SPY Laparoscope

The SPY Laparoscope is an optical instrument that transmits light in both visible and near-infrared spectrum to illuminate anatomy during minimally invasive endoscopic procedures for examination, diagnosis, or therapy. It is intended for gynecological and general procedures in adult or pediatric patients aged one month or older when device dimensions are appropriate for patient anatomy.

The SPY Laparoscope differs from predicates in three specific ways: smaller outer diameter (3.3mm versus 5.4mm and 10mm), shorter working length (25cm versus 30cm, 33cm, and 45cm), and larger field of view (80°±5° versus 75°±5°). These differences do not raise different questions of safety or effectiveness.

Testing conducted per ASTM D4169:2022, ISO 8600-1:2015, ISO 8600-3:2019, ISO 8600-4:2023, ISO 8600-5:2020, IEC 60601-1:2020, IEC 60601-2-18:2009, ISO 10993 series (biocompatibility), AAMI TIR12:2020, ANSI AAMI standards for reprocessing, ISO 17664, ISO 17665, ISO 14937, ISO 22441, ISO 15883 series, and ISO 14971 for risk management.

The subject device has identical indications for use and intended use as the predicate devices, with the same fundamental optical technology. Bench testing demonstrates equivalent optical performance between subject and predicate devices. The technological differences (smaller diameter, shorter length, larger field of view) do not raise different safety or effectiveness questions. Testing against applicable consensus standards confirms the device conforms to design requirements and intended uses, with overall residual risk being acceptable, making it substantially equivalent to the legally marketed predicates.