- Is SurgiWrap® FDA approved?
- What is the difference between a PMA approval and a 510(K) clearance?
- Is an approval necessary for hospitals to purchase a product or a surgeon to use a product?
- Why didn't SurgiWrap® require a PMA?
- What are any known side effects of polylactic acid?
- How is polylactic acid absorbed and expelled from the body?
- What commonly used surgical materials or devices also have 510(K) clearance?
Is SurgiWrap® FDA approved?
SurgiWrap® and its supportive data has been reviewed and cleared for sale in the U.S. by the FDA. This clearance for sale means that the FDA has found SurgiWrap® to be safe and effective in all soft tissues of the pelvic, and abdominal cavities by determining SurgiWrap® to be substantially equivalent to existing "like" products previously cleared by FDA.
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What is the difference between a PMA approval and a 510(K) clearance?
A total new device or material for a new application requires a pre market approval (PMA) because reasonable assurance of safety and effectiveness has not been proven. A 510(K) clearance is issued to devices or materials that are similar to devices or materials that have been on the market prior to 1975 or previously cleared as a 510(K) by FDA.
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Is an approval necessary for hospitals to purchase a product or a surgeon to use a product?
No. Many commonly used surgical instruments such as staples, sutures, and trocars follow the same 510K regulatory pathway as SurgiWrap and therefore are cleared for use, and using FDA wording, are not approved. Products need to be reviewed by the FDA for classification, evaluation, and authorization. Upon review, the FDA will determine if the new product requires further clinical evaluation in the form of a PMA study, or standards testing for a 510(K), both FDA mechanisms are used to access safety and efficacy.
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Why didn't SurgiWrap® require a PMA?
SurgiWrap® was cleared for sale by the FDA because it is comprised of polylactic acid, a material that has been used safely and effectively in the human body for over 30 years in multiple products. Upon review of the preclinical data and bench top testing by the FDA, no additional testing was required to give reasonable assurance of the products safety and efficacy; therefore clearance for sale was granted.
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What are any known side effects of polylactic acid?
There are no known side effects of polylactic acid. In safety studies performed over the past 30 years, there have been no consistent complications related to the use of PLA.
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How is polylactic acid absorbed and expelled from the body?
Lactic acid is naturally produced in the body and is therefore naturally processed by the body. First, through bulk hydrolysis, the body interrupts the lactic chains into separate ester chains. Secondly, the liver breaks the ester chains down into H2O and CO2, and eliminates these by products from the body through respiration.
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What commonly used surgical materials or devices also have 510(K) clearance?
Most surgical devices and implants are cleared through the section 510(K) process, this includes most implants sold by Medtronic, Johnson & Johnson, US Surgical, and most orthopedic implants sold by Smith & Nephew, Stryker, Genzyme Biosurgery, and a host of other organizations.
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