SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC

K063190 · Noble Fiber Technologies, Inc. · QSY · Aug 21, 2007 · SU

Device Facts

Record IDK063190
Device NameSILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
ApplicantNoble Fiber Technologies, Inc.
Product CodeQSY · SU
Decision DateAug 21, 2007
DecisionSESE
Submission TypeTraditional
Device ClassClass U
AttributesTherapeutic

Intended Use

Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.

Device Story

SILVERSEAL® Wound Packing Strips with X-Static® are flexible, non-adherent, sterile wound dressings composed of a knitted nylon fiber substrate coated with a thin layer of metallic silver (approx. 1.5% silver oxide). The device is used as a primary dressing to contact wounds directly. It functions by wicking fluids away from the wound site, cavity, or abscess to encourage drainage and by facilitating the removal of necrotic tissue when applied as a wet-to-dry packing. The silver coating provides antimicrobial protection for the dressing itself. The device is intended for use by healthcare professionals in clinical settings for managing bleeding and wound exudate.

Clinical Evidence

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

Technological Characteristics

Flexible, sterile, non-adherent knitted nylon fiber substrate coated with metallic silver (approx. 1.5% silver oxide). Permeable to oxygen and fluids. Biocompatibility testing conducted per ISO 10993.

Indications for Use

Indicated for patients requiring control of local wound bleeding or nasal hemorrhage, and for those requiring drainage of fluids from body cavities, infected areas, or abscesses, or removal of necrotic tissue from ulcers or infected wounds.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. June 11, 2023 Noble Fiber Technologies, Inc. c/o Patricia Davidson 300 Palm Street Scranton, Pennsylvania 18505 Re: K063190 Trade/Device Name: SILVERSEAL® Wound Packing Strips with X-Static® Regulatory Class: Unclassified Product Code: QSY, LYA Dear Patricia Davidson: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 21, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product codes QSY and LYA. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov. > Sincerely, Julie A. Morabito -S Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/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 stripes extending from its back, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. # Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 1 2007 Noble Fiber Technologies, Inc. % Ms. Patricia Davidson 300 Palm Street Scranton, Pennsylvania 18505 Re: K063190 Trade/Device Name: SILVERSEAL® Wound Packing Strips with X-Static® Regulatory Class: Unclassified Product Code: FRO Dated: July 27, 2007 Received: July 31, 2007 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 tnean 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. 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 {2}------------------------------------------------ Page 2 - Ms. Patricia Davidson marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may oltain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html . Sincerely yours, Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use KO63190 510(k) Number (if known): Device Name: SILVERSEAL® Wound Packing Strips with X-Static® # Indications For Use: Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing. Prescription Use XXX (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 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number 663190 {4}------------------------------------------------ October 17, 2006 | | | 10. 510(k) SUMMARY | K063190<br>Page 1 of 2 | |--------|---------------------------------------------------------------------|-------------------------------------------------------|------------------------| | 10.1 | Summary Information | | | | 10.1.1 | Submitter's Name and Address | | | | | Noble Fiber Technology<br>300 Palm Street<br>Scranton, PA 18505 | | AUG 21 2007 | | | Contact Person and telephone number: | | | | | William McNally<br>Telephone: 877-978-2842<br>Telefax: 877-978-2842 | | | | | Date Summary was Prepared | | | | | October 17, 2006 | | | | 10.1.2 | Name of Device | | | | | Trade Name: | SILVERSEAL® Wound Packing Strip<br>with X-Static® | | | | Common Name:<br>Classification Name: | Silver-nylon packing strip dressing<br>Wound dressing | | ### 10.1.3 Identification of predicate device to which substantial equivalence is being claimed FRO SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to Silverlon Wound Packing Strip (K984210), Dynarex Iodoform Packing Strip (K012816), Medline Wound Packing Strip (K052720) ; SILVERSEAL® Contact Wound Dressing with X-Static® (K033587) , Silverseal® Burn Dressing with X-Static (K050649), with respect to functional design, performance, and intended use as these presently distributed devices #### 10.1.4 Device Description Classification: Explanation of how the device functions: SILVERSEAL® Wound Packing Strip 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. {5}------------------------------------------------ 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 SILVERSEAL® Wound Packing Strip 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 design, materials used, and physical device such as SILVERSEAL® Wound Packing Strip with X-Static are properties: 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. ## 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 Silverseal® Wound Packing Strip with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing. ## 10.1.16 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. ત્વ #### 10.2 Assessment of Performance Data SILVERSEAL® Wound Packing Strip 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 (ISQ) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). The studies indicated that SILVERSEAL® Wound Packing Strip with X-Static® are safe for their intended use.
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%