(84 days)
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general, gynecological, urologic, thoracic, plastic and reconstructive, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tissue bundles is performed (e.g. bowel resections, hysterectomies, gall bladder procedures, Nissen Fundoplication, adhesiolysis, and oophorectomies). 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 ENSEAL X1 Tissue Sealers have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
The ENSEAL X1 Tissue Sealer instrument is a sterile, single patient use surgical instrument to coagulate and transect vessels up to and including 7 mm in diameter, tissue and/or vascular bundles. This device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating shaft, a moveable jaw, and a knife. The instrument shaft can be rotated 360° to facilitate visualization and enable easy access to targeted tissue. The ENSEAL X1 Tissue Sealer has a curved jaw and a straight jaw configuration. The jaws are in a normally-opened position and can be partially or fully closed by squeezing the closing handle. The jaws are designed for grasping and holding targeted tissue when clamped. The ENSEAL X1 Tissue Sealer has separate seal and cut capabilities. The lower jaw of the ENSEAL X1 Tissue Sealer can be used in the open or closed position to deliver energy based on the electrode configuration and jaw design. Bipolar energy is delivered when the SEAL button or the MIN foot pedal is pressed. Pressing the CUT button advances the knife the length of the jaws to cut the targeted tissue. The power cord is permanently attached to the device and connects the instrument to the generator. The ENSEAL X1 Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.
The ENSEAL X1 Tissue Sealers are bipolar electrosurgical instruments intended for use during open or laparoscopic surgical procedures to cut and seal vessels, and to cut, grasp and dissect tissue. The study used to demonstrate the device meets acceptance criteria involved a combination of bench testing and animal studies.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." | The biocompatibility of materials used in the ENSEAL X1 Tissue Sealers was evaluated based on ISO 10993-1 and FDA guidance and found acceptable. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2. | The system complies with IEC 60601-1 and IEC 60601-2-2 for electrical safety. |
| EMC | Compliance with IEC 60601-1-2. | The system complies with IEC 60601-1-2 for electromagnetic compatibility. |
| Sterilization | Achieve a sterility assurance level (SAL) of 10^-6 using Ethylene Oxide per ISO 11135. | Validated to achieve a SAL of 10^-6 using Ethylene Oxide per ISO 11135. |
| Shelf-Life | Demonstrated shelf-life. | The designated shelf-life is 1-year. |
| Mechanical Testing | Ability to perform as well as the legally identified predicate device in axial jaw retention, jaw strength, hinge pin weld strength, and stress testing. | Demonstrated the ability to perform as well as the legally identified predicate device in axial jaw retention, jaw strength, hinge pin weld strength, and stress testing. |
| Bench Testing (Vessel Burst) | Meet predetermined acceptance criteria for sealing and dividing vessels up to 7 mm. | Data generated from the bench testing met the predetermined acceptance criteria for sealing and dividing vessels up to 7 mm. |
| Acute Animal Testing | No difference in tissue effects compared to the predicate device when sealing and dividing vessels up to and including 7 mm. | Demonstrated no difference in tissue effects compared to the predicate device, performing as well as the predicate device when sealing and dividing vessels up to and including 7 mm. |
| Survival Animal Testing | No difference in tissue effects compared to the predicate device when sealing and dividing vessels up to and including 7 mm over a 30-day period. | Demonstrated no difference in tissue effects compared to the predicate device, performing as well as the predicate device when sealing and dividing vessels up to and including 7 mm over 30 days. |
2. Sample Size and Data Provenance (for test set/performance studies):
- Bench Testing (Vessel Burst): The document does not specify a precise sample size for the vessel burst test, only stating that "maximum and minimum values, standard deviation and the mean were recorded." The data source was porcine arteries. This is retrospective data in the sense that it's performed in a lab setting.
- Acute Animal Testing: Two animals were used for each device (ENSEAL X1 Tissue Sealers and the predicate device). The data provenance is from an acute porcine study.
- Survival Animal Testing: Five animals were used for each device (ENSEAL X1 Tissue Sealers and the predicate device). The data provenance is from a chronic survival porcine study.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
Not applicable. The performance studies described are bench tests and animal studies, which do not involve human expert interpretation for ground truth.
4. Adjudication Method (Test Set):
Not applicable, as human expert adjudication is not relevant for the types of studies conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The studies focused on comparing the device's technical performance and biological effects to a predicate device in controlled lab and animal settings.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The ENSEAL X1 Tissue Sealers are a medical device (electrosurgical instruments), not an algorithm or AI system. Their performance is inherent to the device itself.
7. Type of Ground Truth Used:
- Bench Testing: Objective measurements of mechanical properties and vessel burst pressure.
- Animal Studies: Observed tissue effects, ability to seal and divide vessels, and biological responses in live animal models. The "ground truth" here is the direct physiological and mechanical outcome.
8. Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI or machine learning system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.