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Ultrasound Needle Guides are for the attachment of needles to specified ultrasound transducers.

For use in ultrasound guided oocyte harvesting and tissue biopsy.

This is a class II device, registered by Rocket Medical plc (Establishment number: 8010022/9610632). This device is substantially equivalent to medical devices which are currently in commerce and have been submitted to the FDA

Re-usable ultrasound needle guides have been in use for over 20 years. The device is safe and effective for the application for which it is intended. More recently concerns about cross infection and patient pain have produced some single use versions being in use for the past 3 years, without any known incident in the UK.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The document is a 510(k) premarket notification summary for the Embryon® Ultrasound Needle Guide, primarily focused on establishing substantial equivalence to legally marketed predicate devices.

The summary states that "The device is safe and effective for the application for which it is intended" and mentions that "Re-usable ultrasound needle guides have been in use for over 20 years" and "single use versions being in use for the past 3 years, without any known incident in the UK." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about a specific study, including sample sizes, data provenance, ground truth establishment, or expert involvement.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document is a regulatory submission for market clearance, not a clinical study report.

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