SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture

The SPROTTE® STANDARD (LUER/NRFit®) lumbar puncture needle is a single-use spinal needle intended to gain entry into or puncture the spinal cavity for injection or withdrawal of fluids during diagnostic lumbar puncture, myelography, or discography procedures. It consists of a stainless steel cannula with an atraumatic pencil-point tip, a stylet, and an optional introducer, available with either LUER or NRFit connector hubs.

The device has identical core components to the predicate (stainless steel tubing, Sprotte-tip design, stylet, and comparable adhesive bonding). Key differences are: optional alternative packaging material (medical paper with foil, in addition to Tyvek with foil), optional use of a second sterilization facility (HA2 Medizintechnik in addition to Sterigenics), and minor hub material variations between predicate and subject (some hubs now use Tritan copolyester instead of polycarbonate). Diameter range is 18–22G and length 90–200 mm.

ISO 7864 (spinal needles), ISO 9626 (hypodermic needles), ISO 80369-6 (NRFit connectors), ISO 80369-7 (LUER connectors), ISO 11135-1 (sterilization validation), ISO 10993-1 (biocompatibility), and ISO 10993-7 (residual sterilant assessment).

The subject device is substantially equivalent to the predicate because it maintains identical intended use, indications, and core design (Sprotte-tip cannula, stainless steel construction, same bonding technologies). The two main variations—alternative sterilization facility and optional medical-paper packaging—have been validated through ISO 11135-1 sterilization validation (achieving SAL 10⁻⁶ at both sites) and shelf-life testing confirming sterility maintenance and performance retention over 5 years. Both packaging materials (Tyvek and medical paper) and both sterilization sites meet identical safety and effectiveness standards, and these changes were already cleared in predicate K241953.