(13 days)
No
The summary describes a wound dressing with antibacterial properties based on silver technology. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on material properties and antibacterial effectiveness.
Yes
The device is a wound dressing indicated for various types of wounds, including ulcers and burns, and provides an antibacterial barrier to inhibit bacterial growth, which are therapeutic functions aimed at healing and preventing infection.
No
The device description clearly states it is a "Wound Dressing" designed to inhibit bacterial growth and provide an antibacterial barrier, which are therapeutic functions, not diagnostic ones.
No
The device description clearly describes a physical wound dressing made of polyester and HDPE with silver coating, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The exsalt™ T7 Wound Dressing is a wound dressing applied directly to the surface of a wound. Its function is to provide an antibacterial barrier and inhibit bacterial growth in the dressing itself. It does not analyze samples taken from the body to provide diagnostic information.
- Intended Use: The intended use is for the management of various types of wounds, not for diagnosing a condition.
- Device Description: The description focuses on the physical composition of the dressing and the mechanism of action (silver inhibiting bacterial growth in the dressing). It does not describe any components or processes related to analyzing biological samples.
Therefore, the exsalt™ T7 Wound Dressing is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The exsalt™ T7 Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt™ T7 Wound Dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to 7 days.
Product codes
FRO
Device Description
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven polyester with gray Delnet® HDPE mesh layers thermally bonded on both sides. Silver in the exsalt™ T7 Wound Dressing inhibits bacterial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (4.5% w/w). The exsalt™ T7 Wound Dressing is known to be effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.
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
The following performance tests were conducted on the exsalt™ SD7 Wound Dressing: Silver Content, Moisture Content, pH, Absorbency, Anti-bacterial Effectiveness; against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii, Bactericidal Effectiveness, Biocompatibility, Biological Reactivity.
All performance characteristics of the exsalt™ T7 Wound Dressing are the same as the predicate(s). The exsalt™ T7 Wound Dressing raised no new safety concerns relative to biocompatibility. Testing performed on the exsalt™ SD7 Wound Dressing (K083870) showed that it was nontoxic, non-irritant, and did not elicit a sensitization response.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
DEC 1 5 2011
K113564 pag
Exciton Technologies Inc. exsalt™ T7 Wound Dressing
Special 510(k)
510(k) Summary for exsalt™ T7 Wound Dressing
1. Trade (Proprietary) Name
exsalt™ T7 Wound Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
Melanie Ussyk Contact: Quality Assurance Manager
- mussyk@excitontech.com Email: (780) 248-1281 Phone: Fax: (780) 248-5878
Address: Exciton Technologies Inc. Suite 4000-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
4. Device Classification & Panel
A final classification for wound/burn dressings has not been implemented; Class II has been proposed by the General & Plastic Surgery Devices Panel.
- Predicate Device(s)
exsalt™ SD7 Wound Dressing (K103067) exsalt™ SD7 Wound Dressing (K083870)
6. Device Description
Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven polyester with gray Delnet® HDPE mesh layers thermally bonded on both sides. Silver in the exsalt™ T7 Wound Dressing inhibits bacterial growth in the dressing. The concentration of the silver and oxidized silver
December, 2011
1
K113564 page 2/3
Exciton Technologies Inc. exsalt™ T7 Wound Dressing
Special 510(k)
species on the dressing is 0.4 mg/cm² (4.5% w/w). The exsalt™ T7 Wound Dressing is known to be effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.
7. Intended Use
exsalt™ T7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
8. Summary of Substantial Equivalence
The labeled indications and directions for use of the exsalt™ T7 Wound Dressing are equivalent to those of the predicate device, exsalt™ SD7 Wound Dressing (K103067). The design, materials, and manufacturing process are the equivalent to those of the predicate device, exsalt™ SD7 Wound Dressing (K103067), and therefore do not raise any new issues concerning safety or effectiveness.
a) Summary of Technological Characteristics
The exsalt™ T7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ T7 Wound Dressing and the predicate are the same.
The exsalt™ T7 Wound Dressing is sterilized by gamma irradiation.
The change in the exsalt™ T7 Wound Dressing substrate configuration does not raise any concerns related to safety or effectiveness as compared to the predicate device (K103067).
b) Summary of Performance Data
The following performance tests were conducted on the exsalt™ SD7 Wound Dressing:
- . Silver Content
- Moisture Content .
- рн .
- . Absorbency
- Anti-bacterial Effectiveness; against Staphylococcus aureus, Enterococcus faecalis, . Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii
- . Bactericidal Effectiveness
2
K113564 page 3/3
Special 510(k)
- Biocompatibility .
- Biological Reactivity .
All performance characteristics of the exsalt™ T7 Wound Dressing are the same as the predicate(s).
The exsalt™ T7 Wound Dressing raised no new safety concerns relative to biocompatibility. Testing performed on the exsalt™ SD7 Wound Dressing (K083870) showed that it was nontoxic, non-irritant, and did not elicit a sensitization response.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
DEC 1 5 2011
Exciton Technologies, Inc. % Ms. Melanie Ussyk 10230 Jasper Avenue, Suite 4000 Edmonton, Canada TSJ 4P6
Re: K113564
Trade/Device Name: Regulatory Class: Unclassified Product Code: FRO Dated: December 02, 2011 Received: December 02, 2011
Dear Ms. Ussyk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
4
Page 2 - Ms. Melanie Ussyk
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Pete Varm C.A. Vi.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
exsalt™ T7 Wound Dressing Indications for Use
510(k) Number: Ktoso67 K | | 350-
Device Name: exsalt™ T7 Wound Dressing
Indications for Use:
The exsalt™ T7 Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt™ T7 Wound Dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to 7 days.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
Division of Surgical, Orthopedic, and Restorative Dev
510(k) Number K113564