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What 'kind of medical device' is it
Medical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'.
Applications for inclusion of medical devices and IVD medical devices, in the ARTG are made for a kind of medical device. This allows low to medium risk devices to be grouped by defined characteristics under one ARTG entry rather than requiring each product to have its own separate entry in the ARTG.
Devices are taken to be of the same kind if they have the following characteristics:
- the same Sponsor
- the same Manufacturer
- the same Classification
- the same Global Medical Device Nomenclature System Code (GMDN code)
- for Class III, Class AIMD medical devices and Class 4 IVD medical devices (other than an immunohaematology reagent that is a Class 4 IVD medical device) the same unique product identifier (UPI)
Another characteristic that determines kind of medical device for Class III medical devices, AIMD and Class 4 IVD medical devices (other than an immunohaematology reagent that is a Class 4 IVD medical device) is the UPI given to the device by its manufacturer to uniquely identify individual devices and define the products sold (supplied) in the global marketplace.
A variant means a medical device, the design of which has been varied to accommodate different patient anatomical requirements (for example, relating to the shape, size, length, diameter or gauge of the device), if the variation does not change the intended purpose of the device.
Class III and Class AIMD devices can have one or more variants associated with a single Australian Register of Therapeutic Goods (ARTG) entry. This minimises the number of entries required in the ARTG, but still provides a sufficient level of identification of the products.
When applying for a Class III and Class AIMD device, the electronic application form provides a drop-down list of variants that are currently allowable.
Examples of the currently allowable variants are:
- Diameter (mm)
- Gauge (cm)
- Shape (of tip)
- Suture, no. of strands
- Volume (mL)
Angiography catheter curve styles
Angiography catheters are intended to inject contrast media into blood vessels of the cerebral, visceral, or peripheral vasculature for visualisation of the vascular system of a targeted area of the body. Patients undergoing this procedure vary greatly in the size and orientation of their vasculature. Angiography catheters are often supplied in a variety of different 'curve styles' to accommodate for this natural variation between patients.
Common catheter curve styles include:
- Internal Mammary
- Ventricular Pigtail
For the purposes of this example, the delivery system for each curve style is identical and each curve style of the device has the same intended purpose, which is to inject contrast media for the visualisation of the vascular system. Each device has similar physical construction and is manufactured using the same process.
It is therefore acceptable to consider the 'curve style' of the catheter a variant.
Provided the devices can be covered by the same UPI, and the classification and GMDN code do not change as a result of the curve style, only one entry in the ARTG would be required.
When entering variant details in the eBS application, the variant type would be 'Shape (of tip)', and the variant range would include: Amplatz, Femoral, Brachial, Internal Mammary, and Ventricular Pigtail.
Catheter delivery systems
Cardiovascular catheters are directed to the central circulatory system using a pre-positioned guidewire. As an example, two differing designs can be used to locate the catheter using the guidewire either:
- inserting the catheter over and encasing the entire guidewire within the catheter
- constructing the catheter such that only a relatively small portion of the distal end of the catheter is hollow to encase the guidewire, allowing the catheter to be located at the treatment site within the central circulatory system
The intended purpose of both catheters is the same, however, for each of the catheters there are differences in the:
- construction of the catheters
- some or all of the materials used
- physical construction
- clinical use
As a consequence, the risk profile presented by each of the devices is also different, and separate entries in the ARTG are required for each device.
Method of tissue fixation
Manufacturers of prosthetic heart valves fabricated from porcine or other animal tissue use a fixation process to stabilise and render the tissue non-viable as part of the manufacturing process.
In recent years, a number of changes to the manufacturing techniques and processes have been used to minimise calcification build up on the valve once implanted. Where a change to the process is implemented:
|the manufacturer has the change assessed and implemented as part of process refinement
|chooses not to change the product name
a new entry in the ARTG is not required.
Please note: the changed manufacturing process must be assessed and accepted by the TGA.
|the manufacturer has the change assessed and implemented
|adopts a new product name for valves produced using the new process, to differentiate the 'new' product from the 'old'
|a new entry in the ARTG is required as the UPI of the device has changed.
Sutures generally follow the model of describing different variants of sutures using a family name approach. The intended purpose of all types is to approximate the edges of an incision to assist in healing. They are also provided with:
- varying configurations
- with and without varying types of needles
- in different
- pack sizes
They may be supplied constructed using either:
- a single filament of suture material - monofilament
- multiple filaments of material - multifilament
Provided the sutures all carry the same family name, and the relevant variants are listed in the eBS application, it is acceptable to have a single ARTG entry to cover all products within the family.
Unique Product Identifier: LEXAN sutures
|0.7 mm - 4.0 mm
|Suture, no. of strands
|Suture, needle, physical attributes
|curved, straight, blunt, cutting
|1-10 sutures per pack
Adding new allowable variants
When assessing the application for a possible variant, a number of factors are considered when deciding whether a variant is acceptable for identifying a medical device for the purpose of entry onto the ARTG including:
- Are the devices the same classification?
- Do they have the same GMDN codes?
- Are the intended purposes of each of the devices the same?
- Do the devices operate or function in the same way?
- Are the physical design and construction the same or very similar?
- Are the devices made of the same material(s)?
- Are the risk profiles for each of the devices the same?
The intended purpose is determined from all sources of information that accompany the device. This includes information on the label, the Instructions for Use, and any other advertising information or product literature for the device. If there is evidence in the accompanying information to suggest that the intended purpose of a device is more specific than what has been nominated in the eBS application, the more specific intended purpose will be used for assessment purposes.
If you consider a device to have a characteristic that is not listed in the current allowable variants list but fits within the concept and definition of a variant, you are encouraged to contact the TGA via email at firstname.lastname@example.org.
You will need to provide a detailed written submission supporting inclusion of the variant type in the list of allowable variants, and provide supporting documentation such as labelling, Instructions for Use and advertising material.
Additions to the allowable variants list must be approved by the Delegate to the Secretary before they can be included as an allowable variant in the eBS application form.
|Description of change
|Medical Devices Branch