(64 days)
MEG Laparoscopic Electrodes are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures.
Laparoscopic electrodes are surgical instruments with single use or reusable interchangeable tin inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:
- . A removable insert allows for easier cleaning and disinfection of the instrument components.
- Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
- Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
Laparoscopic Electrodes consist of: - I ) Tip Inserts (pre-sterilized single use and non-sterile reusable) that interchangeably fit into a reusable tube.
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- Cartridges (pre-sterilized single use) that fit directly into a reusable handle.
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- Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.
Radiofrequency energy is delivered to the tip through the handle by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle (cleared in 510k # K062337) is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.
- Reusable Tubes (non-sterile, rcusable) that fit directly into a reusable handle and accommodates a variety of tip inserts.
The device, MEG Laparoscopic Electrodes, is a re-submission of K062337 by Aaron Medical. Unfortunately, the provided document does not contain an acceptance criteria table, detailed performance data from a specific study, nor information regarding sample sizes, data provenance, expert involvement, or adjudication methods for a test set. This type of information is not typically included in a 510(k) summary, as the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trial data.
However, based on the provided text, here's what can be gathered regarding the device and its compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a tabular format or detailed performance results in the way a clinical study report would. Instead, the "performance" is implicitly demonstrated through conformance to recognized electrical safety standards and a claim of substantial equivalence to a predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance (Implicit from document) |
|---|---|---|
| Electrical Safety Standards Conformance | Adherence to ANSI/AAMI/ISO HF-18: 2001 | Stated conformance to ANSI/AAMI/ISO HF-18: 2001 |
| Adherence to IEC 60601-2-2- 2006 | Stated conformance to IEC 60601-2-2- 2006 | |
| Functional Equivalence | Ability to grasp, hold, coagulate, and cut tissue | Indicated as capable of grasping, holding, coagulating, and cutting tissue during laparoscopic surgical procedures, similar to predicate. |
| Material/Design Equivalence | Similar technology to predicate (use of high-frequency radiofrequency energy) | Stated as using technology substantially equivalent to Aaron Modular Monopolar Electrodes (K062337) |
| Sterilization Efficacy | Single-use components are sterile, reusable components can be sterilized. | Single use provided sterilized by ethylene oxide gas. Reusable provided non-sterile, requiring steam sterilization. (Implicitly, sterilization is effective if performed according to instructions). |
2. Sample Size and Data Provenance for Test Set:
The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The primary "test" for substantial equivalence often involves comparing technical specifications and intended use with the predicate device, along with adherence to recognized standards. It's unlikely a separate, large-scale test set with patient data was used for this type of submission for this particular device.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of experts to establish ground truth for a test set. The regulatory review process for a 510(k) relies on the FDA's experts reviewing the provided documentation and comparing it to predicate devices and established standards.
4. Adjudication Method for Test Set:
Since a specific test set with patient data or expert review for ground truth is not described, there is no adjudication method provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study was not conducted or reported for this device. Such studies are typically associated with devices that involve interpretation of medical images or other diagnostic tasks where human reader performance is a key metric. This device is a surgical instrument.
6. Standalone (Algorithm Only) Performance Study:
A standalone performance study was not conducted or reported. This device is a manual surgical instrument, not an AI algorithm.
7. Type of Ground Truth Used:
For the purpose of this 510(k) submission, the "ground truth" implicitly refers to:
- Established engineering principles and material science: Ensuring the device's construction and materials are suitable for its intended use.
- Compliance with recognized electrical safety standards (ANSI/AAMI/ISO HF-18: 2001 and IEC 60601-2-2- 2006): These standards define performance expectations for electrosurgical devices.
- The performance and safety profile of the predicate device (Aaron Modular Monopolar Electrodes K062337): The predicate's established safety and effectiveness serve as the benchmark.
8. Sample Size for the Training Set:
The document does not mention a training set or its sample size. This is not an AI/machine learning device that would require such a set.
9. How Ground Truth for the Training Set Was Established:
Since there is no training set for this type of device, this question is not applicable.
§ 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.