US FDA 510K

What is US FDA 510K?

FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ. FDA 510k device classification depends on the intended use and indications of the use of the device.

The US FDA has established classifications for approximately 1700 different generic types of devices and categorized them into 16 medical specialties.

Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

Class I – Low Risk (General Controls)

Devices are subjected to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.

Reusable surgical Instruments
Hospital Furniture
OT equipment

Class II – Moderate Risk (General Controls & Special Controls)

Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

Urology Catheters
Patient Monitors

Class III – High Risk (General Controls & Pre-market approval)

Devices for which general controls, by themselves, are insufficient and for which there is insufficient information to establish special controls to provide reasonable assurance of safety and effectiveness of the device. Class III devices typically require pre-market approval(PMA).

PTCA Catheters
Stents
Heart Valves

Benefits of US FDA 510K

Reduced risk

Reputation

Access to new business

Improved efficiency

Customer satisfaction

Helps you stand out from your competitors

Who can be certified US FDA 510K?

Document required for US FDA 510K

510(k) Documentation includes but not limited to the following:

Identify Device Class, product code, and Regulation
Appropriate Predicate device Identification
Identify Appropriate guidance and control documents
Choosing an appropriate type* of 510(k) submission
Prepare Indication for Use statement
Declaration of Conformity
Identification of Biocompatibility tests
Identification of Performance test
Sampling Plan
Requirements for stability studies
Review of the Risk management file
Sterilization requirements and appropriate documentation
Labeling requirements and review of label
510(k) summary and predicate comparison
Identify any clinical data/ test requirements
Device-specific documentation requirements- includes Software, EMC, and Electrical safety
Review of Final 510(k) File
Pre-submission (Q-submission)
Refuse to Accept Policy for 510(k) acceptance review
E-copy Submission
Interact with FDA – Answering Review Comments and Additional Information requirement during the post submission phase.
Device Listing and Registration
US Agent Services

The extent of Documented Information differs as per:

Role of Shamkris and Process of US FDA 510K

Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.

The implementation process is described below:

Time Frame

Task

Process

Step 1

Phase I

Step 2

Phase II

Step 3

Phase III

Step 4

Phase IV

Step 5

Phase V

FAQ

What is FDA 510k certification?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What you mean by proposed predicative device? Is it necessary to include in 510(k)?

The predicate device is a legally marketed, 510(k) cleared device used to determine substantial equivalence of the proposed/new device for510(k) Submission is called proposed predicate device.

Yes, it is necessary to submit to FDA, as the substantial equivalence of the proposed device with a legally marketed device decides the 510(k) clearance. It is a critical part of 510(k) you should include a comparison table and discussion of the similarities and differences of your device compared to one or more predicate devices to which you are claiming equivalency.

Do you have a ready to edit and use template for Acceptance Checklist for Abbreviated 510(k) Submission?

Using the Acceptance Checklist appropriate to the submission type (traditional, abbreviated, or special), within 15 calendar days of receipt of the 510(k), FDA staff should answer each question for the elements identified as RTA (Refuse to Accept) items.

We do have the PDF version of the acceptance checklist for traditional as well as abbreviated. It can be used internally to ensure all the sections are included in the documentation during submission.

What is Declaration of Conformity? Is it part of FDA 510(k)?

Declaration of conformity is to provide information relating to the use of voluntary consensus standards, including any declarations of conformity or the basis of the general use of such standards for the traditional submissions.

Whereas for abbreviated 510(k) submissions to provide the information regarding the use of standards, or a summary report that describes how the device complies with the special controls associated with the particular device type or that is recommended in any relevant device-specific guidance.

Declaration of conformity is a suitable section for both traditional and the abbreviated 510(k) submissions.

What is Declaration of Conformity? Is it part of FDA 510(k)?

Explain the 510(k) requirement for the Biocompatibility. What is expected by a reviewer?

FDA recommends the evaluation of biocompatibility of tissue contacting materials if the medical device contains components that come into direct or indirect contact with tissue. Biocompatibility testing is performed as per the standard ISO 10993-1.

The biocompatibility studies shall perform even if the material and construction of the subject device and predicate device are the same, to prove the biological safety of the device.

The reviewer will need information regarding detailed testing protocol and reports. The protocol shall include the details of study title and standard, the test article preparation, detailed test method- positive and negative controls, test parameters and acceptance criteria, analysis of results. The report shall include the analysis of test results, conclusions made from the test result, device photograph, etc.

Is Sterilization validation mandatory for 510(k)?

Sterilization validation is required for only sterile medical devices. The section for sterility can be not applicable for non-sterile medical devices.

FDA released two guidance for the Sterility Information in Premarket Notification 510(k) Submissions for Devices Labelled as Sterile and Reprocessed Single-Use Medical Devices.