Description

The VITROPRO ST ENDO IVF NEEDLE, crafted by CIVCO Medical Instruments Co., Inc., is a specialized medical device designed to enhance precision in needle-guided procedures. This sterile, single-use endocavity needle guide is primarily intended for use during in vitro fertilization (IVF) oocyte retrieval, providing a clear and accurate needle path that significantly aids physicians.

Key Features

• Compatibility: Designed to work seamlessly with a wide range of diagnostic ultrasound endocavity transducers from leading manufacturers such as Canon, Siemens, GE Healthcare, and others. This versatility makes it suitable for both transvaginal and transrectal procedures, commonly used in radiology and urology settings.

• Safety and Hygiene: The device is MEA tested, ensuring high standards in supporting successful blastocyst development. It also undergoes LAL testing to maintain endotoxin levels at 20 EU or less per device, reducing the risk of microbial contamination.

• Material Composition: Constructed from ABS thermoplastic with a stainless steel cannula, meeting ISO 10993-1 biocompatibility requirements. The device is non-toxic, non-sensitizing, and non-irritating, with a three-year shelf life.

Testing and Performance

Extensive non-clinical testing underscores its reliability, including biocompatibility assessments and rigorous evaluations of cover breach, probe damage, and needle path verification. The device demonstrates substantial equivalence in safety and effectiveness to other legally marketed disposable endocavity needle guides.

Regulatory Compliance

Classified as a Class II medical device under 21 CFR 892.1570 and 21 CFR 884.6100, the VITROPRO ST ENDO IVF NEEDLE adheres to stringent regulatory standards, ensuring trust and confidence in its application. Supplied in packs of 24, it requires users to provide their own covers and guides that are cleared for IVF use.

Sterilization

Each device is sterilized using ethylene oxide, aligning with best practices for medical equipment, and is intended for prescription use only. This comprehensive approach to design and testing positions the VITROPRO ST ENDO IVF NEEDLE as a vital tool in enhancing procedural outcomes in IVF and other related medical fields.