(342 days)
Not Found
No
The summary describes a physical wound dressing with antimicrobial properties and does not mention any computational or analytical functions that would involve AI or ML.
Yes
The device is described as an "effective barrier to bacterial and fungal penetration" to "help reduce infections in partial and full thickness wounds." This indicates its purpose is to treat or prevent a condition (infection) and promote healing, which aligns with the definition of a therapeutic device.
No
The device is described as an antimicrobial dressing for wound care, which acts as a barrier to prevent infections. Its function is therapeutic and protective, not to diagnose a condition or disease.
No
The device description clearly states it is a physical dressing made of high-density polyethylene mesh with silver, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a dressing applied directly to wounds to act as a barrier and reduce infection. This is a topical treatment applied to the body, not a test performed on samples taken from the body.
- Device Description: The description details a physical dressing with antimicrobial properties. It does not describe a reagent, instrument, or system used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or laboratory equipment
- Measuring analytes or biomarkers
The Acticoat® Primary Antimicrobial Dressing is a medical device intended for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal perfetration. The battler of the areasing may help reduce infections in ulcers, venous stasis ulcers, partial and Tull Thickness wounds informating "accuration" sites and surgical wounds. It may be used over grafted and partial thickness wounds.
Product codes
MGP
Device Description
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-Acticulate phinaly antimisrobial droosings of the sustained release of silver actively protects the wound site from bacterial and fungal1 contamination.
The dressing will be sold in a variety of sizes the size used will depend on the size of the size of the The dressing will be sold in a valiety in alle the largest will be a 4" x 48" roll.
How Supplied
2" x 2" (5cm x 5 cm)
4" x 4" (10 cm x 10 cm)
4" x 8" (10 cm x 20 cm)
8" x 16" (20 cm x 40 cm)
16" x 16" (40 cm x 40 cm)
4" x 48" (10 cm x 120 cm)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
N/A
0
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The sequence starts with the capital letter 'K', followed by the numbers '992221'. The numbers are written in a simple, slightly rounded style, and the entire sequence appears to be written with a dark pen or marker on a white background.
510K Summary of Safety and Efficacy ACTICOAT® Primary Antimicrobial Dressing
May 17, 2000
Westaim Biomedical, Inc Submitter 1. One Hampton Rd. Suite 302 Exeter, NH 03833
Steve Chartier Manager, Regulatory and Clinical Affairs (603) 775-7300
Device Name 2.
| Proprietary Name: | ACTICOAT® Primary Antimicrobial Dressing |
|---|---|
| Common Name: | Dressing |
| Classification Name: | Dressing |
| Regulatory Class: | Unclassified |
Intended Use 3.
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and The Acticoat® Frimary Antimiorobial Broomy 10 the dressing may help reduce infections in fungal perfetration. The battler of the areasing ulcers, venous stasis ulcers, partial and Tull Thickness wounds informating "accuration" sites and surgical wounds. It may be used over grafted and partial thickness wounds.
Device Description 4.
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-Acticulate phinaly antimisrobial droosings of the sustained release of silver actively protects the wound site from bacterial and fungal1 contamination.
The dressing will be sold in a variety of sizes the size used will depend on the size of the size of the The dressing will be sold in a valiety in alle the largest will be a 4" x 48" roll.
How Supplied
| 2" x 2" | (5cm x 5 cm) |
|---|---|
| 4" x 4" | (10 cm x 10 cm) |
| 4" x 8" | (10 cm x 20 cm) |
| 8" x 16" | (20 cm x 40 cm) |
| 16" x 16" | (40 cm x 40 cm) |
| 4" x 48" | (10 cm x 120 cm) |
1 based on in vitro testing. Data on file.
1
5. Predicate Device Comparison
Acticoat® Primary Antimicrobial Dressing is the identical skin contact layer that is used in the Acticoat® Composite dressing (K983883). The absorbent outer laver has been This configuration allows the user to choose an appropriate secondary omitted. dressing.
This product is also similar to N'Terface dressing distributed by Winfield Laboratories. (K820298 and K973538). Both products are manufactured from HDPE and intended for use as a primary dressing to minimize damage to the wound bed during dressing changes. The only difference between these two products is that the Acticoat® dressing has an antimicrobial coating.
The table below compares the features and characteristics of the ACTICOAT® Primary antimicrobial dressing to the predicate products.
Comparison of the ACTICOAT® Contact Layer Dressing to Predicate Products
| | Acticoat
Antimicrobial
Contact Layer
Dressing | Acticoat®
Composite
Dressing
(K983883) | Winfield Labs
N'Terface
(K820198 &
K973538) |
|---------------------------------|--------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------|
| INTENDED USE | | | |
| Wound Dressing | Yes | Yes | Yes |
| DESIGN | | | |
| HDPE Skin Contact
Layer | Yes | Yes | Yes |
| Absorbable | No | Yes | No |
| Antimicrobial silver
coating | YES | Yes | NO |
| MATERIALS | | | |
| | HDPE | HDPE &
Polyurethane
backing
Absorbent
material | HDPE |
6. Biocompatibilitv
biocompatibility of Acticoat® Primary Antimicrobial Dressing has been The demonstrated through appropriate in vivo and in vitro tests as well as previous tests on individual components.
Premarket Notification ACTICOAT® Primary Antimicrobial Dressing Westaim Biomedical Inc.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, with flowing lines above them, resembling a bird or a symbol of flight. The overall design is simple and conveys a sense of unity and progress.
Public Health Service
JUN - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Chartier Manager, Regulatory and Clinical Affairs Westaim Biomedical, Inc. One Hampton Road, Suite 302 Exeter, New Hampshire 03833
Re: K992221
Trade Name: ACTICOAT® Primary Antimicrobial Dressing Regulatory Class: Unclassified Product Code: MGP Dated: April 13, 2000 Received: April 14, 2000
Dear Mr. Chartier:
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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Mr. Steve Chartier
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,
Dmna R. Lochner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Device Name: ACTICOAT® Primary Antimicrobial Dressing K 992221
The Acticoat® silver coated contact layer dressing is an effective barrier to bacterial and fungal penetration. The barner function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasio unes, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor siten and surgical wounds. It may be used over debrided and grafted partial thickness wounds.
It has not been evaluated in third degree burns.
'based on invitro testing. Data on file.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona R. Lochner.
of General Restorative Devices 510(k) Number_K
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)