(24 days)
The Scorpion Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.040" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip) and a 14ga Stiffening Cannula with a 7F Cannula Sheath or 17ga Needle with a 6.2F Catheter (separated with a removable spacer clip) and a 13ga Stiffening Cannula with an 8F Cannula Sheath. The stiffening cannulas and the stylet/needle puncturing tools have curved distal ends, with directional handles that indicate the direction of the curves, which facilitate access into the hepatic vasculature and the creation of a pathway into the portal vein.
The provided text describes a 510(k) premarket notification for a medical device called the "SCORPION Portal Vein Access Set." This report is for a device and not an AI/ML product, so many of the requested fields are not applicable.
Here's the information gleaned from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Fit | Met |
| Hemostasis | Met |
| Leak | Met |
| Simulative Use (including component compatibility) | Met |
| Radiopacity (leveraged from predicate) | Met |
| Echogenicity (leveraged from predicate) | Met |
| Corrosion Resistance (leveraged from predicate) | Met |
| Dimensional & Functional Fit (leveraged from predicate) | Met |
| Tensile Strength (leveraged from predicate) | Met |
| Torque Strength Test (leveraged from predicate) | Met |
| Liquid Leakage (leveraged from predicate) | Met |
| Air Leakage (leveraged from predicate) | Met |
| Burst Pressure (leveraged from predicate) | Met |
| Flow Rate (leveraged from predicate) | Met |
| Simulative Use - performance testing including dimensional, surface and compatibility of components (leveraged from predicate) | Met |
| Luer Functional Testing (leveraged from predicate) | Met |
| Shipping Test (leveraged from predicate) | Met |
| Resistance to Fracture Testing (leveraged from predicate) | Met |
| Biocompatibility (leveraged from predicate): Cytotoxicity (ISO 10993-5) | Met |
| Biocompatibility (leveraged from predicate): Sensitization (ISO 10993-10) | Met |
| Biocompatibility (leveraged from predicate): Intracutaneous Irritation (ISO 10993-10) | Met |
| Biocompatibility (leveraged from predicate): Acute Systemic Toxicity (ISO 10993-11) | Met |
| Biocompatibility (leveraged from predicate): Material Mediated Pyrogen (ISO 10993-11) | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - ASTM Hemolysis – Direct and Indirect Contact | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Complement Activation, SC5b-9 | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - In Vivo Thrombogenicity | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Platelet and Leucocyte counts | Met |
| Biocompatibility (leveraged from predicate): Hemocompatibility (ISO10993-4) - Partial Thromboplastin Time (PTT) | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a distinct "test set" in the context of an AI/ML model. The evaluation is based on non-clinical performance and biocompatibility testing of the physical medical device and its components. No information is provided regarding data provenance as this is not a data-driven AI/ML study.
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)
Not applicable. This is a medical device submission, not an AI/ML study relying on expert-established ground truth from images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device submission, not an AI/ML study requiring adjudication of expert interpretations.
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 is a medical device submission, not an AI/ML assistance device.
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. Performance is assessed through non-clinical testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is established through engineering and biocompatibility standards and specifications. For example, "Hemostasis" acceptance criteria would be based on validated methods to demonstrate the device prevents blood leakage, not expert consensus on images.
8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI/ML product that undergoes a training phase.
9. How the ground truth for the training set was established
Not applicable. This is a medical device submission, not an AI/ML product.
§ 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).