(199 days)
The LigaSure Advance Sealer/Divider is a bipolar/monopolar electrosurgical instrument intended for use in minimally invasive surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Advance Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. The instrument can be used to dissect through tissue planes and to create enterotomies or gastrotomies.
It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, colorectal, bariatric, and gynecologic. Procedures may include, but are not limited to, gastric bypass, 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 LigaSure™ Advance Monopolar Tip Sealer/Divider, Pistol Grip is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics clamped between the jaws, grasping tissue, and blunt dissection during minimally invasive general surgical procedures. The device uses radio frequency (RF) energy to seal vessels, tissue bundles, and lymphatics. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to activate bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to active a blade, which divides the tissue along the seal line.
The LigaSure Advance Sealer/Divider also includes a tip that can deliver monopolar energybased dissection and creation of gastrotomies and enterotomies (openings in the stomach or bowel).
The provided document is a 510(k) premarket notification for a medical device, not a study report detailing specific acceptance criteria and their fulfillment. Therefore, the requested information, particularly quantitative data on acceptance criteria and study results, is not present in the given text.
The document discusses the substantial equivalence of the "LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip" (the subject device) to a predicate device (LigaSure Advance family cleared under K063195). It primarily focuses on the regulatory submission process and the justification for substantial equivalence based on similar indications for use, technological characteristics, and performance data from bench and preclinical testing.
Here's a breakdown of what can be gleaned, and what information is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This specific table is not provided. The document mentions general areas of testing but does not quantify acceptance criteria or specific performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document refers to "bench and preclinical testing" but gives no details about the sample sizes for these tests or the data provenance.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided. Given that the testing mentioned is primarily "bench and preclinical," it's unlikely that human experts were used to establish a "ground truth" in the way radiologists establish ground truth for image interpretation.
4. Adjudication Method
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The device is an electrosurgical instrument, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study for an algorithm is mentioned, as this is a physical medical device, not an algorithm. The "performance" mentioned refers to the physical characteristics and function of the electrosurgical instrument.
7. Type of Ground Truth Used
The concept of "ground truth" in the context of expert consensus, pathology, or outcomes data, as typically applied to diagnostic devices or AI, does not directly apply here. For this electrosurgical device, the "performance" data would likely be based on:
- Bench Testing: Measurements of physical properties, power output, sealing capabilities on surrogate materials, thermal spread, etc.
- Preclinical Testing: In vivo observations in animal models related to sealing vessels, achieving hemostasis, and thermal effects.
- Renal artery burst pressure: This is a specific performance metric indicating the strength of the seal.
The document states:
- "Supporting data were obtained from both bench and preclinical testing to support substantial equivalence include:" followed by bullet points.
- "Preclinical testing for this device includes: Sealing and dividing vessels and tissue bundles up to and including 7 mm, Ability to achieve hemostasis of tissue and vessels, Thermal spread measurements."
- "Comparative test results showed that the current design performs very similarly to the original design."
8. Sample Size for the Training Set
This information is 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
This information is not applicable, as there is no training set for an AI algorithm.
Summary of Available Information from the Provided Text:
- Device: LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip
- Purpose: Ligation and division of vessels, tissue bundles, and lymphatics in minimally invasive surgical procedures. Can be used on vessels up to 7mm. Also provides monopolar energy for dissection and creating enterotomies/gastrotomies.
- Context: 510(k) submission for substantial equivalence to a legally marketed predicate device (LigaSure Advance family, K063195).
- Performance Data Mentioned (General):
- Bench testing (IEC 60601-1, IEC 60601-2-2)
- Biocompatibility (ISO 10993-1)
- Sterilization cycle validation (Ethylene oxide)
- Renal artery burst pressure
- Preclinical testing (sealing/dividing vessels/tissue bundles up to 7mm, hemostasis, thermal spread measurements)
- Conclusion on Performance: "Comparative test results showed that the current design performs very similarly to the original design."
To answer your request comprehensively, a detailed study report or clinical trial documentation for the LigaSure Advance device would be required, which is beyond the scope of this 510(k) summary.
§ 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.