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The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.

The CoolSeal™ Reveal device is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSeal™ Generator. The CoolSeal™ Reveal is a hemostat-style design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.

This is a 510(k) premarket notification for the CoolSeal Reveal electrosurgical cutting and coagulation device. The document does not describe the acceptance criteria and study for AI/ML performance. Instead, it focuses on the substantial equivalence of the CoolSeal Reveal device to predicate devices (LigaSure Exact Dissector, Nano-Coated and JustRight Sealer) based on various performance data types.

Therefore, the following information regarding AI/ML performance acceptance criteria and study specifics cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document details the following performance data to support substantial equivalence:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1.
• Electrical Safety and Electromagnetic Compatibility (EMC): Complies with ANSI/AAMI/EC 60601-2-2 and ANSI/AAMI/IEC 60601-1-2 standards.
• Mechanical and Functional Testing: Carried out to verify expected performance.
• Ex-vivo and In-vivo Vessel Burst Pressure:
  • Ex-vivo: Performed on excised fresh porcine blood vessels for both the subject device and the primary predicate.
  • In-vivo: Performed on lymphatics in live animals for both the subject device and the primary predicate.
• In-vivo Thermal Spread Comparison: Open laparotomy performed in porcine and ovine models, using both the subject device and the primary predicate device to seal vessels and tissue bundles. Samples were excised for three-dimensional histological assessments (length, width, and depth) to quantify thermal spread.
• Chronic Animal Study: A study of 23 days to assess the safety and performance of bipolar vessel sealing with the subject device. All animals survived without complications, and vessel sealing effects maintained chronic hemostasis and healed as anticipated.

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