SILVERSEAL

K040019 · Noble Fiber Technologies · MGQ · Jul 23, 2004 · SU

Device Facts

• Record ID: K040019
• Device Name: SILVERSEAL
• Applicant: Noble Fiber Technologies
• Product Code: MGQ · SU
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

Device Story

X-Static® Silverseal™ Hydrogel Wound Dressing is a flexible, non-adherent primary wound dressing. It consists of a knitted nylon fiber substrate coated with a thin layer of metallic silver (approx. 1% silver oxide) and a water-based hydrogel. The dressing is applied directly to the wound site to manage exudate and provide an antimicrobial barrier. The nylon fabric structure allows for the passage of oxygen and fluids to and from the wound. The silver component protects the dressing itself from microbial contamination. It is intended for use by healthcare professionals or patients for various wound types. The device benefits patients by maintaining a moist wound environment while providing a protective barrier against microbes.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous, and acute reactivity) performed per ISO 10993. Antimicrobial claims supported by in vitro studies; no clinical data provided.

Technological Characteristics

Flexible, non-adherent, knitted nylon fiber substrate coated with metallic silver (approx. 1% silver oxide) and water-based hydrogel. Permeable to oxygen and fluids. Sterilized. No software or electronic components.

Indications for Use

Indicated for management of partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites, and debrided/grafted partial thickness wounds. Provides antimicrobial barrier.

Predicate Devices

• phytacare Alginate Hydrogel Wound Dressing (K980132)
• BurnFree Sterile Burn & Wound Dressing (K010583)
• Collatek Hydrogel Dressing (K022995)
• Woun'Dres Hydrogel Dressing (K991202)
• Nu-Gel Wound Dressing (K983362)
• DuoDerm Hydroactive Gel Dressing (K990368)
• Acryderm Silver Antimicrobial Wound Gel #A (K011994)
• Acticoat Composite Dressing (K002466)

Submission Summary (Full Text)

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**JUL 23 2004**

Noble Fiber Technologies, Inc.

510 (k) Premarket Notific X-Static® Silverseal™ Hydrogel Wound Dressing

July 12, 2004

# 10. 510 (k) SUMMARY

### 10.1 Summary Information

### 10.1.1 Submitter's Name and Address

Noble Fiber Technology, Inc. 421 South State Street Clarks Summit, PA 18411

Contact Person and telephone number:

William McNally, President Telephone: [phone] Telefax: 877-978-2842

Date Summary was Prepared

December 31, 2003

## 10.1.2 Name of Device

| Trade Name: | X-Static® SILVERSEAL™ Hydrogel<br>Wound Dressing |
|----------------------|--------------------------------------------------|
| Common Name: | Silver-nylon Hydrogel Wound<br>Dressing |
| Classification Name: | Hydrogel Wound Dressing |

# 10.1.3 Identification of predicate device to which substantial equivalence is being claimed

X-Static® SILVERSEAL™ Hydrogel Wound Dressing is a flexible, nonadherent, protective dressing consisting of hydrogel (waterbased), and nylon fibers with a metallic silver surface. *It is substantially equivalent to phytacare Alginate Hydrogel Wound Dressing (K980132, PhytaTek Laboratories, Inc.), BurnFree Sterile Burn & Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound Dressing, (K983362, Johnson & Johnson), DuoDerm Hydroactive Gel Dressing, (K990368, Convatec, Div. Of E.R. Squibb & Sons, Inc.), Acryderm Silver Antimicrobial Wound Gel #A, (K011994, Acrymed, Inc.), Acticoat Composite Dressing (K002466, Westaim Biomedical, Inc.)

## 10.1.4 Device Description

Explanation of how the device functions: X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination.

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KO\$\psi\$0019 page 2/2

Noble Fiber Technologies, Inc.

510 (k) Premarket Notification X-Static® Silverseal™ Hydrogel Wound Dressing

July 12, 2004

Basic scientific concepts that form the basis for the device: The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.

# 10.1.5 Statement of the intended use of the device, including general description of the conditions the device will mitigate and the patient population for which the device is intended

The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

## 10.1.6 Statement of how the technological characteristics of the device compare to those of the predicate device

The technological characteristics of the device, such as flexible primary Hydrogel Wound Dressing, permeability to oxygen and fluids, and protection against microbial contamination of the dressing that are substantially equivalent to the predicate devices cited.

## 10.2 Assessment of Performance Data

X-Static® SILVERSEAL™ Hydrogel Wound Dressings were subjected to standard tests including cytotoxicity, sensitization, intracutaneous and acute reactivity. All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). All antibiotic claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting. The studies indicated that X-Static® SILVERSEAL™ Hydrogel Wound Dressings are safe for their intended use.

Represents Confidential or Trade Secret Information and the protection afforded to such confidential information by 18 U.S.C. \$1905, 21 U.S.C. \$331 (j), 5 U.S.C. \$552, and other applicable laws is hereby claimed.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol of three parallel lines curving upwards, resembling a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Mr. William McNally President Noble Fiber Technology, Inc. 421 South State Street Clarks Summit, Pennsylvania 1841 I

Re: K040019

Trade/Device Name: X-Static® SilverSeal™ Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 15, 2004 Received: June 16, 2004

Dear Mr. McNally:

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, 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 (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 - Mr. William McNally

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,

Mark A. Mckenna

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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# Indications for Use

K040019 510(k) Number (if known):

Silverseal Hydrogel Dressing Device Name

Indications For Use: The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial indicated for ado on first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.

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)

Mark A. Millener

Division of General, Restorative, and Neurological Devices

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**510(k) Number** K040019