(13 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 urologic, thoracic, plastic and reconstructive, bowel researcines, hysterectomies, cholecystectomies, 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 provided 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System (K061526) states that preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications. The submission then concludes that the system is equivalent to its predicate device based on these design validation results.
However, the summary does not provide specific details about the acceptance criteria or the study that "proves the device meets the acceptance criteria" in the format of the requested table and detailed analysis. This type of information is typically considered proprietary and is not fully disclosed in a public 510(k) summary. The summary focuses on establishing substantial equivalence to a predicate device (K031133) rather than presenting a detailed performance study with explicit acceptance criteria and results.
Therefore, I cannot fully complete the requested table and analysis due to the limited information available in the provided document.
Here's what can be inferred and what is missing:
Inferred Information from the 510(k) Summary
The summary indicates that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the device was evaluated for its ability to cut and seal vessels, grasp and dissect tissue effectively and safely, similar to its predicate device.
Missing Information - Cannot be Extracted from the Provided Document
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific parameters related to sealing strength, hemostasis, tissue dissection efficacy, thermal spread, etc., were not explicitly detailed in the provided document. | Specific performance values (e.g., vessel bursting pressure, tissue cutting speed, time to hemostasis, maximum thermal spread) were not explicitly detailed in the provided document. |
Reason for missing information: The 510(k) summary did not disclose the specific quantifiable acceptance criteria or the detailed results of the performance tests. It broadly states that tests were done to "meet design specifications."
2. Sample size used for the test set and the data provenance
Reason for missing information: The document does not specify the sample size (e.g., number of vessels, tissues, or animals tested) used in the preclinical laboratory and performance tests. It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Reason for missing information: The document does not mention the involvement of experts for establishing ground truth, as this type of preclinical testing typically involves engineers and researchers evaluating physical performance rather than clinical expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Reason for missing information: This is not applicable to the preclinical bench and performance tests described. Adjudication methods are typically used in clinical studies involving human readers or evaluators.
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
Reason for missing information: This information is not relevant to the device described. The EnSeal system is an electrosurgical instrument, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Reason for missing information: This is not applicable. The EnSeal system is a medical device requiring direct human operation, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Reason for missing information: For preclinical bench testing of an electrosurgical device, the "ground truth" would typically be established by objective measurements against engineering specifications and validated experimental methods (e.g., bursting pressure measurements for seals, microscopic analysis of tissue effects, temperature readings). The document does not specify these methods.
8. The sample size for the training set
Reason for missing information: Not applicable to this type of device. "Training set" is a concept used in machine learning and AI development, not for the validation of an electrosurgical instrument in the manner described. The device's design is based on engineering principles and previous predicate device experience, not a "training set" in the AI sense.
9. How the ground truth for the training set was established
Reason for missing information: Not applicable for the same reason as point 8.
In summary, the provided 510(k) summary states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications," leading to the conclusion of substantial equivalence. However, it explicitly lacks the granular detail regarding acceptance criteria, sample sizes, expert involvement, and specific performance results that would be needed to fulfill the request.
§ 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.