: Objective measurements of physical properties (e.g., diameters, lengths, strengths, leaks, lubricity, kinking, torque, trackability).
- In Vitro modeling results: Performance in simulated environments.
- In Vivo animal testing results: Performance in a porcine model to meet customer requirements.
- Biocompatibility test results: Demonstrating no adverse biological reactions based on standard tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, complement activation, thromboresistance).
The comparison is also made against the technological characteristics of a legally marketed predicate device (Neuron MAX System). The conclusion of "substantial equivalence" is the ultimate "ground truth" for regulatory clearance in this context.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm that requires a 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).