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.

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. 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (exsalt™ T7 Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a standalone clinical study or multi-reader multi-case (MRMC) study for an AI algorithm.

Therefore, many of the requested categories related to AI algorithm evaluation, such as acceptance criteria in terms of diagnostic performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC study details, are not applicable to this type of device and submission.

However, I can extract the relevant information regarding performance testing that was conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Silver Content	Equivalent to predicate (exsalt™ SD7 Wound Dressing)	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
Moisture Content	Equivalent to predicate	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
pH	Equivalent to predicate	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
Absorbency	Equivalent to predicate	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
Anti-bacterial Effectiveness	Effective against specified bacteria for up to 7 days, equivalent to predicate	Effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days (for exsalt™ T7 and implied for predicate).
Bactericidal Effectiveness	Equivalent to predicate	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
Biocompatibility	Non-toxic, non-irritant, non-sensitizing	Testing on exsalt™ SD7 (K083870) showed it was non-toxic, non-irritant, and did not elicit a sensitization response. Exsalt™ T7 raised no new safety concerns relative to biocompatibility.
Biological Reactivity	Equivalent to predicate	Performed on exsalt™ SD7, implied equivalence for exsalt™ T7.
Substrate Configuration Change	No new safety or effectiveness concerns compared to predicate	The change in substrate configuration does not raise any concerns related to safety or effectiveness.

Study Proving Device Meets Acceptance Criteria:

The device's performance is not proven through a single, comprehensive study with explicit acceptance criteria for diagnostic metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (exsalt™ SD7 Wound Dressing, K103067 and K083870) through a series of performance tests and by asserting that differences in design (specifically the substrate configuration) do not raise new issues of safety or effectiveness.

The document states: "All performance characteristics of the exsalt™ T7 Wound Dressing are the same as the predicate(s)." and "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."

The antibacterial effectiveness for exsalt™ T7 is specifically mentioned as being effective in vitro against the listed bacteria for up to 7 days, which is consistent with the intended function.

Details Not Applicable for this 510(k) Submission:

The following information types are typically relevant for AI/software as a medical device (SaMD) submissions involving diagnostic or screening performance, but are not provided or applicable in this 510(k) for a wound dressing, which focuses on material properties, safety, and functionality claims based on in vitro testing and equivalence to an existing product:

Sample size used for the test set and the data provenance: Not applicable. Performance tests were likely conducted on laboratory samples of the dressing, not a patient test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the clinical diagnostic sense was established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" was likely defined by standardized laboratory test results for material and antimicrobial properties.
The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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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

December, 2011

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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

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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.

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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 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

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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

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exsalt™ T7 Wound Dressing Indications for Use

510(k) Number: Ktoso67 K | | 350-

Device Name: exsalt™ T7 Wound Dressing

Indications for Use:

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

Regulation Number and Section

N/A