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510(k) Data Aggregation
(20 days)
ENSEAL TRIO TISSUE SEALING DEVICE
The ENSEAL Trio Tissue Sealing Device is a bipolar electrosurgical instrument for use with a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, 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, oophorectomies, 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) 7 mm and bundles as large as will fit in the jaws of the instruments.
The Ethicon Endo-Surgery ENSEAL Trio Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
The Ethicon Endo-Surgery ENSEAL Trio Tissue Sealing Devices are sterile, single-use surgical instruments designed to seal and cut vessels, and to cut, grasp and dissect soft tissue during open and laparoscopic surgery.
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 Ethicon Endo-Surgery ENSEAL Trio Tissue Sealing Devices have a 5 mm diameter shaft and are available in 4 shaft lengths: 14cm, 25cm, 35cm and a 3mm curved jaw. The jaws are provided in the opened position and can be partially or fully closed by squeezing the closing handle. The device jaws can grasp and hold targeted tissue when clamped. The device uses a combination 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 Trio Tissue Sealing Devices have a modification to the device jaws. The modified jaws are manufactured using a brazed assembly process; the predicate jaws are manufactured using an epoxy assembly process. The Subject device jaws seal and cut vessels, and cut, grasp and dissect soft tissue as intended.
The ENSEAL® Trio Tissue Sealing Device underwent ex-vivo (bench) testing to ensure its performance met design specifications. The device was deemed substantially equivalent to a legally marketed predicate device (The EnSeal™ PTC Tissue Sealing Device, K070896) based on intended use, technological characteristics, and performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document lists categories of performance assessment but does not include specific quantitative acceptance criteria or detailed numerical results for each. Therefore, the table below will list the assessed performance aspects.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility | Performed as intended, met design specifications |
| Electrical Safety | Performed as intended, met design specifications |
| Force to Cut | Performed as intended, met design specifications |
| Air Leak Rate | Performed as intended, met design specifications |
| Device Durability | Performed as intended, met design specifications |
| Vessel Burst Pressure | Performed as intended, met design specifications |
| Jaw Strength | Performed as intended, met design specifications |
| Activation Performance | Performed as intended, met design specifications |
2. Sample Size and Data Provenance:
The document states that "Ex-vivo tests (bench) were performed." However, it does not specify the exact sample sizes used for each test or the data provenance in terms of country of origin or whether it was retrospective or prospective. Given the nature of ex-vivo bench testing, the data would be prospective, as the tests are performed specifically to evaluate the device.
3. Number of Experts and Their Qualifications for Ground Truth:
The document does not mention the use of experts to establish ground truth for the test set. The performance testing appears to be based on engineering and scientific metrics for device functionality rather than expert interpretation of outcomes.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the testing was ex-vivo bench testing focusing on physical and electrical device performance.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed or mentioned. The device is a surgical instrument, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the form of "Ex-vivo tests (bench)" that assessed the device's performance against design requirements. This refers to the device itself, without human-in-the-loop performance measurement.
7. Type of Ground Truth Used:
The ground truth for the performance claims was based on design specifications and engineering metrics commonly used for medical devices, specifically electrosurgical instruments. Examples include "Force to Cut," "Air Leak Rate," "Vessel Burst Pressure," and "Jaw Strength," which are quantifiable physical properties and behaviors of the device.
8. Sample Size for the Training Set:
This information is not applicable. The device is a physical surgical instrument, not an AI algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
This information is not applicable, as there was no training set for an AI algorithm.
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