TL-10 Laparoscopic Scope Cleaner

The TL-10 Laparoscopic Scope Cleaner is a sterile, single-use disposable device that fits in a trocar and cleans the endoscope lens during laparoscopic surgery without removing the scope from the patient. When the lens becomes obscured, the surgeon moves the endoscope back and forth through crisscross silicone elastic strings at the device's distal end to remove contaminants and restore visibility.

The TL-10 uses silicon elastic strings for lens cleaning, compared to an elastomer squeegee in the predicate TroCare TroKit and silicon in the reference ClearCam device. All three are 10 mm compatible, single-use sterile devices delivered via trocar, mechanically wipe the lens, use EtO sterilization, and are biocompatible for externally communicating devices with limited contact (≤24 hours). The primary difference is the cleaning material, which the submission states does not impact substantial equivalence.

ISO 10993-1 (biocompatibility evaluation including cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity, and pyrogen testing); ISO 11135-1 (sterilization validation); ISO 13485 (quality management system design controls and corrective/preventive actions); 21 CFR 876.1500 (endoscope and accessories regulation).

The TL-10 is substantially equivalent because it has identical indications for use and intended purpose as the predicate TroCare TroKit—both provide lens clearing during laparoscopic procedures in the abdominopelvic cavity. All technological characteristics, patient population, anatomical site, design features, sterilization method, and biocompatibility category are the same. The device passed all biocompatibility, sterilization, compatibility, durability, and animal safety/performance tests, demonstrating no new safety or effectiveness issues.