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Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets: Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
Soft-Trans Embryo Transfer Catheter: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. This device is to be used in combination with a cleared, dimensionally compatible Embryo Transfer Guide Catheter for gaining access to the uterine cavity.
Soft-Trans Guide Catheter: Used to supplement and assist uterine access of a cleared, dimensionally compatible Embryo Transfer Catheter for placement of in vitro fertilized (IVF) embryos into the uterine cavity.

This 510(k) covers the following subject devices: Guardia™ Access Nano Embryo Transfer Catheter, Soft-Trans Embryo Transfer Catheter, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter, Soft-Trans Embryo Transfer Catheter, guide catheter, and trial catheter. The transfer catheters are manufactured from polyurethane. The Guardia™ Access Nano Embryo Transfer Catheter has a diameter of 2.8 Fr and is 24 cm in length. The Soft-Trans Embryo Transfer Catheters have a diameter of 4.7 Fr and range in length from 19 to 23 cm. Both transfer catheters also include a stainless steel cannula to provide additional support and depth indicators. The Soft-Trans Embryo Transfer Catheter Set (K-SOFT-5000-TC) also includes a closed-ended polycarbonate/polyurethane/stainless steel trial catheter that has a diameter of 4.0 Fr and is 18 cm in length. The guide catheter for the Guardia™ Access Nano Embryo Transfer Catheter is manufactured from polymethylpentene, and has a diameter of 5.5 Fr and is 17.3 cm in length. This guide catheter also features a bulb tip, silicone position marker, and is provided pre-curved. The guide catheter for the Soft-Trans Embryo Transfer Catheter Sets are manufactured from polyethylene, have a diameter of 8.1 Fr, and are 11.4 or 15.4 cm in length. This guide catheter is provided in a straight configuration. All subject devices are single-use devices and sterilized by ethylene oxide exposure. The transfer catheters, transfer catheter/sets undergo lot release Mouse Embryo Assay (MEA) for embryo toxicity and USP endotoxin (LAL) for pyrogenicity. The subject devices are packaged in peelopen sterile barrier pouches with a three-year shelf life.

The provided text describes the Guardians Access Nano and Soft-Trans Embryo Transfer Catheter Sets, the Soft-Trans Embryo Transfer Catheter, and the Soft-Trans Guide Catheter. It outlines the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the exact sample sizes for each non-clinical test. It mentions that "One-cell mouse embryos were exposed to subject devices" for the MEA, implying a biological sample set, but concrete numbers are not provided. Similarly, for other bench tests, "testing demonstrated" without specific N values.

The data provenance is from non-clinical bench testing and laboratory studies conducted by Cook Incorporated. The document does not indicate country of origin for the specific data beyond the company's location (Bloomington, IN, USA). All studies are prospective in the sense that they are conducted specifically for this device submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. The studies described are non-clinical (bench and laboratory tests), not human clinical trials or image-based diagnostics requiring expert interpretation to establish ground truth. Ground truth for these tests is established by objective measurements against predefined criteria and industry standards (e.g., ISO, ASTM, USP).

4. Adjudication Method for the Test Set:

Not applicable. As the studies are non-clinical bench and laboratory tests, an adjudication method like 2+1 or 3+1 (typically used for clinical endpoints or image interpretation) is not relevant. Results are based on objective measurements and adherence to specified test protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document describes non-clinical performance testing for device equivalence, not a clinical effectiveness study comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical medical instrument (catheter), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant to its evaluation.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical tests is based on objective measurements against established engineering specifications, industry standards, and biological response criteria.

• Engineering Specifications: For dimensional verification, aspiration, leak, and tensile tests.
• Industry Standards: ISO 11135-1:2007 (sterilization), ISO 10993 (biocompatibility), USP <85> and AAMI/ANSI ST72:2011/(R)2016 (endotoxin), ASTM D4169-16 (transportation), ASTM F2096-04, ASTM F88-09 (package integrity).
• Biological Response Criteria: For the Mouse Embryo Assay (MEA), where "≥80% embryos developed to blastocyst in 96 hours" serves as the biological ground truth for non-toxicity.

8. The Sample Size for the Training Set:

Not applicable. This document describes the evaluation of a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

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