(193 days)
ENSEAL X1 Large Jaw Tissue Sealer:
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, gynecologic, thoracic, and vascular procedures. These procedures include hysterectomies, colectomies, Nissen fundoplication, adhesiolysis, oo. 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 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.
Ethicon Generator 11:
The Generator G11 provides radiofrequency power to drive Enseal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Enseal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
The Enseal® X1 Large Jaw Tissue Sealer instrument 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 or MIN foot pedal is 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 to the generator.
The device system has three essential components: the generator, the footswitch and the subject device. The Generator 11 supplies energy to the Enseal® electrosurgical instruments and Harmonic® ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either Enseal® or Harmonic® devices. Connectors (one for Enseal® and one for Harmonic® devices) are used to enable the generator to power currently cleared surgical instruments. The Generator 11 hardware has not changed since the predicate device was cleared under K101990. The Enseal® X1 Large Jaw Tissue Sealer instrument is designed for use exclusively with the Ethicon Generator G11 (GEN11) software version 2016-1 or later, which has been updated to increase the maximum Power output to 200W.
The provided FDA 510(k) summary for the Enseal® X1 Large Jaw Tissue Sealer does not describe a study involving an AI/CADe device. Instead, it details the testing and evaluation of a medical device (an electrosurgical instrument and its generator) against a predicate device to demonstrate substantial equivalence for regulatory approval.
Therefore, many of the typical questions for an AI study, such as expert consensus, MRMC studies, standalone performance, and training set details, are not applicable here.
However, I can extract the acceptance criteria and performance data for the electrosurgical device as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Device performs as intended, able to seal and divide vessels up to 7mm. Data generated met predetermined acceptance criteria for maximum, minimum values, standard deviation, and mean for sealed vessel burst tests. | "Data generated from the bench testing met the predetermined acceptance criteria." The device successfully sealed and divided vessels up to 7mm. The maximum and minimum values, standard deviation, and mean were recorded for sealed vessel burst tests. |
| Acute Animal (Porcine) Testing | No significant difference in tissue effects compared to the predicate device. Ability to seal and divide vessels up to and including 7mm. | "The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." No difference in tissue effects observed. Successfully sealed and divided vessels up to and including 7mm. |
| Survival Animal (Porcine) Testing | No significant difference in tissue effects compared to the predicate device. Ability to seal and divide vessels up to and including 7mm. | "The results of the study demonstrated the ability of the subject device (NSLX120L) to perform as well as the legally identified predicate device." Tissue effects were not different than the predicate device. Successfully sealed and divided vessels up to and including 7mm. |
| Sterilization | Sterilization via ethylene oxide to specified sterility assurance level. | Both subject and predicate devices are sterilized via ethylene oxide to the same sterility assurance level. |
| Biocompatibility | Compliance with ISO 10993:2009 and FDA Blue Book Memorandum #G95-1. Passed specific tests. | The device passed ISO Cytotoxicity, ISO Sensitization, ISO Intracutaneous Reactivity, and ISO Acute Systemic Toxicity tests. |
| EMC (Electrical Safety and Electromagnetic Compatibility) | Compliance with IEC 60601-1-2:2007 (EMC) and IEC 60601-1:2005 & IEC 60601-2-2:2009 (Electrical Safety). | The system complies with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 and IEC 60601-2-2:2009 for electrical safety. |
| Software Verification & Validation | Compliance with FDA Guidance for industry and staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." | Applicable software verification and validation testing was completed per FDA guidance. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench Testing: The document states "sealed vessel burst test were evaluated" and involved "evaluation of the devices performance and ability to seal and divide vessels up to 7 mm." Specific sample sizes (e.g., number of vessels tested) are not provided.
- Acute Animal (Porcine) Testing: "Testing was performed in an acute animal study." The number of animals or specific test cases is not provided. The data provenance is described as "acute animal study" using "porcine" models. This is prospective animal data.
- Survival Animal (Porcine) Testing: "Testing was performed in survival animal studies." The number of animals or specific test cases is not provided. The data provenance is described as "survival animal studies" using "porcine" models. This is prospective animal data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This is not applicable as this is not an AI/CADe study requiring expert interpretation of medical images or data for ground truth. The "ground truth" (or rather, performance validation) was established through direct physical and biological testing (burst pressure, tissue effects, etc.) against pre-defined criteria and comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable, as this is not an AI/CADe study involving human readers or adjudicators for setting ground truth. Performance was measured directly through physical and biological tests.
5. 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
Not applicable. This is not an AI/CADe device or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/CADe device. The performance data refers to the standalone performance of the electrosurgical device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on several methods:
- Pre-defined Performance Specifications: For bench testing, criteria related to burst pressure, ability to seal specific vessel sizes, and maintenance of tissue integrity.
- Comparative Performance to a Predicate Device: For animal studies, the "ground truth" for "safety and effectiveness" effectively means demonstrating performance "as well as" the legally marketed predicate device, with no significant differences in tissue effects.
- Compliance with Standards: For sterilization, biocompatibility, EMC, and software, adherence to established international and FDA standards (ISO, IEC, FDA guidance documents).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/CADe device; there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for an AI model.
Summary of the Study:
The study was a series of non-clinical tests (bench, acute animal, and survival animal studies) conducted to demonstrate the safety and effectiveness of the Enseal® X1 Large Jaw Tissue Sealer and its Generator 11. The primary objective was to demonstrate substantial equivalence to existing legally marketed predicate devices. The studies focused on physical performance characteristics (e.g., vessel sealing capabilities up to 7mm), tissue effects, and compliance with various regulatory standards (sterilization, biocompatibility, electrical safety, software validation). The device met all predetermined acceptance criteria in these tests, indicating it performed as safely and effectively as the predicate devices. No human clinical trial data was used for this premarket notification.
§ 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.