How is My Medical Device Classified: Case Study

Slide 1 

Hello, my name is Commander Kimberly Piermatteo of the United States Public Health Service and I am 

a Consumer Safety Officer within the Center for Devices and Radiological Health’s Division of Industry 

and Consumer Education at FDA. Welcome to CDRH learn, CDRH’s resource for multimedia industry 

education. Within this CDRH Learn module, I will provide you with an illustrative example of how you 

can determine the class of a medical device using three different determination methods. Determining 

how a medical device is classified is instrumental in understanding and identifying the appropriate 

regulatory requirements for a device.

Slide 2 

This module is a companion to the CDRH Learn module titled “How is my medical device classified?” If 

you have not done so already, please review this module first before proceeding to watch this case 

study. 

Slide 3

Before I begin the case study, I’d like to review a few points made in the companion module. First, 

medical devices are classified based on risk. Medical devices may be classified as Class I, Class II or Class 

III. Second, the risk of the device determines the extent of regulatory controls. And lastly, there may be 

an applicable premarket submission type for a device unless exempt. The table displayed on this slide 

was discussed in detail within the companion module, and I have provided it again here as it provides an 

overview of the medical device classes and their applicable regulatory requirements. 

Slide 4 

The following learning objectives will be addressed within this case study. I will describe three different 

classification determination methods. The methods are, one, search for an appropriate product 

classification, two, search for a similar device by clearance or approval, and three, search for a similar 

device by device listing. 

Slide 5

For this case study, I’m going to use a traction device as my example. The intended use of this traction 

device is to treat low back pain through intermittent and static traction.

Slide 6

As I mentioned when determining a device’s product classification, there are three methods that I 

recommend. The first is to directly search for the appropriate product classification. I’ll refer to this as 

method 1 and this is the most common method used. A second method, or method 2, is to search for a 

similar device by its clearance or approval. And lastly, method 3 is to search for a similar device by 

device listing. I’m going to walk through how to conduct each of these search methods over the next 

several slides. 

Slide 7

First, we will look at method 1. 

Slide 8

To search for an applicable product classification, I will be searching the FDA’s public product 

classification database. A screen shot of the product classification database is provided on this slide. You 
may search the various fields provided; however, I recommend you go to the quick search feature which 

is circled in red on this slide. From the quick search, you can search using a key word. 

Slide 9

For this example, I’m going to search using the key word “traction”. I would enter the key word in the 

search field and select search. I could conduct multiple searches using other words, but I feel this one 

most appropriately describes the example device. When searching the product classification database, 

remember to conduct multiple searches using a variety of key terms so that you ensure you capture as 

many potentially related product classifications which you can then narrow down. Keep in mind spelling 

matters and I suggest you avoid plurals and don’t be too specific as this will limit your results. 

Slide 10 

On this slide, you will see a screen shot of my quick search results using the key word “traction”. The 

default display setting for this database is 10 results, so if you wish to expand the number of results 

displayed per page, you can select the drop down circled in blue, at the top right of the screen shot, to 

change the number of results displayed per page. For this example, I have chosen to display up to 100 

results. As noted by the red circle, 11 results are now displayed. I could review each product 

classification to determine if it applies to my traction device, or I could further define the intended use 

of the traction device so that I can narrow down the results even faster. 

For this example, I’m going to clarify the intended use of the traction device to indicate that it is a 

powered traction device. 

Slide 11

Now looking at the results, I see there is a product classification for a non-powered traction apparatus, 

highlighted in yellow on the slide, but then there is a more applicable powered traction equipment 

highlighted in green below. 

Slide 12

Therefore, the ITH product code looks to be more applicable to my powered traction device. I’m going 

to take a further look at this product code to confirm whether the ITH product code appropriately 

describes my device. 

Slide 13

This next slide displays a screen shot of the product classification information for the ITH product code. 

At this point, I want to ensure this product code and the associated regulation number, 21 CFR or code 

of federal regulations, 890.5900, appropriately describes my powered traction device.

Slide 14

Therefore, I’m going to select the hyperlink for the regulation number to further review the description. 

I have highlighted the regulation number I’m going to select in the black box and orange arrow on this 

slide. 

Slide 15

The regulation description states – “Powered traction equipment consists of powered devices intended 

for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to 

exert therapeutic pulling forces on the patient’s body.” Based on this regulation description, I believe 
this would be the most appropriate regulation for the traction device in my example, as well as the ITH 

product code seems to be the most appropriate. 

Slide 16

Going back to the screen shot for the ITH product code in the public Product Classification database, I 

can then determine what regulatory requirements apply to this powered traction device. I can see on 

the screen that the submission type for a powered traction equipment device is 510(k), which is 

highlighted in yellow on this slide, which means I would need to obtain 510(k) clearance prior to 

marketing this device. Additionally, this device type is considered to be class two, which means general 

controls apply as well. If there were any special controls for this device type, I would have been able to 

review them as part of the regulation description. 

Slide 17

Next, I’m going to discuss method 2, which is to search for a similar device by its clearance or approval. 

Using method 2, I will demonstrate that I will come to the same conclusion as Method 1 by determining 

that the ITH product code is the most appropriate for a powered traction device. 

Slide 18 

Using method 2, I can search for a similar device by 510(k) clearance or premarket approval. For this 

method it is important to note, I would only be able to search for devices which have received 510(k) 

clearance or premarket approval. Since most Class I devices are exempt from 510(k), I would not be able 

to find them by using this method. One note I’d like to make is regarding De Novo applications. The De 

Novo pathway provides a possible route to classify novel devices of low to moderate risk. If you think a 

similar device to your own was the first new, novel device type, then this first marketing authorization 

would not be found in the 510(k) clearance database. 

You would need to search the De Novo database to find this first classified device under the newly 

created regulation. To find a device that has been cleared under 510(k), or approved under a Premarket 

Approval Application, or a PMA, you can search the respective public databases using the hyperlinks 

provided on this slide. 

The powered traction device, in this example, is not life supporting or life sustaining, so I can presume 

that it is not likely considered to be high risk, so I wouldn’t need to search the PMA database for a 

similar device. Additionally, I do not believe powered traction devices are new or novel, therefore, I’m 

not going to search the De Novo database either. I’m going to proceed and search the 510(k) clearance 

database to see if I can find the similar device I’m looking for.

Slide 19

On this slide, I’ve provided a screen shot of the public 510(k) clearance database. The Advanced Search 

is the default, but there is also a Quick Search available which is circled in red at the bottom of the 

screen shot. Within the Advanced Search, there are many fields you may search, but I find the Quick 

Search to be more helpful in identifying a wide range of results which I can then narrow down myself. 

In order to steer this example even further, I’m going to state that I’m looking for a similar device called 

the Digit-trac 930. 

So, let’s take a closer look and see if this similar device has a 510(k) clearance which I can review, and 

then determine how it has been classified to ultimately determine if the same classification applies to 

my traction device. 
Slide 20

Within the Quick Search of the 510(k) clearance database, which is pictured on this slide, I still want to 

keep my search broad to capture as many results as possible, so I’m going to enter the word “traction” 

in the search box. 

Slide 21

The screen shot provided on this slide shows that by searching the key word “traction”, I obtained 93 

results, which I’ve circled in red at the top left and the first 14 results are displayed. Note, I conducted 

this search in July of 2019, therefore, if you were to conduct a similar search after this date, you may 

obtain different results if a more recent device received 510(k) clearance. For this example, I said I’m 

looking for the similar device called the Digit-trac 930. 

After reviewing the first few results, I was able to find a device called the “traction system, digit-trac 

930”, as I've highlighted in green. 

Slide 22 

In order to review more information about this 510(k) clearance, I could either select the device name or 

the 510(k) number hyperlink. I’m going to select the 510(k) number K052453 as identified by the red 

arrow. 

Slide 23

This slide shows detailed information about the 510(k) that I selected for the Digit-trac 930. I can see 

this type of device was cleared under the regulation number 21 CFR 890.5900 and product code ITH, as 

highlighted in red. If I want, I can review more information about the regulation and product code by 

selecting the respective hyperlinks which will take me to the product classification database results that 

I viewed previously under method 1. 

After reviewing this information, I could then determine if this regulation and product code 

appropriately describe my traction device. And then I could determine what the regulatory 

requirements are, such as for the ITH product code a 510(k) clearance is required. 

Slide 24 

I could also review the 510(k) summary for the digit-trac 930 to obtain more information on this device’s 

intended use, to ensure this is the similar device I was originally looking for. A hyperlink to the 510(k) 

summary is highlighted in green on this slide. 

Slide 25

The last method I recommend for determining the appropriate product classification for a device is 

method 3, which is to search for a similar device by device listing. This method is useful because 

establishment registration and device listing are a general control, which means all medical device 

manufacturers currently marketing a device in the U.S. must be registered and their devices listed. So, if 

I know of a similar device currently being marketed, I can search for it by its listing and see if the same 

product classification then applies to my example device. 

Slide 26 

A screen shot of the FDA’s public Establishment Registration and Device Listing database is provided on 

this slide. Again, the default is the Advanced Search which allows me to search by establishment or 
trade name, or I could search by key word, again using the Quick Search. I’m going to use the Quick 

Search. 

Slide 27

This slide shows the Quick Search for the Establishment Registration and Device Listing database. The 

Quick Search for this database is very similar to the Quick Searches in the other public databases I used 

for the previous methods. I’m going to also search using the key word “traction”, as circled in red on this 

slide, to see what device listings I can find. 

Slide 28

By searching using the key word “traction”, I obtained 22 results, as circled in blue on this slide. 

Remember, I’m looking for the similar device called the digit-trac 930, so if I review my results, I 

eventually see that there is a digit-trac 930 powered traction equipment listed by the company Ever 

Prosperous instrument, incorporated, which I’ve highlighted in red. 

Slide 29

If I select the establishment name, this will take me to information about the establishment’s 

registration. But I want to know more about the device and see how it is classified, so I’m going to select 

the product name, as indicated by the green arrow on this slide. 

Slide 30

Under this device listing, I can review information about how this device has been classified to 

determine if the same classification applies to my device example. Highlighted in red, I can see the digittrac 930 falls under the product code ITH, it is Class II, and the applicable regulation is 21 CFR 890.5900. 

This is the same classification information I was able to find by searching the two previous methods. If I 

want to review more details about this device type and classification I could, again, select the hyperlink 

to the ITH product code or hyperlink to the regulation number. I could also select the 510(k) number, 

which is highlighted in yellow on this slide, and it will take me to the 510(k) clearance database, where I 

could review the 510(k) summary for this device as well. 

Slide 31

To conclude this case study example, the table provided on this slide summarizes the results of the 

various searches I conducted using methods 1, 2 and 3. By using all three methods, I was able to come 

to the same conclusion regarding the appropriate product classification for my powered traction device. 

For this example, I can conclude that the appropriate class for a powered traction device, which is 

intended to treat low back pain through intermittent and static traction, is Class II, and must comply 

with general controls. The appropriate regulation number is 21 CFR 890.5900, the product code is ITH,

and lastly, a 510(k) clearance is required prior to marketing this device. 

Slide 32

In summary, within this module, I discussed three different methods which are available to help you 

determine how your medical device may be classified by the FDA. Once you know how your device is 

classified, you can then identify the applicable regulatory requirements for your device. 

Slide 33

Additional resources and links are provided on this slide. I will not cover them in detail, but they are 

listed for your reference, as needed. 
Slide 34

CDRH provides multiple opportunities for industry education. On this slide, I have provided you links to 

CDRH Learn, which consists of numerous learning modules covering a wide range of medical device 

topics; as well as Device Advice, which is a text-based resource, and lastly, you may contact the Division 

of Industry and Consumer Education, or DICE, by phone or email with questions. 

Slide 35

My call to action for you is to conduct multiple searches in each of the FDA’s public databases that I 

discussed in this module. By conducting different searches in each of these databases, you will be able 

to cross-check your results, and I hope you will feel more confident when it comes to identifying the 

most appropriate product classification for your device. Thank you for watching and I hope you found 

this module to be informative.

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