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sira rfa electrosurgical device
Innoblative Designs
Summary: The SIRA RFA Electrosurgical Device is used for radiofrequency ablation, primarily in breast conserving surgeries. It is utilized by surgical oncologists to assist in tumor removal.
FDA Clearance Information
Pathway
510K
Number
K232947 ↗
Decision Date
December 12, 2023
Product Code
GEI
Device Class
Class 2
Evidence
0 studies
The SIRA RFA Electrosurgical Device, manufactured by Innoblative Designs, received FDA clearance via the 510k pathway on December 12, 2023. It is a Class 2 medical device.
What It Is
The SIRA RFA Electrosurgical Device is a radiofrequency ablation tool designed to assist in surgical procedures by delivering controlled thermal energy to target tissues. It is particularly useful in oncology for ablating tumor margins during breast conserving surgery, helping to ensure complete removal of cancerous cells while preserving healthy tissue.
Clinical Applications
This device is primarily used in surgical oncology, especially in breast conserving surgeries where precise ablation of tumor margins is critical. It is typically employed in hospital operating rooms by surgical oncologists. The device is suitable for adult patients undergoing procedures to remove breast tumors, aiming to improve surgical outcomes and reduce recurrence rates.
Indications for Use
The FDA has cleared the SIRA RFA Electrosurgical Device for use in procedures requiring tissue ablation, specifically as an adjunct in breast conserving surgeries. It is intended for patients with breast tumors where precise margin ablation is necessary.
Practical Considerations
The device is compatible with standard electrosurgical units and requires proper training for effective use. It is important to consider the size of the ablation zone and adjust settings based on the specific surgical scenario. Proper technique is crucial to avoid damage to surrounding healthy tissues.
Related Literature
The linked study investigated the feasibility of using the SIRA-1000, a model of the SIRA RFA Electrosurgical Device, as an adjunct in breast conserving surgery. Although detailed findings are not available, the study likely focused on the device's safety, effectiveness, and integration into surgical workflows. Limitations may include a small sample size or lack of long-term outcome data.
Frequently Asked Questions
What is the SIRA RFA Electrosurgical Device used for?
It is used for radiofrequency ablation in surgical procedures, particularly in breast conserving surgeries to ablate tumor margins.
What specialties typically use this device?
Surgical oncologists, particularly those specializing in breast cancer surgeries, commonly use this device.
What are the FDA-cleared indications?
The device is cleared for tissue ablation as an adjunct in breast conserving surgeries to improve tumor removal outcomes.
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.