(261 days)
The Reprocessed 5 mm Vessel Sealer-Divider is a bipolar electrosurgical instrument intended for use with the LigaSure Generator in general and gynecologic laparoscopic surgical procedures where ligation of vessels is desired. The instrument creates a seal by the application of RF electrosurgical energy to vascular structures (vessels) interposed between the jaws of the instrument. A blade within the instrument is actuated to divide tissue.
Indications for use include general laparoscopic surgical procedures including urologic, vascular, thoracic and thoracoscopic, and gynecologic laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vacinal hysterectomy, Nissen fundoplication, colectomy, ad hesiolysis, oophorectomy, etc. The Reprocessed 5mm Vessel Sealer-Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Reprocessed 5mm Vessel Sealer-Divider can be used on vessels up to and including 7mm diameter, and tissue bundles as large as will fit in the jaws of the instrument.
The Vessel Sealer/divider is an electrosurgical instrument for use with the LigaSure™ Vessel Sealing Generator (not within the scope of this submission). The device is able to seal vessels, divide vessels and tissue clamped between its jaws, grasp tissue, and is capable of blunt dissection. The diameter of the shaft is 5mm and the working length is 37cm. Device controls are located on the instrument handle. The instrument is supplied sterile for single patient use.
The provided 510(k) summary for the Reprocessed LigaSure Vessel Sealer/divider does not contain information typically associated with clinical studies or performance metrics like sensitivity, specificity, accuracy, or effect sizes for AI-assisted workflows. This document primarily focuses on demonstrating substantial equivalence through bench and laboratory testing.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission defines "performance" as safety and effectiveness demonstrated through specific types of bench and laboratory tests, without providing numerical acceptance criteria or specific quantitative results beyond a general statement of performance.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device meets biocompatibility standards. | Biocompatibility testing was conducted. |
| Safety: Reprocessing methods are validated. | Validation of reprocessing was conducted. |
| Safety: Sterilization methods are validated. | Sterilization Validation was conducted. |
| Effectiveness: Device functions as originally intended. | Function test(s) were conducted. Performance testing demonstrates that Reprocessed Vessel Sealer/dividers perform as originally intended. |
| Safety/Effectiveness: Packaging maintains sterility and device integrity. | Packaging Validation was conducted. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the tests. The document indicates "Each individual Vessel Sealer/divider is tested for appropriate function of its components prior to packaging and labeling operations," suggesting testing of individual reprocessed units, but a specific sample size for validation studies is not provided.
- Data Provenance: The tests are described as "Bench and laboratory testing." This indicates the data is generated in a controlled lab environment. There is no mention of human subject data, country of origin, or whether the data is retrospective or prospective, as this is bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the context of bench and laboratory testing for a reprocessed medical device. "Ground truth" in this context would refer to established engineering and material standards, and the proper functioning of the device as per its original design. The experts involved would likely be engineers, microbiologists, and other technical specialists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Bench and laboratory tests typically involve objective measurements against predefined specifications, rather than expert adjudication of qualitative outcomes.
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
- No MRMC study was done. This submission is for a reprocessed electrosurgical instrument, not an AI-powered diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study and effect size for human readers with/without AI assistance are not relevant and not discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone algorithm performance was done. This device is a physical electrosurgical instrument; it does not contain an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device lies in:
- Original Device Specifications and Performance: The reprocessed device is compared against the performance characteristics of the new, original (predicate) LigaSure™ 5mm Laparoscopic Sealer/divider (K031011).
- Established Standards: Biocompatibility, sterilization, and packaging tests would adhere to established regulatory standards and best practices for medical device reprocessing and manufacturing.
- Functional Parameters: Discrete functional tests (e.g., sealing strength, blade actuation, electrical integrity) measured against specified operational ranges.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of a reprocessed medical device's performance validation. The device does not learn or use algorithms that require training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its implicitly defined acceptance criteria consisted of a series of bench and laboratory tests. These tests covered:
- Biocompatibility: To ensure the reprocessed device is safe for contact with human tissue.
- Reprocessing Validation: To confirm that the reprocessing methods effectively clean, disinfect, and prepare the device for reuse.
- Sterilization Validation: To ensure the device achieves the required sterility assurance level.
- Function Test(s): To verify that all components and mechanisms of the device (e.g., sealing, dividing, grasping, blunt dissection) operate as intended and perform equivalently to a new device. The statement "Each individual Vessel Sealer/divider is tested for appropriate function of its components prior to packaging and labeling operations" suggests a 100% functional check during manufacturing.
- Packaging Validation: To confirm the integrity of the packaging over its shelf life and its ability to maintain sterility.
The overall conclusion from these tests was that "Reprocessed Vessel Sealer/dividers perform as originally intended," leading to the determination that they are "safe, effective, and substantially equivalent to the predicate devices." No specific quantitative results or detailed methodologies of these tests are provided in the summary, which is common for 510(k) summaries where the detailed reports are held by the manufacturer.
§ 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.