(24 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 specialties 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, Nano-coated (LF18XX) devices are sterile, single-use, coated, 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 general surgical procedures (as indicated) using radio frequency (RF) energy. The proposed devices come in three shaft lengths 23 cm (LF1823), 37 cm (LF1837), and 44 cm (LF1844). 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.
Here's a breakdown of the acceptance criteria and study information for the Ligasure Blunt Tip, Sealer/Divider, Nano-coated (K162941) device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that various tests were conducted to demonstrate "equivalent performance" or that the devices "performed as expected" or "similarly" to the predicate devices. The acceptance criteria for each test inherently relate to achieving this equivalence or expected performance.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 | Devices met required standards for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Materials Mediated Pyrogenicity, Hemolysis. |
| Electrical Safety and EMC | Compliance with ANSI AAMI ES 60601-1, IEC 60601-2-2, IEC 60601-1-2 | Devices complied with relevant clauses of these standards. |
| Mechanical/Functional Testing | Performed as expected (functional and design specifications met) | Verified performance for Jaw force, Jaw gap, Device resistance, capacitance, and inductance, Jaw Hyper-Extension, Bench Grasping Performance, Device Cycle Test. |
| Ex-vivo Vessel Burst Pressure | Equivalent performance to predicate devices | Showed equivalent performance between subject and predicate devices. |
| Acute Animal Study | Equivalent sealing performance and lateral thermal damage to predicate devices. Thermal safety evaluated. | Subject devices performed equivalently to the predicate devices. |
| Chronic Animal Study | Maintenance of chronic hemostasis for 21 days. | All animals survived 21 days post-op and all seals maintained chronic hemostasis. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Biocompatibility: Not specified.
- Electrical Safety and EMC: Not specified.
- Mechanical/Functional Testing: Not specified.
- Ex-vivo Vessel Burst Pressure: Not specified, but involved "excised fresh porcine renal arteries and lymphatics." This suggests in vitro testing using animal tissue. Data provenance is therefore in vitro (animal tissue).
- Acute Animal Study: Not specified, but involved "porcine" subjects. This is a prospective animal study. Data provenance is in vivo (animal).
- Chronic Animal Study: Not specified, but involved "animals" that survived 21 days post-op (implying a controlled in vivo study). Data provenance is in vivo (animal).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of human experts being used to establish ground truth for any of the performance tests. The evaluation appears to be based on objective measurements and experimental outcomes (e.g., burst pressure, thermal damage assessment, hemostasis over time).
4. Adjudication Method for the Test Set
Not applicable, as no human readers or subjective assessments requiring adjudication are described for establishing ground truth in the performance tests.
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 assistive tool. Therefore, no MRMC studies or human reader improvement with AI are relevant. The submission "did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a physical electrosurgical instrument. Its performance is inherent to its hardware and function, not software.
7. The Type of Ground Truth Used
- Biocompatibility: Established through standardized in vitro tests according to ISO 10993-1.
- Electrical Safety and EMC: Established through compliance with specific electrical and EMC standards.
- Mechanical/Functional Testing: Established through objective measurements against design specifications.
- Ex-vivo Vessel Burst Pressure: Established through direct measurement of burst pressure in ex-vivo animal tissue samples.
- Acute Animal Study: Established through direct observation and measurement of sealing performance and lateral thermal damage in in vivo animal models.
- Chronic Animal Study: Established through direct observation of animal survival and maintenance of hemostasis over 21 days in in vivo animal models.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
§ 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.