Do you know the difference between a medical device component and an accessory medical device?

[@petersieljacks9475]

Thanks for the excellent explanation. I have a case you may be able to give your thoughts on. Let's say we have a main device that has 2 medical device accessories that are used in combination. A theoretical example could be a ventilator (main device) that connect to a tube (MD accessory 1) which is connected to a mouthpiece (MD accessory 2). In borh the US and EU, both accessories would be considered medical device accessories to the main device. Now here comes the twist. There is an adaptor which allows connecting the tube to different types of mouthpieces. The adaptor is made available and sold on its own, seperately from the main device and the MD accessories. Is this adaptor a medical device accessory in the US and EU? My own analysis is that:: - EU: not a medical device accessory. The definition of a medical device accessory clearly say that 'it is intended by its manufacturer to be used together with one or several particular medical device(s)'. Since the adaptor is intended to be used with two accessories (and not medical devices), it does not qualify as a medical device accessory. It is an accessory of an accessory. - US: the definition of accessory is broader than in the EU. Both accessories and medical device are considered "finished devices" and since an MD accessory is intended to be used with one or more 'parent device' (which is defined as 'finished devices') my conclusion is that, in the US, the adaptor is a medical device accessory because it support the performance of the tube/mouthpiece.

[@MedicalDeviceAcademy]

The challenge with "accessories" is that the regulations are based on what the manufacturer intends for the use of the device and what the device is labeled for--not what users might use the device for "off-label." If the manufacturer of the adapter is intended to be used independently of other devices, then it is a medical device and not an accessory. However, the word "adapter" suggests that the device cannot be used alone and is intended by the manufacturer to be used with two other devices as an adapter (e.g., connection between tube and mouthpiece). Therefore, it cannot be used alone, and it was not intended to be used alone. However, the regulations do not make a distinction between an accessory and an accessory to an accessory. It is an accessory or it is a medical device. In this case, both the EU and US regulators would consider this an accessory device. The adapter could also be integrated into the tube, or the adapter could be integrated into a mask, and it would still be an accessory. The regulatory pathway would depend entirely on the indications for use. An adapter that is intended for use with a ventilator might be regulated differently from an adapter for an oxygen mask. However, the part might be identical in design for both applications. We see this a lot in the case of electrical cables. Unfortunately, in these borderline classifications, the regulator is not always consistent. We have seen bridge software used as an accessory between two other accessory software devices treated as an accessory device by one member state and treated as a non-device by another member state. In these cases, the competent authorities are supposed to yield to the recommendations for the MDCG. In the case of the FDA, the determination is typically made by submitting a 513(g).

[@stefanodeluca2700]

How does FDA revise your SBOM? Does it check an electronic file or do they need a paper copy?

[@MedicalDeviceAcademy]

The FDA eSTAR help indicates that they prefer machine readable version, but I have seen both. The FDA also references a guidance on SBOMs.

[@Jslotau8]

Hi Rob, thank you for making a video on this topic! Can you please describe in more detail the process of getting a medical device FDA cleared if the device is a new accessory (has no utility on its own) that augments a currently 510(k) cleared class II device made by a different company? Thank you!

[@MedicalDeviceAcademy]

Great question, but to understand this I will use an accessory. For example, a monopolar electrocautery device is a device. The holster that the pen would be placed in is an accessory. There is no separate product code that was created for the accessory, but you can get 510(k) clearance for just the holster. You can find a predicate submission that is just a holster or you can use a submission for pen with a holster. In the first case it is straightforward. In the second case, you need to clarify that you are only submitting a 510(k) for the holster and claiming equivalence to the holster--not the pen. Therefore the indications will probably be different from what the predicate has if the predicate is the device and the accessory. It doesn't matter if the accessory is for a competitor product or not, but you will need to show compatibility testing OR you can provide specifications for what devices it can work with.

[@arunasharma9432]

So, it might be a stupid question but just to have a clear understanding of the definition what would band-aid and glue used in band-aid be considered?

[@MedicalDeviceAcademy]

Band-aid is a brand name for a wound dressing (i.e., product classification code FRO). There are many variations on the market, but typically they are sterile, have an absorbent pad for wound exudate, and they have an adhesive to ensure that the dressing stays in place. It is essential the combination of tape and gauze into one product. Topical adhesives are typically cyanoacrylate adhesives that can be used to approximate tissue for a laceration. Adhesives can also be used internally for lacerations of the liver, spleen, etc. Typically, topical adhesives are used with sutures.

[@mayankkapoor217]

HEY ROB..CAN YOU HELP ME WITH THE CLASSIFICATION OF TENS ELECTRODE.. WHETHER TENS ELECTRODE USED IS AN ACCESSORY OR A PART TO THE TENS UNIT MACHINE?

[@MedicalDeviceAcademy]

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

[@MedicalDeviceAcademy]

You're making work hard. I had to actually look this up. GZJ and NUH are the most common product codes used for a TENS device. IPF and NGX are a couple of other codes commonly used. Usually companies include the electrode with the controller and software as a system under the primary code. However, there are electrodes that are separately cleared via a 510(k). GXY is for cutaneous electrodes. I have also seen people include cables that act as an connection between the controller and the electrode. Cables are 510(k) exempt under the IKD product code. There is also a 3-page FDA guidance on cables and electrode wires: www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/electrosurgical-devices-and-application-performance-standard-electrode-lead-wires-and-patient-cables

[@mayankkapoor217]

Thanks and your hard work is much appreciated brother!

[@luisenriqueramirezrojas241]

Rob, this is in the spirit of MDR definition for accessories, so it might be a little different from FDA. MDR defines accessory as "an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s)". I am struggling with the "not a medical device itself". For example, let's think of a IV pump with a dedicated admin set. The pump simply is useless without the admin set and vice versa. In this case, is the whole system the medical device or is the admin set an accessory to the pump? Or, on the other hand, can you say that the pump and admin set are, each one on their own, medical devices even when they do not function unless you use them together? Sorry for the long question.

[@MedicalDeviceAcademy]

That's definitely an advanced question that might be beyond the knowledge level of most people, but I'm happy to answer it. In the EU, the IV pump and the admin set are both medical devices and not accessories. In the USA, we use the word "accessory" more casually and we say that something is an accessory to a device. In the EU the IV pump is a drug delivery device (i.e., Rule 12, Class IIb), and the admin set is also a device, but the intended use is "as channels in active drug delivery system" (i.e., Rule 2, Class IIa). Both of these are clearly identified as examples in the MDCG Guidance 2021-24. health.ec.europa.eu/system/files/2021-10/mdcg_2021-24_en_0.pdf If your company was developing both as a system, you would apply for CE Marking of the system. However, you can also apply for CE Marking of either device individually, and the device can be intended for use with another device. It may not be functional without the other device, but it does not meet the definition of an accessory in the MDR. An example of an accessory in the MDCG Guidance is "a suture organiser." A foot pedal switch used in an OR to turn on an off a device would be an accessory in the MDCG guidance as well. In the realm of software, the answer may be more confusing. In this case you should refer to the infographic provided in MDCG guidances for "Is your software a medical device?" (i.e., MDSW)