(98 days)
The TLAB® Transvenous Liver Biopsy System is intended to be used for percutaneous transjugular and transfemoral venous liver access during diagnostic and interventional procedures.
The TLAB® Transvenous Liver Biopsy System is a single use, disposable, sterile device. The TLAB® Transvenous Liver Biopsy System consists of the following components: 18-Gauge (18Ga) Flexcore Biopsy Needle, 7 French (7Fr) Introducer Sheath with a curved metal stiffener, 5 French (5Fr) Straight Catheter, 5 French (5Fr) Curved Catheter, Tissue Removal Swabs, Bending Tool (used for transfemoral access).
Here's a breakdown of the acceptance criteria and study information for the TLAB® Transvenous Liver Biopsy System, based on the provided text:
This document describes a medical device (TLAB® Transvenous Liver Biopsy System) not an AI/ML device, therefore, sections related to AI/ML specific criteria (such as MRMC studies, standalone algorithm performance, training set details) are not applicable.
Acceptance Criteria and Reported Device Performance
Device Trade Name: TLAB® Transvenous Liver Biopsy System (TF-18C)
Regulation Number: 21 CFR 870.1340 - Catheter Introducer
Regulatory Class: Class II
Product Code: DYB
The device demonstrated substantial equivalence to predicate devices (TLAB® Transjugular Liver Access Set K022634 and Traveler Portal Vein Access Set K213638) based on a comparison of technological characteristics, indications for use, materials, packaging, principle of operation, design features, sterilization process, and in-vitro performance testing.
| Acceptance Criteria Category | Specific Criteria / Test Performed | Reported Device Performance / Outcome |
|---|---|---|
| Performance Testing | Dimensional | Met acceptance criteria |
| Visual | Met acceptance criteria | |
| Radiopacity | Met acceptance criteria | |
| Corrosion Resistance | Met acceptance criteria | |
| Simulated Use | Met acceptance criteria | |
| Tensile Strength | Met acceptance criteria | |
| Torque Strength | Met acceptance criteria | |
| Liquid Leakage | Met acceptance criteria | |
| Luer Functional Testing (ISO 80369-7) | Met acceptance criteria | |
| Catheter Functional Testing (ISO 10555-1) | Met acceptance criteria | |
| Resistance to Breakage (ISO 9626) | Met acceptance criteria | |
| Shipping Qualification Testing | Met acceptance criteria | |
| Design Validation | Met acceptance criteria | |
| Summative Usability | Met acceptance criteria | |
| Biocompatibility (ISO 10993-1:2020) | Cytotoxicity (ISO 10993-5) | Previously performed, applicable to new device; met criteria |
| Sensitization (ISO 10993-23) | Previously performed, applicable to new device; met criteria | |
| Irritation or Intracutaneous Reactivity (ISO 10993-10) | Previously performed, applicable to new device; met criteria | |
| Material Mediated Pyrogen (ISO 10993-11) | Previously performed, applicable to new device; met criteria | |
| Acute Systemic Toxicity (ISO 10993-11) | Previously performed, applicable to new device; met criteria | |
| Hemocompatibility (ISO 10993-4): ASTM Hemolysis Assay, Direct and Extract Methods (ISO) | Previously performed, applicable to new device; met criteria | |
| Hemocompatibility (ISO 10993-4): Complement Activation Assay, SC5b-9 Method with Comparison Article (ISO) | Performed anew; met criteria | |
| Hemocompatibility (ISO 10993-4): Partial Thromboplastin Time (PTT) Assay with Comparison Article (ISO) | Performed anew; met criteria | |
| Hemocompatibility (ISO 10993-4): Heparinized Platelet and Leukocyte Count Assay with Comparison Article (ISO) | Performed anew; met criteria | |
| Sterilization | Minimum SAL 10-6, EtO | Met acceptance criteria |
| Shelf-Life | 3 years | Met acceptance criteria (based on predicate) |
Study Details
-
Sample size used for the test set and the data provenance:
- The document primarily describes bench-top testing (in-vitro performance) and biocompatibility testing. Specific sample sizes for each non-clinical test are not explicitly stated in the provided text, but it mentions that "A series of testing was conducted".
- Data Provenance: All studies were performed following approved protocols under Good Laboratory Practices (GLP) in compliance with FDA GLP, 21 CFR Part 58. This indicates the testing was conducted in a controlled laboratory environment. No specific country of origin or retrospective/prospective nature for these non-clinical tests is given beyond GLP compliance.
-
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 the described studies are non-clinical, bench-top performance and biocompatibility tests. They do not involve human interpretation or subjective clinical "ground truth" that would require expert consensus. The acceptance criteria themselves serve as the 'ground truth' for these engineering and materials tests.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as the described studies are non-clinical, bench-top performance and biocompatibility tests. Adjudication methods are typically used in clinical studies or studies involving subjective human interpretation (e.g., image reading) where disagreement among experts needs resolution.
-
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 as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. Therefore, no MRMC comparative effectiveness study was performed in the context of AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no algorithm to test in a standalone manner.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Performance Testing: The "ground truth" is defined by the acceptance criteria established in accordance with protocols based on guidance and industry standards. These include established engineering and material science standards (e.g., ISO for luer, catheter, and breakage testing) that define acceptable performance.
- For Biocompatibility Testing: The "ground truth" is defined by the internationally recognized standards for biocompatibility (ISO 10993 series) and FDA Guidance, which specify test methods and acceptable limits for biological responses.
-
The sample size for the training set:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device. There is no machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- This question is not applicable as this document describes a conventional medical device (a biopsy system), not an AI/ML powered device.
§ 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).