← Product Code MGQ · K970453 # B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING (K970453) _B.Braun Medical, Inc. · MGQ · Apr 11, 1997 · SU · SN_ **Canonical URL:** https://fda.innolitics.com/device/K970453 ## Device Facts - **Applicant:** B.Braun Medical, Inc. - **Product Code:** MGQ - **Decision Date:** Apr 11, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use The Transorbent and ThinSite Topical Border Wound Dressings are intended for use in the management of partial and full thickness wounds, Stage I - IV pressure ulcers, arterial and venous stasis leg ulcers, and to aid in the prevention of skin breakdown. They are also intended for use in post-surgical wounds, biopsy sites, minor abrasions and lacerations, suture sites, partial thickness and full thickness dermatological sites, laparoscopic incisional sites, and drainage tube sites. ## Device Story Multi-layered topical wound dressings; outer adhesive film border for skin anchorage; adhesive/fabric laminate for wound site bonding; hydrogel layer for exudate absorption and moisture vapor transfer; outer film (ThinSite) or film/foam (Transorbent) layer to regulate moisture loss. Used in clinical or home settings for wound management; applied by healthcare providers or patients. Dressing maintains moist wound environment; facilitates exudate management; protects wound site; aids healing. ## Clinical Evidence Bench testing only; biocompatibility testing performed and compared to predicate devices. ## Technological Characteristics Multi-layered composite dressing; laminar construction; includes skin adhesive, adhesive/fabric laminate, hydrogel layer, and outer film or film/foam backing. Biocompatibility tested. ## Predicate Devices - Transorbent Wound Dressing (Brady Medical Products) - ThinSite (Transorb Thin) Wound Dressing (Brady Medical Products) - B. F. Goodrich Biofilm Transorbent Ulcer and Wound Dressing (B. F. Goodrich) - Tegasorb™ THIN Hydrocolloid Dressing (3M Health Care) - Tegasorb™ Ulcer Dressing (3M Health Care) - Tegaderm™ HP Transparent Dressing (3M Health Care) - Duoderm Flexible Hydroactive Dressing (Convatec, Squibb Co.) - Duoderm Hydroactive Dressing and CGF Dressing (Convatec, Bristol-Myers Squibb Co.) - Duoderm CGF Border Dressings (Convatec, Bristol-Myers Squibb Co.) - Duoderm CGF Extra Thin (Convatec, Bristol-Myers Squibb Co.) - Nu-Derm Foam Island Dressings (Johnson and Johnson Medical, Inc.) - Band-Aid Brand Surgical Dressings (Johnson and Johnson Medical, Inc.) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970453 APR 11 1997 Page 1 of 2 Attachment I 510(k) Summary Transorbent and ThinSite Topical Border Wound Dressing 1. Submitted By: Brady Medical Products Co. 727 West Glendale Avenue Milwaukee, WI 53209 Contacts: Diane Hochrein Quality Assurance/Regulatory Affairs Manager Wallace Reams General Manager Phone: (414) 332-8100 FAX: (414) 961-6095 Date Prepared: November 14, 1994 2. Name of Device: Transorbent Topical Border Wound Dressing ThinSite Topical Border Wound Dressing Common/Usual Name: Wound Dressing Classification Name: Dressing, Wound and Burn, Hydrogel 3. Identification of predicate or legally marketed device or devices to which substantial equivalence claimed: a) Transorbent Wound Dressing Brady Medical Products b) ThinSite (Transorb Thin) Wound Dressing Brady Medical Products c) B. F. Goodrich Biofilm Transorbent Ulcer and Wound Dressing B. F. Goodrich d) Tegasorb™ THIN Hydrocolloid Dressing 3M Health Care e) Tegasorb™ Ulcer Dressing 3M Health Care f) Tegaderm™ HP Transparent Dressing 3M Health Care g) Duoderm Flexible Hydroactive Dressing Convatec, Squibb Co. h) Duoderm Hydroactive Dressing and CGF Dressing Convatec, Bristol-Myers Squibb Co. {1} K470453 page 2 of 2 Attachment I 510(k) Summary Transorbent and ThinSite Topical Border Wound Dressings (con't) Page 2 i) Duoderm CGF Border Dressings Convatec, Bristol-Myers Squibb Co. j) Duoderm CGF Extra Thin Convatec, Bristol-Myers Squibb Co. k) Nu-Derm Foam Island Dressings Johnson and Johnson Medical, Inc. l) Band-Aid Brand Surgical Dressings Johnson and Johnson Medical, Inc. 4. Description of Device: The Transorbent and ThinSite Topical Border Wound Dressings are a multi-layered construction. The dressings utilize these various layers to optimize their functional abilities. The outer border film with adhesive bonds the dressing to the contact skin, and maintains the dressing in position until removed. Then there is an adhesive/fabric laminate that bonds the dressing to the wound site. The next layer is a hydrogel layer which absorbs and transfers exudate away from the wound, and captures it to facilitate the transfer of moisture vapor away from the wound. An integral adhesive bonds this portion of the dressing to an outer film (ThinSite) or film/foam (Transorbent) layer, which prevents excess loss of moisture at the wound site, while assisting in the transmission of moisture vapor from the dressing. 5. Intended use of the Device: The Transorbent and ThinSite Topical Border Wound Dressings are intended for use in the management of partial and full thickness wounds, Stage I - IV pressure ulcers, arterial and venous stasis leg ulcers, and to aid in the prevention of skin breakdown. They are also intended for use in post-surgical wounds, biopsy sites, minor abrasions and lacerations, suture sites, partial thickness and full thickness dermatological sites, laparoscopic incisional sites, and drainage tube sites. 6. The technological characteristics of this device are comparable to the aforementioned devices, in that they are all composite devices which employ a laminar construction. All employ a skin adhesive to provide anchorage to the dressing site. Further, the Transorbent and ThinSite Topical Border Wound Dressings have undergone biocompatibility testing, which Brady Medical Products knows is comparable to the B. F. Goodrich, Transorbent, and ThinSite products. This extensive testing has in all probability been undergone by the other indicated products. --- **Source:** [https://fda.innolitics.com/device/K970453](https://fda.innolitics.com/device/K970453) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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