(262 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial effects of silver, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment.
Yes.
The device is a wound dressing designed to help manage partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and dermal ulcers, indicating it is intended to provide therapeutic benefit for these conditions.
No
The device, SILVERSEAL® Adhesive Strips, is described as a dressing for wound management and protection against microbial contamination. Its intended uses and device description focus on therapeutic or protective functions for injuries and burns, not on identifying, detecting, or monitoring diseases or conditions.
No
The device description clearly describes a physical dressing made of nylon fiber and silver, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns" and for "local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers". These are all applications directly on the body for wound care.
- Device Description: The description details a "sterile, non-adherent fabric" designed to "intimately contact the wound as a primary dressing". This is a physical dressing applied to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue. Its function is to cover and protect a wound on the body.
Therefore, the SILVERSEAL® Adhesive Strips with X-Static® are a wound dressing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
SILVERSEAL® Adhesive Strips 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. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static® consists of 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 1.5% silver oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For over-the-counter use; Under the supervision of a health care professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SILVERSEAL® Adhesive Strips 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 Nittin American Science Associates, Inc. (NAMSA). All claims are the result of In Vitro studies and have not been studied in a clinical setting. The studies indicated that SILVERSEAL® Adhesive Strips with X-Static® are safe for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K033587, K023612, K981299, K023609, K032463
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 -
1
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.
2
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.
3
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
4
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