(142 days)
Intrauterine Insemination Catheters are used for the introduction of washed spermatozoa into the uterine cavity.
The Shepard Intrauterine Insemination Set consists of a 5.4 French polyethylene tubing catheter with a connector cap and a stainless steel inner cannula with a female luer lock adapter (FLLA) hub. The assembled device measures 20 cm in length. A silicone positioner is placed 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal end is curved, with a closed ended tip rounded to a smooth finish. One sideport is located just proximal to the distal tip.
The Soft-Pass™ Coaxial Insemination Catheter is comprised of a guide catheter and an insemination/transfer catheter. The guide catheter is 6.8 French in diameter and measures 12 cm in length. Ink marks are placed on the distal end of the guide catheter to aid in positioning within the cervical canal. The transfer hub has a female luer adaptor to which the preloaded syringe is affixed. The guide catheter hub and transfer hub connect with a friction fit. The transfer catheter is 4.4 French in diameter.
The Insemi-Cath® is 3.5 French in diameter and has a length of 13 cm. It is manufactured from nylon tubing that tapers gradually from 0.195 inches at the proximal end that accepts a standard slip tip syringe and tapers for the remaining 7 cm of the catheter. The distal end is manufactured in both curved and straight configurations. The curved Insemi-Cath® features a silicone positioner placed approximately 7 cm from the distal tip. The positioner is adjustable to aid in positioning the device to the targeted depth within the uterine cavity during a procedure. The distal tip of the catheter is rounded to a smooth finish and designed with an open end.
The provided document is a 510(k) premarket notification for Cook Intrauterine Insemination Catheters (Trade Name: Shepard, Insemi-Cath®, and Soft-Pass™ Coaxial). It outlines the regulatory approval process and includes a "510(k) Summary" which details the device description, indications for use, comparison to predicate devices, and test data to demonstrate substantial equivalence.
Based on the provided text, the device is a medical device (catheter), not an AI/algorithm-based diagnostic device. Therefore, the questions related to acceptance criteria for AI/algorithm performance, human reader studies (MRMC), standalone algorithm performance, expert ground truth establishment, training set size, and data provenance for AI models are not applicable to this document.
The document discusses acceptance criteria and studies relevant to a medical device's physical and biological performance. Here's a breakdown of the applicable information:
Acceptance Criteria and Study for a Medical Catheter Device
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Special Controls (Lot-to-Lot/Batch) | ||
| Human Sperm Survival Assay (HSSA) | ≥70% motility after 24 hours | Predetermined acceptance criteria were met on newly manufactured and aged devices. |
| Endotoxin (LAL) test |
§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).