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510(k) Data Aggregation
(125 days)
Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider
The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.
The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.
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 reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (Model LF4318). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Covidien LigaSure Impact LF4318).
Here's an analysis of the acceptance criteria and the study information, extracting what's available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each test, nor does it provide a direct numerical "reported device performance" against such criteria. Instead, it states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices based on the following tests."
However, we can infer the type of performance evaluation conducted:
| Test Type | Implied Acceptance Criteria (Inferred from "found to be equivalent") | Reported Device Performance (Inferred from "found to be equivalent") |
|---|---|---|
| Electrical Safety and EMC (IEC 60601-1, 60601-1-2) | Compliance with international standards for electrical safety and electromagnetic compatibility. | Compliant (equivalent to predicate). |
| Simulated Use | Performance under simulated surgical conditions comparable to the predicate device. | Equivalent to predicate. |
| Device Integrity | Structural and functional soundness comparable to the predicate device. | Equivalent to predicate. |
| Blade Trigger Advance/Return | Proper functioning of the cutting blade mechanism. | Equivalent to predicate. |
| Shaft Knob Rotation | Proper functioning of the shaft rotation. | Equivalent to predicate. |
| Device Recognition | Correct recognition by the associated energy platform (ForceTriad). | Equivalent to predicate. |
| Thermal Analysis Characterization | Thermal profile during use comparable to the predicate device. | Equivalent to predicate. |
| Handle Locking | Proper functioning of the handle locking mechanism. | Equivalent to predicate. |
| Burst Pressure | Vessel sealing strength (burst pressure) comparable to the predicate device. | Equivalent to predicate. |
| Histopathology | Tissue effect (e.g., seal quality, thermal spread) comparable to the predicate device. | Equivalent to predicate. |
| Seal Quality | Quality of vessel seals comparable to the predicate device. | Equivalent to predicate. |
| Tissue Sticking | Degree of tissue sticking to the device comparable to the predicate device. | Equivalent to predicate. |
| Cleaning: Protein, Carbohydrates | Effectiveness of cleaning process to remove biological contaminants to accepted levels. | Met (implied by "equivalent"). |
| Biocompatibility: Sensitization, Irritation | No adverse biological reactions (sensitization, irritation) when in contact with tissues, comparable to predicate. | Met (implied by "equivalent"). |
| Biocompatibility: Pyrogenicity | Absence of fever-inducing substances (pyrogens) to accepted levels. | Met (implied by "equivalent"). |
| Biocompatibility: Acute Systemic Toxicity | Absence of acute toxic effects, comparable to predicate. | Met (implied by "equivalent"). |
| Performance Qualification | Overall functional performance meeting specified requirements. | Met (implied by "equivalent"). |
| Sterilization Validation | Sterility assurance level (SAL) achieved and maintained. | Met (implied by "equivalent"). |
| Product Stability | Device maintaining its characteristics over shelf life. | Met (implied by "equivalent"). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the tests conducted.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). The nature of the tests (e.g., simulated use, burst pressure, histopathology, cleaning, biocompatibility) suggests they are prospective bench and lab-based studies, rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as this type of preclinical testing typically relies on predefined material properties and functional parameters rather than expert interpretation of complex clinical data. For histopathology, it would typically be a pathologist, but no specifics are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method. This is generally not relevant for the types of bench and lab tests listed.
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 performed or described. The device is a reprocessed electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This section is for AI/software devices. The device is a physical electrosurgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be established through:
- Physical and electrical measurements: For electrical safety, device integrity, blade function, shaft rotation, handle locking, device recognition.
- Material and mechanical properties standards: For burst pressure, product stability.
- Microscopic evaluation/laboratory analysis: For histopathology (tissue effect), seal quality, tissue sticking, cleaning (protein, carbohydrates).
- Standardized biological assays: For biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity).
- Sterility testing: For sterilization validation.
These are objective measurements and standardized tests designed to demonstrate equivalence to the predicate device's established performance specifications.
8. The sample size for the training set
Not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The term "training set" would not apply here.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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