(278 days)
The LigaSure™ Curved, Small Jaw, Open Sealer / Divider is a bipolar electrosurgical instrument intended to be used with the ForceTriad™ energy platform. The instrument is indicated for use in open general surgical procedures where ligation and division of vessels (up to 7 mm in diameter), tissue bundles, and lymphatics is performed, such as urologic, thoracic, plastic, and reconstructive; and including such procedures as bowel resections, gall bladder procedures, Nissen fundoplication, adhesiolysis, etc.
The device is also indicated for open ENT procedures in adults (thyroidectorny, radical neck dissection, parotidectorny, and tonsillectorny) 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™ Curved, Small Jaw, Open Sealer/Divider is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ energy platform (generator) to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics during open general surgical procedures (as indicated). The ForceTriad's tissue-fusion (LigaSure) mode delivers precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion, and has been designed to produce minimal sticking, charring, or thermal spread to adjacent tissue.
LigaSure instruments attach to the generator with a ten-foot containing a "smart" connector. This connector functions as a unique product identifier for device-specific recognition by the generator. The Curved, Small Jaw, Open Sealer/Divider instrument is designed to be both ergonomic and intuitive for the user. Its hemostat-style body and symmetrically placed controls facilitate handling by both left and righthanded users, and its small, curved jaws maximize visibility and access when the instrument is used in confined surgical spaces.
Ring handles function to allow the user to grasp tissue by opening and closing the jaws of the instrument. The interior surfaces of the jaws contain the electrodes, which serve to ligate by delivering energy to the grasped tissue. RF energy can be activated by the user in two ways: (1) through the use of a single button incorporated into the handle body or (2) through the use of a footswitch attached to the generator. A cutting mechanism functions to mechanically divide tissue following tissue fusion. It consists of a stainless steel blade and is controlled by the user through a trigger located on the handle body.
The device in question is the LigaSure™ Curved, Small Jaw, Open Sealer / Divider (LF1212) by Covidien, a bipolar electrosurgical instrument. The purpose of this submission (K113572) is to expand its indications for use to include ENT procedures and remove a warning regarding specific surgical procedures requiring precision. There are no physical changes to the device itself; the design remains the same as its predicate (K102470).
This 510(k) summary does not use a typical "acceptance criteria" table in the form of specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various performance characteristics. For a device like an electrosurgical instrument, "acceptance criteria" are implicitly met if its performance is comparable to or better than previously cleared, substantially equivalent devices, particularly regarding safety and effectiveness.
Here's an interpretation of the performance data and how it addresses the 'acceptance criteria' in the context of substantial equivalence:
1. Table of "Acceptance Criteria" (interpreted as performance comparison to predicates) and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (LigaSure LF1212) |
|---|---|---|
| Burst Pressure | Equivalent or superior mean burst pressure on isolated vessels to predicate devices (LigaSure™ Curved, Small Jaw, Open Sealer/Divider (K102470) and LigaSure™ Precise Instrument Vessel Sealing System (K010010)). | "The subject device was shown to yield higher mean burst pressures on isolated vessels than the predicates." |
| Thermal Profile | Equivalent or superior (lower) mean temperatures after single and multiple activations compared to predicate devices. | "Thermal profile studies showed the subject device has consistently lower mean temperatures than the predicates after single and multiple activations." |
| Mean Thermal Spread | Comparable mean thermal spread to predicate devices for all vessel sizes evaluated. | "The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated." |
| Usability/Usability | Adequate assurance of safety and performance (human factors/usability) in simulated operating environments, including ENT space. | "Usability was evaluated with users in simulated operating environments, including in the ENT space. These studies consisted of several formative and one summative study, which demonstrate the instrument provides adequate assurance of safety and performance (in regards to human factors/usability aspects) for the patient and operator." |
| Clinical Effectiveness/Safety in ENT Procedures | Demonstrable safety and effectiveness for use in ENT procedures, supported by existing clinical knowledge and experience. | "An assessment of published clinical literature demonstrates that there is a considerable body of knowledge and experience that shows the use of LigaSure instruments in ENT procedures is safe and effective." The submission also argues that "The use of the LigaSure Curved, Small Jaw, Open Sealer / Divider in ENT procedures does not raise any new types of questions of safety and effectiveness compared with the predicate devices currently used for these procedures." |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (defined as substantial equivalence to predicates) is a preclinical bench and animal testing study combined with usability studies and a clinical literature review.
2. Sample Size and Data Provenance (for test set, relevant for bench/animal testing and usability):
- Preclinical Bench Testing (Burst Pressure & Thermal Profile): The document states "Preclinical comparative bench testing... was conducted." It does not specify the exact sample size for isolated vessels or the number of activations for thermal profile tests. The data provenance is implied to be laboratory testing conducted by Covidien.
- Animal Testing (Thermal Spread): The document states "Animal Testing: The mean thermal spread of the subject device was shown to be comparable to the predicates for all vessel sizes evaluated." It does not specify the number of animals or the number of vessel seals performed. The data provenance is likely internal animal studies conducted by Covidien.
- Usability / Human Factors: "These studies consisted of several formative and one summative study." It does not specify the number of users (sample size) for these studies. The data provenance is internal usability studies.
All these studies appear to be prospective in nature, as they were conducted specifically for this submission to compare the device against predicates or assess usability. The country of origin for the data is not explicitly stated but is presumed to be the United States, given the submitter's location and the FDA submission.
3. Number of Experts and Qualifications (for establishing ground truth for the test set):
- Bench and Animal Testing: The establishment of ground truth for metrics like burst pressure, thermal profile, and thermal spread typically relies on objective physical measurements and established scientific methodologies, not expert consensus in the human interpretation sense. Therefore, the "experts" would be the scientists and engineers conducting and analyzing these objective tests, following standardized protocols. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided, as this is not a diagnostic device.
- Usability Studies: "Usability was evaluated with users... in the ENT space." These users are the "experts" in terms of operating the device. While their specific qualifications (e.g., "surgeon with X years of experience") are not detailed, it can be inferred that they were medical professionals (surgeons or surgical assistants) experienced in surgical procedures, likely ENT specialists given the mention of "ENT space." No specific number of experts for "ground truth setting" is given in the context of interpretation of results, as the usability studies themselves generate the data.
- Clinical Literature Review: An "assessment of published clinical literature" was performed. This implies medical experts (likely regulatory affairs personnel or medical scientists within Covidien) evaluated existing peer-reviewed studies. No specific number or qualifications of these reviewers are provided.
4. Adjudication Method (for the test set):
Since the "acceptance criteria" are based on objective physical measurements (burst pressure, thermal profile, thermal spread) and directly observed usability, rather than subjective interpretations by multiple experts, a formal "adjudication method" like 2+1 or 3+1 for resolving discrepancies in expert opinions is not applicable or described. The results of bench and animal tests are typically analyzed statistically. Usability studies involve observations and feedback, rather than adjudication of 'ground truth'.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and would not be applicable for this type of device (a surgical instrument). MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess changes in diagnostic accuracy or efficiency. This device is a surgical tool, not an image interpretation or diagnostic aid. Therefore, no effect size of human readers improving with AI assistance is reported.
6. Standalone (Algorithm Only) Performance:
No, a standalone performance study (algorithm only without human-in-the-loop) was not done and is not applicable for this device. This device is a manual surgical instrument that requires a human operator for its function; it does not contain a standalone algorithm in the sense of AI performing a task independently. The "algorithm" here refers to the energy delivery system within the ForceTriad™ platform, which is always used with the human-controlled instrument.
7. Type of Ground Truth Used:
- Bench Test (Burst Pressure, Thermal Profile): The ground truth is based on objective physical measurements using scientific equipment and standardized test methods (e.g., pressure gauges, temperature probes).
- Animal Testing (Thermal Spread): Ground truth is based on objective pathological assessment of tissue sections (histology) or direct macroscopic measurements of the thermal damage zone in animal models.
- Usability Studies: Ground truth is based on observed user performance, task completion, and user feedback in simulated environments, assessed against predefined safety and performance metrics.
- Clinical Literature: The "ground truth" for clinical safety and effectiveness in ENT procedures is derived from the published outcomes data and expert consensus within the scientific and medical literature.
8. Sample Size for the Training Set:
This device is a hardware surgical instrument, not a machine learning or AI algorithm in the typical sense that would require a "training set" for model development. The "ForceTriad™ energy platform (generator)" delivers energy, and its design would be based on engineering principles and previous device experience, not statistical learning from a "training set" of data. Therefore, the concept of a "training set" and its sample size is not applicable or addressed in this submission.
9. How Ground Truth for Training Set Was Established:
As there is no "training set" in the context of a machine learning model, the question of how its ground truth was established is not applicable. The device's 'training' or development is based on engineering design, preclinical testing, and iterative improvements, not a data-driven model training process.
§ 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.