(264 days)
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, and Soft -Trans Malleable Obturator:
Used to supplement and assist uterine access of a cleared, dimensionally compatible embryo transfer device for placement of in vitro fertilized (IVF) embryos into the uterine cavity.
GuardiaTM ETS Embryo-Tested Syringe:
For use with catheters indicated for intrauterine insemination and embryo transfer.
Flushing Catheter:
The Flushing Catheter is intended for instillation of sterile medium into the cervical canal prior to embryo transfer.
This 510(k) covers eight devices from five of COOK's device families. These devices, as outlined in the table below, are sold separately.
The polyurethane obturators are designed to fit dimensionally compatible embryo transfer guide catheters. Some of these devices are designed to be adjustable in length.
The flushing catheter is a 20 cm tube measuring 14.9 Fr at the proximal end and tapering to 3.5 Fr at the distal end. It features a depth indicator and directional side port with an ink mark aligned with the position of the side port. This device is identical to the Insemi-Cath IUI catheter cleared under K172321.
The Guardia Embryo-Tested Syringe is two-part syringe with a polypropylene barrel and a highdensity polyethylene plunger. This device undergoes Mouse Embryo Assay (MEA) and endotoxin testing (LAL) before lot release.
All subject devices are supplied sterile and intended for one-time use. The Guardia Embryo-Tested Syringe has a shelf-life of five years, whereas the remaining subject devices have a shelflife of three years.
The Cook Incorporated K180302 submission describes several devices, including Obturators, an Embryo-Tested Syringe, and a Flushing Catheter. The acceptance criteria and supporting studies are primarily focused on the physical and biological characteristics of these devices rather than a comparative performance study with human readers or AI.
1. Acceptance Criteria and Reported Device Performance
The provided document lists acceptance criteria and reported performance for several non-clinical tests.
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Per ISO 11135-1:2007 (Specific acceptance criteria not detailed, but implied by standard) | Testing performed per ISO 11135-1:2007 |
| Biocompatibility | Per ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2002/2010 for Sensitization & Intracutaneous Irritation (Specific acceptance criteria not detailed, but implied by standards) | Studies performed for Cytotoxicity, Guinea Pig Maximization Sensitization, and Intracutaneous Irritation. |
| Endotoxin Testing | 80% embryos developed to blastocyst in 96 hours | Achieved: "The testing demonstrated that the devices met acceptance criterion of '1-cell MEA >80% embryos developed to blastocyst in 96 hours.'" |
| Bench Performance (General) | All predetermined acceptance criteria were met | Demonstrated that all predetermined acceptance criteria were met in the following tests before and after aging: |
| - Obturator/Flushing Catheter Dimensional Verification | Devices measured and verified against device input requirements (Actual criteria not specified) | Devices are measured and verified against device input requirements. |
| - Flushing Catheter Leak Test | Fluid path does not leak under a predetermined injection pressure (Actual pressure not specified) | Testing ensures that fluid path does not leak under a predetermined injection pressure. |
| - Obturator/Flushing Catheter Tensile Test | Tensile strength value is greater than the predetermined acceptance criterion (Actual value not specified) | Testing demonstrates that the tensile strength value is greater than the predetermined acceptance criterion. |
| - Obturator Handle Securement Test | Adjustment mechanism does not allow the obturator to move from its set position under worst case handling (Specific conditions not detailed) | Testing demonstrates the adjustment mechanism does not allow the obturator to move from its set position under worst case handling under the predetermined acceptance criterion. |
| - Obturator Fracture Test | Test articles do not fracture, loosen, or fail when tested in accordance with ISO 11070:1999 | This testing demonstrated that the test articles do not fracture, loosen, or fail when tested in accordance with ISO 11070:1999 |
2. Sample Size for Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of devices tested for tensile strength or leak tests). The studies are laboratory-based and conducted by the manufacturer, Cook Incorporated, in the United States. They appear to be prospective in nature, as they involve testing newly manufactured devices against established criteria.
3. Number of Experts and Qualifications for Ground Truth
This type of device (assisted reproduction catheters and obturators) does not typically involve human expert interpretation of images or data for establishing ground truth in the same way an AI diagnostic device would. The "ground truth" here is defined by physical performance characteristics, biological safety, and adherence to engineering specifications and international standards. Therefore, information about the number or qualifications of experts for establishing ground truth in this context is not applicable and not provided in the document.
4. Adjudication Method for Test Set
Given that the tests are primarily objective measurements of physical and biological properties against predefined specifications and standards, an adjudication method (like 2+1 or 3+1 used in clinical studies with subjective interpretations) is not applicable. The results are typically pass/fail based on direct measurement or observation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical instrument, not a diagnostic AI device that assists human readers. Therefore, the effect size of how much human readers improve with AI vs. without AI assistance is not relevant or measured.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop) is not applicable here as the device is not an algorithm or an AI system. The performance studies described are essentially "standalone" in that they test the device's physical and biological properties directly.
7. Type of Ground Truth Used
The ground truth for these tests is based on:
- Engineering Specifications: Device input requirements for dimensions, material properties, and functional performance (e.g., leak resistance, tensile strength, securement).
- International Standards: e.g., ISO 11135-1:2007 for sterilization, ISO 10993-5/10 for biocompatibility, AAMI/ANSI ST72:2011 for endotoxin, ASTM D4169-05 for transportation, ASTM F2096-04 and F88-09 for package integrity, ISO 11070:1999 for fracture testing.
- Biological Activity: The Mouse Embryo Assay (MEA) uses the development of embryos to the blastocyst stage as an objective biological measure of non-toxicity.
8. Sample Size for the Training Set
"Training set" is not applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for this device.
§ 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).