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The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a Newborn at delivery. The device is used to hold the cord securely and prevent blodd loss and seepage as the cord dries and shrinks after the birth.

Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp.

This document is a 510(k) summary for the Securline® Umbilical Cord Clamp #3500. It details the device's purpose, classification, and the substantial equivalence determination by the FDA. However, it does not contain the specific information required to answer your questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

A 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through novel studies. The FDA's letter explicitly states that the review determined the device is "substantially equivalent... to legally marketed predicate devices." This typically means the device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate.

Therefore, many of the details you've requested regarding specific performance criteria, study design, and data provenance are generally not included in a 510(k) summary, as the primary goal is to establish substantial equivalence to a predicate, not to present de novo performance data.

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