Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))

The Medline Microdissection Needle is a sterile, single-use monopolar electrosurgical instrument designed for precision cutting, dissecting, and cauterizing soft tissue. It is available in two lengths (3 cm and 4 cm) and is not intended for use in the central nervous system or central circulatory system.

The proposed device uses stainless steel tubing, tungsten needle tip, and polyolefin heat shrink insulation, compared to the predicate's similar construction with added PTFE non-stick coating. The proposed device operates at 4000V peak with 30W max power versus the predicate's 5400V and 50W, and has a 3-year shelf life versus the predicate's 5-year shelf life. Both are single-use, sterile (EO), prescription-only devices compatible with standard monopolar electrosurgical hand pieces.

ISO 10993 series (cytotoxicity, skin sensitization/irritation, acute systemic toxicity, pyrogenicity); IEC/ANSI 60601-1, IEC 60601-1-2, and IEC 60601-2-2 for electrical safety and EMC; ISO 11135 for ethylene oxide sterilization; ISO 11607 for packaging; ASTM F1980 for shelf-life aging; ISO 11737-1 for bioburden; ANSI/AAMI ST 72 and USP <85> for bacterial endotoxin testing.

The devices share identical intended use (precision soft tissue dissection), indications (cutting, dissecting, cauterizing), mechanism of action (monopolar electrosurgical current to small tissue surface area), product classification (GEI, Class II, 21 CFR 878.4400), and design principle (ultra-sharp 5 µm tungsten needle). Minor material and performance specification differences are addressed and validated through comprehensive biocompatibility, thermal damage zone, tip/pencil compatibility, and electrical safety testing, demonstrating the differences do not alter safety or effectiveness.