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510(k) Data Aggregation
(88 days)
Microwave Ablation Antennas
Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.
Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.
The provided text is a 510(k) summary for the Canyon Medical Inc. Microwave Ablation Antennas (K241825). This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a clinical study to prove device performance against specific acceptance criteria in a human clinical trial setting.
Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this type of regulatory submission. These details are typically found in clinical study reports.
However, based on the non-clinical test summary, we can infer some "acceptance criteria" related to the device's engineering performance and safety.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for clinical performance and corresponding device performance data from a clinical study. Instead, it lists non-clinical tests and states that the "results from testing performed confirm the design requirements." This implies that the device met the acceptance criteria for each listed non-clinical test.
| Aspect | Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 standards for medical electrical equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 standards for EMC of medical electrical equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Specific Performance | Compliance with IEC 60601-2-6 standards specific to Microwave Ablation Equipment. | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Thermal Effects & Temp. Monitoring | Performance as per FDA Guidance: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. (Implies achieving expected thermal ablation zones and accurate temperature monitoring). | "Results from testing performed confirm the design requirements." (i.e., Met criteria) |
| Biocompatibility | Compliance with ISO 10993 series standards for biological evaluation of medical devices (for an externally communicating device with tissue for limited duration |
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