(68 days)
The EMBRYON™ Embryo Transfer Catheters / Sets are used for transferring embryos into uterine cavity during IVF procedures.
The EMBRYON™ Embryo Transfer Catheters / Sets are used to place human embryos into the uterine cavity.
These class II devices, registered by Rocket Medical plc. (Establishment number: 8010022/9610632) have been the subject of a reclassification by FDA. The EMBRYON™ Embryo Transfer Catheters / Sets are substantially equivalent to the Cook OB/GYN Embryo transfer catheters / sets in terms of indications for use, design, construction and materials equivalence.
The provided document is a 510(k) summary for a medical device called EMBRYON™ Embryo Transfer Catheters / Sets. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device performance against specific, quantifiable acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a performance study.
Instead, the document makes the following assertions:
- Substantial Equivalence: The EMBRYON™ Embryo Transfer Catheters / Sets are stated to be "substantially equivalent to the Cook OB/GYN Embryo transfer catheters / sets in terms of indications for use, design, construction and materials equivalence."
- Safety and Effectiveness Claim: The manufacturer states, "The devices we believe are safe and effective for the application for which they are intended... having been subjected to full design evaluation and a full Quality Assurance Program."
- Market History: The document mentions that the devices "have been on sale and in commercial distribution within the UK and many other countries for up to 10 years." This suggests real-world experience, but not a focused performance study.
In summary, a 510(k) submission generally relies on demonstrating equivalence rather than providing a detailed performance study with the metrics you've asked for. The document confirms that the device was cleared for market based on its substantial equivalence to an existing 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).