(35 days)
The ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids.
The ConMed/Linvatec LightWave" Integrated Electrode Ablators are a modification of the currently marketed 3.2 mm UltrAblator electrode (Linvatec, K030720) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device. One version incorporates handcontrolled buttons to actuate the "cut" and "coag" functions of the electrosurgical generator. Another version is actuated by foot-control to control "cut" and "coag" functions of the electrosurgical generator. The hand-controlled and foot controlled version consists of an electrical insulation coated electrode and ceramic insulator attached to an integrated handle and cord set, allowing attachment to commonly available electrosurgical generators in distribution.
A third version of the ConMedILinvatec LightWave™ Integrated Electrode Ablators incorporates a suction/aspiration feature and is a modification of the currently marketed 3.2 mm Ult Ablator electrode (Linvatec, K993885) and a Switch Pencil control handle (Linvatec, K983652) integrated into one device, and is similar in technology to Heatwave Hand-Controlled Electrode (Conmed, K021299) and the VAPR™ 3.5mm 90° Suction Electrode (Mitek, K002422), which incorporate aspiration or suction. The device is similar to the hand-controlled device and will also have suction capability and attach to commonly available suction equipment. This electrode will be hollow allowing for the removal of irrigating fluids during surgical procedures.
The front switch contained in the hand-controlled devices provide the surgeon with electrosurgical cut (ablate) capability when depressed. The rear button activates electrosurgical coagulating (coag) current.
The provided text is a 510(k) submission for the LightWave™ Integrated Electrode Ablator and LightWave™ Integrated Electrode Suction Ablator. It aims to demonstrate substantial equivalence to previously marketed devices. However, this document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria, as typically understood in the context of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: "ConMed/Linvatec LightWave™ Integrated Electrode Ablators are intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids."
- Surgical Effect, Function, Materials of Construction, Patient Population, Compliance with Recognized Standards and Published FDA Guidance, and Manufacturing Methods.
The "study" in this context is the 510(k) submission process itself, which asserts that the new device is substantially equivalent to existing predicate devices, implying that its performance is implicitly acceptable because the predicates are already approved.
Therefore, many of the requested details about acceptance criteria for performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission for a Class II electrosurgical device relying on substantial equivalence to establish safety and effectiveness.
Here's a breakdown of what can be gathered from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Explicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K993885, K002422, K021299, K030720, K983652) | "intended to be used for electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures in a conductive fluid environment. Additionally, the suction/aspiration version also has capability for suctioning irrigation fluids." |
| Surgical Effect | Equivalent to predicate devices | Implicitly similar to predicate devices |
| Function | Equivalent to predicate devices | Performs "cut" and "coag" functions (hand-controlled or foot-controlled), with a suction/aspiration feature in one version. |
| Materials of Construction | Equivalent to predicate devices | Implicitly similar to predicate devices |
| Patient Population | Equivalent to predicate devices | Patients undergoing shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. |
| Compliance | Complies with recognized standards/FDA guidance | Implicitly complies, as per the substantial equivalence claim. |
| Manufacturing Methods | Equivalent to predicate devices | Implicitly similar to predicate devices. |
| Electrode Design | Functions of predicate devices integrated into one ergonomic handle and electrode combination with similar performance and technological characteristics. | One-piece design incorporating functions of Linvatec predicate devices. Suction version offers suction through electrode center with max cut power 200W. |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document describes a new electrosurgical electrode and relies on demonstrating substantial equivalence to existing devices. It does not present a "test set" in the sense of clinical data points used to evaluate an AI or diagnostic device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts is not a component of this 510(k) filing for an electrosurgical device.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No test set or adjudication method is described.
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 / Not Provided. This is not an AI-driven device or one that involves human readers interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is an electrosurgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. The "ground truth" for this device's acceptance is its substantial equivalence to legally marketed predicate devices, which are presumed safe and effective based on their established clinical use. Testing typically involves bench testing (e.g., power output, insulation integrity, fluid flow for suction), electrical safety, and biocompatibility, not clinical "ground truth" for performance in the same way a diagnostic device would.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As per point 8, there is no training set mentioned.
§ 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.