(110 days)
The LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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, etc.
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 LigaSure™ Blunt Tip Sealer/Divider (LF1623, LF1644) devices are sterile (EtO), 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 contain software.
This document describes the testing and performance of the LigaSure™ Blunt Tip Sealer/Divider. However, it does not contain explicit "acceptance criteria" presented as quantitative thresholds that the device must meet, nor does it present the "reported device performance" in a structured table directly compared to such criteria for many of the tests.
Instead, the document primarily focuses on verifying that the new shaft lengths of the LigaSure™ Blunt Tip Sealer/Divider devices perform as expected and are substantially equivalent to the predicate device (LigaSure™ Blunt Tip Laparoscopic Sealer/Divider). The studies described are for demonstrating this equivalence and safety, rather than proving performance against specific pre-defined quantitative acceptance criteria in a format typical for AI/software device evaluation.
Here's an attempt to extract and present the information you requested, highlighting where specific details are missing for this type of medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for most of the tests in a table, nor does it provide specific numerical performance results for the device against such criteria. Instead, it generally states that tests were conducted and the device "performs as expected" or "met the predefined acceptance criteria" (for the animal study), or that it has a "safety and effectiveness profile that is similar to the predicate device."
| Test Category | Acceptance Criteria (as implied/stated) | Reported Device Performance (as stated or implied) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and specific tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemolysis). | Evaluation conducted; implied to have passed as it supports substantial equivalence. |
| Electrical Safety & EMC | Compliance with relevant portions of IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 for electrical safety and IEC 60601-1-2 for EMC. | The system complies with the mentioned standards. |
| Mechanical/Functional Testing | Device with new shaft lengths perform as expected (for Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Knife deployment force, Lever latching/unlatching/opening force). Implied to be comparable to the predicate. | Testing carried out to verify that the devices with the new shaft lengths perform as expected. No specific numerical values are given. |
| Ex-vivo Vessel Burst Pressure | To demonstrate bipolar electrosurgical vessel sealing performance comparable to the predicate device. | Testing conducted on both subject and predicate devices. Implied to show comparable performance supporting substantial equivalence. |
| Thermal Profile | To evaluate the thermal profile of the jaw and shaft of the subject device in comparison to the predicate. Implied: demonstrate comparable thermal characteristics. | Bench thermal profile testing conducted. Implied to show comparable thermal profiles demonstrating substantial equivalence. |
| Acute Animal Study | Predefined acceptance criteria for hemostasis rates; thermal safety evaluated by macroscopic and histological evaluation to demonstrate that subject devices are as safe and effective as the predicate. | Hemostasis rates met the predefined acceptance criteria. Macroscopic and histological evaluation demonstrated that the subject devices are as safe and effective as the predicate device. |
| Human Factors and Usability | Compliance with IEC 62366:2007; analysis of user needs and potential use errors; testing to demonstrate representative users can use instruments safely and correctly. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | The usability engineering process applied was in compliance and followed by testing to demonstrate safe and correct use by representative users. |
Study Details:
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Sample sizes used for the test set and the data provenance:
- Biocompatibility: Not specified beyond "patient-contacting materials" being tested.
- Electrical Safety & EMC: Not specified.
- Mechanical/Functional Testing: Not specified.
- Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal, pulmonary arteries, and lymphatics." The number of samples/vessels is not specified.
- Acute Animal Study: "one female pig" was used.
- Chronic Animal Study: Not applicable to a new study; results from K130744 were carried over due to device similarity.
- Human Factors and Usability: "representative users" were used, but the number is not specified.
- Data Provenance:
- Ex-vivo: Porcine tissue.
- Acute Animal Study: Porcine.
- Other tests (Mechanical, Electrical, Biocompatibility): Likely conducted in a laboratory setting (in-house or contracted).
- All studies are prospective for the K142929 submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is more pertinent to diagnostic AI devices. For this electrosurgical device, "ground truth" would be established through direct physical measurements, observation of physiological responses (e.g., hemostasis), or pathological evaluation, rather than human expert interpretation of images/data.
- Acute Animal Study: "Macroscopic and histological evaluation of the tissue that was sealed and divided" was performed. These evaluations would typically be done by veterinary pathologists or trained researchers, but their number and specific qualifications are not detailed in this summary.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device's testing. Ground truth for performance (e.g., burst pressure, hemostasis, thermal damage) is determined by direct physical measurement, observation, or histological analysis, not by human reader consensus/adjudication.
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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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the AI as an aid. The LigaSure™ Blunt Tip Sealer/Divider is a surgical tool, not a diagnostic AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a hand-held surgical instrument requiring human operation. It does not contain an "algorithm" in the sense of an AI or diagnostic software that could perform "standalone." Its performance is always in the context of human use. The document explicitly states, "The proposed devices do not contain software."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Laboratory testing results based on established international standards.
- Electrical Safety & EMC: Measurements against specified standard limits.
- Mechanical/Functional Testing: Direct physical measurements (e.g., force, gap, resistance).
- Ex-vivo Vessel Burst Pressure: Measured burst pressure values of sealed vessels.
- Acute Animal Study: Direct observation of hemostasis and pathological evaluation (macroscopic and histological) of tissue for thermal damage.
- Human Factors and Usability: Observational studies of user interaction and performance of tasks.
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The sample size for the training set:
- The LigaSure™ Blunt Tip Sealer/Divider is a hardware electrosurgical device, not an AI or software algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on engineering principles and prior validated predicate devices.
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How the ground truth for the training set was established:
- As there is no training set for an AI/software algorithm, this question is not applicable. The functional performance of the device's design is established through engineering design, material science, and testing as described.
§ 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.