The exsalt® SD7 Wound Dressing with Adhesive Backing 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® SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad 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 substrate; a non-woven polyester with a gray Delnet® HDPE mesh layer thermally laminated to one side (wound contact layer). The pad is backed with a clear polyurethane film with acrylate adhesive to hold the dressing in the exsalt® SD7 Wound Dressing with Adhesive Backing inhibits bacterial growth in the dressing pad. The concentration of the silver and oxidized silver species on the dressing pad is 0.4 mg/cm² (1.8%w/w). The exsalt® SD7 Wound Dressing with Adhesive Backing has been shown to be effective in vitro against Staphylococcus aureus. Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.

AI/ML Overview

The provided text describes a Special 510(k) submission for the exsalt® SD7 Wound Dressing with Adhesive Backing, which is an modification of an already cleared device, exsalt® SD7 Wound Dressing (K103067). This type of submission generally focuses on demonstrating that the changes do not raise new questions of safety or effectiveness, often by comparing the modified device's performance to the predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Silver Content	Same as predicate	Same as predicate
Moisture Content	Same as predicate	Same as predicate
pH	Same as predicate	Same as predicate
Absorbency	Same as predicate	Same as predicate
Anti-bacterial Effectiveness (against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii)	Effective for up to 7 days	Effective for up to 7 days
Silver Release	Same as predicate	Same as predicate
Biocompatibility	Non-toxic, non-irritant, no sensitization response (for dressing pad); safe for intended use (for adhesive film)	Non-toxic, non-irritant, no sensitization response (for dressing pad); safe for intended use (for adhesive film)
X-ray Diffraction	Same as predicate	Same as predicate

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states: "All performance characteristics of the exsalt® SD7 Wound Dressing with Adhesive Backing are the same as the predicate." This indicates that the primary study proving the device meets the acceptance criteria is a comparison to the predicate device (exsalt® SD7 Wound Dressing, K103067). The core argument is that, because the wound-contacting materials and the underlying technology are the same, and the modifications (addition of adhesive backing) do not impact the core performance aspects, the new device inherently meets the same performance standards as the predicate.

The document lists "The following performance tests were conducted on the exsalt® SD7 Wound Dressing". While it doesn't explicitly state new tests were conducted on the "exsalt® SD7 Wound Dressing with Adhesive Backing" for all these characteristics, the phrasing implies that these characteristics were evaluated for the predicate device, and the new device is deemed equivalent based on its identical core components. Biocompatibility testing was specifically performed on the adhesive backing component to ensure its safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified for individual performance tests. The document refers to the predicate device's performance results as the basis for equivalence. For biocompatibility, the adhesive film was tested, but specific sample sizes are not given.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are internal performance tests conducted by Exciton Technologies Inc. or their commissioned labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable or specified. Performance testing for medical devices like wound dressings typically involves standardized laboratory methods, not expert consensus on interpretations.
Qualifications of Experts: Not specified. Standard laboratory personnel or qualified technicians would perform these types of tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication of results in the way image analysis or clinical trials might. The performance tests are objective laboratory measurements.

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for wound dressings.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This device is a wound dressing, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: The "ground truth" for the performance characteristics are established scientific and engineering standards and methods for testing wound dressings, and the performance of the previously cleared predicate device. For example:
- Antibacterial Effectiveness: In vitro testing against specific bacterial strains.
- Biocompatibility: Standardized tests (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization.
- Material properties: Standardized tests for silver content, pH, absorbency, etc.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device doesn't involve a machine learning algorithm or AI that requires a "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

Exciton Technologies Inc. exsalt® SD7 Wound Dressing with Adhesive Backing

Special 510(k)

510(k) Summary for exsalt® SD7 Wound Dressing with Adhesive Backing

Preparation date: December 1, 2013

1. Trade (Proprietary) Name

exsalt® SD7 Wound Dressing with Adhesive Backing

2. Common Name

Wound or Burn Dressing

3. Contact Information

Contact:	Melanie Ussyk
	Director, Quality Assurance & Regulatory Affairs

Email: mussyk@excitontech.com Phone: (780) 248-1281 Fax: (780) 248-5878

Address: Exciton Technologies Inc. Suite 4000-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada

4. Device Classification & Panel

5. Predicate Device(s)

exsalt® SD7 Wound Dressing (K103067)

6. Device Description

7. Intended Use

exsalt® SD7 Wound Dressing with Adhesive Backing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second

{1}------------------------------------------------

Exciton Technologies Inc.
exsalt® SD7 Wound Dressing with Adhesive Backing

K13B775 Page 2/2

Special 510(k)

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 of the exsalt® SD7 Wound Dressing with Adhesive Backing are equivalent to those of the predicate device, exsalt® SD7 Wound Dressing (K103067). The directions for use of the exsalt® SD7 Wound Dressing with Adhesive Backing have been modified from the predicate by the removal of the instructions to "Secure with surgical tape or a bandage as appropriate" as the new configuration replaces any need for additional securement. The design, materials, and manufacturing methods of the pad that contacts the wound are the same as 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® SD7 Wound Dressing with Adhesive Backing consists of a pad constructed of a wound contact layer of HDPE with an inner layer of absorbent polyester which are all silver-coated. The pad has been placed onto a biocompatible clear polyurethane film with acrylate adhesive that allows for securement of the dressing to the skin. The wound-contacting materials in both the exsalt® SD7 Wound Dressing with Adhesive Backing and the predicate are the same.

The exsalt® SD7 Wound Dressing with Adhesive Backing is sterilized by gamma irradiation.

In summary, the change in the exsalt® SD7 Wound Dressing with Adhesive Backing 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 .
. pH
Absorbency .
Anti-bacterial Effectiveness; against Staphylococcus aureus, Enterococcus faecalis, . Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii
. Silver Release
Biocompatibility �
X-ray Diffraction .

All performance characteristics of the exsalt® SD7 Wound Dressing with Adhesive Backing are the same as the predicate.

The exsalt® SD7 Wound Dressing with Adhesive Backing raised no new safety concerns relating to biocompatibility. Testing performed on the exsalt® SD7 Wound Dressing showed that it was non-toxic, non-irritant, and did not elicit a sensitization response. Testing performed on the polyurethane film with acrylate adhesive showed that it was safe for its intended use based upon the criteria evaluated.

{2}------------------------------------------------

Image /page/2/Picture/0 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 a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

Exciton Technologies Incorporated Ms. Melanie Ussyk Suite 4000-10230 Jasper Avenue Edmonton, Alberta T5J 4P6 Canada

Re: K133775

Trade/Device Name: exsalt® SD7 Wound Dressing with Adhesive Backing Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2014 Received: February 24, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Melanie Ussyk

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 contact 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. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

Exciton Technologies Inc. exsalt® SD7 Wound Dressing with Adhesive Backing

Special 510(k)

exsalt® SD7 Wound Dressing with Adhesive Backing Indications for Use

K133775 510(k) Number:

Device Name: exsalt® SD7 Wound Dressing with Adhesive Backing

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)

Jiyoung Dang -S

December 2013

Regulation Number and Section

N/A