(196 days)
Used to place in vitro fertilized (IVF) embryos into the uterine cavity.
The Pivet and Soft-Pass Embryo Transfer Catheter Sets are a group of devices consisting of embryo transfer catheter and guide catheter or trial/mock catheter and guide catheter. These devices are made of polyethylene and polyurethane in a variety of sizes. The transfer catheters range in diameter from 2.8 to 4.4 Fr and range in length from 19.7 to 24.7 cm. Guide catheters measure 6.8 to 7 Fr and are 12 to 17.3 cm in length. Transfer catheters may have a supporting stainless steel cannula, depth indicators, open ends with side ports, or an echogenic band on the distal tip. Trial/mock catheters aid in verifying access and positioning of embryo transfer catheters prior to to placing transfer catheters containing embryos into the uterine cavity. The trial/mock catheters are the same as the transfer catheters they represent, except that they have a closed end without a side port. All of the subject devices are single-use devices and sterilized by ethylene oxide exposure. These products, except trial/mock catheters that will not contact embryos during use, 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.
This document describes the Cook Incorporated Pivet and Soft-Pass Embryo Transfer Catheter Sets (K173103). The study provided focuses on non-clinical performance testing to demonstrate substantial equivalence to a predicate device (K983594).
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical performance tests with explicit or implicit acceptance criteria.
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|---|
| Sterilization Validation | Sterilization Validation per ISO 11135-1:2007 | Compliance with ISO 11135-1:2007 | "Sterilization Validation testing per ISO 11135-1:2007" (Implies successful validation based on standard.) |
| Biocompatibility | Cytotoxicity testing | Compliance with ISO 10993-5:2009 | Implied compliance, as part of "Biocompatibility studies" leading to determination of substantial equivalence. |
| Guinea Pig Maximization Sensitization | Compliance with ISO 10993-10:2002 or 2010 | Implied compliance, as part of "Biocompatibility studies" leading to determination of substantial equivalence. | |
| Intracutaneous Irritation testing | Compliance with ISO 10993-10:2002 or 2010 | Implied compliance, as part of "Biocompatibility studies" leading to determination of substantial equivalence. | |
| Endotoxin | Endotoxin testing | and AAMI/ANSI ST72:2011/(R)2016) | Met the specified acceptance criterion. |
| Packaging & Shelf Life | Transportation Simulation study | Compliance with ASTM D4169-05 | "Transportation Simulation study per ASTM D4169-05" (Implies successful completion without significant damage affecting integrity.) |
| Bubble Leak test | No leaks detected | "Package Integrity testing after real-time aging: Bubble Leak test per ASTM F2096-04" (Implies successful completion without leaks affecting integrity.) | |
| Seal Strength testing | Compliance with ASTM F88-09 | "Package Integrity testing after real-time aging: Seal Strength testing per ASTM F88-09" (Implies successful completion.) | |
| Visual Inspection of Package | No damage (tears, folds, puncture holes, etc.) | "Visual Inspection: No package displayed damage (tears, folds, puncture holes, etc.)" (Successful.) | |
| Mouse Embryo Assay (MEA) | One-cell MEA (before and after aging) | ≥80% embryos developed to blastocyst in 96 hours | "The testing demonstrated that the devices met acceptance criterion of '1-cell MEA ≥80% embryos developed to blastocyst in 96 hours.'" (Successful.) |
| Bench Performance | Dimensional verification of catheter | Verified against device input requirements | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Dimensional verification of catheter Catheters are measured and verified against device input requirements." (Successful.) |
| Transfer Catheter Aspiration Test | No air leaking into the syringe through the transfer catheter | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Transfer Catheter Aspiration Test Testing ensures there is no air leaking into the syringe through the transfer catheter." (Successful.) | |
| Transfer Catheter Leak Test | Fluid path catheter assembly does not leak under a predetermined injection pressure | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Transfer Catheter Leak Test Testing ensures that fluid path catheter assembly does not leak under a predetermined injection pressure." (Successful.) | |
| Tensile Testing (Catheter Hub-shaft) | Tensile strength value > predetermined acceptance criterion | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Tensile Testing (Catheter Hub- shaft) Testing demonstates that the tensile strength value is greater than the predetermined acceptance criterion." (Successful.) | |
| Echotip Band Test | Outer diameter of the band does not impede smooth passage through the guide catheter | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Echotip Band Test Testing ensures that the outer diameter of the band does not impede smooth passage through the guide catheter." (Successful.) | |
| Echotip Band Echogenicity Test | Provides increased brightness (visual comparison by ultrasound imaging) | "Bench Performance studies... demonstrated that all predetermined acceptance criteria were met in the following tests: Echotip Band Echogenicity Test Visual comparison testing by ultrasound imaging of catheters with and without an EchoTip band verified that the band provides increased brightness." (Successful.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for each non-clinical test conducted. It generally states that "all predetermined acceptance criteria were met" for bench performance studies and "the testing demonstrated" results for MEA and endotoxin.
The studies are non-clinical (bench testing, lab assays). Therefore, there is no human data provenance (e.g., country of origin, retrospective/prospective). The data provenance is from Cook Incorporated's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies are non-clinical performance tests for a medical device (catheter) rather than diagnostic algorithms or imaging evaluations that would require expert human review or ground truth establishment. The "ground truth" for these tests is defined by established international standards (e.g., ISO, ASTM, USP) and predefined engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable. As these are non-clinical engineering and biological tests, adjudication methods like 2+1 or 3+1 (typically used for resolving discrepancies in human expert reviews) are not relevant. Test results are determined by objective measurements against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms, particularly in diagnostic imaging, and comparing human reader performance with and without AI assistance. The submitted information pertains to the physical and biological characteristics of an embryo transfer catheter set, not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study as typically understood for AI algorithms (i.e., algorithm-only performance) was not done. The Pivet and Soft-Pass Embryo Transfer Catheter Sets are physical medical devices, not algorithms.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests described is based on:
- Established International Standards and Guidelines: ISO 11135-1:2007, ISO 10993-5:2009, ISO 10993-10:2002/2010, USP , AAMI/ANSI ST72:2011/(R)2016, ASTM D4169-05, ASTM F2096-04, ASTM F88-09.
- Predefined Engineering Specifications/Device Input Requirements: For dimensional verification, aspiration, leak, and tensile tests.
- Biological Activity: For Mouse Embryo Assay (MEA), the criterion of ≥80% embryos developed to blastocyst stage.
- Visual Assessment: For Echotip Band Echogenicity (visual comparison) and package inspection.
8. The Sample Size for the Training Set
This information is not applicable. This document describes the testing of a physical medical device. There is no AI algorithm involved, and therefore no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for a machine learning model described in this submission.
§ 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).