MediPurpose Receives U.S. FDA 510(k) Clearance for Redesigned babyLance Safety Heelstick

Document Sample
MediPurpose Receives U.S. FDA 510(k) Clearance for Redesigned babyLance Safety Heelstick Powered By Docstoc
					MediPurpose Receives U.S. FDA 510(k) Clearance for Redesigned babyLance
Safety Heelstick

Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication

Atlanta, GA, February 20, 2013 --( MediPurpose(tm), a manufacturer and master distributor of
medical products, today announced that it has received 510(k) clearance from the U.S. Food and Drug
Administration to market its recently redesigned babyLance(tm) safety heelstick with a sharps prevention

The new 510(k) clearance permits MediPurpose to promote its new infant heel incision device as a safety
medical device in the United States.

MediPurpose had previously received a 510(k) in July 2010 for its original babyLance, reported to be the
first infant heelstick device to be given FDA clearance for a sharps prevention indication. According to
MediPurpose, babyLance remains the only safety heelstick on the market to have 510(k) clearance.

MediPurpose founder and CEO Patrick Yi, who also lead the babyLance redesign team, said, "Although
applying for a 510(k) involves considerable time and cost, we wanted to submit our innovative new infant
heel incision device so that we could remain absolutely certain that it still meets FDA guidelines for a
safety device with sharps prevention indications."

Heelstick Simulated Use Studies to Validate Sharps Safety, New Design Characteristics

As a requirement for babyLance's 510(k) application, MediPurpose was required to submit results from
simulated use studies (SUS) of at least 500 samples in accordance with FDA Guidance on Medical
Devices with Sharps Injury Prevention Features, August 9, 2005.

Along with the 510(k) requirements, MediPurpose also conducted the SUS and clinical use studies (CUS)
to validate that its new heelstick design was meeting end-user expectations and requirements.

The studies were performed at several neonatal nursing facilities in the United States and Austria, some
of which have been summarized in a series of free, downloadable white papers and case studies.

The studies yielded a 100-percent success rate for babyLance's safety characteristics. Additionally, the
CUS results produced an average usage score of 4.6, based on a Likert scale of 1-5, indicating responses
of no/poor to yes/excellent for questions about the device's ergonomics, functionality and ease of use. The
score exceeded MediPurpose's internal minimum score of 4.0 before it would release the product to

About babyLance Safety Heelsticks

After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched

                                                  Page 1/3
                      Press Release Distribution   Terms of Use
its all-new neonatal heel incision device in August 2012.

babyLance is available in two models, each with a specific blade penetration:

* babyLance BLP (preemie): 0.85 mm depth
* babyLance BLN (newborn): 1.0 mm depth

Specifically designed to meet end-user expectations for the ideal heelstick, the new babyLance provides
enhanced stability, comfort and ease of use.

For more information about babyLance safety heelsticks -- including no-cost product sample requests --
please visit

About MediPurpose

Founded in 1999, MediPurpose is an innovative medical device company headquartered in Singapore,
with offices in the United States and Europe.

Known for its popular babyLance(tm) safety heelstick, SurgiLance(tm) safety lancet and MediPlus(tm)
advanced wound care products, MediPurpose has leveraged its success in the medical device industry to
become a master medical product distributor that provides unique solutions for both medical product
manufacturers and distributors.

MediPurpose's Medical Device Innovation division offers angel funding and developmental expertise for
new medical device inventors and innovative medical product companies that seek entrance into new
medical device markets.

For more information about MediPurpose's medical products and solutions for inventors, innovators,
manufacturers and distributors, please visit

                                                  Page 2/3
                      Press Release Distribution   Terms of Use
Contact Information:
Derek Rudnak
Contact via Email

Online Version of Press Release:
You can read the online version of this press release at:

                                                  Page 3/3
                      Press Release Distribution   Terms of Use

Shared By:
Description: Only Infant Heelstick to Have FDA 510(k) Clearance for Sharps Prevention Indication