510K is a Pre-Market Notification (PMN) for new or modified medical devices

Description: 510K certifies that the medical device is at least as safe and effective as a predicate device

Brief Introduction to 510k

 

What is 510K?

510K is called as Pre-Market Notification (PMN) and is applicable for new or modified medical devices for marketability in the United States of America. 510K clearance has to be obtained from FDA. This clearance refers to the Section 510K of the 1976 Federal Food, Drug and Cosmetic Act which deals with Class II category medical devices.

A 510K clearance means that the medical device is at least as safe and effective as a predicate device that is legally marketed and not subject to premarket approval.

Classification of Medical Devices

The medical devices are categorized into three Classes, by the Federal Food, Drug and Cosmetic Act, based on the risk factors involved:

  1. Class I-these are low risk devices like bed pans, crutches or elastic bandages
  2. Class II-these pose moderate level of risk like sutures, intravenous administration sets, blood pressure cuffs and many other devices
  3. Class III- these are high risk devices like implantable pacemakers, breast implants and others.

Note that the Class I does not require FDA clearance, Class II requires 510K clearance (PMN) and Class III requires Premarket Approval (PMA).

Circumstances that Require 510 K Clearances

A new medical device or changes in the intended use of an existing device, changes in basic operation, changes in sterilization method, or changes in performance specification, changes in blood contacting materials or any contraindications are the circumstances that call for a fresh 510K clearance.

Contents of a 510KSubmission

A submission for 510K clearance should contain documents pertaining to the

  1. Description of the device
  2. Data pertaining to preclinical, clinical or non-clinical performance
  3. The label on the device
  4. Device usage instructions
  5. Product comparison with the predicate
  6. Documentation pertaining to any software or a firmware is used in the device
  7. Any other applicable documentation or specific requirements of the medical device.

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