(156 days)
No
The 510(k) summary describes a wound dressing and does not mention any AI or ML components or functionalities.
No
The description states that the dressing functions as a barrier to bacterial penetration and may help reduce infection in various types of wounds, which describes a preventative or supportive function rather than a direct therapeutic treatment of disease or injury.
No
Explanation: The device is a wound dressing designed to act as a barrier to bacterial penetration and absorb exudate from wounds. Its description and intended use focus on treatment and protection, not on diagnosing a condition.
No
The device description clearly identifies the device as a physical dressing made of calcium alginate fabric with a coating, formatted in various sizes and packaged in pouches. There is no mention of software as the primary component or function.
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 to wounds to act as a bacterial barrier and absorb exudate. 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 physical dressing material, not a reagent, instrument, or kit used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Acticoat® Calcium Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.
Product codes
KMF
Device Description
The Acticoat® Calcium Alginate Dressing is a highly absorbent non-woven calcium alginate fabric with an Acticoat® coating applied directly to its surface. It has a light grey appearance. Formatted in various sizes (5cm x 5cm, 10cm x 12.5cm, 15cm x 15cm, and a 2.5cm x 30cm rope) and packaged in Tyvek pouches.
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
The biocompatability of Acticoat® Calcium Alginate Dressing has been demonstrated in The blocomparabliny of Actional in vitro and in vivo testing has demonstrated accordance with 100 roover ristics of Acticoat® Calcium Alginate Dressing are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K000051 Acticoat® Foam Dressing, K983210 Algisite M Calcium Alginate Dressing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Westaim Biomedical Acticoat® Calcium Alginate Dressing Premarket Notification
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Acticoat® Calcium Alginate Dressing, which is substantially equivalent to previously marketed devices intended for wound care.
| Submitted by: | Westaim Biomedical, Inc.
One Hampton Road, Suite 320
Exeter, NH 03833 |
|--------------------|---------------------------------------------------------------------------------|
| Contact Person: | Steven Chartier |
| Date prepared: | September 15, 2000 |
| Classification: | A final classification for wound/burn dressings has not been
implemented. |
| Trade Name: | Acticoat® Calcium Alginate Dressing |
| Common Name: | Alginate Dressing |
| Predicate Devices: | K000051 Acticoat® Foam Dressing
K983210 Algisite M Calcium Alginate Dressing |
Indication for Use:
The Acticoat® Calcium Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic wounds. Acticoat® dressings may be used over debrided and partial thickness wounds.
Description:
The Acticoat® Calcium Alginate Dressing is a highly absorbent non-woven calcium alginate fabric with an Acticoat® coating applied directly to its surface. It has a light grey appearance. Formatted in various sizes (5cm x 5cm, 10cm x 12.5cm, 15cm x 15cm, and a 2.5cm x 30cm rope) and packaged in Tyvek pouches.
1
As with other Acticoat® dressings, the Alginate dressing is an effective physical and As with other Actional "uressings, the Alginate aresearly of the climity of the climit full thickness wounds.
Testing:
The biocompatability of Acticoat® Calcium Alginate Dressing has been demonstrated in The blocomparabliny of Actional in vitro and in vivo testing has demonstrated accordance with 100 roover ristics of Acticoat® Calcium Alginate Dressing are substantially equivalent to the predicate devices.
Summary of Substantial Equivalence:
The Acticoat® Calcium Alginate Dressing consists of a non-woven calcium alginate The Actional Oalchum Alginato Broosany of the Algisite M Calcium Alginate Dressing dressing, which is substantially oqurvated with nanocrystalline silver in a manner predicate device. This dressing nation of Foam Dressing predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2001
Mr. Steve Chartier Manager, Regulatory and Clinical Affairs Westaim Biomedical, Inc. One Hampton Road, Suite 320 Exeter, New Hampshire 03833
Re: K002896
Trade Name: Acticoat® Calicium Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: December 22, 2000 Received: December 22, 2000
Dear Mr. Chartier:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to use sutted in 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 Cosment for (110). I The general controls provisions of the Act include requirements for provisions or ation, 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 (1 remarket i fprovial), was device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the rurent 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 sation. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does rodern regions for gour 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) Finstitution will and in you've began 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 11 you desire specific and for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and Compliance at (301) 59 m 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 nothroution (21 OF Croom 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 vours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ATTACHMENT 7
Westalm Biomedical Acticoat® Calcium Alginate Dressing Premarket Notification
510(k) Number (if known): K002896
Calicium Alginate Device Name:____ Acticoat
Indications For Use:
The Acticoat Calcium Alginate Dressing is an effective barrier The barrier functions of the dressing to bacterial penetration. may help reduce infection in moderate to heavily exudative partial and full thickness wounds including decubitus ulcers, diabetic ulcers, venous stasis ulcers, surgical and traumatic Acticoat dressings may be used over debrided and wounds. partial thickness wounds.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K002896