(57 days)
The Reprocessed LF1212A 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 Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) 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 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 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 the submission only includes the addition of a second reprocessing cycle to the previously cleared Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (K220411) and not the Covidien 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 is a 510(k) summary for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It describes the device, its intended use, comparison with predicate devices, and performance data. However, the document does NOT provide detailed acceptance criteria or the specific results of the studies in the format requested. While it lists types of tests performed, it does not specify quantitative acceptance criteria or the reported device performance against those criteria. It also does not explicitly mention sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC studies.
Therefore, many of the requested fields cannot be answered from the provided text. I will extract what information is available and state when information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several functional performance tests but does not explicitly state the quantitative acceptance criteria or the numerical reported device performance for each. It mentions "verification/comparative testing (to the predicate device)" and "evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, and functional attribute tests," suggesting that the reprocessed device performed comparably to the predicate or met general functional expectations for vessel sealing.
| Test Category | Specific Test / Performance Metric | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|---|
| Biocompatibility | Not specified | Not specified | Performed (implied acceptable) |
| Reprocessing Validation | Not specified (e.g., cleanliness, resterilization efficacy) | Not specified | Validated (implied acceptable) |
| Sterilization | Not specified | Not specified | Performed (implied acceptable) |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 conformity | Not explicitly stated (e.g., limits, emissions) | Conformed to standards (implied acceptable) |
| Functional Performance | Blade Trigger Actuation Force | Not specified | Performed (implied acceptable comparable to predicate) |
| Clamp Arm Closing and Seal Button Force | Not specified | Performed (implied acceptable comparable to predicate) | |
| Clamp Arm Opening Force | Not specified | Performed (implied acceptable comparable to predicate) | |
| Clamp Arm Deflection | Not specified | Performed (implied acceptable comparable to predicate) | |
| Jaw Clamp Force | Not specified | Performed (implied acceptable comparable to predicate) | |
| Blade Excursion | Not specified | Performed (implied acceptable comparable to predicate) | |
| Jaw Opening Angle | Not specified | Performed (implied acceptable comparable to predicate) | |
| Burst Pressure (for 1mm to 7mm vessels) | Not specified (e.g., minimum pressure) | Performed, evaluated (implied acceptable for intended use) | |
| Maximum Jaw Temperature | Not specified (e.g., maximum temp limit) | Performed, evaluated (implied acceptable for intended use) | |
| Device Reliability | Not specified | Performed (implied acceptable) | |
| Functional Attribute Testing | Not specified | Performed (implied acceptable comparable to predicate) | |
| Generator Software Compatibility | Not specified | Performed (implied compatible) | |
| Preclinical (Animal Model) | Thermal spread | Not specified (e.g., acceptable thermal spread limits) | Evaluated (implied acceptable for intended use) |
| Ability to achieve hemostasis (for vessels of various sizes, 1-7mm) | Not specified (e.g., success rate, time to hemostasis) | Evaluated (implied acceptable for intended use) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for any of the test sets (bench, laboratory, or preclinical). It mentions "preclinical laboratory evaluations in an animal model," but does not specify the type or number of animals used. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The studies described are primarily bench testing and animal model evaluations, which typically do not involve human expert interpretation for "ground truth" in the way a diagnostic imaging study would.
4. Adjudication method for the test set
Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation where consensus or a tie-breaking mechanism is needed for ground truth. This was not such a study.
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. The device described is an electrosurgical sealer/divider and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument and requires human operation. The performance studies focused on the instrument's functional characteristics and its ability to achieve its intended effect (sealing vessels).
7. The type of ground truth used
For the bench and laboratory testing, the "ground truth" would be objective measurements and established engineering standards (e.g., force, temperature, burst pressure tolerances, electrical safety standards). For the preclinical animal studies, the "ground truth" would be physiological outcomes observed directly (e.g., successful hemostasis, measured thermal spread, histological analysis) compared against expected performance or predicate device performance.
8. The sample size for the training set
Not applicable. This device is a reprocessed surgical instrument, not a machine learning or AI algorithm, so there is no training set in that context. The "training" here refers to the process qualifications and validation of the reprocessing procedure itself.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.