(32 days)
The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
The Wallace Oocyte Retrieval Set is a medical device and therefore its acceptance criteria is based on safety and efficacy rather than performance metrics like sensitivity or specificity.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Performance |
|---|---|
| Visual Inspection | Sufficient to ensure efficacy and safety |
| Dimensional Accuracy | Sufficient to ensure efficacy and safety |
| Functional Performance | Sufficient to ensure efficacy and safety |
| Two-cell Mouse Embryo Assay | Performed and deemed sufficient to ensure efficacy and safety |
| Bacterial Endotoxin (Limulus Amoebocyte Pyrogen) Test | Performed and deemed sufficient to ensure efficacy and safety |
| Biological Safety (ISO 10993, Part 1:1994) | Assessment performed and deemed sufficient to ensure efficacy and safety |
2. Sample Size and Data Provenance
The document does not specify a distinct test set or sample size for each performance test. The device is a "set" implying multiple components and likely multiple units were subjected to these tests. Given the 2001 date, it is highly probable that all testing was retrospective and conducted in the UK, where the applicant (SIMS Portex Ltd) is located.
3. Number of Experts and Qualifications
No information is provided regarding the number or qualifications of experts involved in establishing acceptance criteria or interpreting test results. The implication is that internal company experts conducted and assessed the tests.
4. Adjudication Method
No formal adjudication method is described. The acceptance appears to be based on the internal assessment of the conducted tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The Wallace Oocyte Retrieval Set is a medical device, not an AI or imaging diagnostic tool that would typically involve a multi-reader, multi-case study.
6. Standalone (Algorithm Only) Performance
Not applicable. The Wallace Oocyte Retrieval Set is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth for acceptance appears to be established by adherence to internal company-developed tests and the ISO 10993 standard for biological safety, rather than external expert consensus, pathology, or outcomes data in the context of diagnostic accuracy. The "two-cell Mouse Embryo Assay" provides a biological ground truth for embryo toxicity.
8. Sample Size for Training Set
Not applicable. The device is not an AI model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
Not applicable.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).