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 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".

AI/ML Overview

The provided 510(k) summary for the Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver primarily focuses on demonstrating substantial equivalence to a predicate device and includes performance testing related to its antimicrobial properties and biocompatibility.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Antimicrobial Efficacy: Successful inhibition of bacteria, yeast, and mold at the 7th day (ASTM E2549-01)	Performed successfully
Biocompatibility: No adverse reactions in cytotoxicity, sensitization, skin irritation, intracutaneous, systemic toxicity, and muscle implantation studies	Performed successfully

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the antimicrobial efficacy or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or provided in the context of these types of performance tests for a wound dressing. Ground truth in this context would be defined by the outcome of the laboratory tests themselves (e.g., bacterial inhibition, cellular viability).

4. Adjudication method for the test set

Not applicable for these types of laboratory performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical dressing, not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a medical dressing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests would be established by the results of the standardized laboratory assays:

Antimicrobial Efficacy: Bacterial, yeast, and mold growth inhibition conforming to the standards of ASTM E2549-01.
Biocompatibility: Absence of toxic or irritating effects in the specified in vitro and in vivo models according to established biological evaluation standards.

8. The sample size for the training set

Not applicable. This document describes performance testing for a physical medical device (dressing), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's performance was validated through a series of laboratory tests:

Antimicrobial Testing: Antimicrobial testing was performed using ASTM E2549-01 to demonstrate successful inhibition of bacteria, yeast, and mold at the 7th day. The document states this was "performed successfully."
Biocompatibility Testing: A suite of biocompatibility studies including Cytotoxicity, Sensitization, Skin Irritation Study, Intracutaneous Study, Systemic Toxicity Study, and Muscle Implantation study were performed. These studies were also reported as having been "performed successfully" using the Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver.

The focus of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (Calcium Alginate Dressing with Antimicrobial Silver, K052536). The performance testing was conducted to address modifications to the previously cleared 510(k), specifically the inclusion of an over-the-counter use claim and an increase in the duration of use from 5 days to 7 days, necessitating the demonstration of sustained antimicrobial activity for the extended duration.

Summary

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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

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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 **

� 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

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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.

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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.

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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

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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

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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)

Regulation Number and Section

N/A