(214 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, 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 7mm 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. 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 provided document describes the substantial equivalence of the "ENSEAL X1 Tissue Sealer" to a predicate device, the "ENSEAL G2 Tissue Sealer." The acceptance criteria and the study that proves the device meets those criteria are primarily focused on performance data from bench and animal testing rather than a clinical trial with human subjects.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list a table of "acceptance criteria" alongside specific numerical results for all tests in a single cohesive table. However, it states that "Data generated from the bench testing met the predetermined acceptance criteria." The primary measurable acceptance criterion mentioned is for vessel seal performance.
| Acceptance Criterion | Reported Device Performance (ENSEAL X1 Tissue Sealer) |
|---|---|
| Sealed Vessel Burst Pressure | 240 mmHg Burst Pressure |
| Ability to seal and divide vessels up to and including | 7 mm (demonstrated in bench and animal testing) |
| Biocompatibility | Met ISO 10993-1 and FDA guidance |
| Electromagnetic Compatibility (EMC) and Electrical Safety | Complies with IEC 60601-1-2, IEC 60601-1, and IEC 60601-2-2 |
| Sterility Assurance Level (SAL) | 10^-6 (validated using Ethylene Oxide per ISO 11135) |
| Shelf-Life | 5 years |
| Mechanical Performance (Axial Jaw Retention Strength, Compression System Stress Test, Hinge Pin Weld Strength) | Demonstrated ability to perform as expected and minimized risk of mechanical failures |
| Performance in acute porcine study | Performed as well as the legally identified predicate device |
| Performance in chronic/survival porcine study | Performed as well as the historical performance of the legally identified predicate device |
2. Sample Size Used for the Test Set and Data Provenance
-
Bench Testing (Vessel Burst Pressure):
- Sample Size: Not explicitly stated as a number of vessels, but mentioned as "Porcine arteries were used."
- Data Provenance: Porcine (animal tissue). Retrospective (if referring to previously obtained tissue) or Prospective (if tissue was freshly obtained for the study) is not specified.
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Acute Animal Testing:
- Sample Size: Four animals for each device (ENSEAL X1 Tissue Sealer and predicate device).
- Data Provenance: Porcine (animal model). Prospective (as these were conducted tests).
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Chronic/Survival Animal Testing:
- Sample Size: Ten animals for each device (ENSEAL X1 Tissue Sealer and predicate device).
- Data Provenance: Porcine (animal model). Prospective (as these were conducted tests).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of human experts to establish "ground truth" in the context of radiologists or similar interpretations for the animal or bench studies. The testing methodologies (e.g., burst pressure measurements, observation of tissue effects) inherently provide the "ground truth" for the performance criteria.
4. Adjudication Method for the Test Set
Not applicable, as the data collection from bench and animal studies does not typically involve human adjudication in the way clinical image interpretation studies do. The measurements and observations are direct.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." Thus, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (electrosurgical instrument), not an AI algorithm. Its performance is evaluated directly through physical and biological tests, not through an algorithm's output.
7. The Type of Ground Truth Used
- Bench Testing: Direct physical measurements (e.g., force, pressure, visual observation of sealing/cutting) on porcine vessels.
- Animal Testing: Direct observation and evaluation of tissue effects (e.g., vessel sealing, tissue dissection, complications) in live porcine models, both acutely and chronically. The "ground truth" here is the biological and mechanical outcome in the animal models.
8. The Sample Size for the Training Set
Not applicable. The device is a physical instrument, not an AI/ML algorithm 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 a physical electrosurgical 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.