ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)

The ARMI® Hysteroscopy System 2.0 is a hysteroscope system consisting of a reusable video image processor and single-use hysteroscope instruments in 13 different models with varying diameters, tip angles, and image resolutions (160,000 to 1,000,000 pixels). It is intended for viewing the adult cervical canal and uterine cavity to perform diagnostic and operative hysteroscopic procedures.

The subject device offers multiple models with outer diameters of 3.0–6.5 mm (versus predicate's 4.8 mm), working lengths of 245 mm (versus 200 mm), variable tip angles (0°, 15°, 18°, 22° versus predicate's 16°), and three image resolution options versus the predicate's single 160,000-pixel resolution. Both use CMOS imaging with 2 LEDs and ethylene oxide sterilization; the subject has a reusable image processor with disposable cannulae, comparable to the predicate.

IEC 60601-1:2005+A1:2012+A2:2020, IEC 60601-2-18:2009, IEC 60601-1-2:2020, IEC 62133-2:2017, ISO 11135:2014, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017, ISO 11607-1:2009, ISO 11737-2:2019, ASTM D4169, ASTM F1980, ASTM F88, ASTM D3078-02, ASTM F1929, ASTM F1886, DIN 58953-6:2023.

The subject device is substantially equivalent to predicate K210270 because both are hysteroscope systems with disposable cannulae and reusable image processors intended for the same diagnostic and operative applications. Although the subject device offers design variations (multiple models, higher resolution options, variable tip angles, longer working length) and uses different image sensors and LED models, these differences do not raise new safety or effectiveness questions and are supported by comprehensive non-clinical testing demonstrating compliance with applicable standards.