(88 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 Enerqy Platform and Valleylab FT10 Energy Platform.
The scope of the submission only includes the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider 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.
This document is a 510(k) premarket notification for a reprocessed medical device, the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It demonstrates substantial equivalence to a predicate device.
Important Note: The provided document is for a reprocessed surgical instrument, not an AI-based diagnostic or therapeutic device. Therefore, the questions related to AI-specific criteria (such as multi-reader multi-case studies, expert consensus for ground truth, training set information, effects of AI assistance on human readers) are not applicable to this submission. The "acceptance criteria" discussed in this document refer to the performance of the reprocessed physical device, not an AI algorithm's performance against clinical endpoints.
Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria and reported device performance in a formal table with specific numerical thresholds. Instead, it lists the types of tests conducted to demonstrate substantial equivalence to the predicate device. The general acceptance criterion for this 510(k) submission is that the reprocessed device performs "at least as safe and effective as the predicate" and "as well as the identified legally marketed predicate device."
Here's a summary of the performance tests conducted, implying the "reported device performance" met the equivalence standard for each:
Acceptance Criteria (Implied: Performance comparable to or equivalent to the predicate device for safe and effective use)
| Test Category | Specific Tests Mentioned | Reported Device Performance (Implied) |
|---|---|---|
| Biocompatibility | Not detailed, but generally involves testing for biological safety (e.g., cytotoxicity, sensitization, irritation). | Demonstrated biocompatibility, indicating the reprocessed device does not pose new or unacceptable biological risks. |
| Validation of Reprocessing | Not detailed, but typically includes cleaning, disinfection/sterilization, and functional restoration processes. This includes "removal of adherent visible soil and decontamination." | Reprocessing methods were validated to ensure the device is safely and effectively prepared for reuse. Each device is "tested for appropriate function of its components prior to packaging and labeling operations." |
| Sterilization | Not detailed, but involves validation of the sterilization method. | Sterilization was validated to ensure the device is sterile for patient use. |
| Electrical Safety and EMC | IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic compatibility), IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). | The device met the requirements of the specified IEC standards, indicating safe electrical operation and electromagnetic compatibility. |
| Functional Performance Tests | Blade Trigger Actuation Force, Clamp Arm Closing and Seal Button Force, Clamp Arm Opening Force, Clamp Arm Deflection, Jaw Clamp Force, Blade Excursion, Jaw Opening Angle, Burst Pressure, Maximum Jaw Temperature, Device Reliability, Functional Attribute Testing. Evaluated ability to "seal and divide vessels from 1mm to 7mm." | All functional tests demonstrated performance "at least as safe and effective as the predicate" and "as well as the identified legally marketed predicate device." Specifics include successful sealing and division of vessels 1mm to 7mm, with satisfactory burst pressure, maximum jaw temperature, reliability, and functional attributes. |
| Preclinical Laboratory Evaluations | Acute and chronic survival studies in an animal model to evaluate "thermal spread and the ability to achieve hemostasis of vessels." | Animal studies confirmed the reprocessed device performs similarly to the predicate in terms of thermal spread control and hemostasis effectiveness. The conclusion states these studies "demonstrate that the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device." |
2. Sample sized 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 exact numerical sample sizes for each test conducted (e.g., number of devices tested for each functional performance metric, 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 tests were conducted by Stryker Sustainability Solutions, a U.S. company. The data would primarily originate from their internal testing facilities. The nature of the testing (bench, in-vitro, and animal studies) is prospective for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This pertains to an AI/imaging device. For this reprocessed surgical instrument, "ground truth" is established through engineering and performance testing against predefined mechanical, electrical, and functional specifications, as well as comparative performance in an animal model. There is no concept of expert human image interpretation or "ground truth" in the AI sense for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This pertains to an AI/imaging device where human readers might disagree. For a physical device, testing involves quantitative measurements and observations against specifications. Any discrepancies would be handled through standard engineering quality control and retesting protocols, not through expert adjudication in a clinical reading context.
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 is specific to AI devices and their impact on human reading performance. This document is for a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is specific to AI algorithms. This is a physical surgical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this physical device, the "ground truth" is based on:
- Engineering Specifications and Benchmarking: Mechanical properties (e.g., force, angles, excursion), electrical properties, and material integrity tested against established standards and the performance of the predicate device.
- Physiological Performance in Animal Models: "Thermal spread and the ability to achieve hemostasis of vessels" in an animal model serve as a form of "ground truth" for the device's functional performance in a biological system, compared to the expected performance of new devices or the predicate.
There is no "expert consensus" or "pathology" as "ground truth" in the context of clinical endpoints for an AI system.
8. The sample size for the training set
- Not Applicable: This question relates to AI model training. This document is about a reprocessed physical device, which does not have a "training set" in the machine learning sense. The device is re-manufactured and tested, not "trained."
9. How the ground truth for the training set was established
- Not Applicable: As above, this pertains to AI model training.
§ 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.