(106 days)
The LigaSure™ Open Dissector Divider is a bipolar electrosurgical instrument intended for use with the LigaSure™ Generator in open, general, surgical procedures where dissection, ligation and division of vessels is desired. This device creates ligation by application of bipolar electrosurgical RF anerizy and pressure to vessels/tissue interposed between the jaws of the device. The ligation can then be transected using the built in cutting mechanism. The device can be used for vessels up to and including 7 mm in diameter and tissue bundles as large as will fit into the jaws of the instrument.
Indications for use include general, open procedures including urologic, vascular, thoracic, and plastic and reconstructive, procedures where dissection, ligation and division of vessels are performed such as: spleenectomies, thryoidectomies, nephrectomies, prostatectomies, bowel resection are clobe vomy.
The LigaSure Vessel Sealing System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.
The LigaSure Open Dissector Divider is a multi-functional, electrosurgical instrument intended for use with the LigaSure Vessel Sealing Generator (K981916) when performing open surgery. The instrument is capable of sealing and dividing vessels and tissue clamped between its jaws, grasping tissue, and dissection. Sealing of vessels and tissue containing vessels can be activated using the activation button on the device or via a footswitch. The instru incorporates a mechanical cutting mechanism that divides tissue.
The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type to the generator. The instrument is supplied sterile for single-use.
The provided text describes the Valleylab LigaSure™ Open Dissector Divider (K041587) and its clearance by the FDA without extensively detailing specific acceptance criteria or a comprehensive study report in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics against pre-defined acceptance criteria.
However, based on the information provided, I can infer and extract some relevant details regarding the device's performance and the nature of the evaluation.
Inferred Acceptance Criteria and Reported Device Performance (based on the summary's scope):
The document states that performance (bench) testing and a preclinical study were conducted to ensure the device "functions as intended" and "meets design specifications," and that "sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria." While specific numerical targets for acceptance criteria are not explicitly given, the general criteria can be inferred from the device's intended use and comparison to predicates.
| Acceptance Criteria (Inferred from intended use and comparison to predicates) | Reported Device Performance (as stated or implied) |
|---|---|
| Ability to seal and divide vessels up to 7mm in diameter. | The device can be used for vessels up to and including 7 mm in diameter. Performance data from bench testing and preclinical studies deemed sufficient to show effectiveness. |
| Ability to seal and divide tissue bundles as large as will fit into the jaws. | Tissue bundles as large as will fit into the jaws of the instrument can be sealed and divided. Performance data from bench testing and preclinical studies deemed sufficient to show effectiveness. |
| Effective ligation through application of bipolar RF energy and pressure. | Device creates ligation by application of bipolar electrosurgical RF energy and pressure. Performance data from bench testing and preclinical studies deemed sufficient. |
| Effective transection using the built-in cutting mechanism. | Ligation can then be transected using the built-in cutting mechanism. Performance data from bench testing and preclinical studies deemed sufficient. |
| Functional with the LigaSure Vessel Sealing Generator (K981916). | Instrument intended for use with the LigaSure Vessel Sealing Generator. The instrument attaches to the LigaSure™ generator with a ten (10) foot cable and a "smart" connector that identifies the instrument type. |
| Substantial equivalence to predicate devices (Valleylab LS1200 LigaSure™ Precise Instrument for configuration, sealing, dissection; Valleylab LS1500 LigaSure™ 5mm Laparoscopic Sealer-Divider Instrument for cutting). | The sponsor determined and the FDA concurred that the device is substantially equivalent to the listed predicate devices based on technological characteristics and performance data. |
| Safety and effectiveness in open, general, and gynecologic surgical procedures for specified indications (e.g., spleenectomies, thyroidectomies). | Performance data from bench testing and preclinical studies deemed sufficient to show it meets safety and effectiveness criteria for its intended use. |
Study Details:
The provided text only briefly mentions the types of studies conducted without providing extensive details on their methodology or results.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only states "Performance (bench) testing and a preclinical study were done."
- Data Provenance: Not specified, but generally, bench testing and preclinical studies for FDA submissions are conducted domestically (USA) or in accredited labs globally. The document does not indicate if it was retrospective or prospective, though preclinical studies are inherently prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not mention the involvement of experts in establishing ground truth for the performance studies, other than the general oversight and review by the manufacturer's regulatory and R&D teams.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document does not describe any expert adjudication process for the performance testing.
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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:
- No. This device is an electrosurgical instrument, not an AI/imaging device. Therefore, an MRMC study with human readers/AI assistance is not applicable to its evaluation. The "improvement with AI vs. without AI" is not relevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Performance (bench) testing" and "preclinical study" described are likely standalone evaluations of the device's physical and functional capabilities, independent of human interaction for interpretation (as would be the case for an imaging algorithm). The device's performance (e.g., sealing strength, cutting efficacy) is assessed directly.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing, ground truth would be based on engineering specifications and measurements (e.g., burst pressure for sealed vessels, tensile strength, cut precision).
- For the preclinical study, ground truth would involve direct observation, potentially physiological measurements, and possibly pathology if tissue samples were analyzed for sealing integrity or thermal damage. The document does not specify.
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The sample size for the training set:
- Not applicable. This device is a physical electrosurgical instrument, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- 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.