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Evaluation of Automatic Class III Designation (De Novo) Decision : K124065 added

Wed, 02/20/2013 - 12:00am
U.S. Food & Drug Administration

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate.

The De Novo process applies to low and moderate risk devices that have been classified as class III because they were found not substantially equivalent (NSE) to existing devices. Applicants who receive this determination may request a risk-based evaluation for reclassification into class I or II within 30 days of receipt of an NSE determination. Devices that are classified through the De Novo process may be marketed and used as a predicate for future Premarket Notification [510(k)] submissions.

FDA has begun releasing De Novo Summary documents for devices granted market authority through the De Novo process. The De Novo Summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis of the decision to grant a de novo petition. The Summary outlines how FDA determined that the device for which a petition is granted is low to moderate risk and that general and/or special controls provide reasonable assurance of safety and effectiveness. The De Novo Summary also serves as a resource on the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the de novo device as a predicate for future 510(k) submissions.

Links to all available De Novo Summary documents can be found in the table below.

Device Name510(k) NumberApproval LetterDecision Summary
Infrascanner Model 1000 K080377 Approval Letter  
Zeltiq™ Dermal Cooling Device K080521 Approval Letter  
Erchonia ML Scanner K082609 Approval Letter  
NuMED NuCLEUS and NuCLEUS-X BAV Catheters K082776 Approval Letter Decision Summary
Hem-Avert Perianal Stabilizer K083692 Approval Letter  
RIDASCREEN Norovirus 3rd Generation EIA K093295 Approval Letter  
Prostate Mechanical Imager K093579 Approval Letter Decision Summary
LipiFlow Thermal Pulsation System K093937 Approval Letter  
Steris Verify Spore Test Strip for S40 K100049 Approval Letter Decision Summary
InBios DENV Detect IgM Capture ELISA K100534 Approval Letter Decision Summary
Widex C4-PA Wireless Air-Conduction Hearing Aid K101699 Approval Letter Decision Summary
Aptus Endovascular Suturing System K102333 Approval Letter Decision Summary
ImmunoCAP Tryptase K103039 Approval Letter Decision Summary
Percutaneous Surgical Set with 5 mm or 10 mm Attachments K110431 Approval Letter Decision Summary
STRATIFY JCV Antibody ELISA K112394 Approval Letter Decision Summary
Proteus Personal Monitor Including Ingestion Event Marker K113070 Approval Letter Decision Summary
PORTRAIT TOXIGENIC C. DIFFICILE ASSAY K113358 Approval Letter Decision Summary
Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP) K113450 Approval Letter Decision Summary
xTAG® Gastrointestinal Pathogen Panel (GPP) K121454 Approval Letter Decision Summary
FerriScan R2-MRI Analysis System K124065 Approval Letter Decision Summary

 

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