(213 days)
The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division 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 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, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss 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 coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.
The provided text is a summary of a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A.
The key aspect of this document is demonstrating substantial equivalence to an existing predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The study's purpose is not to prove the device meets pre-defined clinical acceptance criteria for a novel functionality, but rather to show that the reprocessed device performs as safely and effectively as the original, legally marketed device.
Therefore, the "acceptance criteria" here largely refer to demonstrating performance consistent with the predicate device across various functional and safety aspects.
Here's an analysis of the acceptance criteria and the study, based on the provided text, while acknowledging that a 510(k) summary often provides high-level information without deep specifics on study methodologies:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a reprocessed device, the "acceptance criteria" are generally that the reprocessed device performs equivalently to the original device. The "reported device performance" is the demonstration through various tests that this equivalence is met.
| Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Electrical Safety and Electromagnetic Compatibility | Found equivalent to predicate devices based on tests in accordance with IEC 60601-2-2 and 60601-1-2. |
| Simulated Use | Functional characteristics evaluated, found equivalent. (Specific metrics not detailed, but implies comparison to predicate performance during simulated surgical scenarios). |
| Device Integrity | Functional characteristics evaluated, found equivalent. (Implies structural soundness and resistance to failure under expected conditions). |
| Blade Trigger Advance/Return | Functional characteristics evaluated, found equivalent. (Implies smooth and reliable operation of the cutting mechanism). |
| Activation Button Device Recognition | Functional characteristics evaluated, found equivalent. (Ensures proper interaction with the electrosurgical generator). |
| Thermal Analysis Characterization | Functional characteristics evaluated, found equivalent. (Ensures thermal spread remains within acceptable limits, comparable to the predicate). |
| Tissue Sticking | Functional characteristics evaluated, found equivalent. (Ensures minimal sticking to tissue, similar to the predicate, for ease of use and reduced collateral damage). |
| Blade Sharpness | Functional characteristics evaluated, found equivalent. (Ensures effective cutting performance comparative to the predicate). |
| Transient Cooling Analysis Burst Pressure | Functional characteristics evaluated, found equivalent. (Likely assesses the integrity and strength of the sealed vessels under pressure after the sealing cycle, comparing to the predicate). |
| Histopathology | Functional characteristics evaluated, found equivalent. (Examines tissue changes at a microscopic level after sealing, comparing the reprocessed device's effect to the predicate's). |
| Seal Quality | Functional characteristics evaluated, found equivalent. (Directly assesses the effectiveness of the vessel sealing functionality, likely through metrics like burst pressure, tensile strength, or visual inspection, against predicate performance). |
| Cleaning (Protein, Carbohydrates, Endotoxin) | Demonstrated effective cleaning to acceptable levels. (Ensures removal of biological contaminants from previous use). |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity) | Demonstrated acceptable levels for all listed parameters. (Ensures the device materials, after reprocessing, do not elicit harmful biological responses). |
| Sterilization Validation | Demonstrated effective sterilization. (Ensures the device is sterile when provided for use). |
| Product Stability | Demonstrated. (Ensures the device maintains its performance and safety over its shelf life after reprocessing). |
| Intended Use / Indications for Use | The reprocessed device shares the identical Intended Use and Indications for Use as the predicate device. The only difference is the manufacturer of the specific device, and that one is "reprocessed." |
| Technological Characteristics | The technological characteristics and fundamental scientific technology of the proposed device are identical to the predicate device. Both use bipolar energy to seal and divide vessels up to and including 7mm. Both are designed for use with the ForceTriad Electrosurgical Generator running software version 3.40 or higher. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each of the performance tests (e.g., number of devices tested for electrical safety, number of tissue samples for histopathology). It only lists the types of tests performed.
The data provenance is not explicitly stated in terms of country of origin. However, the FDA 510(k) submission process typically requires data generated in accordance with Good Laboratory Practice (GLP) or similar standards. Given it's a US FDA submission, it's highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The data is retrospective in the sense that the predicate device's performance already exists, and the reprocessed device is being compared against it. New prospective testing is done on the reprocessed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For a device like this, "ground truth" isn't typically established by expert consensus in the way it would be for an AI diagnostic algorithm. Instead, it's established by:
- Engineering specifications and regulatory standards: These define acceptable performance ranges (e.g., electrical parameters, burst pressure requirements, cleanliness levels).
- Predicate device's established performance: The predicate device, already on the market, sets the benchmark for equivalent performance.
- Scientific and clinical literature: Informing what constitutes safe and effective tissue sealing and cutting.
- Pathology results: For tests like histopathology, a qualified pathologist would interpret the tissue samples, but this is part of the test result generation, not "ground truth" establishment in the AI sense.
The document does not mention the number or qualifications of experts establishing ground truth in the context of an AI study. However, the evaluation of the various tests would be performed by qualified personnel (e.g., engineers, microbiologists, toxicologists, pathologists) relevant to each specific test.
4. Adjudication Method for the Test Set
Not applicable in the context of a 510(k) for a reprocessed surgical instrument. Adjudication methods like "2+1" or "3+1" are characteristic of studies establishing ground truth for diagnostic AI, especially in image interpretation, where multiple human readers resolve discrepancies. Here, objective measurements and comparisons to established standards and predicate performance are used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret images or data, and the AI's impact on their performance (with or without AI assistance) is evaluated. This 510(k) is for a physical surgical instrument, not a diagnostic AI.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm. It's a physical electrosurgical instrument that is used by a human surgeon. The performance tests evaluate the instrument's physical and functional capabilities, which are inherently "standalone" in the sense that the instrument itself is being tested, but always within the context of its intended use by a human.
7. The Type of Ground Truth Used
The "ground truth" for this reprocessed device is multifactorial:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The reprocessed device must demonstrate equivalent performance across all tested parameters.
- Industry Standards and Regulatory Requirements: Technical standards (e.g., IEC 60601 series for electrical safety) and FDA regulations set minimum acceptable performance and safety thresholds.
- Objective Measurements: Laboratory tests yield objective data (e.g., electrical resistance, burst pressure, protein levels, cell viability) that can be directly compared against specified limits or predicate device data.
- Pathology: For histopathology, the ground truth would be the pathological assessment of tissue effects.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth to establish.
§ 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.