(334 days)
MedGyn IUI Catheters are used for the introduction of washed spermatozoa into the uterine cavity through the cervix.
MedGyn straight IUI, mini IUI, and curved, mini IUI catheters are used for intrauterine insemination for delivery of washed spermatozoa through the cervical os. The straight IUI is composed of a 21.4 cm length tube with subparts consisting of a polyethylene tube connecting with a polypropylene tube. The outer diameter of the polyethylene tube is 2.1 mm. That of the polypropylene tube is 2.75 cm. The tube is connected proximally to an ABS connector for attachment to a syringe. The mini IUI is exactly the same as the straight IUI except that the outer diameter of the inner polyethylene tube is 1.6 mm. The curved, mini IUI is exactly the same as the mini IUI except that it is slightly curved at its distal tip.
The provided text describes a 510(k) premarket notification for MedGyn IUI Catheters, asserting their substantial equivalence to a predicate device. The information primarily focuses on demonstrating that the new device does not raise different questions of safety and effectiveness, rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy or performance metrics typical for AI/software devices.
The document discusses various performance tests conducted to support the safety and shelf life of the device, which are physical properties rather than AI model performance metrics.
Here is a breakdown of the requested information based on the provided text, acknowledging that many fields will be "N/A" due to the nature of this medical device (a catheter) as opposed to a software or AI device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| - Cytotoxicity | Grade '0', Non-Cytotoxic |
| - Intracutaneous Reactivity | No significantly greater biological reaction than control |
| - Skin Sensitization | No sensitization reactions |
| Sterility/Safety Function: | |
| - Endotoxin levels (LAL) | Conducted per USP (results implied to be acceptable) |
| - Mouse Embryo Assay (MEA) | Conducted (results implied to be acceptable) |
| - Human Sperm Survival Assay (HSSA) | Motility remained consistent, no sign of affecting motility |
| Shelf Life/Stability: | |
| - Stability (accelerated aging) | Substantiates 1-year shelf life |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of catheters or tests, but tests were "conducted on each version of the MedGyn IUI catheters." For biocompatibility tests, specific animal (rabbits, guinea pigs) and cell assays were used, but the exact number of samples or runs is not detailed.
- Data Provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by MedGyn Products, Inc. or their contracted labs. Not applicable to country of origin, retrospective or prospective in the context of clinical data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth for these physical and biological tests (e.g., cytotoxicity, endotoxin levels, sperm motility) is established through standardized laboratory assays and objective measurements, not expert human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. The tests are objective laboratory assays with defined pass/fail criteria, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Comparative Effectiveness Study: No. This is a physical medical device (catheter), not an AI/software device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance tests mentioned (biocompatibility, sterility, sperm survival, stability) is based on objective laboratory measurements and standardized assay results (e.g., USP for endotoxin, ASTM F1980-07 for accelerated aging, microscopic evaluation for cytotoxicity).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.
Summary based on the Provided Text:
The document describes the regulatory submission for IUI catheters, focusing on physical and biological safety testing to demonstrate substantial equivalence to a predicate device. It is not an AI or software-as-a-medical-device (SaMD) submission, so many of the requested criteria (like MRMC studies, AI performance metrics, training sets, and expert adjudication for nuanced interpretations) are not relevant to this document. The "studies" mentioned are laboratory tests designed to ensure device safety, biocompatibility, and functionality according to established medical device standards.
§ 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).