Question:

1) Is touth brush medical device? If so, does it complied with Biocompatibility requirements?
2) Is paper cup we used at home or at hospital for drining water medical device? If so, does it complied with Biocompatibility requirements?

This is a rather bizarre post. :confused:


Toothbrushes, toothpaste, household soap, toothpicks, hairbrushes etc are not typically considered to be medical devices.
For toothbrushes I can't be sure that is the case in every country in the world, but it would be my guess.

As for biocompatibility, any product needs to be safe for use. If that means you need to demonstrate the product is biocompatible, well, that's what you need to do. Note that that wouldn't necessarily mean you would have to do additional testing.


Paper cup? Doesn't sound like a medical device. Look in ISO13485 for the definitions of a medical device.

Typically, MDD etc. defines medical device as instrument, etc. intended for diagnostic or therapeutic purposes. ISO 10993 is a good reference even if the item does not meet the definition of medical device. At least I hope my water glass meets it.

The OP seems to be rather silly until one re-reads the 13485 definition of a "medical device".

13485's definition should include something like "objects of types that are broadly used in common hygiene procedures and daily life activities by healthy individuals are only medical devices if they are specially adapted to meet a medical need, and/or they are prescribed by or at the direction of a physician."

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The following information on FDA website can answer the question if toothbrush is biocompatible or not.

[URL="http://www.fda.gov/cdrh/pdf2/K020776.pdf"]http://www.fda.gov/cdrh/pdf2/K020776.pdf (http://www.medicinenet.com/script/main/art.asp?articlekey=51647)

“The flment was determined to be biocomgatible using the methods recommended in IS0 10993 Biological Testing ofMedica1 and Dental Materials and Devices.

Summary:
The antimicrobial agent used is the DENTOSANB filament does not raise any new safety or
effectiveness concerns. The biocompatibility and effectiveness of the antibacterial agent was
tested using established scientific methods and test protocols. Therefore, the Medoral Hygienic
Toothbrush with DENTOSANB filaments is believed to be substantially equivalent to the
predicate devices.”

When I used to work for a large oral hygiene product supplier, looking after the technical aspects of such items a toothbrushes etc, the main emphasis was that the polymers were "food grade". The same would apply to your cup, a plastic butter container, PET pop bottle etc etc. However, there was a special case were I did some work on softness of bristles for a company supplying very very soft bristle brushes for oral care for people with cancer (I assume oral) - so in this case this may be going over the boundary. However, this was all a shed load of years ago.:2cents:

Heh. I finally bothered to look this up in the FDA classification database.

The answer is for toothbrushes is yes. Product Code EFW, Class I, GMP exempt, regulation = 872.6855. As always, patient contact materials are expected to conform to ISO 10993 per guidance memo G95-1 and other guidance info.

The answer for drinking cups is no, unless they're a DAAD (daily activity assist device) for a person with abnormal physical limitations, in which case they're Product Code ILC, Class I, GMP exempt, regulation = 890.5050.

In addition to above Powered toothbrush is classified in FDA Sec. 872.6865

Powered toothbrush.

(a)Identification. A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 872.9.

Thanks and Regards
S. Subramaniam

Question:

1) Is touth brush medical device? If so, does it complied with Biocompatibility requirements?
2) Is paper cup we used at home or at hospital for drining water medical device? If so, does it complied with Biocompatibility requirements?

Hi

If you look the definition in European Medical device guidance document (Definition of "medical devices”, Definition of "accessory", Definition of "manufacturer" (MEDDEV 2.1/1, 2004 point no 1.1 (d) page No 5), Tooth brush is not a medical device, it considered as a Medical toiletry purpose, find the definition below.

Medical - toiletry purpose

The definition of "medical device" should be understood to include products intended to be used principally for a medical use. Therefore products intended to have a toiletry or cosmetic purpose are not medical devices even though they may be used for prevention of a disease. Examples for products for which a medical purpose can normally not be established:

- tooth brushes, dental sticks, dental floss;

- baby diapers, hygiene tampons;

- contact lenses without corrective function intended to provide another colour to the eyes,

- bleaching products for teeth [needs to be further discussed with regard to products intended specifically for application by dentists]

- instruments for tattooing.

Examples for products, where depending on the circumstances, a medical purpose can be established :

- incontinence products.

Attached is MEDDEV 2.1/1, 2004

Regards
S. Subramaniam