(63 days)
Delivery of washed sperm into the uterus.
The IUI Catheter is a balloon catheter for intrauterine insemination. The catheter is placed in the uterus and sperm is intracted through the catheter in less than several minutes. The IUI Catheter is a packaged , sterile, disposable, flexible, plastic catheter with two lumens, one for inflation of the balloon and one for injection of washed sperm. A balloon inflation syringe is provided with the product.
The provided text describes a 510(k) summary for the "IUI Catheter" (K120154). This submission is for a medical device that claims substantial equivalence to a predicate device, not for an AI/ML powered device. As such, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like sensitivity, specificity, F1-score, reader studies, training sets, and ground truth establishment by experts) are not applicable or detailed in this document.
The acceptance criteria and study information provided focus on the physical and functional characteristics of the traditional medical device, particularly in comparison to its predicate.
Here's an analysis of the provided information based on your request, highlighting where information is absent or not applicable due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
The "Equivalence Summary" table on page 2 of the 510(k) document serves as the primary source for acceptance criteria and how the proposed device (IUI Catheter) meets them by demonstrating equivalence to the predicate device.
| Acceptance Criterion (Item) | Predicate Device Specification | Proposed Device Performance (Specification) | Comments/Discussion |
|---|---|---|---|
| Components | Mechanical Actuator, Insemination Syringe, Leg Strap, IUI Catheter | Not included (for first three), IUI Catheter | Proposed device does not include Mechanical Actuator, Insemination Syringe, or Leg Strap as they are specific to the predicate's "Slow Release" function, which is not part of the proposed device's "bolus injection" intended use. The IUI Catheter component is identical to the predicate. |
| Indication for Use | Delivery of approx. 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump. | Delivery of washed sperm into the uterus. | Proposed device is for standard IUI use (injection over a shorter period). Considered as "Comparable use for both products." |
| Use (Insemination Duration) | 3-4 hour insemination |
§ 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).