(79 days)
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.
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.
The provided text does not contain information on acceptance criteria for a medical device or a study proving that a device meets such criteria. The document is a 510(k) Summary for Transorbent and ThinSite Topical Border Wound Dressing, focusing on device description, predicate devices, and intended use for regulatory clearance. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Information about a multi-reader, multi-case (MRMC) comparative effectiveness study, or effect sizes of human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document mentions "biocompatibility testing" but provides no details about the acceptance criteria for this testing, the study design, or the results.
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Attachment I
510(k) Summary Transorbent and ThinSite Topical Border Wound Dressing
- Brady Medical Products Co. 1. Submitted By: 727 West Glendale Avenue Milwaukee, WI 53209
- Diane Hochrein Contacts: Quality Assurance/Regulatory Affairs Manager
Wallace Reams General Manager
FAX: (414) 961-6095 (414) 332-8100 Phone:
Date Prepared: November 14, 1994
- Transorbent Topical Border Wound Name of Device: 2. Dressing ThinSite Topical Border Wound Dressing Common/Usual Name: Wound Dressing Dressing, Wound and Burn, Hydrogel Classification Name:
- Identification of predicate or legally marketed device or 3. devices to which substantial equivalence claimed:
- Transorbent Wound Dressing a) Brady Medical Products
- ThinSite (Transorb Thin) Wound Dressing b) Brady Medical Products
- B. F. Goodrich Biofilm C) Transorbent Ulcer and Wound Dressing B. F. Goodrich
- Tegasorb™ THIN Hydrocolloid Dressing d) 3M Health Care
- Tegasorb™ Ulcer Dressing e ) 3M Health Care
- Tegaderm™ HP Transparent Dressing E) 3M Health Care
- Duoderm Flexible Hydroactive Dressing ਕੇ ) Convatec, Squibb Co.
- Duoderm Hydroactive Dressing and CGF Dressing h) Convatec, Bristol-Myers Squibb Co.
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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.
- Duoderm CGF Extra Thin j) Convatec, Bristol-Myers Squibb Co.
- Nu-Derm Foam Island Dressings k) Johnson and Johnson Medical, Inc.
- Band-Aid Brand Surgical Dressings 1) Johnson and Johnson Medical, Inc.
- Description of Device: The Transorbent and ThinSite Topical 4 . 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.
- Intended use of the Device: The Transorbent and ThinSite 5. 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.
- The technological characteristics of this device are 6. 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.
N/A