The Clinicians Speak, page-812

I have just copied and pasted the linked post above ... all credit to @hottod



From what I can gather, it is effectively a trade name for the same temporary use product.

I don’t agree. Though there are obvious similarities, the following sections from the separate FDA approvals of Suprathel and SupraSDRM indicate that there are also multiple differences between the two products. Firstly, they differ in the devices to which they were found to be substantially equivalent. Also, SupaSDRM is substantially thicker and has larger pore sizes.

The section from the FDA approval of BTM shows that, while it shares some indications for use with Suprathel and is said to be made from a similar synthetic foam material, its thickness and porosity are substantially equivalent to Integra’s Bilayer Matrix Wound Dressing. As is PMI’s SupraSDRM.


Suprathel (FDA Approval, 2009)

EQUIVALENCE TO MARKETED PRODUCT

The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing shares indications and design principles with the following predicate devices which have been determined by-FDA to be substantially equivalent to pre-amendment devices: BioCore Medical Collatek Sheet (K012995), Biomet Merck Topkin Foil (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing (K982939), and Integra Life Sciences HeliDerm (K990086); Class II medical devices that were cleared for marketing in the United States under K012995, K031684, K031712, K031955, K061227, K062558, K982939, and K990086 respectively.

DEVICE DESCRIPTION

….The thickness of the PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing ranges from 50µm to 200µm according to the region to be treated. The PolyMedics Innovations (PMI) Suprathel Wound and Bum Dressing is provided-in solid sheets that contain micropores that range in size from 2µm to 50µm.

https://www.accessdata.fda.gov/cdrh_docs/pdf9/K090160.pdf



SupraSDRM (FDA Approval, 2017)

EQUIVALENCE TO MARKETED PRODUCT

The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing shares indications and design principles with the following predicate device and reference devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Suprathel Wound and Burn Dressing (K090160) predicate device and the Integra LifeSciences Bilayer Matrix Wound Dressing (K021792) reference device, and Progressive Woundcare Technologies Iodophor Foam Dressing (K122634) reference device; Unclassified medical devices that were cleared for marketing in the United States under K090160, K021792 and K122634 respectively.

DEVICE DESCRIPTION

….The thickness of the PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing ranges from 1,500µm to 2,100µm according to the region to be treated. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in solid sheets that contain micropores that range in size from 13µm to 300µm.

https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170213.pdf



Novosorb BTM (FDA Approval, 2015)

Comparison of Indications for Use:

BTM Wound dressing, shares indications for use principles with the predicate devices, Suprathel Wound and burn dressing (Suprathel) and Integra’s Bilayer Matrix Wound Dressing (Integra) as both are all indicated for use in partial and full thickness wound management. The proposed Indication for Use for BTM Wound dressing exactly matches that of the Integra predicate device.

Comparison of Design and Materials:

BTM Wound dressing is composed of a synthetic foam with a polyurethane sealing membrane, while the Integra predicate device is composed of collagen foam with a silicone sealing membrane. The Suprathel predicate device is comprised of polyester-carbonate which is a similar synthetic foam material as the BTM Wound dressing but without a sealing membrane. BTM Wound dressing contains a skin-facing layer that is designed to biodegrade in the wound which is substantially equivalent to both predicates. The average porosity of BTM Wound dressing was measured to be 188µm which is substantially equivalent to the Integra predicate device. Mechanical testing was performed on the BTM Wound dressing and showed improved tensile strength and elongation at break compared to Suprathel predicate device. In addition, BTM Wound dressing demonstrated superior cyclic testing robustness in comparison to Suprathel predicate device. The average thickness of BTM Wound dressing was measured to be approximately 2mm. The average thickness of Suprathel predicate device was measured to be approximately 160 μm and the thickness of the Integra predicate device is 2 mm, which is equivalent to that of the BTM Wound dressing.

https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142879.pdf