(126 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of the dressing, with no mention of AI or ML.
Yes.
The device is indicated for use in treating various wounds such as abrasions, lacerations, cuts, burns, diabetic foot ulcers, leg ulcers, pressure ulcers, donor sites, and traumatic and surgical wounds, which are all conditions that require therapeutic intervention for healing. Additionally, it helps maintain a moist environment for optimal wound healing and provides an effective barrier to bacterial penetration.
No
This device is a wound dressing designed to protect wounds, absorb exudate, and provide an antimicrobial barrier for healing. It does not perform any diagnostic functions.
No
The device description clearly states it is a physical wound dressing made of Calcium Alginate containing Silver, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The description clearly states that this is a "primary wound dressing" applied directly to the wound. It interacts with wound exudate (fluid from the wound) to form a gel and release silver ions.
- Intended Use: The intended use is for treating various types of wounds (abrasions, cuts, burns, ulcers, etc.) by providing a barrier to bacterial penetration and maintaining a moist healing environment. This is a therapeutic application, not a diagnostic one.
- Lack of diagnostic elements: There is no mention of analyzing samples from the body, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, this device falls under the category of a wound care dressing, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:
- abrasions
- minor lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a healthcare professional, Algicelle Ag (Calcium Algiante Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as:
- diabetic foot ulcer
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology
- pressure ulcers/sores (partial and full thickness)
- donor sites, and traumatic and surgical wounds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Calcium Alginate Dressing with Antimicrobial Silver is a primary wound dressing made of Calcium Alginate containing 1.4% Silver. In the presence of wound exudate, the sodium ions from the exudates take the place of the silver ions, releasing the silver ions. As wound exudate is absorbed, the alginate forms a gel, which assist in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions released in the presence of wound fluid protect the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration.
The Sciences Derma Calcium Alginate Dressing with Antimicrobial Silver are sterile, single-use wound care dressings for use in moist wound management. This dressing is offered in several sizes including the following: 2"X2". 4.25"X4.25",4"X5",4"X8",8"X12".
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
Over-the-counter use; under the supervision of a healthcare professional
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)
Antimicrobial testing performed to demonstrate successful inhibition of bacteria, yeast and mold at the 7th day (ASTM E2549-01). Cytotoxicity, Sensitization, Skin Irritation Study, Intracutaneous Study, Systemic Toxicity Study and Muscle Implantation study were performed successfully using the Desma Sciences Calcium Alginate Dressing with Antimicrobial Silver.
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
N/A
0
510(k) Summary
JUN 2 7 2008
for
Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver
COMPANY NAME AND ADDRESS: Derma Sciences Canada Inc. 104 Shorting Road
Toronto, Ontario MIS 3S4 Canada
Contact Person: Sharmini Atheray Derma Sciences Canada Inc. 104 Shorting Road Toronto, Ontario MIS 3S4 Telephone:416-299-4003 x245 Facsimile:416-299-4912
ಗಳ DEVICE NAME:
Proprietary Name:
Common/Usual Name: Classification Name:
Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver Wound dressing Dressing
3. PREDICATE DEVICES:
Calcium Alginate Dressing with Antimicrobial Silver (K052536)
DEVICE DESCRIPTION: র্বা
Calcium Alginate Dressing with Antimicrobial Silver is a primary wound dressing made of Calcium Alginate containing 1.4% Silver. In the presence of wound exudate, the sodium ions from the exudates take the place of the silver ions, releasing the silver ions. As wound exudate is absorbed, the alginate forms a gel, which assist in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions released in the presence of wound fluid protect the dressing from bacterial colonisation, and provides an effective barrier to bacterial penetration.
1
The Sciences Derma Calcium Alginate Dressing with Antimicrobial Silver are sterile, single-use wound care dressings for use in moist wound management. This dressing is offered in several sizes including the following: 2"X2". 4.25"X4.25",4"X5",4"X8",8"X12".
5. INTENDED USE:
For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:
- abrasions ﻴﻦ
- minor lacerations ー
-
- minor cuts
- minor scalds and burns **
Under the supervision of a healthcare professional, Algicelle Ag (Calcium Algiante Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as:
- � diabetic foot ulcer
- � leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology
- � pressure ulcers/sores (partial and full thickness)
- donor sites, and traumatic and surgical wounds. �
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver is essentially identical to the device that has been cleared under 510(k) 052536.
Both these devices contain 1.4% silver which is delivered via a sophisticated ionic transfer technology. The net effect is a controlled and sustained release of antimicrobial silver that is effective against infectious pathogens.
Both the dressings are intended as an effective barrier to bacterial penetration for moderate to heavily exudating wounds such as diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology), pressure ulcers, sores (partial and full thickness), donor sites and traumatic and surgical wounds.
12080497151
7/7
2
10080459151 The following modifications have been made to the originally cleared 510k and instructions for use modified accordingly.
- Include over-the- counter use claim in addition to the prescription claim.
- Increase the duration of use of the dressing from 5 days to 7 days.
PERFORMANCE TESTING
testing performed Antimicrobial to demonstrate successful inhibition of bacteria, yeast and mold at the 7th day (ASTM E2549-01). Cytotoxicity, Sensitization, Skin Irritation Study, Intracutaneous Study, Systemic Toxicity Study and Muscle Implantation study were performed successfully using the Desma Sciences Calcium Alginate Dressing with Antimicrobial Silver.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dorma Sciences Canada, Inc. % Sharmini Atheray Corporate Director QA/RA 214 Carnegie Center, Suite 100 Princeton, New Jersey 08540
JUN 27 2008
Re: K080497
Trade/Device Name: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver Regulatory Class: Unclassified Product Code: FRO Dated: June 18, 2008 Received: June 20, 2008
Dear Sharmini Atheray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Sharmini Atheray
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
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FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
Indications for Use
510(k) Number (if known): K080497
Device Name: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver
Indications for Use:
For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:
- abrasions
- minor lacerations
- minor cuts
- minor scalds and burns
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K080487
111
6
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.S. Food and Drug Administr
D RADIOLOG
FDA Home Page | CDRH Home Page |-Search | CDRH A-Z Index | Contact CDRH
Indications for Use
510(k) Number (if known): K080497
Device Name: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver
Indications for Use:
Under the supervision of a health care professional. Algicell Ag (Calcium Alginate Dressing with Antimicrobial Silver) is an effective barrier to bacterial penetration in moderate to heavily exuding wounds such as:
- diabetic foot ulcer
- leg ulcers (venous stasis ulcers, arterial ulcers and leg -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------ulcers of mixed etiology)
- pressure ulcers/sores (partial and full thickness)
- donor sites, and traumatic and surgical wounds
Presoription Use 194 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)