(135 days)
The ENSEAL® G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with the Generator GENI 1 (GEN11). They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures. Nissen fundoplication, adhesiolysis, oophorectornies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7mm and tissue and/or vascular bundles as large as will fit in the iaws of the instruments.
The ENSEAL® G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
The Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers are sterile, singleuse surgical instruments designed to seal and cut vessels, and to cut, grasp and dissect soft tissue during open and laparoscopic surgery.
The energy activation and knife lock are activated by a single button. The instrument shaft can be rotated using the rotation knob to facilitate visualization and enable easy access to targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL G2 Articulating Tissue Sealers include an articulation capability that allows the user to articulate the end-effector during surgical procedures.
The Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers components are similar to the Predicate. The ENSEAL G2 Articulating Tissue Sealers have a 5 mm diameter shaft and are available in two shaft lengths: 35 and 45cm; and two jaw types: 3mm curved jaw and 5mm straight jaw. The jaws are normally in the opened position and can be partially or fully closed by squeezing the closing handle. The jaws have atraumatic teeth for grasping and holding targeted tissue when clamped. The handles of the Subject ENSEAL G2 Articulating Tissue Sealers have an ergonomic interface for the user. Like the Predicate, the Subject devices include an integrated energy activation button. The devices use a combination of the application of bipolar electrosurgical energy in conjunction with the I-BLADE knife, to compress, coagulate, and transect tissue.
In addition to the similar technological characteristics as the Predicate, the ENSEAL G2 Articulating Tissue Sealers instrument shaft device articulates approximately 60° to the left and the right of center. The instrument shaft can be articulated using the articulation wheel to gain additional access to tissue and facilitate the user's ability to target tissue and vascular bundles up to 60°. The top of the articulation wheel has a white arrow to indicate when the device shaft is straight and not articulated. When the articulation wheel is rotated clockwise, the shaft articulates to the right; when the articulation wheel is rotated counterclockwise, the shaft articulates to the left. While articulated, the device jaws seal and cut vessels, and cut, grasp and dissect soft tissue as intended. The Subject ENSEAL G2 Articulating Tissue Sealers performance is equivalent to the Predicate ENSEAL G2 Tissue Sealers.
The provided information is for the Ethicon Endo-Surgery, LLC, 510(k) Premarket Notification (Traditional) for ENSEAL® G2 Articulating Tissue Sealers. This submission does not pertain to an AI/ML powered device, but rather a surgical instrument. Therefore, some of the requested information regarding AI/ML device evaluation metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) is not applicable and will not be found in the document.
Here's the available information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance meets the definition of substantial equivalence to the Predicate device, ENSEAL G2 Tissue Sealers. | Ex-vivo and in-vivo tests were performed to verify that the performance of the ENSEAL G2 Articulating Tissue Sealers meets the definition of substantial equivalence to the Predicate device, ENSEAL G2 Tissue Sealers. |
| Performance assessed against design requirements. | Device performance was assessed against design requirements. |
| Performs as intended. | A 30-day chronic survival study was performed to demonstrate that the Ethicon Endo-Surgery ENSEAL G2 Articulating Tissue Sealers perform as intended. |
2. Sample size used for the test set and the data provenance:
The document mentions "Ex-vivo and in-vivo tests" and a "30-day chronic survival study" but does not specify the sample sizes used for these tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a surgical instrument and its performance evaluation does not involve establishing ground truth through expert review in the context of an AI/ML diagnostic or prognostic system.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as #3.
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:
This information is not applicable as the device is a surgical instrument, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a surgical instrument and has human-in-the-loop operation by its nature.
7. The type of ground truth used:
The "ground truth" for evaluating this surgical instrument's performance would be against established surgical effectiveness, safety standards, and comparison to the predicate device. This is implicitly evaluated through the "Ex-vivo and in-vivo tests" and the "30-day chronic survival study" which assess its ability to effectively seal and cut vessels, and dissect tissue as intended, consistent with the performance of the predicate device. The document states "Device performance was assessed against design requirements" and to "perform as intended," and also its substantial equivalence to the predicate.
8. The sample size for the training set:
This information is not applicable as the device is a surgical instrument, not an AI/ML system that utilizes a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is a surgical instrument, not an AI/ML system.
§ 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.