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The Precision Capillaries for Micromanipulation are microcapillaries intended for the following uses in assisted reproduction procedures: - Holding human oocytes, blastocysts, or other suspension cells . - Transferring and injecting sperm (or cells of a similar size) using the ICSI . (Intracytoplasmic Sperm Injection) technique

The proposed Precision Capillaries for Micromanipulation (Precision Capillaries) product line contains the following types of microcapillaries: - VacuTips Holding Capillary, used for holding human oocytes, blastocysts, or ● other suspension cells - TransferTips® (ICSI), used for transferring sperm and perforating oocytes . using the ICSI (Intracytoplasmic Sperm Injection) technique The Precision Capillaries and the substantially equivalent devices are borosilicate glass microcapillaries designed for use in assisted reproduction procedures. The proximal end of the shaft is inserted into the capillary holder of the micromanipulator or microinjector. The distal end is drawn to a narrow tip that contacts the gamete for transfer and/or perforation. The distal end of the VacuTips is blunt for cell transfer. The TransferTips (ICSI) have spiked tips for perforation of the gamete. Three forms of the TransferTips (ICSI) are described in the 510(k), TransferTips-F, TransferTips-R, and TransferTips-RP. The TransferTips vary in shaft length, tip length, and flexibility of the flange. Each Precision Capillary is mounted in a "Capillary Safe" consisting of a holder and protective tube to protect the capillary and the user during transport and handling. The Precision Capillary mounted in the Capillary Safe is sealed in a foil pouch to maintain sterility. The packaged devices are sterilized by gamma irradiation.