For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of: SILVERSEAL® Adhesive Strips with X-Static® are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

Device Description

SILVERSEAL® Adhesive Strips with X-Station 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 abainst microbial contamination. The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5 silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL: Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 silver oxide.

AI/ML Overview

This 510(k) premarket notification for the SILVERSEAL® Adhesive Strip with X-Static® does not include acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic device would.

Instead, the submission focuses on substantial equivalence to existing predicate devices. The performance data provided are biocompatibility tests, which are standard for medical devices that come into contact with the body.

Here's an breakdown based on the information provided, highlighting why some sections of your request cannot be fully addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this type of device (biocompatibility) are generally qualitative (e.g., "safe," "non-sensitizing") rather than quantitative performance metrics like sensitivity/specificity for a diagnostic device. The document states all tests were performed in accordance with ISO 10993 and indicated safety.

Feature / Test Category	Acceptance Criteria (Implied by ISO 10993)	Reported Device Performance
Biocompatibility	No cytotoxicity	Met (indicated safe)
	No sensitization	Met (indicated safe)
	No acute intracutaneous reactivity	Met (indicated safe)

Explanation of Device Performance:

Biocompatibility: The device was subjected to standard in vivo biocompatibility tests, including cytotoxicity, sensitization, and acute intracutaneous reactivity.
Results: All tests were performed in accordance with ISO 10993 (Biological Evaluation of Medical Devices) by Nittin American Science Associates, Inc. (NAMSA). The studies indicated that SILVERSEAL® Adhesive Strips with X-Station are safe for their intended use.
Microbial Contamination Protection (of dressing): The silver and silver oxide in the dressing provide "effective protection of the dressing against microbial contamination." This claim is based on "In Vitro studies" and has not been studied in a clinical setting. This is a functional claim for the dressing itself, not a direct patient outcome claim.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Biocompatibility): Not specified in the provided document. Biocompatibility tests usually involve animal models (in vivo) or cell cultures (in vitro), with a specific number of subjects/samples depending on the ISO 10993 part being followed. The document only mentions "standard in vivo biocompatibility tests."
Data Provenance: Not explicitly stated, but "Nittin American Science Associates, Inc. (NAMSA)" is a contract research organization (CRO) with a global presence, often performing tests in various locations.
Retrospective or Prospective: Biocompatibility tests are typically prospective studies performed specifically for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in this context. For biocompatibility testing, the "ground truth" is established by adherence to standardized protocols (ISO 10993) and established scientific methods, rather than expert consensus on complex diagnostic interpretations. The CRO (NAMSA) is implicitly qualified to perform these tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert image review or clinical outcome assessment in studies where human judgment is a primary input. Biocompatibility testing relies on objective, laboratory-based measurements and observations according to validated protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this device. These studies are typically performed for diagnostic imaging devices to evaluate how AI affects human reader performance.

6. If a Standalone Study Was Done

Yes, in essence. The biocompatibility studies described are "standalone" in the sense that they evaluate the device's inherent safety properties without human intervention in the loop. The "In Vitro studies" for microbial protection are also standalone algorithm/device performance, though the details are not provided.
"Algorithm only without human-in-the loop performance": This phrasing is more applicable to AI/software as a medical device. For a wound dressing, the "algorithm" is the physical/chemical properties of the dressing. Its performance (e.g., biocompatibility or antimicrobial action against the dressing itself) is assessed directly.

7. The Type of Ground Truth Used

Biocompatibility: The "ground truth" is established by standardized biological responses observed in validated in vivo and in vitro models, as defined by ISO 10993. This is based on established scientific principles regarding material interaction with biological systems.
Microbial Protection: The ground truth for the dressing's protection against microbial contamination is based on in vitro microbiological assays, which quantitatively measure microbial growth on the dressing material under controlled conditions. This is a form of laboratory-based evidence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical wound dressing, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this type of device.

In summary, the 510(k) submission for the SILVERSEAL® Adhesive Strip with X-Static® relies on demonstrating substantial equivalence to predicate devices and proving biocompatibility through standard in vivo tests. It also mentions in vitro studies for protection against microbial contamination of the dressing itself. The performance data presented are not in the context of diagnostic AI algorithms, so many of the requested categories (like sample size for test/training sets, expert ground truth, adjudication, or MRMC studies) are not directly applicable or available in the provided text.

Summary

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K050726

Noble Fiber Technologies, Inc.

510 (k) Premarket Notification rseal® Adher ive Strip with X-Static

DEC 5

mber 8, 2005

10. 510 (k) SUMMARY

Summary Information 10.1

10.1.1 Submitter's Name and Address

Noble Fiber Technology 300 Palm Street Scranton, PA 18505

Contact Person and telephone number:

William McNally Telephone: 877-978-2842 Telefax: 877-978-2842

Date Summary was Prepared

November 8, 2005

10.1.2 Name of Device

SILVERSEAL® SILVERAID™ with X-STATIC® OTC Name: Professional Trade Name: SILVERSEAL® Adhesive Strip with X-Static® Common Name: Silver-nylon adhesive strip Classification Name: Wound and burn dressing

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

SILVERSEAL® Adhesive Strip with X-Static® is a flexible, nonadherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to SILVERSEALE Contact Wound Dressing with X-Static# (K033587), Silverlon Adhesive Strips and Wound Contact Dressings (K023612, K981299, K023609), and Curad Silver Bandage (K032463) with respect to function, intended use, and composition.

10.1.4 Device Description

Explanation of how the device functions: SILVERSEAL® Adhesive Strips with X-Station 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 abainst microbial contamination.

basic scientific concepts that form the casis for the device: The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5

17 -

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050726

510 {k} Premarket Notification Silverseal® Adhesive Strip with X-Static

November 8, 2005

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® Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 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

For over-the-counter use, SILVERSEAL® Adhesive Strips are sterile dressings used in first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. For the professional wound care market, SILVERSEAL® Adhesive Strips are indicated for local 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: Adhesive Strips with X-Static® were subjected to standard in vivo biocompatibility tests including cytotoxicity, sensitimation, and acute intracutaneous reactivity. All tests were performed in accordance with Part-10993 o: the International Standard Organization ISC) Standard (Biological Evaluation of Medical Devices) by Nittin American Science Associates, Inc. (NAMSA). All claims are the result of In Vitre studies and have not been studied in a clinical setting. The studies indicated that SIDVERSEAL® Adhesive Strips with X-Station 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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 5 2005

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

Re: K050726

K050726
Trade/Device Name: SILVERSEAL® SILVERAID™, SILVERSEAL® Adhesive Strip
Trade/Device Name Mark Caris & Silver pylon adhesive strip. Wound and burn dre SILVERSEAL "SILVERTID", Silver-nylon adhesive strip, Wound and burn dressing
with X-Static®, Silver-nylon adhesive strip, Wound and burn dressing

Regulatory Class: Unclassified Product Code: FRO Dated: November 8, 2005 Received: November 9, 2005

Dear Ms. Davidson:

We have reviewed your Section 510(k) premarket notification of intent to market the devices in We have reviewed your Section 5 lv(x) premants. Included to the indications
referenced above and have determined the are destantelly equivalent (for the indications referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to the enactment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the of the Federal Food, Drug, commerce prior to May 28, 1976, the enactions with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance when when a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The and Cosmetic Act (Act) that do not require approval or a porchanters) provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the general vommal registration, listing of
general controls provisions of the Act include requirements for amisst misbrandi general controls provisions of the Act Include requirements and more and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), (1 If your devices are classified (see above) into entrols. Existing major regulations affecting your device
they may be subject to such additional controls. Existing major re they may be subject to such additional controls. Little 200 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Perts 800 to 898 can be found in the Code of Federal Regulations, This Ely may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA's issuance of a substantal education other requirements of the Act
that FDA has made a determination that your devices comply with other requiremen that FDA has made a defermination inal your derrees of the Federal agencies. You must
or any Federal statutes and regulations administered by other registration and listing or any Federal statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not be registration as set comply with all the Act's requirements, including, out manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); god in and it anticable, the eloc CFR Part 807); labeling (21 CFR Part 801); good manageming practicalle, the elcotronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, 1050 forth in the quality systems (QS) regulation (21 CFR Parts)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Patricia Davidson

This letter will allow you to begin marketing your devices as described in your Section 510(k)
The are and the more of a FD of aling of substantial equivalence of your device This letter will allow you to begin marketing your devices of your devices to a legally
premarket notification. The FDA finding of substantial equivalerice and this, permits premarket notification. The FDA finding of substantal oqur havine of your device and thus, permits your devices to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r in the support of the may on 1949 276 Also, please note the regulation If you desire specific advice for your device of our fabentify the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please not 97). You may o contact the Office of Compliance at (240) 276-0115. Pract 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may oftain "Misbranding by reference to premarket notification " (21CF A v art on the Division of Small
other general information on your responsibilities under the Act from the Divisio other general information on your responsibilities uncer as area mere (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) by Manufacturers, International and Consumer Assistance at its on free internet (4)
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Bouchet

Mark N. Melkerson 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

510(k) Number (if known):__K050726

Device Name:

SILVERSEAL® SILVERAID™ SILVERSEAL® Adhesive Strip with X-Static® Silver-nylon adhesive strip Wound and burn dressing

Indications For Use: For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® may be

used for: used for:

First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor
scalds and burns scalds and burns.

Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of:

SILVERSEAL» Adhesive Strips with X-Static? are sterile, non-adherent dressings intended for local management of patial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabrairen

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) Page 1 of 1

Claiborne Buell Bowman
(Division Sign Off)

and Neurological Devices

510(k) Number K056726

Regulation Number and Section

N/A