FirstFit Surgical Kit

The FirstFit Surgical Kit is used during surgery to create a puncture between the trachea and esophagus (tracheoesophageal puncture), dilate that puncture, and guide placement of a voice prosthesis in patients who have had their larynx surgically removed. The kit includes a puncture needle, guidewire, pharynx protector, and a pre-loaded Blom-Singer Indwelling Voice Prosthesis device for voice rehabilitation.

The FirstFit Surgical Kit is a convenience kit that bundles surgical instruments (13-gauge curved needle, 36-inch guidewire, pharynx protector tool) with a pre-loaded Blom-Singer Indwelling Voice Prosthesis. It is designed for primary or secondary tracheoesophageal puncture with retrograde voice prosthesis insertion, sterilized by ethylene oxide, and packaged in a sealed tray ready for use.

Testing performed per ISO 11135 and ISO 10993-7 (sterilization validation), ASTM F1980-21 (shelf life), ASTM F1886/F1140/F1929 (packaging validation), EN ISO 10993-1 (biocompatibility), and IEC 62366-1 (usability engineering via cadaver study with 15 users performing 30 total punctures and placements).

The device is substantially equivalent because it performs the same intended function as the predicate Provox Vega Puncture Set—creating and dilating a tracheoesophageal puncture and facilitating voice prosthesis placement. The cadaver study demonstrated users could effectively perform the procedure with no tissue damage. The labeling was updated with warnings to proceed with care and abort if dilation requires excessive force, aligning with the predicate's safety profile. Performance testing including sterilization, shelf life, and biocompatibility demonstrates the device is safe and effective for its intended use.