(144 days)
The Ethicon Endo Surgery ENSEAL® G2 Cordless Curved Jaw Tissuc Sealers are intended for use during open or laparoscopic, general and gynccological surgery to cut and scal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and scaling), tissue grasping and dissection are performed. The devices can be used on vessels up to (and including) 7mm and bundles as large as will fit in the jaws of the instruments.
The device 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 Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer is a sterile, single patient use, self-contained, disposable RF electrosurgical instrument. The cordless hand-held device is powered by a Lithium Ion Polymer (LiPo) battery with an RF (radiofrequency) generator integrated into the device handle and does not require connection to an external generator or power source. The integrated generator provides the required RF energy to seal vessels during a surgical procedure. The battery is a DC power source that is charged during manufacturing; the battery cannot be removed from the device, or be recharged by the user. The device is configured with 3mm curved jaw and is intended to cut, grasp and dissect soft tissue, and coagulate and transect vessels up to and including 7mm in diameter.
The ENSEAL G2 Cordless Curved Jaw Tissue Sealer is a medical device designed for cutting, grasping, dissecting, and sealing tissue and vessels during surgical procedures. The provided 510(k) summary outlines the performance data used to demonstrate its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance. Instead, it demonstrates performance through comparative testing against predicate devices. The implicit acceptance criterion is that the subject device performs comparably to the predicate devices in key areas.
| Performance Metric/Characteristic | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Biocompatibility | Met for predicate devices | Met |
| Electrical Safety | Met for predicate devices | Met |
| Software Validation | Met for predicate devices | Met |
| Vessel Burst Pressure | Comparable to predicate devices | Comparable to predicate devices |
| Acute Animal Studies | Comparable to predicate devices | Comparable to predicate devices |
| Survival Animal Studies | Comparable to predicate devices | Comparable to predicate devices |
Note: The document states, "Based on performance testing and functional similarities to the predicate devices, the Ethicon Endo-Surgery ENSEAL G2 Cordless Curved Jaw Tissue Sealer devices are substantially equivalent to the predicate devices." This implies that the observed performance of the subject device met the unstated acceptance criteria of being "comparable to" or "not worse than" the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each test (e.g., number of vessels tested for burst pressure, number of animals in acute/survival studies). It refers to "bench testing and laboratory evaluations in an animal model."
- Data Provenance: The studies were conducted in an "animal model," indicating prospective animal studies and bench testing (in vitro/ex vivo). The country of origin of the data is not specified, but the applicant is Ethicon Endo-Surgery, LLC, with a contact in the US (Cincinnati, Ohio), suggesting the studies were likely conducted in the US or under their oversight.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (electrosurgical instrument) does not typically involve human experts establishing "ground truth" in the same way an AI diagnostic device would. Instead, performance is measured objectively through physical characteristics or physiological outcomes.
- Ground Truth Establishment: For vessel burst pressure, acute, and survival animal studies, the "ground truth" is likely established by objective measurements (e.g., pressure readings, histological analysis, observation of physiological outcomes). These measurements would be performed by trained lab personnel, veterinarians, and potentially pathologists, but not "experts" in the context of diagnostic image interpretation.
- Qualifications: Not specified, but implied to be qualified laboratory and veterinary professionals involved in preclinical testing.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for this device's performance studies is based on objective measurements and physiological outcomes, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on reader performance. The ENSEAL G2 is an electrosurgical instrument, not a diagnostic device, so an MRMC study is not applicable.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The ENSEAL G2 is a physical medical device (an electrosurgical instrument), not an AI algorithm. Its performance is inherent to the device itself and its interaction with tissue, not a standalone algorithm.
7. Type of Ground Truth Used
The "ground truth" used for performance evaluation includes:
- Objective Measurements: For bench testing (e.g., vessel burst pressure, electrical parameters).
- Physiological/Pathological Outcomes: In acute and survival animal studies (e.g., tissue healing, integrity, adverse events, histological assessment).
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.