(275 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, and ENT surgical procedures or any procedure where vessel ligation (cutting and sealing), tissue grasping, dissection, and division of vessels, lymphatics, and tisue 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 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 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. 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 provided text describes the acceptance criteria and the study conducted to prove that the ENSEAL X1 Tissue Sealers meet these criteria. The device is an electrosurgical instrument for cutting and sealing vessels and tissues.
Acceptance Criteria and Reported Device Performance
The core performance acceptance criterion for the ENSEAL X1 Tissue Sealers is its vessel seal performance, measured by burst pressure. Other criteria relate to electrical safety, sterility, mechanical integrity, and biocompatibility.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Vessel Seal Performance | |
| Burst Pressure | 240 mmHg (on vessels up to 7 mm) |
| Maximum Indicated Vessel Size | 7 mm |
| Electrical Safety & EMC | |
| IEC 60601-1-2 (EMC) | Complies |
| IEC 60601-1 & IEC 60601-2-2 (Electrical Safety) | Complies |
| Sterility/Shelf-Life | |
| Sterility Assurance Level (SAL) | $10^{-6}$ (using Ethylene Oxide per ISO 11135) |
| Shelf-Life | 5-years |
| Biocompatibility | Evaluated based on ISO 10993-1 and FDA guidance |
| Mechanical Integrity | |
| Axial Jaw Retention Strength | Demonstrated ability to perform as expected; risks minimized |
| Compression System Stress Test | Demonstrated ability to perform as expected; risks minimized |
| Hinge Pin Weld Strength | Demonstrated ability to perform as expected; risks minimized |
Study Proving Device Meets Acceptance Criteria
The study conducted to prove the device meets acceptance criteria involved a combination of bench testing and animal studies.
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Sample Size and Data Provenance:
- Bench Testing: Used porcine arteries for sealed vessel burst pressure testing. The exact number of samples is not explicitly stated, but it is indicated that "Data generated from the bench testing met the predetermined acceptance criteria."
- Acute Animal Testing: Performed in four animals for each device (subject and predicate) targeting arteries, veins, and vessel pedicles less than or equal to 7mm in diameter. Data provenance is from an acute porcine study.
- Chronic/Survival Animal Testing: Performed in ten animals for each device (subject and predicate) targeting arteries, veins, and vessel pedicles less than or equal to 7mm in diameter. Data provenance is from a 30 (±2) day chronic survival study in animals (implied porcine).
- The studies were pre-clinical (animal and bench), not human clinical trials. The country of origin for the data is not specified but is implicitly associated with the manufacturer's testing facilities.
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Number of Experts and Qualifications for Ground Truth (Test Set):
- This section is not applicable as the studies described are pre-clinical bench and animal studies (not human-in-the-loop diagnostic studies). Ground truth was established through physical measurements (e.g., burst pressure) and direct observation of tissue effects in animals.
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Adjudication Method for the Test Set:
- This section is not applicable for the type of pre-clinical studies conducted. The evaluation involved objective measurements and observations, not expert consensus on interpretations.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The studies were focused on the device's technical performance and comparative equivalence to a predicate device in an animal model, not on human reader performance with or without AI assistance.
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Standalone Performance:
- Yes, the studies essentially evaluated the "standalone" performance of the algorithm/device. The bench testing directly measured the device's ability to seal vessels and achieve a certain burst pressure. The animal studies assessed its performance in vivo (tissue effects, sealing/dividing vessels) independent of human interpretive input. The description directly evaluates the device's inherent functional capabilities.
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Type of Ground Truth Used:
- The ground truth for the performance evaluations was based on:
- Physical Measurements: E.g., burst pressure (mmHg) for vessel sealing, precise diameter measurements of vessels used (up to 7mm).
- Direct Observation/Pathological Assessment: Evaluation of tissue effects, ability to seal and divide vessels, and assessment of outcomes in animal models (both acute and chronic survival, looking at tissue health and healing post-procedure).
- The ground truth for the performance evaluations was based on:
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Sample Size for the Training Set:
- This concept is not applicable to this type of device and study. The ENSEAL X1 Tissue Sealers are a physical electrosurgical instrument, not an AI/machine learning algorithm requiring a "training set" of data. The "training" for such a device involves engineering design, manufacturing, and preclinical validation.
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How the Ground Truth for the Training Set Was Established:
- This concept is not applicable for the reasons stated above.
§ 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.