(57 days)
The Reprocessed 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 Covidien™ LigaSure™ Blunt Tip Laparoscopic Sealer/Divider (LF1637) is a bipolar electrosurgical instrument intended for use with the Covidien Electrosurgical Generators in general and gynecologic laparoscopic/open surgical procedures where ligation and division of vessels and lymph is desired. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The outer diameter of the instrument shaft is 5 mm with a working length of 37 cm. The following controls are located on the instrument handle:
- A lever for opening and closing the instrument jaws. The mechanism incorporates a latch to hold the jaws in the closed position during vessel sealing and cutting.
- An activation button for generator power to initiate vessel sealing.
- A trigger for actuating the cutter. The cutter can only be actuated when the jaws are closed and latched.
- A rotation wheel to rotate the instrument jaws.
All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attaches to the generator via a cable with a connector that identifies the instrument type to the generator.
The instrument is compatible with the Covidien™ ForceTriad™ Energy Platform and Valleylab™ FT10 Energy Platform.
The scope of this submission only includes the reprocessed Covidien™ sealer/divider device and not the ForceTriad™ Energy Platform or Valleylab™ FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.
The provided text describes a 510(k) premarket notification for a Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider (LF1637). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this reprocessed device revolve around demonstrating substantial equivalence to the original predicate device (Covidien™ LigaSure™ Blunt Tip Laparoscopic Sealer/Divider LF1637). This typically means the reprocessed device must meet the same performance specifications as the original. The text outlines the types of tests performed to achieve this, and the reported performance confirms equivalence.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Functional Performance | Verification/comparative testing to the predicate device. Evaluation of: | The reprocessed device effectively cut and coagulated vessels up to and including 7mm in diameter. The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended. "The design, materials, and intended use of the reprocessed device are equivalent to the predicate device. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and size is utilized." |
| - Burst pressure | ||
| - Maximum jaw temperature | ||
| - Device functionality | ||
| - Device reliability | ||
| - Generator compatibility | ||
| Electrical Safety | IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18 | Performance testing demonstrated compliance with these standards. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | Performance testing demonstrated compliance with this standard. |
| Biocompatibility | (Specific tests not detailed, but states "Biocompatibility" was conducted) | Results demonstrate satisfaction of biocompatibility requirements. |
| Reprocessing Validation | (Specific tests not detailed, but states "Validation of Reprocessing" was conducted) | The validated reprocessing methods ensure the device meets specified safety and cleanliness standards. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations. |
| Sterilization Validation | (Specific tests not detailed, but states "Sterilization Validation" was conducted) | The validated sterilization methods ensure the device meets specified sterility assurance levels. |
| Packaging Validation | (Specific tests not detailed, but states "Packaging Validation" was conducted) | Ensures package integrity and sterility maintenance. |
| Clinical Performance (Preclinical) | Acute and Chronic survival studies (animal model) to evaluate thermal spread and hemostasis achievement. | The results of the evaluations demonstrate that the Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider effectively cut and coagulated vessels up to and including 7mm in diameter and achieved hemostasis. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes for each test set (e.g., number of devices tested for burst pressure, number of animals in preclinical studies). It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
- Data Provenance: The preclinical studies were conducted in an animal model, making them prospective in nature. The bench testing would also be prospective, evaluating newly reprocessed devices. The country of origin for the data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of human experts or an expert panel to establish ground truth for the performance testing. The ground truth for functional performance (like burst pressure, jaw temperature, functionality, reliability, and generator compatibility) would be established through direct physical measurements and engineering specifications, compared against the predicate device's known performance. Similarly, the preclinical animal studies would rely on observable physiological outcomes (e.g., successful hemostasis, measured thermal spread) as their ground truth.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing involves objective measurements against engineering specifications and observable biological outcomes in animal models, rather than subjective human interpretation needing consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was performed as this device is a surgical instrument and not an imaging or diagnostic device that would typically involve human readers. The study focuses on the physical and functional performance of the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a surgical instrument, not an AI algorithm. Its performance is inherent to its mechanical and electrical design, not dependent on an algorithm.
7. The Type of Ground Truth Used
- Bench and Laboratory Testing: Ground truth was established through engineering specifications, physical measurements, and comparison to the predicate device's known performance across various parameters (burst pressure, max jaw temperature, functionality, reliability, generator compatibility).
- Preclinical Animal Studies: Ground truth was established through observable physiological outcomes in an animal model, such as successful hemostasis and measured thermal spread, which are direct indicators of the device's intended biological effect.
8. The Sample Size for the Training Set
This question is not applicable. The document describes the testing and validation of a reprocessed medical device, not an AI system. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set mentioned in the context of this device's submission.
§ 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.