Description

The VITROPRO ST ENDO IVF NEEDLE by CIVCO is a specialized medical device designed to enhance precision and safety in in vitro fertilization (IVF) procedures. This sterile, single-use needle guide is crafted to assist clinicians during oocyte retrieval, providing a reliable tool for needle-guided aspirations and biopsies.

Key Features

• Compatibility: Designed for use with a wide range of diagnostic ultrasound endocavity transducers, including those from leading manufacturers such as Canon, Siemens, GE Healthcare, and Philips. This versatility makes it suitable for both transvaginal and transrectal procedures.

• Echomarking: Equipped with echomarking for enhanced visibility, ensuring accurate needle placement and reducing the risk of complications.

• Ultra-Sharp Tip: Features an ultra-sharp tip for minimal penetration resistance, allowing for precise targeting and reduced tissue trauma.

• Design and Packaging: Includes colour-coded peel-off labels for easy identification and a bent cannula to prevent tubing kinking. The needle cork is adapted for easier flushing with a standard Luer slip syringe. Each needle is double sterile packaged to maintain hygiene standards.

Manufacturing Excellence

• Quality Control: Manufactured in a cleanroom environment with microscopical inspection of each needle. The sterilization process is validated using ethylene oxide, ensuring lot-to-lot consistency.

• Materials: Constructed from ABS thermoplastic and stainless steel, offering durability and reliability.

Safety and Testing

• MEA and LAL Testing: Undergoes rigorous testing, including Mouse Embryo Assay (MEA) and Limulus Amebocyte Lysate (LAL) testing, to ensure biocompatibility and low endotoxin levels.

• ISO Compliance: Meets ISO 10993-1 biocompatibility standards, with comprehensive non-clinical testing covering various performance aspects.

Regulatory Information

• Class II Medical Device: Classified under 21 CFR 892.1570 and 21 CFR 884.6100, with product codes ITX and MQE. It is intended for prescription use only, aligning with FDA requirements.

Packaging and Availability

• Shelf Life and Storage: Offers a shelf life of 3 years, with storage conditions ranging from +2 to +30°C. Available in various sizes and configurations, and supplied in packs of 24.

This device significantly enhances the accuracy and safety of oocyte retrievals, providing clear needle paths and reducing microbial contamination risks. Its design supports improved visualization and alignment with ultrasound probes, ultimately contributing to more efficient procedures and confident clinical outcomes.