PrinterPrezz is a 3D printing medical company offering design, prototyping, mass production and regulation assistance to orthopedic device companies. We help customers at every stage of the innovation life cycle, and specialize in titanium and other medical materials. During this time, we are keeping our facilities open to create test swabs to aid the medical community in fighting this pandemic.
EnvisionTEC engineers have designed a 3D printed collection tip for a flexible nasal swab that has completed testing in an IRB-approved clinical trial for use in this unprecedented time. In order to be given this approval, a rigorous, multi-phase testing procedure was required. This testing of both the design and the material included several rigorous mechanical and chemical tests. This was done to ensure that the swabs pick up viral RNA particles and do not interfere with PCR/reagents, that they are chemically safe, that they would bend 180 degrees without breaking, and that the design would be able to safely collect enough viral particles from the nasal passage to effectively test.
Test swab samples are available in sterilized or unsterilized options, based on customer needs.
Up to 1 million per day through its network of Envision One users.
The swabs are Class 1 and do not require FDA approval but are registered on the FDA website and an IRB-approved clinical trial has been completed.
As part of the rigorous testing performed by BIDMC, a spiked sample was used to test performance of the 3D printed swab against a polyester control swab. The results between the two swabs did not vary.
NP Swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR 880.6025 Absorbent tipped applicator.
The FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR 807.20.
PrinterPrezz facilities are FDA registered:
PrinterPrezz, Inc. FDA Registration Number: 3016580753
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