Description

The VITROPRO ST ENDO IVF NEEDLE, developed by CIVCO, is a specialized medical device designed to enhance the precision and safety of in vitro fertilization (IVF) procedures. This sterile, single-use endocavity needle guide is crafted to assist in the accurate retrieval of oocytes from ovarian follicles, minimizing the risk of microbial contamination and ensuring a clear needle path.

Key Features

• Compatibility: Designed for seamless integration with a wide range of ultrasound transducers from leading manufacturers such as Canon, Siemens, GE Healthcare, and Philips. This ensures versatility across various clinical settings.
• Configuration Options: Available in both single and double lumen configurations, providing flexibility to meet specific procedural needs.
• Echomarking: Equipped with echomarking for enhanced visibility, allowing for precise needle placement during retrieval.
• Ultra-Sharp Tip: Features an ultra-sharp tip to reduce penetration resistance, ensuring high precision and minimal tissue disruption.
• Color-Coded Labels: Includes color-coded peel-off labels for easy identification and management.

Manufacturing and Packaging

Each needle is individually packaged in a double sterile barrier and manufactured in a cleanroom environment. Rigorous quality control measures include microscopic inspection of each needle to ensure consistency and reliability. The device is made from ABS thermoplastic and stainless steel, with sterility maintained through a validated ethylene oxide process.

Testing and Safety

The VITROPRO ST ENDO IVF NEEDLE undergoes comprehensive testing to meet stringent safety standards. It is MEA tested to ensure non-toxicity and LAL tested for endotoxin levels. The device complies with ISO 10993-1 biocompatibility requirements and is evaluated for various factors such as cytotoxicity, sensitization, and needle path verification.

Regulatory Compliance

Classified as a Class II medical device, this needle guide adheres to regulations under 21 CFR 892.1570 and 21 CFR 884.6100. It is deemed substantially equivalent to other legally marketed devices in its category, ensuring compliance and reliability.

Storage and Shelf Life

The device should be stored at temperatures between +2 to +30°C and boasts a shelf life of three years. It is supplied in packs of 24, making it a practical choice for IVF clinics and reproductive medicine centers.

Intended Use

Beyond IVF applications, the needle guide is suitable for various ultrasound-guided procedures in radiology and urology settings, including tissue biopsy and fluid aspiration. Its prescription-only status underscores its specialized nature, intended for professional use in advanced medical environments.