← Product Code FRO · K080497 # DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) (K080497) _Derma Sciences Canada, Inc. · FRO · Jun 27, 2008 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K080497 ## Device Facts - **Applicant:** Derma Sciences Canada, Inc. - **Product Code:** FRO - **Decision Date:** Jun 27, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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. ## Device Story Primary wound dressing composed of calcium alginate containing 1.4% silver. Functions via ionic transfer; sodium ions from wound exudate replace silver ions, releasing silver into the wound environment. Alginate absorbs exudate to form a gel, maintaining a moist healing environment and allowing intact removal. Released silver ions provide an antimicrobial barrier against bacterial colonization and penetration. Used in clinical settings or home care; applied by healthcare professionals or patients. Dressing duration extended to 7 days. Benefits include moisture management and protection against bacterial infection in chronic and acute wounds. ## Clinical Evidence Bench testing only. Antimicrobial efficacy against bacteria, yeast, and mold demonstrated at 7 days per ASTM E2549-01. Biocompatibility testing included cytotoxicity, sensitization, skin irritation, intracutaneous study, systemic toxicity, and muscle implantation. ## Technological Characteristics Calcium alginate dressing containing 1.4% silver. Utilizes ionic transfer technology for controlled silver release. Sterile, single-use. Available in multiple sizes. Biocompatibility verified via standard toxicological testing. Antimicrobial performance validated per ASTM E2549-01. ## Predicate Devices - Calcium Alginate Dressing with Antimicrobial Silver ([K052536](/device/K052536.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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: 1. 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. 7. ## 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}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a stylized font, with the words "U.S. Food and Drug Administration" written out to the right of the letters. The text is in a sans-serif font and is white against a dark background. Image /page/5/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo includes the department's emblem on the left, which features a stylized caduceus. To the right of the emblem, the text "Department of Health and Human Services" is displayed in a clear, legible font. 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}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with outstretched wings on the left. To the right of the eagle is the text "Department of Health and Human Services" in a sans-serif font. The text is arranged in three lines, with "Department of" on the first line, "Health and" on the second line, and "Human Services" on the third line. .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) --- **Source:** [https://fda.innolitics.com/device/K080497](https://fda.innolitics.com/device/K080497) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com