(60 days)
The Enseal® X1 Large Jaw Tissue Sealer instrument is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. It is a bipolar instrument for use with the Ethicon Generator G11 (GEN11). It is intended for use during open surgery to cut and seal vessels, cut, grasp, and dissect tissue during surgery. Indications for use include open general, gynecological, thoracic, and vascular procedures. These procedures include hysterectomies. Nissen fundoplication. adhesiolysis, oophorectomies, etc. The devices can be used on vessels (arteries, veins, pulmonary vasculature, lymphatics) up to and including 7 mm and tissue bundles.
The Enseal® X1 Curved Large Jaw instrument 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 efficacy of the Enseal® X1 Curved Large Jaw instrument for the indication of contraceptive tubal coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the EnSeal® Tissue Sealing Device is significantly different from bipolar designs that are marketed for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the procedure and failure rates may not be comparable.
The Enseal® X1 Large Jaw Tissue Sealer device is a sterile, single patient use surgical instrument used 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 curved 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. Bipolar energy is delivered when the seal button (blue button) or MIN foot pedal is pressed. Pressing the cut button advances the knife the length of the jaws to cut the targeted tissue. It should be noted that this device has independent seal and cut capabilities. The power cord is permanently attached to the device and connects the instrument directly to the Generator 11. The Enseal® X1 Large Jaw Tissue Sealer device is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, packaged separately.
Here's a breakdown of the acceptance criteria and the studies performed for the ENSEAL X1 Large Jaw Tissue Sealer, based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Ex-vivo Bench Testing | ||
| Sealed vessel burst test | Data generated from the bench testing met the predetermined acceptance criteria. Performance and ability to seal and divide vessels up to 7 mm. | The device demonstrated the performance and ability to seal and divide vessels up to 7 mm. |
| Thermal profile testing | Demonstrated equivalence to the predicate device. | Demonstrated equivalence to the predicate device. |
| Acute Animal (Porcine) Testing | ||
| Tissue effects | No difference in tissue effects compared to the predicate device. | "The results of all studies demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." |
| Performance (seal & divide vessels, lymphatics) | Performance and ability to seal and divide vessels up to and including 7 mm, as well as lymphatics testing. | "The results of all studies demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." |
| Survival Animal (Porcine) Testing | ||
| Tissue effects | No difference in tissue effects compared to the predicate device. | "The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." |
| Performance (seal & divide vessels) | Performance and ability to seal and divide vessels up to and including 7 mm. | "The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." |
| Biocompatibility | No new issues of biocompatibility raised. | No new issues of biocompatibility are raised. |
| Sterilization/Shelf-Life | Sterility assurance level of 10^-6 | Validated to achieve a sterility assurance level of 10^-6 using Ethylene Oxide per ISO 11135. |
| Shelf-life for launch | 2 years | Designated shelf-life for the Enseal® X1 Large Jaw Tissue Sealer at launch is 2 years. |
| Electrical Safety and EMC | Compliance with IEC 60601-1 and IEC 60601-1-2 standards. | The device complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for electromagnetic compatibility. |
Study Details:
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Sample size used for the test set and the data provenance:
- Ex-vivo Bench Testing: The document does not specify an exact numerical sample size for "sealed vessel burst tests" or "thermal profile testing." It states that "maximum and minimum values, standard deviation and the mean were recorded," implying multiple tests were performed.
- Acute Animal (Porcine) Testing: The document does not specify an exact numerical sample size. It states "Testing was performed in an acute animal study."
- Survival Animal (Porcine) Testing: The document does not specify an exact numerical sample size. It states "Testing was performed in survival animal studies."
- Data Provenance: The animal studies were performed on porcine subjects, indicating animal data, not human. The document does not specify the country of origin for the data, but the company is Ethicon Endo-Surgery, located in the USA (Cincinnati, Ohio, and Guaynabo, PR). The animal studies are prospective as they were conducted specifically for the device's validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts or a "ground truth" in the context of human interpretation for establishing performance metrics for these engineering and animal studies. Performance was measured objectively through physical tests (burst pressure, thermal profiles) and observed physiological effects in animal models.
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Adjudication method for the test set:
- Not applicable. The studies described are objective performance and animal studies, not human reader studies requiring adjudication.
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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:
- No. This is a medical device (tissue sealer), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm. However, the device itself has "standalone" performance metrics that were evaluated through the bench and animal tests, independent of human surgical skill, to demonstrate its inherent capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ex-vivo Bench Testing: Ground truth was based on objective physical measurements (e.g., burst pressure, temperature readings).
- Animal Testing (Acute and Survival): Ground truth was established through physiological observations and potentially histological/pathological examination of tissue effects in the animal models, comparing the subject device to the predicate device.
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The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical medical 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.