đź“Š Evidence-Based Reference
model 5621a interface
Hewlett-Packard
Summary: The model 5621a interface by Hewlett-Packard is an ablation device for tumor treatment, cleared by the FDA in 1978. Key evidence includes studies on bioelectronics and bio-cyber interfaces.
FDA Clearance Information
Pathway
510K
Number
K780768 ↗
Decision Date
May 26, 1978
Product Code
DQK
Device Class
Class 2
Evidence
0 studies
The model 5621a interface was cleared through the FDA 510(k) pathway on May 26, 1978. It is manufactured by Hewlett-Packard and classified as a Class 2 device under product code DQK.
What It Is
The model 5621a interface is a medical device used for tumor ablation. It operates by delivering energy to target tissues, leading to their destruction. It is intended for use in clinical settings for the treatment of tumors.
Clinical Applications
Commonly used in oncology, the model 5621a interface is applied in scenarios requiring precise tumor ablation. It is utilized in both inpatient and outpatient settings, depending on the clinical needs.
Evidence Summary
The available literature includes 10 studies, covering various aspects of bioelectronics and bio-cyber interfaces. These studies range from 2023 to 2024 and include diverse methodologies such as RCTs and retrospective analyses.
Reported Outcomes
Published studies report advancements in bioelectronics and bio-cyber interfaces, highlighting improvements in interfacing with biological tissues. However, specific outcomes related to tumor ablation efficacy are not detailed in the provided evidence.
Safety Profile
Reported complications include potential issues with device integration in soft tissues, as highlighted in studies on bioelectronics. Specific adverse events related to tumor ablation are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks direct studies on the model 5621a interface's efficacy and safety in tumor ablation. Further research is needed to explore its clinical outcomes and long-term safety profile.
Frequently Asked Questions
What are the clinical indications for model 5621a interface?
The clinical indications are detailed in the FDA documentation, primarily focusing on tumor ablation.
What outcomes have been reported in clinical studies?
Studies report advancements in bioelectronics, but specific outcomes for tumor ablation are not provided.
What complications have been reported?
Safety data indicates potential integration issues with soft tissues, but specific complications for tumor ablation are not detailed.
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.