SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC

K050649 · Noble Fiber Technologies, Inc. · FRO · Jun 13, 2005 · SU

Device Facts

• Record ID: K050649
• Device Name: SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
• Applicant: Noble Fiber Technologies, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns. Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

Device Story

Flexible, non-adherent, knitted nylon fabric dressing; surface coated with metallic silver containing ~1.5% silver oxide. Functions as primary wound contact dressing; permits passage of oxygen and fluids to/from wound. Silver provides antimicrobial protection to dressing. Used in clinical settings by healthcare professionals or at home by patients for first aid. Output is physical barrier/dressing; aids wound management by maintaining environment conducive to healing and preventing microbial contamination of dressing.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, including cytotoxicity, sensitization, and acute intracutaneous reactivity. No clinical data provided.

Technological Characteristics

Knitted continuous nylon fiber substrate; surface coated with metallic silver (~1.5% silver oxide). Flexible, non-adherent, permeable to oxygen and fluids. Sterile. No electronic components or software.

Indications for Use

Indicated for OTC use for first aid of minor abrasions, cuts, scrapes, scalds, and burns. Indicated for professional use for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).

Predicate Devices

• SILVERSEAL Contact Wound Dressing with X-Static (K033587)
• Silverlon™ Contact Wound Dressing (K023612)

Submission Summary (Full Text)

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# JUN 1 3 2005

K050649 p. 1/2

## 10. 510(k) SUMMARY

#### 10.1 Summary Information

- 10.1.1 Submitter's Name and Address
人 上一

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

March 9, 2005

#### 10.1.2 Name of Device

Trade Name: SILVERSEAL® Burn Glove with X-Static® SILVERSEAL® Burn Wrap with X-Static® SILVERSEAL® Burn Contact Wound Dressing SILVERSEAL® Barrier Wound Contact Dressing With X-Static® Common Name: Silver-nylon contact wound dressing Classification Name: Contact wound dressing

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

SILVERSEAL® Burn Contact Wound Dressing with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to SILVERSEAL Contact Wound Dressing with X-Static® (K033587), and Silverlon™ Contact Wound Dressing (K023612) with respect to function, intended use, and composition.

#### 10.1.4 Device Description

Explanation of how the device functions: SILVERSEAL® Burn Contact Wound Dressings with X-Static® 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.

Basic scientific concepts that form the basis for the The nylon fabric permits the passage of oxygen and device:

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K050649 p.2/2

fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Contact Wound Dressings with X-Static® 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: SILVERSEAL® Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.

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

For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

## 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 contact 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

SILVERSEAL® Contact Wound Dressings with X-Static® were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitization, and acute intracutaneous 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 claims are the result of In Vitro studies and have not been studied in a clinical The studies indicated that SILVERSEAL® Contact Wound setting. Dressings with X-Static® are safe for their intended use.

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Image /page/2/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 three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 3 2005

し

Ms. Patricia Davidson Noble Fiber Technologies Incorporated 421 South State Street Clarks Summit, Pennsylvania 18411

Re: K050649

Trade/Device Name: SILVERSEAL® Burn Glove with X-Static®, SILVERSEAL® Burn Wrap with X-Static®, SILVERSEAL® Burn Contact Wound Dressing, SILVERSEAL® Barrier Wound Contact Dressing With X-Static® Regulatory Class: Unclassified

Product Code: FRO Dated: March 11, 2005 Received: March 14, 2005

Dear Ms. Davidson:

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 – Ms. Patricia Davidson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing of substantial equivalence of your device to a legally premarket notification. The I DA midning of basistan 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 If you desire specific advice ion your aconcerner of the same of the regulation entitled, and Colliact the Office of Compliance at (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general Information on your responsions at its toll-free number (800) 638-204 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) con Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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 1 .

Koso649

510(k) Number (if known):

Device Name:

SILVERSEAL® Burn Glove with X-Static® SILVERSEAL® Burn Wrap with X-Static® SILVERSEAL® Burn Contact Wound Dressing SILVERSEAL® Barrier Wound Contact Dressinq With X-Static®

Indications for Use:

For over-the-counter use, Silverseal® Wound Contact Dressing with Xror over gyobe used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

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)

(Division Sign-Off)
Division of Remedial Restoration

Division of General, Restorative
and Neurological Devices

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