510(k) Testing
ServicesTesting510(k) TestingInfinity Laboratories provides a variety of analytical solutions to support medical device 510(k) filings by helping determine product equivalency. We have extensive experience working with Class II and Class III medical devices as well as combination products incorporating a pharmaceutical component.
Infinity Laboratories provides a variety of analytical solutions to support medical device 510(k) filings by helping determine product equivalency. We have extensive experience working with Class II and Class III medical devices as well as combination products incorporating a pharmaceutical component.
What Is 510(k) Testing?
510(k) testing is a broad term describing the analytical investigations necessary to demonstrate that a new medical device is equivalent to another medical device currently on the market.
These investigations must show that the new device is as safe and efficacious as the predicate device. Typically, this means the new device will be made from the same materials and have a similar design to the predicate device.
Materials & Analytical Technique Expertise
Infinity has extensive experience with a variety of medical device materials, including:
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PolymersPlastic, rubber, elastomer, coatings, adhesives -
MetalsAlloys, electroplated material, titanium, stainless steel
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CeramicsAlumina, aluminum oxide, zirconia compounds
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Specialty and composite materials
While the above lists the most common medical device materials, our team is familiar with less common or emerging materials. To provide precise, high-quality medical device materials characterization data, we leverage state-of-the-art technologies and techniques, including:
- Chromatography — HPLC, UPLC, LC/MS, GC/MS, GC/FID, GC/TCD, GPC/SEC
- Spectroscopy — ICP-MS, NMR, MS, PXRD, TF-XRD, UV-Vis, FTIR, Raman
- Microscopy — SEM, TEM, AFM, STM, LSCM
- Other — TGA, DSC, TOC, BET surface area/pore size analyzer
510(k) Testing Services
Infinity provides the flexibility and service of a local lab with the resources and expertise of a national organization. Guided by the standards of the world’s leading regulatory agencies, we deliver on-time results and high data integrity.
Bioabsorbable Polymers
Bioabsorbable Polymers
Standard: ASTM F1635
Seeks to understand whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device.
Chemical Characterization for Medical Devices & Combination Products
Chemical Characterization for Medical Devices & Combination Products
Standard: ISO 10993
Chemical characterization of medical device materials, including polymers, metals, ceramics, and composites, to provide ISO 10993 biocompatibility data for regulatory filings. Additionally, tests characterize ancillary chemicals associated with device production, such as plasticizers, fillers, additives, cleaning agents, and release agents.
Material Compatibility
Material Compatibility
Standard: Product dependent
Seeks to understand whether or not the different component materials in a medical device, including a drug component, can negatively interact with each other and impact the performance or safety of the overall device.
Medical Device Extractables & Leachables
Medical Device Extractables & Leachables
Standard: ISO 10993 Chemical Characterization Testing
Set of methods to characterize complex chemical interactions in medical device materials (polymers, metals, ceramics, and composites) to characterize extractables and leachables properly.