Device Type	FDA-Cleared Example	Description	Special Controls
Adjunctive Open Loop Fluid Therapy Recommender	Edwards Lifesciences’ Acumen Assisted Fluid Management (AFM) Software Feature	Prescription device using software algorithms to analyze cardiovascular vital signs and predict a patient's estimated response to fluid therapy, intended for adjunctive use with other physical vital sign parameters.	Clinical performance testing; labeling; non-clinical performance testing; software verification, validation, and hazard analysis; usability assessment.
Blood Collection Device for Cell-free Nucleic Acids	Streck, Inc.’s Cell-Free DNA BCT	Device intended for medical purposes to collect, store, transport, and handle blood specimens and to stabilize and isolate cell-free nucleic acid components prior to further testing.	Certain design verification and validation.
Endoscopic Pancreatic Debridement Device	Interscope, Inc’s EndoRotor	Device intended to be inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity, used to remove necrotic tissue from a walled-off pancreatic necrosis cavity.	Biocompatibility evaluation; clinical performance testing; electrical safety testing; electromagnetic compatibility testing; labeling; non-clinical performance testing; package integrity testing; pyrogenicity testing; shelf-life testing; software validation, verification, and hazard analysis; sterilization validation; and training.
Hemodialyzer With Expanded Solute Removal Profile	Baxter Healthcare Corp.’s Theranova Dialyzers	Part of an artificial kidney system for the treatment of patient with renal failure by performing such therapies as hemodialysis, hemofiltration, and hemodiafiltration. A hemodialyzer with expanded solute removal profile includes modifications to the semipermeable membrane that allows for increased removal or uremic retention solutes compared with standard high-flux hemodialyzers of the high permeability hemodialysis system classification, including solutes at the upper end of the “middle” molecular weight range (0.5 kDa to 60 kDa). This device is intended to be used with the extracorporeal hemodialysis delivery systems, blood tubing sets, blood access devices, and accessories.	Biocompatibility evaluation; clinical performance testing; labeling; non-clinical performance testing; pyrogenicity testing; shelf-life testing; sterilization validation.
Heparin and Direct Oral Factor Xa Inhibitor Drug Test System	Instrumentation Laboratory Co.'s HemosIL Liquid Anti-Xa	Drug test system intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors to aid in the management of therapy in conjunction with other clinical and laboratory findings.	Certain analytical studies; clinical studies in design verification and validation; labeling.
Hydrophilic Re-Coating Solution	Tangible Science, Inc.'s Tangible Boost	Home-use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components.	Biocompatibility evaluation; clinical performance testing; coating effectiveness testing; coating performance testing; disinfection solution compatibility testing; human factors evaluation; labeling; lens solution compatibility testing; shelf-life testing; sterility testing ; validation.
Radiofrequency Toothbrush	Home Skinovations Ltd.'s ToothWave	Device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth, intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.	Battery safety testing; biocompatibility evaluation; electrical safety testing; electromagnetic compatibility (EMC) testing; label comprehension and self-selection study; labeling; non-clinical performance testing; software validation, verification, and hazard analysis; usability evaluation; use life testing.

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