SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC

K051256 · Noble Fiber Technologies, Inc. · ISH · Jul 21, 2005 · Physical Medicine

Device Facts

• Record ID: K051256
• Device Name: SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
• Applicant: Noble Fiber Technologies, Inc.
• Product Code: ISH · Physical Medicine
• Decision Date: Jul 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3420
• Device Class: Class 1

Indications for Use

SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.

Device Story

SILVERSEAL® Orthotic Components are knitted stockinettes designed for external skin contact when used with orthotic devices like cervical collars or braces. Fabric composition consists of 90% cotton or polyester and 10% X-Static® (nylon fiber substrate coated with 1.5% silver oxide). The silver oxide layer provides an antimicrobial barrier to protect the skin from microbial contamination. The device is intended for use in clinical or home settings as part of an orthotic application.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 standards, including sensitization and acute intracutaneous reactivity, confirmed the device is safe for its intended use.

Technological Characteristics

Knitted stockinette fabric; 90% cotton or polyester, 10% X-Static® (nylon fiber substrate with 1.5% silver oxide). Antimicrobial barrier function via metallic silver. Biocompatibility tested per ISO 10993.

Indications for Use

Indicated for use as a component on orthotic devices, such as cervical collars or braces, to provide an antimicrobial barrier to the skin.

Regulatory Classification

Identification

An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.

Predicate Devices

• SILVERSEAL® Tubular Cast Component with X-Static® (K043526)

Submission Summary (Full Text)

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K05/256 1/2

Noble Fiber Technologies, Inc.

510 (k) Premarket Notification Silverseal® Orthotic Components with X-Static® June 17, 2005

9. 510(k) SUMMARY

Summary Information 9.1 9.1.1 Submitter's Name and Address

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

JUL 2 1 2005

Contact Person and telephone number:

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

Date Summary was Prepared

June 17, 2005

9.1.2 Name of Device

| Trade Name: | SILVERSEAL® Orthotic Component With X-Static® |
|----------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Limb Orthosis Stockinette<br>Orthotic Applicance Stockinette<br>Cervical Collar Stockinette |
| Classification Name: | ISH |

- 9.1.3 Identification of predicate device to which substantial equivalence is being claimed
SILVERSEAL™ Orthotic Component with X-Static® is substantially equivalent to SILVERSEAL® Tubular Cast Component with X-Static® (K043526, Noble Fiber Technologies, Inc.), with respect to the function, intended use and composition of the knitted stockinette.

9.1.4 Device Description

Explanation of how the device functions: SILVERSEAL® Orthotic Components with X-Static® are designed to externally contact the skin.

Basic scientific concepts that form the basis for the device: The surface of the nylon fibers in SILVERSEAL® Orthotic Component with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection against microbial contamination.

Significant physical and performance characteristics of the device such as device design, materials used, and physical SILVERSEAL® Orthotic Components with X-Static® are properties: made of flexible, non-adherent fabric consisting of a knitted or made or in fabric which is 90% cotton or polyester, and 10% of a

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Kc 51212
2/2

Noble Fiber Technologies, Inc.

continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.

9.1.5 Statement of the intended use of the device, including general 9.1.5 Stacement of conditions the device will mitigate and the patient population for which the device is intended

SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The parposes anal cises a knitted stockinette which is made of 90% component compareer, and 10% X-Static®, which is 1.5% silver The component provides the skin with an antimicrobial oxide. barrier.

- Statement of how the technological characteristics of the device 9.1.5.1 compare to those of the predicate device
The technological characteristics of the device, aids in the protection against microbial contamination of the skin that are substantially equivalent to the predicate devices cited.

## Assessment of Performance Data 9.2

SILVERSEAL® Orthotic Components with X-Static® were subjected to standard in Silverkomment of thousand more with the sensitization, and acute vivo blocompactibity. All tests were performed in accordance with Part-Inclacataleous reactivery - Standard Organization (ISO) Standard (Biological 10995 OF the Incelliables) by North American Science Associates, Inc. Evaluation of hearcar betroom of the Vitro studies and have not been (Namba) . Hil claime l setting. The studies indicated that SILVERSEAL® Orthotic Components with X-Static® are safe for their intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

JUL 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William F. McNally President Noble Fiber Technologies Incorporated 421 South State Street Clarks Summit, Pennsylvania 18411

Re: K051256

Trade/Device Name: Silverseal® Orthotic Components X-Static® Regulation Number: 21 CFR 890.3420 Regulation Name: External limb prosthetic component Regulatory Class: I Product Code: ISH Dated: May 12, 2005 Received: May 16, 2005

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 F. 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/industry/support/index.html.

Sincerely yours,

Ech

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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K051256

## Indications for Use

510(k) Number (if known):

Device Name:___SILVERSEAL® ORTHOTIC COMPONENTS X-STATIC®

Indications For Use:

SILVERSEAL® Orthotic Components with X-Static® are used as components on stuvunosias orthotic devices intended for medical purposes that can be worn as a various or anotic development component comprises a knitted stockinette which cerrical of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.

- : . . . .

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)

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of General Re-gative

ion of General, Reative
Neurological Devi. s

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