(251 days)
The Embolx Occlusion Balloon Catheter is intended for use in the peripheral vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Embolx Occlusion Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.
The Embolx Occlusion Balloon Catheter is a coaxial dual lumen device that consists of an occlusion balloon at the distal end with two embedded radiopaque bands to allow for visualization and positioning of the device under fluoroscopic guidance. The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by EtO and is intended for single use. The occlusion catheter has an outside diameter of 2.9F proximally and 2.2F distally. The occlusion balloon on the distal end can be inflated up to 5mm in diameter and 11mm in length. The usable length of the device is 110cm. The device can withstand an infusion pressure up to 900 psi.
This document is a 510(k) premarket notification for a medical device called the Embolx Occlusion Balloon Catheter. It is a submission to the FDA seeking to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative testing rather than detailed novel performance criteria and studies as would be expected for a de novo submission or a device with new indications.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, pass/fail manner for many of the tests listed. Instead, it states that "all testing was conducted on sterilized and aged test articles" and that "Substantial equivalence was demonstrated through the following non-clinical testing." This implies that the device met whatever internal or recognized standard criteria existed for each test to demonstrate equivalence.
Here's a table based on the "Summary of Supporting Data" with reported performance being that the device "demonstrates substantial equivalence" or "is as safe, as effective, and performs as well as or better than the predicate device."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | No cytotoxic effects | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Sensitization | No sensitization | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Irritation | No irritation | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Acute Systemic Toxicity | No acute systemic toxicity | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Complement Activation (C3a and Sc5b-9) | Acceptable levels of complement activation | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Hemocompatibility (ASTM Hemolysis) | Acceptable levels of hemolysis (direct and indirect) | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Hemocompatibility (In-vivo Thrombogenicity) | Acceptable levels of thrombogenicity in a canine model | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Hemocompatibility (PTT & PT) | No significant interference with coagulation times | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Pyrogenicity (LAL) | No pyrogenic response | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Material-mediated Pyrogenicity | No material-mediated pyrogenic response | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Sterilization Validation | Validation of sterilization process effectiveness | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Packaging Seal Integrity | Maintenance of sterile barrier and seal integrity | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Dye Penetration | No dye penetration into packaging | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Transit Testing | Packaging integrity maintained after transit simulation | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Dimensional Verification | Device dimensions meet specifications (e.g., 2.9F proximally, 2.2F distally, 5mm diameter, 11mm length for balloon, 110cm usable length) | Verified to specifications (implied, as part of demonstrating substantial equivalence) |
| Balloon Prep, Deployment, & Retraction | Successful preparation, deployment, and retraction in simulated use | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Balloon Rated Burst Volume | Balloon withstands specified burst pressure | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Balloon Fatigue | Balloon maintains integrity over repeated inflation/deflation cycles | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Balloon Compliance | Balloon inflates and conforms as expected | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Balloon Inflation/Deflation Time | Inflation/deflation within acceptable timeframe | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Balloon Position Test | Radiopaque markers visible for accurate positioning | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Catheter Bond Strength (tensile) | Bonds withstand required tensile forces | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Tip Pull Strength (tensile) | Tip withstands required tensile forces | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Flexibility & Kink Test | Device demonstrates adequate flexibility and resistance to kinking | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Torque Strength | Device transmits torque adequately without damage | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Radiopacity | Device/markers are visible under fluoroscopy | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Coating Integrity | Coating remains intact | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Catheter Body Burst Test | Catheter body withstands specified burst pressure | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Catheter Body Leakage Test | Catheter body exhibits no leakage | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Contrast Media Flow Rate | Contrast media flows at an acceptable rate | Satisfactory (implied, as part of demonstrating substantial equivalence) |
| Corrosion Resistance | Device materials exhibit adequate corrosion resistance | Satisfactory (implied, as part of demonstrating substantial equivalence) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical testing" which typically refers to bench testing, in-vitro (e.g., cytotoxicity, hemolysis), and animal studies (in-vivo thrombogenicity in canine).
- Sample sizes: Specific sample sizes for each test are not provided in this summary.
- Data provenance: Not specified. Given it's a 510(k) for a US market, the testing likely adheres to US or international standards (e.g., ISO for biocompatibility). The in-vivo thrombogenicity study was done using canine models, which is an animal model. All tests appear to be prospective in nature, as they were conducted to support the submission.
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 is a medical device submission, not an AI software submission. Therefore, the concept of "ground truth" as established by human experts (e.g., radiologists) for a test set of images or data relevant to an AI algorithm does not apply here. The "truth" for these tests is based on objective laboratory measurements, physical testing parameters, and established biocompatibility standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is also not applicable as it pertains to expert consensus for data labeling (ground truth) relevant to AI/diagnostic software. The testing outlined for this medical device involves physical, mechanical, and biological evaluations, not expert adjudication of clinical cases.
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 question is not applicable. This is a submission for a physical medical device (an occlusion balloon catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or assessment of human reader improvement with AI assistance would have been performed or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. No algorithm performance is being evaluated for this physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained in point 3, the concept of "ground truth" for expert consensus on images or outcomes data for an AI algorithm is not applicable. The "truth" in this context is defined by:
- Physical measurements: For dimensional verification, tensile strength, burst pressures, flow rates.
- Chemical/Biological assays: For cytotoxicity, sensitization, irritation, acute systemic toxicity, complement activation, LAL (pyrogenicity), PTT/PT.
- In-vivo observations/histopathology: For in-vivo thrombogenicity in canine models.
- Industry/Regulatory Standards: Adherence to recognized standards for sterility, packaging, and biocompatibility.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. No training set or associated ground truth for an AI algorithm is involved in this medical device submission.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).