(393 days)
The Canady Plasma Coagulator devices are intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma Coagulator devices are Argon Plasma Coagulation Unit designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit models and compatible monopolar and/or bipolar RF handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes.
The Canady Plasma"M Electrosurgical Unit Series with Accessories is an High Frequency (HF) Electrosurgery Unit (ESU) used in combination with Canady Plasma™ Coagulators (Argon 2 and Argon 4) gas units and probes (Canady Plasma™ GIT probe and Canady Plasma™ TBS probe). The Canady Plasma (ESU) series combines (HF) voltage to electrically enhanced plasma gas (i.e. Argon) to produce a plasma gas stream. Current density upon arrival at the tissue surface from Canady Plasma Probes causes coagulation of the tissue. Canady Plasma (ESU) series is also a monopolar and bipolar RF surgical device for cutting and coagulation. It is used for tissue removal and coagulation in accordance with the operative procedure performed by the physician. The unit provides various cutting and coagulation modes to meet the physician flexibility performing the specific procedure with the device.
The Canady Plasma Electrosurgery Unit Model SS-200E is to only be used with the Canady Plasma Coagulator Argon 2. The Canady Plasma Electrosurgery Unit Model SS-601 Mca is to only be used with the Canady Plasma Coagulator Argon 4.
The provided 510(k) summary for the Canady Plasma Electrosurgical Unit Series (K100669) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (especially for AI/software-based devices) is not applicable or not provided in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Not Specified |
| (No specific quantitative performance metrics or acceptance thresholds are mentioned for the device itself.) | The document states "These devices are equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices." and compliance with several NBR IEC standards for electromedical equipment (60601-1, 60601-2-2, 60601-1-2). |
Explanation: In submissions for devices like electrosurgical units, the "acceptance criteria" are typically met through adherence to recognized national and international safety and performance standards for electromedical equipment, as well as demonstration of equivalence to legally marketed predicate devices. The document explicitly states compliance with relevant NBR IEC standards. No novel performance claims requiring specific clinical acceptance criteria are being made.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample size for test set: Not applicable. The submission does not describe a clinical study with a test set of data points for performance evaluation in the way one might for an AI/software device.
- Data provenance: Not applicable. The testing described (compliance with NBR IEC standards) is typically laboratory-based engineering and electrical safety testing, not based on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
Explanation: As no clinical test set with ground truth is described, this information is not relevant to this submission.
4. Adjudication Method for the Test Set:
- Adjudication method: Not applicable.
Explanation: No clinical test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC study: No.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.
Explanation: This device is an electrosurgical unit, not an AI-assisted diagnostic or clinical decision support tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Standalone study: No.
Explanation: This device is a physical electrosurgical unit, not an algorithm. Performance is assessed through compliance with standards and equivalence to predicate devices, used directly by a physician.
7. Type of Ground Truth Used:
- Type of ground truth: Not applicable.
Explanation: As this is an electrosurgical unit, the "ground truth" would relate to its physical and electrical characteristics as determined by engineering tests and adherence to standards, not clinical "ground truth" labels for a dataset.
8. Sample Size for the Training Set:
- Sample size for training set: Not applicable.
Explanation: This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established:
- How ground truth was established: Not applicable.
Explanation: As this is not an AI/machine learning device, there is no training set and thus no ground truth establishment for a training set.
Summary of Focus in this 510(k) Submission:
The K100669 submission for the Canady Plasma Electrosurgical Unit primarily focuses on demonstrating:
- Substantial Equivalence: The crucial aspect of this submission is showing that the device is "equivalent in intended use, technological characteristics, and performance characteristics to the named predicate devices." This is the cornerstone of a 510(k) submission.
- Intended Use: Clearly defining the intended use, which is for gas-enhanced coagulation and general tissue cutting/coagulation during surgery.
- Compliance with Standards: Adherence to recognized national and international safety standards for electromedical equipment (NBR IEC 60601-1, 60601-2-2, 60601-1-2). This indicates that the device has undergone electrical, mechanical, and electromagnetic compatibility testing to ensure it operates safely and effectively within expected parameters.
For physical medical devices like electrosurgical units, the regulatory pathway often relies on comparison to existing, legally marketed predicate devices and compliance with established safety and performance standards, rather than large-scale clinical trials establishing new performance metrics or comparative effectiveness studies involving AI.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.