(91 days)
For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
SILVERSEAL® Burn Contact Wound Dressings 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® Contact Wound Dressings 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.
SILVERSEAL® Contact Wound Dressings are 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SILVERSEAL® Burn Glove with X-Static® and related dressings:
No acceptance criteria or study demonstrating performance against such criteria are explicitly provided in this 510(k) summary.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility.
Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does NOT explicitly state any acceptance criteria for device performance (e.g., specific percentages for infection reduction, healing rates, or other clinical outcomes).
Instead, the "performance" discussed is related to biocompatibility and protection against microbial contamination of the dressing itself.
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| N/A (No specific numerical acceptance criteria for clinical efficacy are provided.) | - Biocompatibility: Passed standard in vivo tests (cytotoxicity, sensitization, acute intracutaneous reactivity) in accordance with ISO 10993. - Protection Against Microbial Contamination (of the dressing): The silver content provides effective protection of the dressing against microbial contamination (based on in vitro studies). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set for Biocompatibility: The sample size for the in vivo biocompatibility tests (cytotoxicity, sensitization, acute intracutaneous reactivity) is not specified.
- Data Provenance: The biocompatibility tests were performed by North American Science Associates, Inc. (NAMSA), which is a common contract research organization for medical device testing. The country of origin for the data is implicitly the USA, where NAMSA operates. These tests are typically prospective in nature, conducted specifically for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
- For biocompatibility tests, "ground truth" is typically established by laboratory standards and protocols (e.g., observing for specific cellular reactions, skin reactions) rather than expert consensus on a clinical outcome.
- There is no mention of a human-centric "test set" requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable.
As there is no "test set" requiring human interpretation or clinical judgment in the traditional sense for efficacy or diagnostic performance, no adjudication method is mentioned. Biocompatibility results are typically objective measurements or observations against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done.
The document explicitly states: "All claims are the result of In Vitro studies and have not been studied in a clinical setting." This confirms that no clinical studies comparing the device's effectiveness, either with or without AI assistance, were performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not Applicable, and no such study was performed.
This is a medical dressing, not an algorithm or AI device. Therefore, the concept of "standalone algorithm performance" does not apply. The performance evaluation was focused on materials, biocompatibility, and antimicrobial properties of the dressing itself.
7. The Type of Ground Truth Used
- Biocompatibility: The "ground truth" for biocompatibility was established through performance against standardized laboratory protocols and observations for cytotoxicity, sensitization, and acute intracutaneous reactivity, as defined by ISO 10993.
- Antimicrobial properties (of the dressing): The "ground truth" for protection against microbial contamination of the dressing was established through in vitro studies, which involve lab-based testing of the material's ability to inhibit microbial growth.
8. The Sample Size for the Training Set
Not applicable.
This product is a medical dressing, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
As there is no AI algorithm or "training set," there is no ground truth established in this context.
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K050649 p. 1/2
10. 510(k) SUMMARY
10.1 Summary Information
- 10.1.1 Submitter's Name and Address
人 上一
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
March 9, 2005
10.1.2 Name of Device
Trade Name: SILVERSEAL® Burn Glove with X-Static® SILVERSEAL® Burn Wrap with X-Static® SILVERSEAL® Burn Contact Wound Dressing SILVERSEAL® Barrier Wound Contact Dressing With X-Static® Common Name: Silver-nylon contact wound dressing Classification Name: Contact wound dressing
10.1.3 Identification of predicate device to which substantial equivalence is being claimed
SILVERSEAL® Burn Contact Wound Dressing with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is substantially equivalent to SILVERSEAL Contact Wound Dressing with X-Static® (K033587), and Silverlon™ Contact Wound Dressing (K023612) with respect to function, intended use, and composition.
10.1.4 Device Description
Explanation of how the device functions: SILVERSEAL® Burn Contact Wound Dressings 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.
Basic scientific concepts that form the basis for the The nylon fabric permits the passage of oxygen and device:
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K050649 p.2/2
fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Contact Wound Dressings 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 such as device design, materials used, and physical properties: SILVERSEAL® Contact Wound Dressings are 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.
the intended use of the device, 10.1.5 Statement of 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® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the 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® Contact Wound Dressings 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 North American Science Associates, Inc. (NAMSA). All claims are the result of In Vitro studies and have not been studied in a clinical The studies indicated that SILVERSEAL® Contact Wound setting. Dressings with X-Static® 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 & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2005
し
Ms. Patricia Davidson Noble Fiber Technologies Incorporated 421 South State Street Clarks Summit, Pennsylvania 18411
Re: K050649
Trade/Device Name: SILVERSEAL® Burn Glove with X-Static®, SILVERSEAL® Burn Wrap with X-Static®, SILVERSEAL® Burn Contact Wound Dressing, SILVERSEAL® Barrier Wound Contact Dressing With X-Static® Regulatory Class: Unclassified
Product Code: FRO Dated: March 11, 2005 Received: March 14, 2005
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 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 – Ms. Patricia Davidson
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing of substantial equivalence of your device to a legally premarket notification. The I DA midning of basistan 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 If you desire specific advice ion your aconcerner of the same of the regulation entitled, and Colliact the Office of Compliance at (21 notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general Information on your responsions at its toll-free number (800) 638-204 or
Manufacturers, International and Consumer Assistance at its toll-free number (800) con Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
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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INDICATIONS FOR USE 1 .
Koso649
510(k) Number (if known):
Device Name:
SILVERSEAL® Burn Glove with X-Static® SILVERSEAL® Burn Wrap with X-Static® SILVERSEAL® Burn Contact Wound Dressing SILVERSEAL® Barrier Wound Contact Dressinq With X-Static®
Indications for Use:
For over-the-counter use, Silverseal® Wound Contact Dressing with Xror over gyobe used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
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)
(Division Sign-Off)
Division of Remedial Restoration
Division of General, Restorative
and Neurological Devices
50649
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