(131 days)
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter: Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
The Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter cover six subject devices from two of COOK's device families, Guardia™ Access and Guardia™. All embryo transfer catheters have an outer diameter of 2.8 Fr and range in length from 23 to 25 cm. The transfer catheters have internal or external supporting cannula, depth indicators, and may have an echogenic band. The Guardia™ Access guide catheters are precurved and feature a bulb-shaped tip. They measure 6.6 Fr in outer diameter and are 16.7 to 17.3 cm in length. All subject devices are single-use devices and sterilized by ethylene oxide exposure. They undergo lot release Mouse Embryo Assay (MEA) testing for embryo toxicity and USP endotoxin (LAL) testing for pyrogenicity. The subject devices are packaged in peel-open sterile barrier pouches with a three-year shelf life.
The provided text details the 510(k) summary for the Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter. This is a medical device, and the document focuses on demonstrating its substantial equivalence to a predicate device, rather than the performance of a software algorithm or AI model, which is typically what the request refers to when asking about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance.
Therefore, the information required to populate the fields related to AI/ML model performance, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not available in the provided document. The document describes the testing of a physical medical device, not a software or AI product.
However, I can extract the acceptance criteria and study descriptions for the physical device as presented in the document.
Here's a summary of the acceptance criteria and the studies conducted for the physical medical device:
Acceptance Criteria and Reported Device Performance (Physical Device)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Validation (per ISO 11135-1:2007) | Performed (details of specific acceptance metric not provided, but implied to be successful validation) |
| Biocompatibility (per ISO 10993-5, 10, 10, 10) | Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Irritation testing performed (implied to meet acceptance). |
| Endotoxin Testing (per USP and AAMI/ANSI ST72:2011/(R)2016) | predetermined criterion) |
| Echotip Band Test (outer diameter does not impede smooth passage) | Testing ensures that the outer diameter of the band does not impede smooth passage through the guide catheter (implied to meet acceptance). |
| Echotip Band Echogenicity Test (provides increased brightness via ultrasound) | Visual comparison testing by ultrasound imaging of catheters with and without an EchoTip band verified that the band provides increased brightness. |
Information NOT Applicable/Available (as this is not an AI/ML device)
- Sample size used for the test set and the data provenance: Not applicable to a physical device. Testing involved physical samples of the device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device refers to established engineering and biological standards and tests.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This is for an AI/ML product.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For MEA, it's a biological assay (embryo development). For other tests, it's engineering specifications, material properties, and regulatory standards.
- The sample size for the training set: Not applicable to a physical device's performance testing.
- How the ground truth for the training set was established: Not applicable.
§ 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).