(79 days)
Not Found
Not Found
No
The description details a multi-layered wound dressing with passive absorption and moisture management properties, with no mention of computational analysis or algorithms.
Yes
The device is intended for use in the management of partial and full thickness wounds, ulcers, and to aid in the prevention of skin breakdown, which are therapeutic interventions.
No
The device is a wound dressing designed for the management and healing of various types of wounds, not for diagnosis.
No
The device description clearly outlines a multi-layered physical wound dressing with adhesive, hydrogel, and film/foam components, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a topical wound dressing for managing various types of wounds and preventing skin breakdown. This is a direct therapeutic application to the body surface.
- Device Description: The description details the physical construction and function of a multi-layered dressing designed to absorb exudate, maintain moisture balance, and adhere to the skin. This aligns with the characteristics of a wound dressing.
- Lack of IVD Characteristics: The text does not mention any of the key elements associated with IVDs, such as:
- Analyzing samples taken from the body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or analytical methods to perform tests.
Therefore, the Transorbent and ThinSite Topical Border Wound Dressings are classified as a medical device (specifically, a wound dressing), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
a) Brady Medical Products Transorbent Wound Dressing, b) Brady Medical Products ThinSite (Transorb Thin) Wound Dressing, C) B. F. Goodrich Transorbent Ulcer and Wound Dressing B. F. Goodrich, d) 3M Health Care Tegasorb™ THIN Hydrocolloid Dressing, e ) 3M Health Care Tegasorb™ Ulcer Dressing, E) 3M Health Care Tegaderm™ HP Transparent Dressing, ਕੇ ) Convatec, Squibb Co. Duoderm Flexible Hydroactive Dressing, h) Convatec, Bristol-Myers Squibb Co. Duoderm Hydroactive Dressing and CGF Dressing, i) Convatec, Bristol-Myers Squibb Co. Duoderm CGF Border Dressings, j) Convatec, Bristol-Myers Squibb Co. Duoderm CGF Extra Thin, k) Johnson and Johnson Medical, Inc. Nu-Derm Foam Island Dressings, l) Johnson and Johnson Medical, Inc. Band-Aid Brand Surgical Dressings
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 11 1997
Page 1 of 2
2 11:40
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.
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.
- 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.