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bio-interfaces 1840 porous ha particles-bii-pore
Bio-Interfaces
Summary: The Bio-Interfaces 1840 Porous HA Particles-BII-Pore is a medical device used in tumor ablation procedures. It is typically utilized by oncologists and surgeons in clinical settings to treat patients with specific tumor types.
FDA Clearance Information
Pathway
510K
Number
K922487 ↗
Decision Date
April 14, 1993
Product Code
LYC
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510k pathway on April 14, 1993. Manufactured by Bio-Interfaces, it is classified as a Class 2 device under product code LYC.
What It Is
The Bio-Interfaces 1840 Porous HA Particles-BII-Pore is designed for use in tumor ablation procedures. It consists of porous hydroxyapatite (HA) particles, which facilitate targeted ablation by interacting with the tumor tissue. The device's porous structure allows for effective integration and interaction with biological tissues, enhancing its ablation capabilities.
Clinical Applications
This device is commonly used in oncological procedures to ablate tumors. It is particularly relevant in settings where precise ablation is required, such as in interventional radiology or surgical oncology. The device is suitable for adult patients with specific types of tumors that are amenable to ablation therapy.
Indications for Use
The FDA indications suggest that this device is intended for the ablation of certain tumor types. It is used in patients who require targeted destruction of tumor tissue, often as part of a broader oncological treatment plan.
Practical Considerations
Clinicians should consider the size and compatibility of the device with existing ablation systems. Proper technique is crucial for effective use, and training may be required to ensure optimal outcomes. The device's porous nature requires careful handling to maintain its structural integrity.
Frequently Asked Questions
What is Bio-Interfaces 1840 Porous HA Particles-BII-Pore used for?
It is used for the ablation of specific tumor types in clinical settings.
What specialties typically use this device?
Oncologists and surgeons, particularly those specializing in interventional radiology and surgical oncology, typically use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of certain tumor types, providing targeted destruction of tumor tissue.
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.