(137 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 surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.
The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation 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 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 vessel sealing and cutting, with a single activation button incorporated into the body of the device.
The provided text describes a 510(k) premarket notification for the LigaSure Exact Dissector, Nano-coated device, seeking to demonstrate its substantial equivalence to a predicate device. This type of submission generally relies on performance testing rather than extensive clinical studies to prove safety and effectiveness.
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative manner for specific performance metrics with predefined thresholds. Instead, the "acceptance criteria" are implied to be achieving performance comparable to the predicate device, demonstrating safety, and meeting relevant electrical safety, EMC, and biocompatibility standards. The reported device performance is presented as successfully meeting these implied criteria.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies with International Standard ISO 10993-1. |
| Electrical Safety | Complies with relevant clauses of IEC 60601-1 and IEC 60601-2-2 standards. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Mechanical/Functional Performance | Mechanical, electrical, and functional testing verified that the proposed devices performed as expected. |
| Ex-vivo Vessel Sealing Performance (Burst Pressure) | Demonstrated bipolar electrosurgical vessel sealing performance comparable to the predicate devices on excised fresh porcine renal arteries and lymphatics. |
| Acute Sealing Performance and Lateral Thermal Damage | Acute animal study in porcine showed that the subject devices are as safe and effective as the predicate devices, with thermal safety evaluated. |
| Chronic Seal Quality | Chronic animal study (21 days) showed all animals survived without major complications, and all seals maintained chronic hemostasis and healed as expected. |
| Substantial Equivalence to Predicate Device | Based on preclinical performance, the device has a safety and effectiveness profile similar to the predicate device. Verification and validation data support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document provides the following information:
- Ex-vivo Vessel Burst Pressure: "excised fresh porcine renal arteries and lymphatics" were used. The exact number of vessels or samples is not specified. Data provenance is porcine (animal origin).
- Acute Animal Study: "a porcine" was used. The exact number of animals is not specified, but the use of "a porcine" suggests it might have been a small number, possibly one or a few. Data provenance is porcine (animal origin) and acute (short-term observation).
- Chronic Animal Study: "All animals" (plural) survived 21 days. The exact number of animals is not specified, but it was a cohort observed over 21 days (chronic). Data provenance is porcine (animal origin).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies conducted (ex-vivo and in vivo animal studies) are preclinical in nature and typically involve researchers and veterinary professionals evaluating outcomes based on physiological measurements, histological analysis, and observed healing, rather than a "ground truth" established by human expert readers in the context of interpretation, like in imaging studies.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth. Since this submission relies on preclinical animal and ex-vivo studies, an adjudication method in this sense is not applicable and therefore not mentioned. The evaluation of outcomes would have been based on objective measurements and observations by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." MRMC studies inherently involve human readers and clinical cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is typically relevant for AI/ML-driven devices. The LigaSure Exact Dissector is a physical electrosurgical instrument. Therefore, the concept of "standalone performance" of an algorithm without human-in-the-loop is not applicable. The device's performance is intrinsically tied to its use by a human surgeon.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the methods used to assess the device's performance and safety. It appears to be a combination of:
- Objective Physiological Measurements: Ex-vivo burst pressure to assess seal strength.
- Direct Observation and Macroscopic Assessment: During acute and chronic animal studies, including observations of hemostasis, healing, and presence/absence of major complications.
- Histological Analysis: Implied by the evaluation of "lateral thermal damage" and "healing" in animal studies, suggesting microscopic examination of tissue.
- Compliance with Standards: Verification against biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-2), and EMC (IEC 60601-1-2) standards.
8. The Sample Size for the Training Set
This question is typically relevant for AI/ML devices. Since the LigaSure Exact Dissector is a physical electrosurgical device, there is no "training set" in the machine learning sense. The device's design and manufacturing rely on engineering principles, materials science, and verified production processes, not on data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for this type of medical device, this question is not applicable.
§ 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.