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510(k) Data Aggregation
(255 days)
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels. Ivmphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.
The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The Medline ReNewal Remanufactured LigaSure Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, handle-held bipolar vessel sealing device designed for use with compatible Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasp tissue, and perform blunt dissection during general surgical procedures (as indicated) using radio frequency (RF) energy. A hemostat style body allows the user to open or close the instrument jaws during vessel sealing and cutting, with a single activation button incorporated into the body of the device.
The provided text describes the 510(k) summary for the Medline ReNewal Reprocessed LigaSure Exact Dissector, a remanufactured surgical instrument, not an AI-powered diagnostic device. Therefore, the concepts of "acceptance criteria," "study that proves the device meets the acceptance criteria," "test set," "ground truth," "experts," "adjudication," "MRMC study," and "training set" as typically applied to AI/ML diagnostic devices, are not applicable in this context.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of functional characteristics, materials, and technological aspects.
Here's how to reframe the information based on the provided text for a non-AI medical device:
The device under review is the Medline ReNewal Remanufactured LigaSure Exact Dissector, without Nano-coating (LF2019). This is a reprocessed version of a legally marketed predicate device. The "acceptance criteria" in this context refer to demonstrating that the reprocessed device performs equivalently to the original and meets necessary safety and functional standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Implied by testing) | Reported Device Performance (Summary from text) |
|---|---|---|
| Functional Performance | Equivalent sealing, cutting, and grasping capabilities to the predicate device. | "The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests: Functional performance: simulated use and artificial soiling; visual inspection; device functionality; in vivo acute and chronic animal studies." |
| Electrical Safety | Safe electrical operation and insulation. | "Electrical Safety" testing performed. |
| Cleaning Validation | Effective removal of biological and other contaminants from used devices to ensure reprocessing quality. | "Cleaning Validation" performed. |
| Biocompatibility | Materials of construction (post-reprocessing) do not elicit adverse biological responses. | "Biocompatibility" testing performed. |
| Sterilization Validation | Device is terminally sterilized and maintains sterility. | "Sterilization Validation" performed. |
| Packaging & Shelf Life | Packaging maintains device integrity and sterility for the specified shelf life. | "Packaging and shelf life validation" performed. |
| Residuals Testing | Acceptable levels of process residuals (e.g., ethylene oxide, ethylene chlorohydrin). | "bioburden testing; and ethylene oxide and ethylene chlorohydrin residuals testing" performed. |
| Product Stability | Device maintains its properties and performance over its shelf life. | "Product stability" testing performed. |
| Indications for Use | Same as the predicate device. | "The predicate and proposed devices in this application have the same indications for use and technological characteristics." (See "Indications for Use" section in the comparison table, which is identical to the predicate). |
| Technological Characteristics | Maintain essential features and operation as the predicate device, with understanding of nano-coating difference. | "The technological characteristics, materials, and the fundamental scientific technology of the subject device is equivalent to the predicate device. The proposed device is a reprocessed version of the predicate device... The original equipment manufacturer of the LigaSure Exact Dissector, Nano-coated applied a nano-coating to the device jaws to reduce tissue sticking. Medline ReNewal does not replace the coating on the device jaws in its process..." |
2. Sample size used for the test set and the data provenance:
The document summarizes testing categories but does not provide specific sample sizes or provenance information for each test performed (e.g., how many devices were tested for functional performance or biocompatibility). This level of detail is typically found in the full 510(k) submission, not the summary document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable for a reprocessed surgical instrument. The assessment is based on quantifiable engineering and biological tests, not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication method for the test set:
Not applicable. Testing involves objective measurements and predefined pass/fail criteria for mechanical and biological performance.
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 a reprocessed surgical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of device, "ground truth" is established through:
- Engineering specifications and performance standards: The device must meet predefined mechanical, electrical, and functional parameters.
- Biological safety standards: Biocompatibility testing compares material responses to established safe limits.
- Sterilization efficacy standards: Validation ensures a specified sterility assurance level (SAL).
- Comparison to predicate device performance: The reprocessed device is expected to perform comparably to the original during functional tests.
8. The sample size for the training set:
Not applicable. There is no "training set" for a reprocessed surgical instrument.
9. How the ground truth for the training set was established:
Not applicable.
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