510(k) Testing
ServicesTesting510(k) TestingInfinity Laboratories provides a variety of analytical solutions as part of our comprehensive medical device laboratory testing services. Our team leverages decades of experience working with medical devices to help determine product equivalency and support your product’s 510(k) filings. Infinity is your contract laboratory testing partner for accelerating the development of Class II and Class III medical devices with 510(k) testing.
Infinity Laboratories provides a variety of analytical solutions as part of our comprehensive medical device laboratory testing services. Our team leverages decades of experience working with medical devices to help determine product equivalency and support your product’s 510(k) filings. Infinity is your contract laboratory testing partner for accelerating the development of Class II and Class III medical devices with 510(k) testing.
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 and are crucial to perform to facilitate the approval of Class II and Class III medical devices. 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 is an experienced medical device testing lab with extensive experience evaluating 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 encapsulate the most common medical device material categories, our team also has experience testing less common types and 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
Characterization of the properties and degradation profiles of bioabsorbable medical-grade polymers, components, and devices.
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.