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510(k) Data Aggregation
(163 days)
K141153 LigaSure; Curved Small Jaw Sealer/Divider, 5mm Blunt Tip Sealer/Divider, Maryland Jaw One Step
The Medline ReNewal Reprocessed LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or 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 surgery and such surgical specialities as urologic, vascular, thoracic and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
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 Reprocessed LigaSure Blunt Tip Sealer/Divider (LF1623, LF1637) devices are sterile single-use, hand-held bipolar vessel sealing devices designed for use with Covidien electrosurgical generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics clamped between the jaws, grasping tissue and blunt dissection during open and minimally invasive general surgical procedures (as indicated) using radio frequency (RF) energy. A hand-actuated lever allows the user to open or close the instrument jaws, and includes a latching mechanism that holds the jaws in the closed position during vessel sealing and cutting. The proposed devices do not include software.
The document describes the Medline ReNewal Reprocessed LigaSure Blunt Tip Sealer/Divider (a reprocessed medical device) and its substantial equivalence to its predicate device. This is a premarket notification (510(k)) for a reprocessed electrosurgical instrument, not a new AI/ML device. Therefore, many of the requested categories related to AI performance, sample sizes for test/training sets, expert ground truth, and MRMC studies are not applicable.
However, I can extract information relevant to the device's acceptance criteria and the studies performed to demonstrate its equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device through various performance tests. The reported device performance aligns with these criteria by achieving comparable results to the predicate.
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-2 | Found to be equivalent to the predicate devices. |
| Electromagnetic Compatibility | IEC 60601-1-2 | Found to be equivalent to the predicate devices. |
| Functional Equivalence | Simulated use | Found to be equivalent to the predicate devices. |
| Device integrity | Found to be equivalent to the predicate devices. | |
| Blade trigger advance/return | Found to be equivalent to the predicate devices. | |
| Shaft knob rotation | Found to be equivalent to the predicate devices. | |
| Device recognition | Found to be equivalent to the predicate devices. | |
| Handle locking | Found to be equivalent to the predicate devices. | |
| Thermal Performance | Thermal analysis characterization | Found to be equivalent to the predicate devices. |
| Sealing Performance | Burst pressure | Found to be equivalent to the predicate devices. |
| Histopathology | Found to be equivalent to the predicate devices. | |
| Seal quality | Found to be equivalent to the predicate devices. | |
| Tissue sticking | Found to be equivalent to the predicate devices. | |
| Reprocessing Effectiveness | Cleaning (protein and carbohydrates) | Demonstrated effective cleaning. |
| Biocompatibility | Sensitization, irritation, pyrogenicity, acute systemic toxicity | Demonstrated biocompatibility. |
| Stability/Shelf Life | Sterilization validation | Demonstrated sterility post-reprocessing. |
| Product stability | Demonstrated stability over time, likely covering shelf-life claims. | |
| Overall Equivalence | Comparison of indications for use, intended use, technological characteristics, and performance data. | The reprocessed devices are substantially equivalent to the predicate in terms of indications for use, intended use, technological characteristics, and performance data. The only stated difference in device characteristics is the length of the shaft. |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. For medical device reprocessing, usually, a sufficient number of devices are reprocessed and then subjected to the tests listed to demonstrate performance consistent with new devices and specified reprocessing parameters. The provenance of the data is prospective testing conducted by Medline ReNewal to support the substantial equivalence claim for their reprocessed devices. The country of origin of the data is not explicitly stated but is implicitly linked to the applicant (Medline ReNewal, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable in the context of this 510(k) submission for a reprocessed surgical instrument. "Ground truth" usually refers to definitive labels or diagnoses for AI/ML model training and evaluation. Here, the "ground truth" for demonstrating device performance relies on established engineering standards (e.g., IEC standards), material science, and biological testing methodologies (histopathology, biocompatibility tests), which are evaluated by qualified professionals in those fields (e.g., engineers, biologists, pathologists). The document does not specify the number or qualifications of these testing personnel.
4. Adjudication method for the test set
Not applicable. The tests performed are objective measurements (e.g., electrical resistance, burst pressure, chemical residue, histopathology) against established standards or comparisons to the predicate device's performance, rather than subjective assessments requiring adjudication.
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 medical device clearance for a reprocessed surgical instrument, not an AI/ML diagnostic or assistive device. There are no "human readers" or AI assistance involved in the function or evaluation of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument and does not incorporate an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the "ground truth" for this device's performance is based on:
- Established engineering standards: For electrical safety, EMC, and mechanical performance.
- Material science principles: For device integrity, handle locking, etc.
- Biological testing methodologies: For burst pressure, histopathology (tissue effects), tissue sticking, biocompatibility, cleaning efficacy (protein/carbohydrate residue).
- Comparison to the predicate device: The ultimate "ground truth" for a 510(k) is demonstrating performance that is equivalent to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no AI/ML component, therefore no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component or training set.
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