(266 days)
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial effects of silver in a wound dressing, with no mention of AI or ML technologies.
Yes
The device is intended for the local management of various types of wounds, indicating a therapeutic purpose.
No
Explanation: The device is a wound dressing designed for local management of wounds, not for diagnosing any condition.
No
The device description clearly indicates it is a physical wound dressing made of nylon fabric with a metallic silver surface. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Contact Wound Dressing" for the "local management" of various types of wounds. This describes a device that is applied directly to the body for therapeutic purposes.
- Device Description: The description details a physical dressing made of fabric and silver, designed to be in contact with a wound. This aligns with a topical medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's condition. The function described is wound management and protection against microbial contamination of the dressing itself.
- Performance Studies: The performance studies focus on biocompatibility and in vitro studies related to the dressing's properties, not on diagnostic accuracy or the detection of biomarkers.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
X-Static SILVERSEAL Contact Wound Dressings 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
FRO
Device Description
X-Static SILVERSEAL Contact 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 Contact Wound Dressing consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static SILVERSEAL Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% 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
Not Found
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
X-Static SILVERSEAL 1-Layer and 4-Layer Contact Wound Dressings 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 setting. The studies indicated that X-Static SILVERSEAL 1 Layer and 4 Layer Contact Wound Dressings are safe for their intended use.
Key Metrics
Not Found
Predicate Device(s)
K970566, K955453, K981299, K023612, K023609, K984210, K890354
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
AUG = 5 2004
K033587 Page1
Noble Fiber Technologies, Inc.
510 (k) Premarket Notificat x-Static® Silversea1™ Contact Wound Dressing
July 30, 2004
10. 510(k) SUMMARY
Summary Information 10.1 Submitter's Name and Address 10.1.1
Noble Fiber Technology, Inc. 421 South State Street Clarks Summit, PA 18411
Contact Person and telephone number:
William McNally, President Telephonc: 877-978-2842 Telefax: 877-978-2842
Date Summary was Prepared
November 7, 2003; revised July 22, 2004
10.1.2 Name of Device
| Trade Name: | X-Static® SILVERSEAL™ Contact Wound Dressing (1 and 4 Layer) |
|---|---|
| Common Name: | Silver-nylon contact wound dressing |
| Classification Name: | Contact wound dressing |
Identification of predicate device to which substantial 10.1.3 equivalence is being claimed
X-Static® SILVERSEAL™ Contact Wound Dressings are substantially equivalent in function and intended use to the following cleared contact wound dressings: Arglaes Film Dressing (K970566), Acticoat Silver Coated Dressing (K955453), Silverlon Contact Wound Dressing (K981299) (K023612) (K023609) (K984210), and Tegapore Wound Contact Material (K890354).
Device Description 10.1.4
X-Static® SILVERSEAL™ Explanation of how the device functions: Contact 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.
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™ Contact Wound Dressing consists of a thin layer of metallic silver containing approximately 1% silver oxide that
1
K033587 page 2/2
Noble Fiber Technologies, Inc.
510 (k) Premarket Notification X-Static® Silverseal™ Contact Wound Dressing
July 30, 2004
provides effective protection of the dressing against microbial contamination.
Significant physical and performance characteristics of the physical device such as device design, materials used, and X-Static® SILVERSEAL™ Contact Wound Dressings are properties: made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 18 silver oxide.
Statement of the intended use of the device, including 10.1.5 general description of the conditions the device will mitigate and the patient population for which the device is intended
X-Static® SILVERSEAL™ Contact Wound Dressings are sterile, nonadherent 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).
Statement of how the technological characteristics of the device 10.1.6 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
X-Static® SILVERSEAL™ 1-Layer and 4-Layer Contact Wound Dressings 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 setting. "The studies indicated that X-Statio® SILVERSEAL™ 1 Layer and 4 Layer Contact Wound Dressings 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 & 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
AUG - 5 2004
Ms. Patricia Davidson Noble Fiber Technologies, Inc. 421 South State Street Clarks Summit, Pennsylvania 18411
Re: K033587
Trade/Device Name: Silverseal Contact Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 22, 2004 Received: July 23, 2004
Dear Ms. Davidson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) pressured is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 as stated in the encreate) to regars and ment date of the Medical Device Amendments, or to commerce processified in accordance with the provisions of the Federal Food, Drug, de necs that have been rout do not require approval of a premarket approval application (PMA). and Costine Act (71ct) that to nevice, subject to the general controls provisions of the Act. The r ou may, merelove, mains of the Act include requirements for annual registration, listing of general controll provision 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 may be subject to back address legulations, 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 r rease oe actived that i Drivination that your device complies with other requirements of the Act that I Dr Has made a statutes and regulations administered by other Federal agencies. You must or uny i vith all the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Fee 810 (21 CFR Part 801); good manufacturing practice requirements as set CI IN Fart 6077; adoning (21 CFR Part 820); and if applicable, the electronic forth in and quind) 25000 provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Patricia Davidson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in yours of substantial equivalence of your device to a legally prematicated predicated on: "The Pressification 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 spocific at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain Millsbraining of Yererence to pour responsibilities under the Act from the Division of Small other general 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,
Miriam C. Provost
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
4
Indications for Use
510(k) Number (if known):__K033587
Device Name:______SILVERSEAL CONTACT WOUND DRESSING
Indications For Use:
x-Static® SILVERSEAL™ Contact Wound Dressings are sterile, non-adherent A-acallow intended for local management of partial thickness burns, incisions, dressings incended for focal managams, 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)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number_ K033587
Page 1 of