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510(k) Data Aggregation
Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical 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 such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.
The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.
Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-2-2 and 60601-1-2. (The reprocessed device meets these standards, implying equivalence to the predicate which would also meet these standards). |
| Simulated Use | Evaluated and found equivalent to the predicate devices. This implies the reprocessed devices perform as expected during simulated surgical procedures. |
| Device Integrity | Evaluated and found equivalent to the predicate devices. This suggests the physical and structural integrity of the reprocessed devices is maintained. |
| Blade Trigger Advance/Return | Evaluated and found equivalent to the predicate devices. The cutting mechanism functions correctly. |
| Activation Button Device Recognition | Evaluated and found equivalent to the predicate devices. The device properly interacts with the associated electrosurgical generators. |
| Thermal Analysis Characterization | Evaluated and found equivalent to the predicate devices. The reprocessed device's thermal performance (e.g., heat generation during use) is comparable to the predicate. |
| Tissue Sticking | Evaluated and found equivalent to the predicate devices. The reprocessed device minimizes tissue sticking during use, similar to the predicate. |
| Burst Pressure | Evaluated and found equivalent to the predicate devices. This likely refers to the strength of the seal created by the device on vessels, demonstrating its ability to occlude vessels effectively, comparable to the predicate. |
| Histopathology | Evaluated and found equivalent to the predicate devices. This suggests the tissue effects (e.g., thermal damage, seal quality) produced by the reprocessed device are similar to those of the predicate. |
| Seal Quality | Evaluated and found equivalent to the predicate devices. This is a direct measure of the effectiveness of the device in sealing vessels, confirming it performs comparably to the predicate. |
| Cleaning: Protein, and Carbohydrates (Residuals After Reprocessing) | Evaluated and found equivalent to the predicate devices. This confirms the reprocessing methods effectively remove biological contaminants to a safe level, meeting the standards necessary for a reprocessed device. (Though "equivalent to the predicate" is stated, for cleaning, the acceptance is typically passing a defined threshold for residuals, implying the reprocessed devices meet these thresholds). |
| Biocompatibility: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, and Acute Systemic Toxicity | Evaluated and found equivalent to the predicate devices. This indicates that the materials and reprocessing do not induce adverse biological responses, meeting established biocompatibility standards. (Similar to cleaning, "equivalent to the predicate" here means meeting the same biological safety standards of a new device). |
| Performance Qualification | Evaluated and found equivalent to the predicate devices. This generally refers to verification that the manufacturing process consistently produces device that meets specifications. |
| Sterilization Validation | Evaluated and found equivalent to the predicate devices. This confirms the sterilization process effectively renders the reprocessed devices sterile to an acceptable sterility assurance level (SAL). |
| Product Stability | Evaluated and found equivalent to the predicate devices. This assesses the device's ability to maintain its safety and performance characteristics over its shelf life. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.
The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.
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 not a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of this reprocessed device is established by:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
- Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
- Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
- Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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