MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450

K033732 · Medtrade Products , Ltd. · FRO · Dec 1, 2004 · SU

Device Facts

• Record ID: K033732
• Device Name: MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450
• Applicant: Medtrade Products , Ltd.
• Product Code: FRO · SU
• Decision Date: Dec 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites

Device Story

Antiseptic Barrier Silver Foam Dressing is an exudate-handling system for low-to-moderate exuding wounds. Device consists of a hydropolymer foam island with medical pressure-sensitive adhesive. During use, the absorbent island expands to manage exudate and maintain a moist wound environment. Antibacterial activity is provided by silver, demonstrated against Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli. Used in clinical settings under healthcare professional direction. Benefits include moisture management and antimicrobial barrier protection to support wound healing. Device is supplied sterile via gamma irradiation.

Clinical Evidence

Bench testing only. Laboratory testing demonstrated significant antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus, and Escherichia coli. Biocompatibility testing, including dermal sensitization, cytotoxicity, acute systemic toxicity, and hemocompatibility/hemolysis, was successfully completed per ISO/Tripartite guidelines.

Technological Characteristics

Hydropolymer foam island dressing with 100% medical pressure-sensitive adhesive coverage. Foam thickness 3±1mm; backing thickness 0.4mm ± 10%. Density 350-450 kgs/m3. Sterilized via gamma irradiation per ANSI/AAMI/ISO 11137 and AAMI TIR8.

Indications for Use

Indicated for patients with pressure ulcers, lower extremity ulcers (venous, arterial, mixed etiology), diabetic ulcers, and donor sites. Requires healthcare professional direction.

Predicate Devices

• MedTrade Products Self Adhesive Foam Island Dressings (K993627)

Reference Devices

• Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing (K990804)

Submission Summary (Full Text)

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## DEC - 1 2004

K033732 page 1/2

Safety & Effectiveness: MedTrade Products Antiseptic Barrier Silver Foam Dressing

Classification Name: 79 MGP, 878.4020 Dressing, Wound and Burn, Occlusive

Contact: Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs

Prepared: October 21, 2003

Description: MedTrade Product's Antiseptic Barrier Silver Foam Dressing is an exudate handling system intended for low to moderate exuding wounds. The antibacterial activity acting in the dressing is supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginose, Staphylococcus aureus & Escherichia coli. The island dressing maintains a moist wound environment, which is conducive to optimal wound healing. During use the absorbent island gently expands as it takes up exudate. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation

MedTrade Product's Antiseptic Barrier Silver Foam Dressing should be used under health care professional direction for the following indications: Pressure ulcers, Lower extremity uicers, Venous, Arterial, Mixed etlology, Diabetic ulcers, Donor sites.

Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation. 30 Edition (ANS/AAMI/SO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 7

Packaging will consist of a single dressing in either a paper / paper / poly pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.

Biocompatability testing including: Dermal Sensitization, Cytotoxicity, Acute Systemic Toxicity and HemocompatibilityHemolysis have been successfully completed per ISO/Tripartite guidelines.

The MedTrade Product's Antiseptic Barrier Silver Foam Dressings are similar in design, composition and function to MedTrade Products Self Adhesive Foam Island Dressings 510(k) #K993627. A table of comparative features may be found below.

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K033732 page 2/2

| Characteristics | MedTrade Product's<br>Self Adhesive Foam Island<br>Dressing | MedTrade Products<br>Antiseptic Barrier Silver<br>Foam Dressings |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Hydropolymer Foam Island<br>Dressing with medical<br>pressure-sensitive adhesive<br>coated on one side. | Hydropolymer Foam Island<br>Dressing with medical<br>pressure-sensitive adhesive<br>coated on one side. |
| Backing Foam | Thickness 0.4mm± 10%<br>Density 350-450 kgs/m3<br>Tensile Strength >1<br>kg./25mm width at 0.4mm<br>Elongation >200% at break | Thickness 0.4mm± 10%<br>Density 350-450 kgs/m3<br>Tensile Strength >1<br>kg./25mm width at 0.4mm<br>Elongation >200% at break |
| Foam Island | Thickness 3+1mm | Thickness 3+1mm |
| Adhesive Coverage | 100% | 100% |
| Colour | Light Skin Tone | Light Skin Tone |
| Indications For Use | MedTrade Product's<br>Foam Dressings should be<br>used under health care<br>professional direction for the<br>following indications:<br>Pressure ulcers<br>Lower extremity ulcers,<br>including:<br>1. Venous<br>2. Arterial<br>3. Mixed etlology<br>Diabetic ulcers<br>Donor sites | MedTrade Product's<br>Antiseptic Barrier Silver<br>Foam Dressings should be<br>used under health care<br>professional direction for the<br>following indications:<br>Pressure ulcers<br>Lower extremity ulcers,<br>including:<br>1. Venous<br>2. Arterial<br>3. Mixed etlology<br>Diabetic ulcers<br>Donor sites |
| Packaging | Printed Pouch | Printed Pouch |
| Sterilisation Method | Gamma Irradiation | Gamma Irradiation |

## COMPARATIVE FEATURES

Additionally, as with Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing K99080 AddRenally, as the macrer Moulea D Arglass AD Antiseptic Rooms Novel
(attached), MedTrade Products Antiseptic Barrier Silver Foam Dressing has been shown to be an
antibacteri

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 2004

Mr. Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs MedTrade Products Ltd Electra House Crewe Business Park, Crewe CW16GL United Kingdom

Re: K033732

K035732
Trade/Device Name: Antiseptic Barrier Silver Foam Dressings Regulatory Class: Unclassified Product Code: FRO Dated: November 1, 2004 Received: November 4, 2004

Dear Mr. Ranfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard actual date of the Medical Device Amendments, or to commerce print to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) that to not require appent of the general controls provisions of the Act. The r ou may, increrore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (tional controls. Existing major regulations affecting your device can may be subject to suen additional collisers, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase of actived that I Brinination that your device complies with other requirements of the Act that I Drinas Internations and regulations administered by other Federal agencies. You must or any I odelar statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the Fee orequirements (01); good manufacturing practice requirements as set CI K Fat 6077; adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and qtion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Jonathan Ranfield

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

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K0 33732

## Indications for Use

510(k) Number (if known):_ K033732

Device Name: MedTrade Product's Antiseptic Barrier Silver Foam Dressings

Indications For Use:

MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriame C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

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**510(k) Number** K633732