(175 days)
The LigaSure Sealer/Divider 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 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, breast procedures, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectomy, and tonsillectomy) for ligation and division of vessels, lymphatics 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 LigaSure™ Exact Dissector, Nano-coated (LF2019) device is a sterile, single-use, coated, hand-held bipolar vessel sealing devices 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 and cutting, with a single activation button incorporated into the body of the device.
The provided text describes the 510(k) summary for the "LigaSure™ Exact Dissector, Nano-coated" device (K202917). This submission is for an expanded indication for use (inclusion of breast procedures) for a device previously cleared under K173281. The central argument is that the device itself is unchanged from the predicate, and therefore, previously conducted studies and comparable literature support the expanded indication.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list acceptance criteria in a quantitative table format with corresponding reported device performance values. Instead, it refers to prior testing and literature as evidence of safety and effectiveness for a device that is mechanically and technologically identical to its predicate. The expanded indication for "breast procedures" is supported by showing that similar LigaSure™ devices have been successfully used in these procedures without new safety concerns.
The comparison table provided (page 5) focuses on technological characteristics for substantial equivalence to the predicate device, not on quantitative performance against pre-defined acceptance criteria for the new indication.
2. Sample size used for the test set and the data provenance
- Test Set Description: The document states, "No design or specification changes are associated with the expanded indication of the LigaSure™ Exact Dissector, Nano-coated (LF2019) device." This implies that no new test set was generated specifically for this submission beyond what was previously submitted for K173281, as the device itself is unchanged.
- Data Provenance: The new expanded indication relies on "Clinical Literature Summary" for breast procedures. The literature pertains to "hemostat-style open LigaSure™ devices," which are similar to the subject device. The provenance of this literature would be varied (e.g., various countries of origin, likely retrospective and prospective studies published in medical journals). No specific sample size for a "test set" in the context of a new study for K202917 is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new primary test set or ground truth establishment process is described for this 510(k) submission. The submission relies on previously established performance data from the predicate device (K173281) and findings from existing clinical literature.
4. Adjudication method for the test set
Not applicable, as no new primary test set or adjudication process is described for this 510(k) submission.
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 device is an electrosurgical instrument, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical instrument, not an algorithm.
7. The type of ground truth used
The notion of "ground truth" as typically applied to diagnostic AI algorithms does not directly apply here. Instead, the submission relies on:
- Established Performance: Previous bench and animal studies (from K173281).
- Clinical Outcomes Data: From existing clinical literature on similar LigaSure™ devices in breast procedures, demonstrating "effective hemostasis, operative time, blood, thermal damage, and intraoperative and postoperative complications."
8. The sample size for the training set
Not applicable. The device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm that requires a training set.
Summary of Device Performance and Rationale for Acceptance:
The device (LigaSure™ Exact Dissector, Nano-coated) is being cleared for an expanded indication to include "breast procedures." The submission's core argument for acceptance is based on substantial equivalence to its own predicate device (also LigaSure™ Exact Dissector, Nano-coated, cleared under K173281) and a reference device (LigaSure™ Curved, Small Jaw, Open Sealer/Divider, K152286).
The key points are:
- Identical Device: The subject device is unchanged from its predicate in terms of intended use, design, performance, and technological characteristics. The only difference is the updated "indications for use" to include breast procedures.
- Prior Performance Data: Evidence of safety and effectiveness for the device's fundamental operation was presented in the original 510(k) (K173281), including:
- Testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 (electrical safety, EMC)
- Biocompatibility (ISO 10993-1)
- Device functionality
- Bench burst pressure
- In vivo acute and chronic animal studies
- Clinical Literature Summary: To support the expanded indication for breast procedures, a review of clinical literature was conducted. This literature demonstrates that "hemostat-style open LigaSure™ devices" (including the reference device, which was the predicate for the original LigaSure Exact) have been successfully used in breast procedures. The outcomes reported (hemostasis, operative time, blood loss, thermal damage, complications) were consistent with other surgical procedures performed with LigaSure™ devices.
- Conclusion: The manufacturer concludes that, since the device itself is identical to its cleared predicate and literature supports the safe and effective use of similar LigaSure™ technology in breast procedures, no new safety issues are identified, and the device is suitable for the proposed expanded indications.
§ 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.