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The InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet is an assisted reproduction catheter used in IVF assisted reproduction procedures to introduce embryo(s) into the female uterus.

The Embryo Transfer Catheter and Accessory Stylet are sterile, single patient use, disposable devices supporting transfer of an in vitro fertilized embryo to the uterus. The Embryo Transfer Catheter is a 5 Fr Catheter within a 7 Fr Guide Sheath. The 5 Fr Catheter is in contact with the embryo and the uterus. The embryo passes through the Catheter, which is open at the end. The Catheter is available in 18 and 23 cm lengths. The Catheter has marks a 1 cm intervals for depth of insertion. The 7 Fr Guide Sheath provides a smooth passage into the uterus and is open at the end. This Guide Sheath is available in 18 and 23 cm lengths. The Guide Sheath has marks at 1 cm intervals for depth of insertion. Both the 5 Fr Catheter and 7 Fr Guide Sheath have color-coded hubs to indicate the length variation. An optional accessory stylet is available to aid in the initial placement of the Guide Sheath. Both 18 and 23 cm length stylets are available.

This 510(k) submission (K050521) for the InnTec, Inc. Embryo Transfer Catheter and Accessory Stylet does not include a study to demonstrate device performance against acceptance criteria.

Instead, this submission seeks substantial equivalence to a predicate device (Life Tech Medical, Inc.'s Embryo Glide™ Embryo Transfer Catheter and Accessory, K992307) based on similarities in intended use, technology, materials, and manufacturing processes. Therefore, the information requested in your prompt regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.

The provided document explicitly states:

• "The intended use, technology, materials and manufacturing processes of the InnTec, Inc. Embryo The meeter and Accessory Stylet are the same as the predicate device. No new questions of safety or effectiveness are raised."

This indicates that the submission relies on the established safety and effectiveness of the predicate device rather than presenting new performance data for InnTec's device.

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