📊 Evidence-Based Reference
Liver Access and Biopsy Sets
Summary: Liver access and biopsy sets by Cook are used for liver tissue sampling. Cleared by FDA via 510k pathway. Key evidence includes AI models predicting molecular profiles in liver conditions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K171853 ↗
Decision Date ?
August 24, 2017
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The liver access and biopsy sets by Cook were cleared by the FDA through the 510k pathway on August 24, 2017. They are classified as Class 2 devices under product code DYB.
What It Is
Liver access and biopsy sets are medical devices designed to obtain liver tissue samples for diagnostic purposes. They facilitate percutaneous access to the liver, allowing for tissue extraction and analysis.
FDA-Cleared Indications
- Percutaneous access to the liver for obtaining tissue samples.
- Collection of liver tissue for histopathological examination and diagnostic evaluation.
Clinical Applications
- Sampling liver tissue when evaluation of liver disease requires histopathology.
- Obtaining tissue from a suspected focal liver lesion when a biopsy is clinically indicated.
- Percutaneous liver biopsy performed with imaging guidance, such as ultrasound or computed tomography.
Evidence Summary
The available literature includes 10 studies, covering various research types such as RCTs, prospective, and retrospective studies. The studies span recent years, providing insights into the device's clinical utility.
Reported Outcomes
Published studies report that AI models can predict outcome-related molecular profiles and the presence of microvascular invasion in liver conditions. These findings suggest potential clinical utility in personalized management of liver diseases.
Safety Profile
Reported complications include potential risks associated with percutaneous liver access, such as bleeding and infection. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence base is limited by a lack of large-scale RCTs directly evaluating the device's efficacy and safety. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Practical Considerations
- The available needle, introducer and biopsy components vary by set and should be selected for the target lesion, access route and required sample.
- The procedure is commonly performed through a percutaneous transhepatic route using ultrasound or CT guidance, with local anesthetic and sometimes moderate sedation.
- Bleeding risk, infection, injury to nearby organs and inadequate tissue sampling should be assessed before the procedure. Coagulation abnormalities and ascites may require correction or may make biopsy unsuitable.
- MRI safety and conditional-use information must be confirmed in the specific product labeling. Do not bring an unverified set into the MRI environment.
- These are generally single-use devices. They should not be reused or resterilized unless the labeling specifically permits it.
Frequently Asked Questions
What are the clinical indications for liver access and biopsy sets?
They are indicated for obtaining liver tissue samples for diagnostic purposes, particularly in liver disease evaluation.
What outcomes have been reported in clinical studies?
AI models have been shown to predict molecular profiles and microvascular invasion in liver conditions.
What complications have been reported?
Reported complications include bleeding and infection, though specific safety data is limited in the provided evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.