MediPurpose Receives FDA 510(k) Clearance

MediPurpose, a master distributor and manufacturer of medical products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the babyLance infant heel incision device with sharps prevention indications.

“babyLance is the first infant heel stick to receive 510(k) clearance with sharps prevention indications,” says MediPurpose medical device regulatory consultant Julie Stephens.

MediPurpose launched the babyLance in July 2010 in the United States without the sharps prevention claims while the FDA reviewed the heel incision device’s non-obligatory 510(k) application. With the 510(k) clearance, MediPurpose may now market its infant heel stick in the United States as a safety medical device.

“The 510(k) clearance favorably positions the new safety heel incision device for healthcare professionals that are being cautioned about multiple-use lancing devices,” says MediPurpose President Randy Prather.

On August 26, the FDA and the Centers for Disease Control and Prevention issued health notifications stating that lancing devices should never be used on more than one patient because of the risk of transmitting bloodborne pathogens.

“babyLance was designed to maximize safety for both the infant and healthcare provider,” says MediPurpose founder and CEO Patrick Yi. “The 510(k) allows us to provide data about the safety features and benefits of the babyLance.”

Defining the babyLance Sharps Prevention Indications
babyLance is a single-use heel incision device utilized to obtain a blood sample from the heel of newborn (babyLance BLN) and preemie (babyLance BLP) infants. It has four integrated components that were crucial for its 510(k) with sharps prevention indications clearance:

   * A locking mechanism to prevent accidental activation of the device.
   * A housing that conceals the blade before and after the device is used.
   * An internal spring that automatically retracts the blade after use.
   * A stop feature that disables the device after a single use.

Simulated Use Study
To receive the 510(k) clearance for babyLance, MediPurpose was required to submit results from a simulated use clinical study of 500 samples.

Conducted in March 2010 at the Nanyang Polytechnic School of Health Sciences in Singapore, the simulated clinical use study mimicked actual clinical use by using a foam foot as a patient substitute. Twenty registered nurses tested the safety and function of a total of 500 babyLance devices.

The study yielded a 100% success rate for the babyLance’s safety features and function, with not a single test participant encountering any problems with or malfunctions of the devices.

The study concluded that babyLance functioned safely with a single-handed technique, and evaluators commented that the device was relatively easy to use.

More information about babyLance—including demonstration videos and no-cost product sample requests—is available at http://www.medipurpose.com/babylance/.