(41 days)
Not Found
No
The summary describes a passive wound dressing with a silver coating for antimicrobial barrier function. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The device acts as a barrier to reduce infection and manage wounds, which are supportive functions rather than direct therapeutic interventions to treat an underlying disease.
No
Explanation: The device, Acticoat® Composite Wound Dressing, is described as a barrier to bacterial penetration and a wound dressing. Its intended use is to help reduce infection in wounds and it acts as an antimicrobial barrier. It does not perform any diagnostic function such as identifying, analyzing, or determining the presence or nature of a disease or condition.
No
The device description clearly outlines a physical wound dressing made of multiple layers and materials, including silver-coated mesh. It is a tangible medical device, not software.
Based on the provided information, the Acticoat® Composite Wound Dressing is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to act as a barrier to bacterial penetration in various types of wounds. This is a therapeutic function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical dressing with a silver coating designed to be applied to a wound. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic measurements.
- Performance Studies: The performance studies focus on the physical and antimicrobial properties of the dressing itself (silver dissolution, absorptivity, tensile strength, biocompatibility, antimicrobial activity), not on the accuracy or reliability of a diagnostic test.
Therefore, the Acticoat® Composite Wound Dressing is a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.
Product codes (comma separated list FDA assigned to the subject device)
KMF
Device Description
Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated 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® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, 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® Composite Coated Dressing was subjected to the following performance tests:
- Silver dissolution ●
- Absorptivity and moisture content .
- Drop penetration and vapour transmission .
- Tensile strength
- Biocompatibility studies (including skin irritation, sensitization and . cytotoxicity)
- Silver ion exposure levels
- In vitro studies of antimicrobial activity .
In all instances, the Acticoat Composite Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices.
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.
K955453, Bioderm's Composite Wound Dressing, Conformant 28 Wound Dressing.
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
ATTACHMENT 8
510(K) SUMMARY FOR THE WESTAIM CORPORATION'S ACTICOAT® COMPOSITE WOUND DRESSING
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Westaim Biomedical Division The Westaim Corporation 10102 - 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 The Westaim Corporation Hogan & Hartson, L.L.P. 555 Thirteenth Street NW Washington, DC 20004-1109 Phone: (202) 637-5794 Facsimile: (202) 637-5910
Date Prepared: March 1, 1998
1
Name and Device and Name/Address of Sponsor
Acticoat® Composite Wound Dressing
Sponsor
Westaim Biomedical Division The Westaim Corporation 10102 - 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
Common or Usual Name
Composite wound dressing
Classification Name
Wound dressing
Predicate Devices
The Company's Acticoat® Composite Wound Dressing, covered by this submission, is substantially equivalent to other legally marketed wound dressings. Specifically, Actional Composite Wound Dressing is substantially equivalent The Westaim Corporation's Acticoat® Antimicrobial Barrier Dressing (K955453) and Bioderm's Composite Wound Dressing. The wound contact layer is also substantially equivalent to the Conformant 28 Wound Dressing.
WESTAIM
2
Intended Use
The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat dressings may be used over debrided and grafted partial thickness wounds
Technological Characteristics and Substantial Equivalence
Description of the Acticoat® Composite Wound Dressing A.
Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated 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® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, adhesion, and tensile strength.
Substantial Equivalence of the Acticoat® Composite Wound Dressing B.
The predicate devices also provide the same or similar functions, characteristics, and accessories as described above for the Acticoat® Composite Wound Dressing. The dressings have the same intended use and are recommended for the same indications (e.g., ulcers, trauma wounds, surgical wounds, abrasion, lacerations, and donor sites).
Like the subject composite wound dressing the Acticoat " Antimicrobial Barrier 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 antimicrobial effect. Additionally, both dressings are non-toxic, nonirritating, and non-sensitizing. Similar to the subject device, the silver coated dressing is gas permeable and has a soft, pliable, cushioning texture.
Both the subject dressing and its predicates are effective over similar periods of time (i.e., between dressing changes). Additionally, the dressings are secured to the wound site via traditional dressing methods such as tape, gauze, or elastic bandage. The predicate dressings, like the composite wound dressings, also have been shown to have low adhesivity to the wound site.
AWESTAIM
3
Although there are some differences between the Acticoat® Composite Wound Dressing and its predicates, these differences are minor and raise no new questions of safety or effectiveness. First, the Bioderm device is described as a similar 3-ply gauze bandage without the silver coating on the lower layer of HDPE. Similarly, the Acticoat® Antimicrobial Barrier Dressing is described as a device similar to the subject dressing but lacks the occlusive polyurethane film and is not as absorptive. The labelling for all of the devices indicate that the frequency of dressing changes should be determined, in part, by the amount of wound exudate and general condition of the predicate silver coated dressing is also sterilized by gamma irradiation as is the subject composite wound dressing. These few differences in technological characteristics between the Acticoat® Composite Wound Dressing and its predicate devices are minor and do not present any new issues of safety or effectiveness.
Performance Data
The Acticoat® Composite Coated Dressing was subjected to the following performance tests:
- Silver dissolution ●
- Absorptivity and moisture content .
- Drop penetration and vapour transmission .
- Tensile strength
- Biocompatibility studies (including skin irritation, sensitization and . cytotoxicity)
- Silver ion exposure levels
- In vitro studies of antimicrobial activity .
In all instances, the Acticoat Composite Wound Dressing is both effective for its intended use and functions in a substantially equivalent manner to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1998
Westaim Biomedical, Inc. c/o Jonathan S. Kahan Regulatory Counsel for The Westaim Corporation Hogan and Hartson L.L.P. 555 Thirteenth Street NW Washington, DC 20004
Re: K983833
Trade Name: Acticoat® Composite Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: October 30, 1998 Received: October 30, 1998
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate 2. of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of 4. wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
5
Page 2 - Mr. Jonathan S. Kahan
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
iK983833
HOGAN & HARTSON LL.P.
510(k) Number (if known): __ K983833
Device Name: Acticoat@ Composite Wound Dressing
Indications For Use:
The Acticoat@ Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter OR Prescription Use Use (Per 21 CFR 801.109) (Optional Format 1-2-96)