(168 days)
The Scorpion Portal Vein Access Sets are intended for transjugular liver access in diagnostic and interventional procedures.
The Scorpion Portal Vein Access Sets have two models. One model has a Stylet as the puncture tool and the other model has a 17ga Needle as the puncture tool. The Scorpion Stylet Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA catheter, a 14ga Stiffening Cannula, a 0.040" Nitinol Stylet with a 5Fr PEEK Catheter, and a 7F Cannula Sheath. The 14ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171") sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Stylet Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (0.040" Stylet) through the parenchyma. The puncture tool (Stylet) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Stylet Portal Vein Access Set components are removed.
The Scorpion Needle Portal Vein Access Set contains a 10F Introducer Sheath, a 10F Dilator, a 5F MPA Catheter, a 13ga Scorpion Stiffening Cannula, 17ga Nitinol Needle, a 6.2F PEEK Catheter, and 8F Sheath Introducer. The 13ga stiffening cannula with cannula sheath has a directional handle that indicates the direction of the curve. The 17ga Nitinol Needle has a directional handle that indicates the direction of the 10F Introducer Sheath hemostatic valve is designed to be compatible with up to 13F (4.3mm/0.171″) sleeve. These components are used to create a pathway through the liver parenchyma through which an endoprosthetic can be delivered. The Scorpion Needle Portal Vein Access Set is used to gain access to the hepatic vein and guide a sharp puncture tool (17ga Needle) through the parenchyma. The puncture tool (Needle) is used to make a pathway from the hepatic vein to the portal vein, and then the pathway is dilated to provide access for a larger sheath. The shunt is inserted through the sheath and deployed through the pathway. Then, all of the Scorpion Needle Portal Vein Access Set components are removed.
A Portal Vein Access Set is typically in use in procedures up to 4 hours.
The provided document is a 510(k) summary for the Scorpion Portal Vein Access Set. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
For medical devices applying for 510(k) clearance, the primary study conducted is generally non-clinical performance testing and biocompatibility testing, rather than clinical studies involving human patients or complex AI algorithm performance analysis. The goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove superior or improved efficacy through a comparative effectiveness study involving human readers with and without AI assistance.
Therefore, the requested information pertaining to AI studies (MRMC studies, standalone AI performance, number of experts for ground truth, sample size for training set, etc.) is not applicable to this type of device clearance.
Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets those criteria:
1. A table of acceptance criteria and the reported device performance
The document lists various performance and biocompatibility tests conducted to demonstrate substantial equivalence to the predicate device. For each test, the implicit acceptance criterion is that the device meets the requirements outlined in the protocols based on guidances and industry standards. The reported device performance is stated as "shown to meet the acceptance criteria" or "meets the requirements for its intended use." Specific quantitative results or detailed pass/fail thresholds for each individual test are generally not included in a 510(k) summary, as it focuses on the conclusion of equivalence rather than the raw data.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Performance Testing | Dimensional and Functional Fit | Met acceptance criteria / Requirements for intended use fulfilled |
| Surface Inspection | Met acceptance criteria / Requirements for intended use fulfilled | |
| Component Compatibility | Met acceptance criteria / Requirements for intended use fulfilled | |
| Tensile Strength | Met acceptance criteria / Requirements for intended use fulfilled | |
| Torque Strength Test | Met acceptance criteria / Requirements for intended use fulfilled | |
| Liquid Leakage | Met acceptance criteria / Requirements for intended use fulfilled | |
| Air Leakage | Met acceptance criteria / Requirements for intended use fulfilled | |
| Corrosion Resistance | Met acceptance criteria / Requirements for intended use fulfilled | |
| Simulative Use | Met acceptance criteria / Requirements for intended use fulfilled | |
| Radiopacity | Met acceptance criteria / Requirements for intended use fulfilled | |
| Echogenicity | Met acceptance criteria / Requirements for intended use fulfilled | |
| Luer Connector Functional Testing | Met acceptance criteria / Requirements for intended use fulfilled | |
| Burst Pressure | Met acceptance criteria / Requirements for intended use fulfilled | |
| Flow Rate | Met acceptance criteria / Requirements for intended use fulfilled | |
| Resistance to Fracture Testing | Met acceptance criteria / Requirements for intended use fulfilled | |
| Shipping Test | Met acceptance criteria / Requirements for intended use fulfilled | |
| Biocompatibility Testing | Cytotoxicity (ISO 10993-5) | Met acceptance criteria / Requirements for intended use fulfilled |
| Sensitization (ISO 10993-10) | Met acceptance criteria / Requirements for intended use fulfilled | |
| Intracutaneous Irritation (ISO 10993-10) | Met acceptance criteria / Requirements for intended use fulfilled | |
| Acute Systemic Toxicity (ISO 10993-11) | Met acceptance criteria / Requirements for intended use fulfilled | |
| Material Mediated Pyrogen (ISO 10993-11) | Met acceptance criteria / Requirements for intended use fulfilled | |
| Hemocompatibility (ISO 10993-4) | Met acceptance criteria / Requirements for intended use fulfilled | |
| - ASTM Hemolysis Direct/Indirect Contact | Met acceptance criteria / Requirements for intended use fulfilled | |
| - Complement Activation, SC5b-9 | Met acceptance criteria / Requirements for intended use fulfilled | |
| - Thrombogenicity | Met acceptance criteria / Requirements for intended use fulfilled | |
| - Platelet and Leucocyte Counts | Met acceptance criteria / Requirements for intended use fulfilled | |
| - Partial Thromboplastin Time (PTT) | Met acceptance criteria / Requirements for intended use fulfilled |
2. Sample size used for the test set and the data provenance
The document does not specify the precise sample sizes for each of the non-clinical performance or biocompatibility tests. These tests typically involve a defined number of devices or material samples as per the relevant ISO or ASTM standards.
Regarding data provenance, the testing was conducted non-clinically and is typically performed at the manufacturer's facility or by a contract testing organization. The document refers to "protocols based on requirements outlined in guidances and industry standards," implying controlled laboratory settings. There is no mention of geographical data provenance for test sets (e.g., country of origin), as this is not a clinical study. The studies are prospective in the sense that they were designed and executed to specifically test the device for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is a 510(k) submission for a physical medical device (catheter introducer) and involves non-clinical performance and biocompatibility testing, not AI/imaging studies that require expert annotation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or imaging studies where human interpretation or consensus is required to establish ground truth or assess outcomes. These are not relevant for bench testing of physical device properties.
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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-powered diagnostic devices or imaging interpretation aids, which is not the case for the Scorpion Portal Vein Access Set. The device is a surgical access tool, not an AI or imaging product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device does not incorporate an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance and biocompatibility tests, the "ground truth" is established by the defined acceptance criteria within established industry standards (e.g., ISO, ASTM) and internal protocols. For example, a tensile strength test would have a specified minimum breaking strength required by the device's design specifications. Biocompatibility tests have specific endpoints and thresholds defined by ISO 10993 series standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth as these are not clinical or diagnostic studies.
8. The sample size for the training set
This question is not applicable. This device is a physical medical device and does not involve AI algorithms that require a "training set."
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).