(224 days)
No
The device description and performance studies focus on the material properties and antimicrobial effectiveness of the wound dressing, with no mention of AI or ML.
No
The device is a wound dressing designed for first aid of minor skin injuries, which aligns with the definition of a general wellness device rather than a therapeutic device in the medical context. Its primary function is to inhibit microbial growth and provide a protective barrier.
No
This device is a wound dressing designed for first aid and to inhibit microbial growth, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (HDPE, polyester, silver coating) and performance studies relate to physical properties (absorptive capacity, adhesion, abrasion, etc.), indicating it is a physical wound dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a wound dressing designed to be applied to the skin. It contains silver to inhibit microbial growth in the dressing itself, not to diagnose a condition.
- Performance Studies: The performance studies focus on the physical properties of the dressing (absorptive capacity, adhesion, etc.) and its antimicrobial effectiveness in vitro (meaning in a lab setting, not on a patient sample for diagnosis). Biocompatibility studies are also relevant to a topical device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This wound dressing does not fit that description.
N/A
Intended Use / Indications for Use
The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds.
Product codes
FRO
Device Description
The exsalt™ Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. Exciton Technologies Inc. has developed exsalt™ technology; a proprietary chemical process, which deposits oxidized silver species onto the non-woven polvester coated with Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressit™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.
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
The device is intended to be used over-the-counter.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted on the exsalt™ 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 were found to be substantially equivalent to the predicate.
The exsalt™ Wound Dressing showed no new safety concerns relative to biocompatibility. It was shown to be non-toxic, non-irritant, and does not elicit a sensitization response.
The exsalt™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
exsalt™ SD7 Wound Dressing (K083870), CURAD Silver Bandage (K032463), Silverlon Silver Strips™ Adhesive Strips (K023609)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for "Exciton Technologies Inc." The logo features a stylized letter "E" with a swooping design, followed by the text "xciton" in a bold font. Below "xciton" is the text "TECHNOLOGIES INC" in a smaller, sans-serif font. The logo is black and white.
Exciton Technologies Inc. exsalt™ Wound Dressing
K 100560
Premarket Notification 510(k)
510(k) Summary for exsalt™ Wound Dressing
OCT 1 2 2010
1. Trade (Proprietary) Name
exsalt™ Wound Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
- Mr. Rod Precht Contact : President and COO rprecht@excitontech.com
Address: Exciton Technologies Inc. Suite 4000-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
Phone: (780) 248-5868 Fax: (780) 248-5878
Date of 510(k) Summary Preparation: 17 September 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) CURAD Silver Bandage (K032463) Silverlon Silver Strips™ Adhesive Strips (K023609)
6. Device Description
The exsalt™ Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. Exciton Technologies Inc. has developed exsalt™ technology; a proprietary chemical process, which deposits oxidized silver species onto the non-woven
Confidential
30 Sep 2010
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Exciton Technologies Inc. exsalt™ Wound Dressing
polvester coated with Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressit™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.
7. Intended Use
The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds. The device is intended to be used over-the-counter. The exsalt™ Wound Dressing provides a barrier with silver as a preservative to inhibit microbial growth in the dressing. The exsalt™ Wound Dressing has shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.
8. Summary of Substantial Equivalence
The labeled indications and directions for use of the exsalt™ Wound Dressing are equivalent to those of the predicate devices, CURAD® Silver Bandage and Silver Strips™ Adhesive Strips. The device design, materials, and manufacturing methods are the same as exsalt™ SD7 Wound Dressing submission (K083870) and therefore does not raise any new issues concerning safety or effectiveness.
a) Summary of Technological Characteristics
The exsalt™ 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™ Wound Dressing and the predicate are the same. exsalt™ Wound Dressing was found to be safe in Biocompatibility Tests, including tests for irritation, sensitization, and cytotoxicity.
Silver is deposited on the exsalt™ Wound Dressing using an aqueous chemistry approach. The process produces oxidized silver species that are applied to the substrate. The application of silver to the dressing does not affect the efficacy or safety of the device as demonstrated by the results of the bactericidal and antimicrobial efficacy testing, and biocompatibility testing. The exsalt™ Wound Dressing and the predicate are sterilized by gamma irradiation. There were no changes in the exsalt™ Wound Dressing in terms of technological characteristics as compared to the predicate device exsalt™ SD7 Wound Dressing (K083870).
30 Sep 2010
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Image /page/2/Picture/0 description: The image shows the logo for "Exciton Technologies Inc." The word "Exciton" is written in a stylized font, with the "E" being part of a circular design. Below "Exciton" is the text "TECHNOLOGIES INC" in a smaller, sans-serif font. The logo is in black and white.
b) Summary of Performance Data
The following performance tests were conducted on the exsalt™ 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 were found to be substantially equivalent to the predicate.
The exsalt™ Wound Dressing showed no new safety concerns relative to biocompatibility. It was shown to be non-toxic, non-irritant, and does not elicit a sensitization response.
The exsalt™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Enterococcus faecalis.
Confidential
30 Sep 2010
/y
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Exciton Technologies, Inc. % Ms. Melanie Ussyk, ASO COA Manager, Quality Assurance Suite 4000-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada
OCT 1 2 2010
Re: K100580
Trade/Device Name: exsalt™ Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 30, 2010 Received: October 1, 2010
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
4
Page 2 - Ms. Melanie Ussyk, ASO CQA
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/ReportalProblem/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
Mark N. Mellekerson
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for "Exciton". The logo is in black and white and features a stylized font. The text "Exciton" is written in a bold, sans-serif font, with the letters slightly overlapping each other. Below the main text, there is some smaller text that is difficult to read due to the image quality.
Exciton Technologies Inc. exsalt™ Wound Dressing
Premarket Notification 510(k)
Indications for Use
510(k) Number (if known): K100580
OCT 1 2 2010
Device Name: exsalt™ Wound Dressing
Indications for Use:
The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kranefelter MXM
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100580
Page of
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10August2010
Confidential