Classification of Medical Device Accessories

A

AJayC

#1
Online, I often see the following quote regarding medical device accessory classifcation.

"Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device."


Does any one know what FDA document or regulation this comes from.
 
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Ajit Basrur

Staff member
Admin
#2
Refer under Accessories/components - http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126288.htm

Accessories/components to a device take on the same classification as the "parent" device unless they are separately classified

Another reference :

Refer Point 6 - http://www.fda.gov/MedicalDevices/D...sions/PremarketNotification510k/ucm142651.htm

Accessories to classified devices take on the same classification as the "parent" device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the "parent" device with the highest risk, i.e., class
 
M

MIREGMGR

#4
The device/accessory relationship is very clearly defined in the MDD, but not at all consistently in FDA rules and guidances. It's easy enough to find statements in the regulations such as quoted above, for single regulatory issues. The problem is that there is no consistent general rule or guidance, even though such statements often are worded as if the writer assumes there is such a general rule or guidance.

Some regulations specifically mention accessories, and others don't. In my experience, this results in examiners sometimes taking the regulations literally, i.e. if accessories aren't mentioned, they're not included and must be separate devices.

FDA has major legacy issues with device definition and its classification system. There are several possible ways to classification-analyze common device types, leading to different clearance requirements. The device vs. accessory question is one aspect of this problem.

An example: X-ray fluoroscopic imaging equipment frequently is used during surgical intervention such as cardiac catheterizations to provide image-guidance in real time. Such equipment necessarily must be close to and above the invasive site, therefore it has been common clinical practice for forty years or more to apply a sterile disposable barrier-cover made of polyethylene film or another suitable sterilizable material over the upper imaging equipment components. As of 1978, FDA considered such sterile disposable covers to be accessories. As of 1982, FDA changed its approach and considered them to be devices under KKX. That however presented a definitional problem because they weren't "patient coverings", so Product Code MMP was created. But that code didn't quite align with the underlying regulation, so it's only been applied a few times since it was created, even though hundreds of such device-designs are marketed. More recently FDA has evolved back to a stance that a product that doesn't meet the specific regulation definition cannot be KKX or MMP, so it must be an accessory...except there are no guidances for sterile barrier covers as accessories.

KKX and MMP are Class II, 510(k)-required Product Codes. They have rigorous requirements...KKX is the Product Code for surgical drapes. Do non-patient-contact plastic film barrier covers need to be as highly qualified as surgical drapes? But, maybe the product is an accessory to the imaging system. Most such imaging systems are Class II, but their clearance process usually pretty much ignores the many minor accessories. Does that go too far in the opposite direction, with little or no oversight of the cover products? Also, if the accessory comes from a separate marketer than the imaging system, how is it to be regulated, as the whole concept of accessories is that they're included in the primary device clearance...? And, depending on the application of the cover, maybe instead it's an accessory to the surgical table. Surgical tables are Class I Exempt. But since there's imaging happening, maybe the table is a radiology-type, in which case it's Class II...but if it's being used for surgery, which is it? And where does the regulation go if the product will be used outside of the sterile field...since FDA doesn't even define "sterile field", even though the term is used or implied in many rules and guidances? Is it sensible to apply the same rigorous, expensive KKX requirements that would apply to an invasive-site-proximal apertured surgical drape, to a cleanliness-only footswitch control for an imaging system, sitting on the nonsterile floor?

It's a bit of an inconsistent mess, in need of a new system.
 
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M

maaquilino

#6
It would have been really nice if the FDA just gave us all a definition of an accessory. As they didn't, I've often used the resources below to find out if a particular accessory is considered part of the device or not (usually because I have to prove to the project manager and upper management why this accessory IS considered a medical device and why it has to be validated ;) )

The MDD did give one and I see it as being close, if not exact, as to what the FDA means for an accessory:
Article 1(2) (b) MDD defines an accessory of a medical device as follows:
?Accessory? means an article which whilst not being a (medical) device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
http://ec.europa.eu/health/medical-devices/files/meddev/2_1_3_rev_3-12_2009_en.pdf


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820&showfr=1
CFR820.3 (c) states: (c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.

CFR820.3(l) states: (l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.


http://www.fda.gov/medicaldevices/d...nce/overview/classifyyourdevice/ucm051512.htm
See Medical Device Definition; this covers accessories though they don't define an accessory.


At these links you can do a search for any component or accessory and ifit's there, it will give you the classification, which then lets you know they see it as a medical device:
http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051521.htm

http://www.fda.gov/MedicalDevices/D...nce/Overview/ClassifyYourDevice/ucm051530.htm


I also refer to the preamble to 820 a lot as it tells me a lot more about what the FDA is saying in the regulation. I just do a search on the term I have questions about and see what it says.
http://www.fda.gov/MedicalDevices/D...ments/QualitySystemsRegulations/ucm230127.htm

There's a post on here that discusses accessories also:
http://elsmar.com/Forums/showthread.php?t=52776
 

Chrisx

Involved In Discussions
#7
This issue of classification of accessories has come up recently. We manufacture orthopedic implants. We have always stated that the instruments are class 1 and not subject to design controls. Now a customer issued a finding in an audit that some instruments might be accessories to the implant and therefore subject to design control. They did not specify which instrument, so I am left never knowing which instrument might be subject to design controls.

They claimed that if the instruments are designed to work with the implant, then they are accesories. Like most orthopedic companies, we design a tray that contains all the instruments to complete the procedure. According to this logic, even a screwdriver is now the same class as an implant. I guess they think it is an implantable screwdriver. :mad: Clearly surgical instruments don't meet the regulatory definition of the implants. The whole thing doesn't make much sense. Are we supposed to identify a predicate screwdriver and submit a 510(k) for a screwdriver! There are no screwdrivers with premarket clearance.

I'm going to classify all the instruments and site all the product codes and regulations for each one. However, I will never know whether this will be accepted. It is not a very workable regulatory classification scheme.
 
M

MIREGMGR

#8
My interpretation on the FDA side (i.e. not MDD)...or maybe wild guess, since I don't know of any written guidance and the verbal interactions I've had with multiple persons at FDA over the past couple of years have been highly inconsistent...is that if a product-to-be-classified is use-specific to a single device or a family of closely related devices from the same maker, and the product-to-be-classified is made or offered by the same maker as the devices for which it is use-specific, then that product-to-be-classified may be an accessory to the devices for which it is use-specific...unless it is subject to a regulation and Product Code that particularly encompasses its type and use, in which case who knows.

The two points of importance, I think, are:

1. On the FDA side, a product-to-be-classified cannot be an accessory to a device for which it is use-specific unless it is made or offered by the same maker as the devices for which it is use-specific. That's because the 510(k) system has no provision for an accessory-to-a-device to be cleared except as part of the 510(k) process for the superior device. If you submit an accessory by itself it must be classified according to its own characteristics, and most accessories don't have the same core function as the device for which they are an accessory.

This of course allows for the common instance of a superior-device maker buying another device to include with (or offer for use with) the superior-device as an accessory.

2. A product-to-be-classified that may be used with more than one superior device, and particularly may be used with superior devices from more than one maker, cannot be an accessory unless it is offered as above by the superior-device maker. There would be no logical way to require such a product-to-be-classified to be incorporated into a superior-device 510(k) that was submitted by an unrelated company, unless that unrelated company voluntarily wanted to include the device-to-be-classified as an accessory.

Thus a product-to-be-classified that is of a type that might be considered to be an accessory, but is made and marketed by a third party and not offered as an accessory by the superior-device maker, must be classified other than as an accessory.

The definitive way to determine the classification of a device, of course, is to file a 513(g).
 
M

maaquilino

#9
This issue of classification of accessories has come up recently. We manufacture orthopedic implants. We have always stated that the instruments are class 1 and not subject to design controls. Now a customer issued a finding in an audit that some instruments might be accessories to the implant and therefore subject to design control. They did not specify which instrument, so I am left never knowing which instrument might be subject to design controls.

They claimed that if the instruments are designed to work with the implant, then they are accesories. Like most orthopedic companies, we design a tray that contains all the instruments to complete the procedure. According to this logic, even a screwdriver is now the same class as an implant. I guess they think it is an implantable screwdriver. :mad: Clearly surgical instruments don't meet the regulatory definition of the implants. The whole thing doesn't make much sense. Are we supposed to identify a predicate screwdriver and submit a 510(k) for a screwdriver! There are no screwdrivers with premarket clearance.

I'm going to classify all the instruments and site all the product codes and regulations for each one. However, I will never know whether this will be accepted. It is not a very workable regulatory classification scheme.
Possibly some helpful info
http://www.cutis.com/fileadmin/qhi_archive/ArticlePDF/AJO/036080407.pdf
 
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Chrisx

Involved In Discussions
#10
When FDA trained me as a 3rd party 510(k) reviewer, they emphasized that the 513(g) is only their opinion at that time is not a final decision. The final decision on classification is the 510(k). For sure a 513(g) helps, but is no guarantee.
 
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