(199 days)
The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
X-Static® SILVERSEAL™ Hydrogel Wound Dressings 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 X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.
The provided text describes the X-Static® SILVERSEAL™ Hydrogel Wound Dressing, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets those criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.
The "Assessment of Performance Data" section primarily focuses on safety testing (cytotoxicity, sensitization, intracutaneous, and acute reactivity) performed in accordance with ISO 10993 standards. It explicitly states, "All antibiotic claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting." This means there is no clinical data presented to support performance related to antimicrobial efficacy on actual wounds or other clinical outcomes.
Therefore, I cannot fill out the requested table or answer the questions related to performance criteria, sample sizes for test/training sets, expert involvement, or AI-related metrics because this information is not present in the provided document.
The document discusses:
- Safety Assessments: The device underwent standard tests for cytotoxicity, sensitization, intracutaneous, and acute reactivity as per ISO 10993.
- Antimicrobial Claims Basis: Antimicrobial claims are based solely on in vitro studies, and the effect has not been studied in a clinical setting.
Without further information describing performance criteria and a study that assesses the device against those criteria (beyond basic safety), a complete answer to your request cannot be generated from the given text.
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JUL 23 2004
Noble Fiber Technologies, Inc.
510 (k) Premarket Notific X-Static® Silverseal™ Hydrogel Wound Dressing
July 12, 2004
10. 510 (k) SUMMARY
10.1 Summary Information
10.1.1 Submitter's Name and Address
Noble Fiber Technology, Inc. 421 South State Street Clarks Summit, PA 18411
Contact Person and telephone number:
William McNally, President Telephone: 877-978-2842 Telefax: 877-978-2842
Date Summary was Prepared
December 31, 2003
10.1.2 Name of Device
| Trade Name: | X-Static® SILVERSEAL™ HydrogelWound Dressing |
|---|---|
| Common Name: | Silver-nylon Hydrogel WoundDressing |
| Classification Name: | Hydrogel Wound Dressing |
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
X-Static® SILVERSEAL™ Hydrogel Wound Dressing is a flexible, nonadherent, protective dressing consisting of hydrogel (waterbased), and nylon fibers with a metallic silver surface. *It is substantially equivalent to phytacare Alginate Hydrogel Wound Dressing (K980132, PhytaTek Laboratories, Inc.), BurnFree Sterile Burn & Wound Dressing (K010583, Ambu, Inc.), Collatek Hydrogel Dressing (K022995, BioCare Medical Technology, Inc.), Woun'Dres Hydrogel Dressing (K991202, Coloplast Corp.), Nu-Gel Wound Dressing, (K983362, Johnson & Johnson), DuoDerm Hydroactive Gel Dressing, (K990368, Convatec, Div. Of E.R. Squibb & Sons, Inc.), Acryderm Silver Antimicrobial Wound Gel #A, (K011994, Acrymed, Inc.), Acticoat Composite Dressing (K002466, Westaim Biomedical, Inc.)
10.1.4 Device Description
Explanation of how the device functions: X-Static® SILVERSEAL™ Hydrogel Wound Dressings 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.
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KO$\psi$0019 page 2/2
Noble Fiber Technologies, Inc.
510 (k) Premarket Notification X-Static® Silverseal™ Hydrogel Wound Dressing
July 12, 2004
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 X-Static® SILVERSEAL™ Hydrogel Wound Dressing 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: X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% 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
The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
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 Hydrogel 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
X-Static® SILVERSEAL™ Hydrogel Wound Dressings were subjected to standard tests including cytotoxicity, sensitization, intracutaneous and acute 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 antibiotic claims are the result of In Vitro studies and that the effect of the antibiotic has not been studied in a clinical setting. The studies indicated that X-Static® SILVERSEAL™ Hydrogel Wound Dressings are safe for their intended use.
Represents Confidential or Trade Secret Information and the protection afforded to such confidential information by 18 U.S.C. $1905, 21 U.S.C. $331 (j), 5 U.S.C. $552, and other applicable laws is hereby claimed.
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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 & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three parallel lines curving upwards, resembling a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Mr. William McNally President Noble Fiber Technology, Inc. 421 South State Street Clarks Summit, Pennsylvania 1841 I
Re: K040019
Trade/Device Name: X-Static® SilverSeal™ Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: June 15, 2004 Received: June 16, 2004
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 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mckenna
Celia M. Witten, Ph.D., M.D. 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
K040019 510(k) Number (if known):
Silverseal Hydrogel Dressing Device Name
Indications For Use: The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial indicated for ado on first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
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)
Mark A. Millener
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K040019
N/A