X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING

K033900 · Noble Fiber Technologies · FRO · Jan 14, 2005 · SU

Device Facts

• Record ID: K033900
• Device Name: X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
• Applicant: Noble Fiber Technologies
• Product Code: FRO · SU
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

X-Static Silverseal Hydrocolloid Film and Island Dressings are indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.

Device Story

X-Static SILVERSEAL Hydrocolloid Film and Island Dressing is a primary wound dressing designed to contact the wound bed and permit fluid passage. The device consists of a colloid-film laminate combined with silver-plated nylon (containing ~1.5% elemental silver). The silver provides antimicrobial protection for the dressing itself. The nylon fabric allows oxygen and fluid exchange. The device is intended for clinical use on various wound types. It functions as a physical barrier and antimicrobial dressing to protect the wound environment.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation).

Technological Characteristics

Colloid-film laminate with silver-plated nylon (nylon fiber coated with ~1.5% elemental silver). Dimensions: 4" x 4" OD with 2.5" x 2.0" square silver-colloid pad. Permeable to oxygen and fluids. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for patients with partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure, diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.

Predicate Devices

• Arglaes Film Dressing (K990810)
• Acticoat™ 7 Dressing (K001519)
• Tegapore™ Hydrocolloid Dressing (K982893)
• Hydrocolloid & Intelligent Hydrocolloid Wound Dressing (K983303)
• Contreet Hydrocolloid Dressing (K013525)

Submission Summary (Full Text)

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JAN 1 4 2005

# KO33900

January 7, 2005

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## 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 5, 2003, Revised January 6, 2005

#### 10.1.2 Name of Device

X-Static® SILVERSEAL™ Hydrocolloid Trade Name: Film and Island Dressing Silver-nylon Hydrocolloid Film and Common Name: Island Dressing Hydrocolloid Film and Island Classification Name: Dressing

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

X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings are substantially equivalent in function and intended use to the following cleared Hydrocolloid Film and Island Dressings: Arglaes Film Dressing (K990810, Maersk Medical, Ltd.), Acticoat™ 7 Dressing (K001519, Westaim Technologies, Inc.), Tegapore™ Hydrocolloid Dressing (K982893, 3M Health Care), Hydrocolloid & Intelligent Hydrocolloid Wound Dressing (K983303, Innovative Technologies, Limited), and Contreet Hydrocolloid Dressing (K013525, Coloplast Corporation).

#### 10.1.4 Device Description

Explanation of how the device functions: X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Laboratory antibacterial testing has demonstrated that the silver provides effective protection of the dressing against microbial contamination.

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®

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January 6, 2005

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SILVERSEAL™ Hydrocolloid Film and Island Dressing consists of a thin layer of metallic silver containing approximately 1.5% of 99% elemental silver 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 Physical Description: 4 % x 4 % OD with a 2.5" x properties: 2.0" square silver-colloid pad. The pad will consist of a colloid-film laminate, laminated to X-Static silver-plated nylon, number 90203.

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

X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.

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

The technological characteristics of the device are substantially equivalent to the technological characteristics as the predicate devices cited.

## 10.2 Assessment of Performance Data

X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings were subjected to standard tests including cytotoxicity, sensitization, acute intracutaneous reactivity, acute systemic toxicity, and tissue compatibility (muscle implantation study). All in vitro 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 claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

JAN 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Patricia Davidson Director of Legal Affairs Noble Fiber Technologies 421 S. State Street Clarks Summit, Pennsylvania 18411

Re: K033900

Trade/Device Name: X-Static Silverseal Hydrocolloid Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 11, 2004 Received: November 12, 2004

Dear Ms. Davidson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your betermined the device 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 encrosaly to regists of the Medical Device Amendments, or to conninered pror to 11ab 2016 11:12 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 I ou may, therefore, mains of 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 to such additional controls. Existing major regulations affecting your device can may or sations to back are are and 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 r lease be actived that I germination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any it cacal statuates and regirements, including, but not limited to: registration and listing (21 Comply with an the Hot of CFR Part 801); good manufacturing practice requirements as set CI IT at 6077, nuoning (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) 35001 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Ms. Patricia Davidson

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/industry/support/index.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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# Indications for Use

510(k) Number (if known): ____K033900

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use: X-Static Silverseal Hydrocolloid Film and Island Dressings mare indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, are indicated for. "partial antic), superficial wounds, abrasions, first and second degree burns, and donor sites.

Prescription Use X (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)

Miriam C. Provost

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

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510(k) Number_ Ko33900