(184 days)
Not Found
No
The device description and performance studies focus on the physical and antimicrobial properties of a silver-coated wound dressing, with no mention of AI or ML.
Yes
The device is intended to reduce infection of wounds, acting as an effective barrier to bacterial penetration. It also functions similarly to untreated gauze-based dressings in terms of absorptivity and moisture content. These are characteristics of a therapeutic device designed to treat or alleviate a condition.
No
The device is a wound dressing designed to act as a barrier to bacterial penetration and reduce infection, not to diagnose a condition or disease.
No
The device description clearly states it is a 3-ply gauze wound dressing with physical components (rayon/polyester core, silver coated polyethylene mesh). It is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use as a barrier to bacterial penetration and to reduce infection of wounds. This is a therapeutic and protective function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a wound dressing with a silver coating. This is a physical device applied externally.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Acticoat™ silver coated dressing is a 3-ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver coated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Acticoat™ silver coated dressing was subjected to the following performance testing:
- Silver dissolution .
- Absorbtivity and moisture content .
- Abrasion resistance and adhesion .
- Tensile strength .
- . Biocompatibility studies (including skin irritation, sensitization ( and cytotoxicity)
- . Silver ion exposure levels
- In vitro and in vivo studies of antimicrobial activity ◆
- Shelf life testing .
In all instances, the Acticoat™ silver coated dressing functioned as intended. These test results demonstrated that the Acticoat™ silver coated dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
K925453
31 ms
ATTACHMENT 9
510(k) SUMMARY FOR WEST SIM TECHNOLOGIES, INC.' ACTICOAT™ SILVER COATED DRESSIN
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Westaim Technołogies Inc. 10101 - 114 Street Fort Saskatchewan, Alberta T8L 3W4 CANADA
Phone: (403) 992-5380 Facsimile: (403) 992-5325
Contact Person: Robert Burrell, Ph.D. Phone: (403) 992-5380 Facsimile: (403) 992-5325
Jonathan S. Kahan, Esq. Regulatory Counsel for Westaim Technologies Inc. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
and the comments of
Date Prepared: November 7, 1995
Name of Device and Name/Address of Sponsor
Acticoat™ silver coated dressing
Sponsor
Westaim Technologies Inc. 10101 - 114 Street Fort Saskatchewan, Alberta T8L 3W4 CANADA
Phone: (403) 992-5380 Facsimile: (403) 992-5325
1
Robert Burrell, Ph.D. Contact Person: Phone: (403) 992-5380 Facsimile: (403) 992-5325
Common or Usual Name
Silver coated dressing
Classification Name
Wound and burn dressing
Predicate Devices
The Company's Acticoat™ silver coated dressing covered by this submission is substantially equivalent to other legally marketed burn and wound dressings. Specifically, Acticoat™ silver coated dressing is substantially equivalent to Vitaphore Corporation's Silver Foam Dressing (K914579).
Intended Use
Acticoat™ silver coated dressing is intended for use as an effective barrier to bacterial penetration and as a method to reduce infection of partial and full thickness wounds.
Technological Characteristics and Substantial Equivalence
Description of the Acticoat™ Silver Coated Dressing A.
Acticoat™ silver coated dressing is a 3-ply gauze wound dressing consisting of an absorbent rayon/polyester core and an upper and lower layer of silver coated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat™ silver coated dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content, abrasion resistance and adhesion, and tensile strength.
2
K95545:
Substantial Equivalence of the Acticoat™ Silver Coated Dressing B.
The predicate device also provides the same or similar functions, characteristics, and accessories as described above for the Acticoat™ silver coated dressing. Both dressings have the same intended use and are recommended for the same indications (e.g., ulcers, first and second degree burns, trauma wounds, surgical wounds, abrasion, lacerations, and donor
sites). sites).
Like the Acticoar™ dressing, the predicate Vitaphore dressing consists of an absorbent material, and the dressing releases silver ions into and around the wound site when activated by moisture. Both products are provided sterile to the user, and both have an sentimierobial effect. Additionally, both dressings are non-toxic, non-irritating, and non-irritating, and non-Similar to the Acticoat™ device, the predicate Vitaphore dressing is gas permeable and has a soft. pliable, cushioning texture.
Both the Acticoat™ dressing and its predicate are effective over similar periods of time (i.e., between dressing changes). Additionally, both wound dressing devices are secured to the wound site via traditional dressing methods such as tape, gauze, are elastic bandage. The predicate Vitaphore dressing, like the Acticoat™ dressing, also has been shown to have low adhesivity to the wound site.
Although there are some differences between the Acticoat™ product and its predicate Vitaphore Silver Foam Wound Dressing, bese differences are minor and its
new questions of safety or effectiveness . Fijm the and its and its new questions of safety or effectiveness. First, the predicate Vitaphore dressing is described as a 1-ply dressing with a silver-outaining collagen-derived gel, whereas the Acticoar™ dressing is a 3-ply dressing whose upper and lower layers of mesh are coated with a silver Additionally, the labeling for the prodicate Vitaphore dressing suggests that the film. that more frequent changes are necessers during than 24 hours, but also indicates that more frequent changes are necessary during the initial wound healing stages and that the frequency of dressing changes should be determined by a medical practitioner. On the other hand, the Acticat™ dressing is recommended to be replaced at least once every 24 hours. The predicate Vitaphore dressing also is sterilized with an ethylene oxide ("EtO)" process. while the Actical™ dressing is sterilized using gamma radiation. However, these few differences in technological characteristics between the Acticoae™ dressing and its predicate device are minor and do not present any new issues of safety or effectiveness.
: --
3
Performance Data
The Acticoat™ silver coated dressing was subjected to the following performance testing:
- Silver dissolution .
- Absorbtivity and moisture content .
- Abrasion resistance and adhesion .
- Tensile strength .
- . Biocompatibility studies (including skin irritation, sensitization ( and cytotoxicity)
- . Silver ion exposure levels
- In vitro and in vivo studies of antimicrobial activity ◆
- Shelf life testing .
In all instances, the Acticoat™ silver coated dressing functioned as intended. These test results demonstrated that the Acticoat™ silver coated dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate device.