(59 days)
The Ellusa Bipolar Wands are intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed.
The Ellusa Bipolar Wand family is a line of disposable bipolar electrosurgical devices which is intended for use by a physician familiar with electrosurgery in bipolar coagulation for general surgery where coagulation of soft tissue is needed. The basic design of the Ellusa Bipolar Wands is a plastic handle, an elongated, insulated electrode shaft, a bipolar electrode tip, and an integrated cable and plug which is designed to connect exclusively to the Ellusa line of highfrequency RF energy sources. The operational principle of the device is common to all active bipolar electrosurgical devices; the active tip of the Ellusa Bipolar Wand emits RF energy generated according to settings established on the Ellusa Generator which emits high frequency, low temperature radiowaves directed to the electrode tip. The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. This energy is capable of cutting or coagulating target tissue depending on the waveform associated with the mode and power setting of the generator. The devices are disposable and intended for single use only. The devices are intended for transient contact with the patient and are provided sterilized by ethylene oxide and has a shelf life of three years from the date of sterilization.
This document describes the Ellusa Bipolar Wands, an electrosurgical device, and its acceptance criteria as part of its 510(k) submission (K202558) to the FDA. The submission aims to demonstrate substantial equivalence to a predicate device, the Soniquence Bipolar Electrodes (K190336).
1. Table of Acceptance Criteria and Reported Device Performance
The device is assessed against a predicate device, the Soniquence Bipolar Electrodes (K190336). The acceptance criterion is that the Ellusa Bipolar Wands are "Identical to predicate" across a range of technological characteristics.
| Technological Characteristic | Acceptance Criteria (Predicate: Soniquence Bipolar Electrodes, K190336) | Reported Device Performance (Ellusa Bipolar Wand) |
|---|---|---|
| Intended Use | The Soniquence Bipolar Electrode is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. | Identical to predicate |
| Product Code | GEI | Identical to predicate |
| Device Classification | Class II | Identical to predicate |
| Functions | Cutting/coagulation | Identical to predicate |
| Operating principle | Bipolar | Identical to predicate |
| Energy Source | RF Energy | Identical to predicate |
| Electrode Materials | Stainless steel | Identical to predicate |
| Tip Configurations | Ball Tip, Standard, Hex blade | Identical to predicate |
| Tip dimensions | 0.5 - 8mm | Identical to predicate |
| Shaft lengths | 11 - 40cm | Identical to predicate |
| Shaft diameter | 1.2 - 6mm | Identical to predicate |
| Stability and Shelf Life | 3 years | Identical to predicate |
| Coating | None | Identical to predicate |
| Cable Length (m) | 3m | Identical to predicate |
| Activation Method | Footswitch | Identical to predicate |
| Testing standards used | IEC 60601-1 and IEC 60601-2-2 | Identical to predicate |
| Biocompatibility | ISO 10993 | Identical to predicate |
| Sterilization Methods | Ethylene Oxide | Identical to predicate |
| Packaging | Sterile, Blister Tray | Identical to predicate |
| Min., Max., Default output Values (Wattage) | 0-170 | Identical to predicate |
The study demonstrates that the Ellusa Bipolar Wands meet these acceptance criteria by asserting that they are "identical in technological characteristics to the Soniquence Bipolar Electrodes (K190336) based on a comparison of physical and performance characteristics."
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify a sample size for a "test set" in the context of an AI/algorithm-based device as this is a medical device (electrosurgical wands) that relies on physical and performance testing for substantial equivalence, not algorithmic performance. The testing involved ex vivo tissue (liver, kidney, and muscle tissue) for performance bench tests. The quantity of tissue samples used is not provided. The data provenance is derived from these bench tests and adherence to various ISO and IEC standards. The data would be prospective, generated during the verification and validation activities for the Ellusa Bipolar Wands.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not an AI/algorithm-based device requiring expert ground truth establishment for a test set. The substantial equivalence is determined by comparing physical and performance characteristics against a predicate device and adherence to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/algorithm-based device requiring an adjudication method. The assessment is based on objective measurements and compliance with standards.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-only device. It is a physical electrosurgical instrument.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Predicate Device Characteristics: The known, legally marketed predicate device (Soniquence Bipolar Electrodes, K190336) serves as the benchmark for technological characteristics and intended use.
- Industry Standards: Adherence to recognized national and international standards (IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-2, IEC 60601-2-2 for electrical safety and performance; ISO 11135, ISO 11737-1, ISO 11737-2, ISO 11138-1, ISO 11138-2 for sterilization; ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11 for biocompatibility; ASTM F1886/F1886M, ASTM F1929, ASTM F1980 for shelf life). This implies that meeting these standards constitutes acceptable performance and safety.
- Bench Test Results: Direct measurements of thermal effects on ex vivo tissue and temperature profiles during simulated use to demonstrate safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.