(214 days)
No
The summary describes a wound dressing with antimicrobial properties based on silver technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
A therapeutic device is one that treats a disease or condition. While the wound dressing aids in wound management and inhibits microbial growth, its primary function is protective and supportive rather than directly therapeutic in the sense of actively healing or treating the underlying condition. It manages the wound rather than curing the cause of the wound.
No
Explanation: The device is a wound dressing intended for the management of wounds by inhibiting microbial growth, which is a therapeutic function rather than a diagnostic one. It does not gather information about a patient's condition for the purpose of diagnosis.
No
The device description clearly describes a physical wound dressing with a proprietary chemical process and material composition, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing with antimicrobial properties. It is applied directly to the wound.
- Performance Studies: The performance studies focus on characteristics relevant to a wound dressing (absorptive capacity, adhesion, antimicrobial effectiveness in vitro against bacteria in direct contact with the dressing), not on analyzing samples from the human body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The exsalt™ SD7 Wound Dressing is indicated for the management of 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.
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 needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.
The exsalt™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ SD7 Wound Dressing and the predicate are the same.
For the predicate device (K083870), silver was deposited on the exsalt™ SD7 Wound Dressing using an aqueous chemistry (emersion) approach. This application process has been changed to an aqueous chemistry (direct coating) of the silver onto the substrate. This method of application of the silver to the dressing does not affect the efficacy or safety of the device as the final product specifications remain unchanged. exsalt™ SD7 Wound Dressing is sterilized by gamma irradiation.
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: Absorptive Capacity, Moisture Content, Drop Penetration, Adhesion, Abrasion, Silver Content, Anti-microbial (Bacterial) Effectiveness, Bactericidal Effectiveness, Biocompatibility, Biological Reactivity.
Absorptive capacity, moisture content, adhesion, and abrasion characteristics are the same as the predicate.
The exsalt™ SD7 Wound Dressing showed no new safety concerns relative to biocompatibility. The predicate was shown to be non-toxic, non-irritant, and did not elicit a sensitization response.
The exsalt™ SD7 Wound Dressing (K083870) has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonas aeruginosa and Staphylococcus aureus.
Key Metrics
Not Found
Predicate Device(s)
exsalt™ SD7 Wound Dressing (K083870)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K103067 page
Exciton Technologies Inc. exsalt™ SD7 Wound Dressing (7-Day Claim)
Premarket Notification
510(k) Summary for exsalt™ SD7 Wound Dressing MAY 2 0 2011
1. Trade (Proprietary) Name
exsalt™ SD7 Wound Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
- Mr. Rod Precht Contact: President and Founder
- RPrecht@excitontech.com Email: Phone: (780) 248-5868 (780) 248-5878 Fax:
- Address: Exciton Technologies Inc. Suite 4232-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
Date of 510(k) Summary Preparation: October 1, 2010
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.
5. Predicate Device(s)
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 needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound
22
1
K103067 Page
2/3
Exciton Technologies Inc. exsalt™ SD7 Wound Dressing (7-Day Claim)
Premarket Notification
Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.
7. Intended Use
exsalt™ SD7 Wound Dressing is indicated for the management of 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.
8. Summary of Substantial Equivalence
The labeled indications and directions for use of the exsalt™ SD7 Wound Dressing are equivalent to those of the predicate device, exsalt™ SD7 Wound Dressing (K083870), with the additional claim that it maintains its antibacterial activity for up to 7 days as shown in vitro against Pseudomonas aeruginosa and Staphylococcus aureus. The design, materials, and manufacturing methods are similar to those of the predicate device, exsalt™ SD7 Wound Dressing (K083870), and therefore do not raise any new issues concerning safety or effectiveness.
a) Summary of Technological Characteristics
The exsalt™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ SD7 Wound Dressing and the predicate are the same.
For the predicate device (K083870), silver was deposited on the exsalt™ SD7 Wound Dressing using an aqueous chemistry (emersion) approach. This application process has been changed to an aqueous chemistry (direct coating) of the silver onto the substrate. This method of application of the silver to the dressing does not affect the efficacy or safety of the device as the final product specifications remain unchanged. exsalt™ SD7 Wound Dressing is sterilized by gamma irradiation.
In summary, the change in the exsalt™ SD7 Wound Dressing manufacturing process does not raise any concerns related to safety or effectiveness as compared to the predicate device (K083870).
b) Summary of Performance Data
The following performance tests were conducted on the exsalt™ SD7 Wound Dressing:
2
Exciton Technologies Inc.
exsalt™ SD7 Wound Dressing (7-Day Claim)
K103067 page
3/3
Premarket Notification
- Absorptive Capacity ●
- . Moisture Content
- Drop Penetration .
- Adhesion .
- Abrasion ●
- . Silver Content
- Anti-microbial (Bacterial) Effectiveness ●
- Bactericidal Effectiveness
- Biocompatibility .
- Biological Reactivity �
Absorptive capacity, moisture content, adhesion, and abrasion characteristics are the same as the predicate.
The exsalt™ SD7 Wound Dressing showed no new safety concerns relative to biocompatibility. The predicate was shown to be non-toxic, non-irritant, and did not elicit a sensitization response.
The exsalt™ SD7 Wound Dressing (K083870) has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonas aeruginosa and Staphylococcus aureus.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 0 2011
Exciton Technologies, Inc. % Mr. Rod Precht 10230 Jasper Avenue, Suite 4232 Edmonton, Alberta T5J 4P6 Canada
Re: K103067
Trade/Device Name: exsalt™ SD7 Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 07, 2011 Received: April 11, 2011
Dear Mr. Precht,
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 - Mr. Rod Precht
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/Reportal?roblem/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.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 3 - Mr. Rod Precht
exsalt™ SD7 Wound Dressing Indications for Use
510(k) Number (if known): K103067
Device Name: exsalt™ SD7 Wound Dressing
Indications For Use:
The exsalt™ SD7 Wound Dressing is indicated for the management of 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kieu for MXM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103067