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510(k) Data Aggregation
(88 days)
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 < 24h). | "Relevant tests are conducted as per ISO 10993 series standards." and "meet ISO 10993 biocompatibility requirements." (i.e., Met criteria) |
| Package Validation | Maintenance of sterility and integrity per ISO 11607-1 and ISO 11607-2. | "The integrity performance as per ISO 11607-1 and ISO 11607-2 is carried out." (Implies Met criteria, as no issues are reported). |
| Transport | Packaging integrity maintained after compression, vibration, and shock tests. | "The result indicates that packaging is not damaged." (i.e., Met criteria) |
| Shelf Life | Device functionality and safety maintained after accelerated aging equivalent to 3 years. | "The test results demonstrate that the aged samples complied with the pre-determined acceptance criteria." (i.e., Met criteria) |
| EO/ECH Residual | Compliance with allowable limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals as per ISO 10993-7. | "The results meet the requirements." (i.e., Met criteria) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set. The reported tests are non-clinical (laboratory/bench testing). The sample sizes for these non-clinical tests (e.g., number of antennas tested for electrical safety) are not specified in this summary.
- Data Provenance: The listed tests are non-clinical, conducted by the manufacturer (Canyon Medical Inc.) or authorized testing facilities, likely in the People's Republic of China, where the company is based. The data is thus internal, prospective non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical submission. Ground truth, in a clinical sense (e.g., disease presence), is not established for this type of testing. The "ground truth" for non-clinical tests is adherence to established engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical submission, not involving human readers or clinical endpoints requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This submission is for a medical device (Microwave Ablation Antennas), not an AI/software device intended for diagnostic interpretation or to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This submission is for a medical device (Microwave Ablation Antennas), not an AI/software device.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is typically defined by:
- Compliance with recognized consensus standards: (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility).
- Pre-determined design specifications and requirements: The device's performance is measured against its own established engineering specifications (e.g., for power delivery, temperature profile, mechanical integrity).
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not a machine learning or AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is a medical device, not an AI algorithm.
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