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 --(PR.com)-- 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 indication.
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 market.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched 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 http://www.medipurpose.com/babylance.
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 http://www.medipurpose.com.
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 market.
About babyLance Safety Heelsticks
After investing more than a year in the redesign of its babyLance safety heelstick, MediPurpose launched 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 http://www.medipurpose.com/babylance.
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 http://www.medipurpose.com.
Contact
MediPurpose
Derek Rudnak
888-808-6494
www.medipurpose.com
Derek Rudnak
888-808-6494
www.medipurpose.com
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