(96 days)
The Remanufactured 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 surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure 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 Remanufactured LigaSure Exact Dissector. Without Nano-coating (LF2019) is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:
- Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
- . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
- . A trigger for actuating the blade.
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 attached to the qenerator via a cable with a connector that identifies the instrument type to the qenerator.
For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.
The instrument is compatible with the Covidien Valleylab FT10 Enerqy Platform.
The scope of the submission only includes the Remanufactured LigaSure Exact Dissector. Without Nano-coating and not the Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess, remanufacture, or market the generators or footswitch.
The provided text describes the acceptance criteria and the study conducted for the Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019). Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. However, it states that the device was evaluated against the predicate device and that the results "demonstrate that the Remanufactured LigaSure Exact Dissector, Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device."
Therefore, the implicit acceptance criteria are that the remanufactured device performs comparably to the predicate device in the specified tests, particularly regarding safety and effectiveness.
| Test Category | Reported Device Performance and Acceptance Criteria (Implicit) |
|---|---|
| Bench and Laboratory Testing | Demonstrated performance (safety and effectiveness) comparable to the predicate device. |
| Biocompatibility | Adequacy for medical device use. |
| Validation of Reprocessing | Reprocessing methods validated to ensure safety and effectiveness. |
| Sterilization | Sterilization methods validated to achieve required sterility assurance levels. |
| Electrical Safety and Electromagnetic Compatibility | Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 standards. |
| Functional Performance Tests (general) | Verification/comparative testing to the predicate device. The remanufactured device performs comparably. |
| Blade Trigger Actuation Force | Performance comparable to the predicate device. |
| Clamp Arm Closing and Seal Button Force | Performance comparable to the predicate device. |
| Clamp Arm Opening Force | Performance comparable to the predicate device. |
| Clamp Arm Deflection | Performance comparable to the predicate device. |
| Jaw Clamp Force | Performance comparable to the predicate device. |
| Blade Excursion | Performance comparable to the predicate device. |
| Jaw Opening Angle | Performance comparable to the predicate device. |
| Burst Pressure | Evaluation of performance and ability to seal and divide vessels from 1mm to 7mm, comparable to the predicate device's expected performance. |
| Maximum Jaw Temperature | Evaluation to ensure temperatures are within safe operating limits and comparable to the predicate. |
| Device Reliability | Evaluation to ensure reliable performance, comparable to the predicate device. |
| Functional Attribute Testing | Evaluation of various functional attributes, comparable to the predicate device. |
| Preclinical Laboratory Evaluations (Animal Model) | Demonstrated ability to achieve hemostasis of vessels and acceptable thermal spread, comparable to the predicate device, for both acute and chronic survival studies. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample size for each bench test or the number of animals used in the preclinical studies. It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
- Data Provenance: The document does not provide details on the country of origin of the data. The studies appear to be prospective as they were conducted specifically to demonstrate the performance of the remanufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies described are primarily performance and comparative tests against a predicate device, rather than subjective evaluations requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/not provided. The performance data described are objective measurements (e.g., forces, temperatures, burst pressure) or observations in animal models that do not typically involve an adjudication method by multiple human readers.
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:
This is not applicable. The device described is a surgical instrument (Electrosurgical Cutting and Coagulation Device), not an AI-powered diagnostic or imaging tool. Therefore, an MRMC study related to human reader
improvement with AI is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical surgical instrument; it is not an algorithm, and its performance inherently involves human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests appears to be based on:
- Predicate Device Performance: The primary method for establishing effectiveness is comparison against the legally marketed predicate device (LigaSure Exact Dissector, Nano-coated LF2019, K173281). The remanufactured device needed to perform "as well as" the predicate.
- Established Engineering and Medical Standards: Compliance with electrical safety and electromagnetic compatibility (IEC 60601 series).
- Direct Physical Measurements: For functional performance tests (e.g., force, temperature, burst pressure).
- Biological Outcomes: In the animal model, the ground truth would be the observed hemostasis and thermal spread characteristics.
8. The sample size for the training set:
This is not applicable. The device is a remanufactured physical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this type of 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.