(228 days)
Delivery of approximately 1 ml of sperm into the uterus over 3-4 hours using a controlled release pump.
The IUI Catheter is a balloon catheter for slow release insemination. The catheter is placed in the uterus and sperm is injected through the catheter. The kit includes a standard BD 3 ml syringe and a mechanical actuator, as well as an ancillary component, a leg strap. Sperm is loaded into the syringe which is attached to the IUI catheter. The syringe is placed in a plastic, spring loaded mechanical actuator to press on the syringe plunger and deliver the sperm over a 3-4 hour period.
The provided text describes a 510(k) premarket notification for the "Fertiligent Slow Release IUI Catheter Kit". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically associated with novel technology or diagnostic devices.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert qualifications, ground truth, and comparative effectiveness studies cannot be fully extracted from the provided document.
Here's a breakdown of what can be inferred or directly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for this 510(k) submission type. The submission focuses on substantial equivalence to a predicate device. Performance is generally assumed to be comparable to the predicate. | The device completed "Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf life testing" to document safety and effectiveness. A "small clinical trial" was also included, which "lent support to the safety and effectiveness of the device." |
Missing: Specific quantitative performance metrics (e.g., success rates, complication rates, time to delivery accuracy) that would constitute "acceptance criteria" for a novel device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: A "small clinical trial" was performed. The exact sample size is not disclosed.
- Data Provenance: Not explicitly stated, but clinical trials are typically prospective. The country of origin is not specified.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable/Not Provided: For a device like an IUI catheter, "ground truth" in the diagnostic sense (e.g., disease diagnosis by expert consensus) is not directly relevant. The assessment of safety and effectiveness in a clinical trial would involve medical professionals observing outcomes, but their role isn't described as "establishing ground truth" in the context of an algorithm's performance.
4. Adjudication Method for the Test Set:
- Not Applicable/Not Provided: Adjudication methods (like 2+1 or 3+1) are typically used for evaluating human or AI interpretations of data where ambiguity exists. This is not described for the clinical trial of an IUI catheter.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. This device is a pure medical device (catheter and mechanical actuator), not an AI-powered diagnostic or assistive tool.
6. Standalone (Algorithm Only) Performance:
- No: This device is a physical medical device; there is no standalone algorithm to evaluate.
7. Type of Ground Truth Used:
- Outcomes Data/Clinical Observation: For the
small clinical trial, the "ground truth" would be the observed clinical outcomes related to the safety and effectiveness of the device (e.g., successful sperm delivery, absence of adverse events). This is inferred from the statement "lent support to the safety and effectiveness."
8. Sample Size for the Training Set:
- Not Applicable: There is no "training set" for an AI algorithm, as this is a physical medical device.
9. How Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no training set for an AI algorithm, this question is not relevant.
Summary of Device and Evidence Presented:
The Fertiligent Slow Release IUI Catheter Kit is a balloon catheter for slow-release intrauterine insemination. The 510(k) submission primarily relies on demonstrating substantial equivalence to an existing legally marketed device (K032835 H/S Catheter) by stating identical technologies, materials, and function.
The evidence for safety and effectiveness includes:
- Non-clinical testing: Biocompatibility, endotoxin, HSSA, sterility validation, mechanical function, and shelf-life testing.
- Clinical testing: A "small clinical trial" which "lent support to the safety and effectiveness of the device." No further details on this trial (sample size, specific results, methodology) are provided in the summary.
Key takeaway: This document is a regulatory submission focused on substantial equivalence, not a detailed scientific paper describing the performance of a novel diagnostic or AI-driven medical device against pre-defined acceptance criteria. Therefore, many of the requested details related to AI/diagnostic performance studies are not present.
§ 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).