(330 days)
The Casmed UK Single/Double Lumen Oocyte Collection Needle Set and Single/Double Lumen Needle are assisted reproduction needles indicated for use and intended for aspiration and flushing of gametes/oocytes from the body.
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I am sorry, but the provided text only contains a letter from the FDA regarding a 510(k) premarket notification for Oocyte Aspiration Needles and an "Indications for Use Form." This document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria (as outlined in your request) is not present in the provided text. The document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
This FDA letter is a regulatory approval document and not a scientific study report.
§ 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).