1. Premarket Notification 510(k) process
Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.

2. medical device classification
Regulatory classes were established in thanks to the Medical Device Amendment.
It defined the degree of control necessary to ensure that the devices are safe and effective.
Classification :
Class 1 : Low-risk devices (general controls)
Class 2 : Moderate-risk devices (general and special controls)
Class 3 : High-risk devices (general controls and premarket approval)

3. What is a 510(k)?
Premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent (SE) to a legally marketed device which is not subject to PreMarket Approval (PMA) .
Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
A legally marketed device, as described in 21 CFR (a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the Act.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR (a)(3)) that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. A legally marketed device, as described in 21 CFR (a)(3), is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate. Legally marketed also means that the predicate cannot be one that is in violation of the Act.

4. Substantial equivalence
A device is substantially equivalent if, compared to a predicate, it :
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;  or
has different technological characteristics and the information submitted to FDA;
does not raise new questions of safety and effectiveness; and
demonstrates that the device is at least as safe and effective as the legally marketed device.
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.

5. Predicate devices
Submitters must compare their 510(k) device to a similar legally marketed device.
Any legally U.S. marketed device may be used as a predicate :
A device cleared through the 510(k) process,
A device that was legally marketed prior to May 28, 1976 (preamendment devices),
A device that was originally on the U.S. market as a Class III device (Premarket Approval) and later downclassified to Class II or I.
The term "preamendments device" refers to devices legally marketed in the U.S. by a firm before May 28, 1976and which have not been: significantly changed or modified since then; and for which a regulation requiring a premarket approval (PMA) application has not been published by FDA.
Devices meeting the above criteria are referred to as "grandfathered" devices and do not require a 510(k). The device must have the same intended use as that marketed before May 28, If the device is labeled for a new intended use, then the device is considered a new device and a 510(k) must be submitted to FDA for marketing clearance.
The legally marketed device(s) to which equivalence is drawn is known as the predicate device(s). A claim of substantial equivalence does not mean the device(s) must be identical. Substantial equivalence is established with respect to: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. You can claim SE to either a preamendments or postamendments device that is or was legally marketed. Legally marketed means that the predicate cannot be one that is or was in violation of the Federal Food Drug & Cosmetic (FD&C) Act. An applicant may claim SE to a device that is no longer being marketed in the U.S.

6. When is a 510(k) required?
A new complete 510(k) application is required for :
Introducing a device into commercial distribution for the first time.
Proposing a different intended use for a device which you already have in commercial distribution.
Changes or modifications to an existing device, if the modifications could significantly affect the safety or effectiveness of the device, or if the device is to be marketed for a new or different indication.
Examples of modifications that may require a 510(k) :
Sterilization method
Structural material
Manufacturing method
Operating parameters or conditions of use
Patients or user safety features …
After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510(k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date. If your device was not marketed by your firm before May 28, 1976, a 510(k) is required.
When a 510(k) holder decides to modify an existing device, the holder must decide whether the proposed device modification(s) requires submission of a 510(k). It is not FDA's intent that a 510(k) must be submitted for every modification. However, all changes in indications for use require the submission of a 510(k). A change in indication for use includes prescription use to over the counter use.
There are no provisions for a 510(k) amendment or supplement to the existing 510(k). A new 510(k) must be submitted. However, FDA developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k)

7. The 510(k) submission process
The SE determination is usually made within 90 days and is made based on the information submitted.
Once the device is determined to be SE, it can then be marketed in the U.S.
A device may not be marketed in the U.S. until the submitter receives a letter declaring the device substantially equivalent. If FDA determines that a device is notsubstantially equivalent, the applicant may:
resubmit another 510(k) with new data,
request a Class I or II designation through the de novo process file a reclassification petition,
or submit a premarket approval application (PMA).

8. The submission methods
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, andAbbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
In 1998, FDA developed "The New 510(k) Paradigm" to streamline the evaluation of Premarket Notifications. The New 510(k) Paradigm provides two optional approaches to the Traditional 510(k) method for obtaining 510(k) marketing clearance under certain instances: Special 510(k) and Abbreviated 510(k). The Special 510(k): Device Modification utilizes certain aspects of the Quality System Regulation; and the Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review.
All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed (predicate) device. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

9. The submission methods

10. 510(k) review fees
The 510(k) Review Fee is the same for Traditional, Special, and Abbreviated 510(k).
Small businesses may qualify for a reduced fee.
Application is considered incomplete if the fee is not paid.
Application type
Standard fee
Small business fee
510(k)
$5,228
$2,614
PMA
$234,495
$58,624

11. Examples and figures
EOS imaging (November 7th, 2016) for kneeEOS online 3D planning software.
SeaSpine Holdings (November 7th, 2016) for Mariner Posterior Fixation System.
Merit medical systems (November 7th, 2016) for swiftNINJA steerable microcatheter.
EOS : provide an optimized surgical plan for Total Knee Arthroplasty
Seaspine : surgical solutions for the treatment of spinal disorders, multiple intra-operative options to facilitate posterior lumbar fixation
Merit : inflation devices used in angioplasty and stent placement, peripheral and coronary applications

12. Examples and figures

13. Thank you for your attention