Search Results

The InnTec, Inc. Intrauterine Insemination (IUI) Catheter is used for intrauterine insemination.

The InnTec IUI Catheter has been specifically designed for Intrauterine Inseminations. The over all Catheter length is 17.5cm, and tapers from 7 Fr. at the hub down to 5 Fr at the distal tip which is 5cm long. The tip is closed and smoothly rounded, eyelets are located at 180° from one another. Catheter internal volume is .07cc. Centimeter marks are printed at 6, 7, 8, 9, & 10cm from the tip, the ink is non-toxic and will not rub off.

The provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for an "IUI Catheter" by InnTec, Inc., focusing on demonstrating substantial equivalence to a predicate device. It discusses the device's description, intended use, technology, and substantial equivalence determination by the FDA.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, or information about MRMC or standalone studies. The document only states that the "intended use, technology, materials and manufacturing processes of the Inn Tec, Inc. IUI Catheter are the same as the predicate device. No new questions of safety or effectiveness are raised." This implies that the device is considered safe and effective based on its similarity to an already approved device, rather than through specific performance metrics or a detailed clinical study with acceptance criteria.

Ask a specific question about this device

The InnTec, Inc. Oocyte Retrieval Needle Set is an assisted reproduction needle indicated for used and intended to be used for obtaining female gametes / oocytes from the body.

The Oocyte Retrieval Needle Sets are sterile, single patient use, disposable devices supporting obtaining female gametes/oocytes from the body. The Oocyte Retrieval Needle Sets are packaged in a commercially available, sterile barrier pouch.

This document describes a 510(k) premarket notification for Oocyte Retrieval Needle Sets. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies is not applicable to this type of regulatory submission.

The document explicitly states:

• "The technology of the device is the same as the predicate."
• "Concesses of the manufacturing processes of the InnTec, Inc. Oocyte Retrieval Needle Sets are the same as the predicate device. No new questions of safety or effectiveness are raised."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

This indicates that the submission relies on the established safety and effectiveness of the predicate device, and no new studies were conducted to define or meet specific performance acceptance criteria for this particular device.

Ask a specific question about this device

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.

Ask a specific question about this device