(8 days)
The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. It is intended for use during open or laparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical procedures (including unlake polluding and reconstructive, bowel resections, hysterectomies, cholecysted, theracter, plactions and resolunts, bowel resedunts. edbacialysis contrasses in the secures, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. 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 SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
EnSeal™ Vessel Sealing & Hemostasis System. The functionality of the System is the same as the predicate device. The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.
The medical device in question is the SurgRx EnSeal Vessel Sealing & Hemostasis System.
1. Acceptance Criteria and Reported Device Performance:
The document mentions that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." However, no specific quantitative acceptance criteria or their corresponding performance results are provided in the extracted text. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics against pre-defined thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "Preclinical laboratory (bench) and performance tests."
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not specify the number of experts used and their qualifications for establishing ground truth for any test set.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating equivalence to a predicate device.
6. Standalone (Algorithm Only) Performance:
This device is an electrosurgical instrument system, not an AI-powered algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
7. Type of Ground Truth Used:
The document implies that the ground truth for "design validation" was based on the "function as intended" and "meet design specifications." This suggests a bench test and performance test-driven ground truth, likely based on engineering specifications and direct observation of the device's physical performance (e.g., ability to seal vessels of a certain size, cutting capabilities). It is not pathology, outcomes data, or expert consensus in a diagnostic sense.
8. Sample Size for the Training Set:
This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established:
This device is not an AI/ML algorithm that requires a training set. Therefore, this question is not applicable.
Summary of the Study:
The study performed was a design validation using "Preclinical laboratory (bench) and performance tests." The primary objective was to demonstrate substantial equivalence to a predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K061526). The document concludes that "The EnSeal System is equivalent to the predicate device based on results of design validation." It is implied that the device met its design specifications and performed as intended in these preclinical tests, thus satisfying the requirement for substantial equivalence. No detailed analytical study with quantitative acceptance criteria, specific test data, or statistical analysis against the predicate device is provided in the summary.
§ 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.