(213 days)
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any computational or analytical functions that would typically involve AI/ML.
Yes
The device is a wound dressing indicated for the management of various partial and full thickness wounds, which is a therapeutic purpose. It also aids in killing bacteria in the wound, further supporting its therapeutic function.
No
The device description indicates it is a wound dressing designed for management of wounds and killing bacteria, not for diagnosing conditions.
No
The device description clearly describes a physical wound dressing made of materials like HDPE and polyester, coated with silver. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of various types of wounds. This is a direct treatment or management of a physical condition on the body.
- Device Description: The description details a wound dressing with physical components (HDPE, polyester, silver coating) designed to be applied externally to a wound.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
The device is a therapeutic wound dressing, not a diagnostic tool.
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, 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 (comma separated list FDA assigned to the subject device)
FRO
Device Description
The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 characteristics were found to be substantially equivalent to the predicate.
While the amount of silver ion release from the exSALT™ SD7 Wound Dressing is less than that of Acticoat® 7 dressing over similar time periods, this does not affect the antimicrobial properties of the device. Antimicrobial effectiveness and bactericidal efficacy against Pseudomonas aeruginosa and Staphylococcus aureus were found to be the same when comparing the exSALT™ SD7 Wound Dressing and the predicate, tested under similar conditions.
The exSALT™ SD7 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Acticoat® 7 Dressing (K001519)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
page 1 of 3
Response to FDA Request for Al
510(k) Summary for exSALT™ SD7 Wound Dressing
1. Trade (Proprietary) Name
exSALT™ SD7 Wound Dressing
2. Common Name
Wound or Burn Dressing
3. Contact Information
| Address: | Exciton Technologies Inc. |
|---|---|
| Suite 4232-10230 Jasper Avenue | |
| Edmonton, Alberta T5J 4P6 | |
| Canada |
- Phone: (780) 248-5868 Fax: (780) 248-5878
- Contact: Rod Precht President and CEO
Date of 510(k) Summary Preparation: June 29, 2009
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)
Acticoat® 7 Dressing (K001519)
6. Device Description
The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.
Confidential
June 30, 2009
JUL 80 2009
1
K083870
pase 2093
Response to FDA Request for Al
7. Intended Use
The exSALT™ SD7 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™ SD7 Wound Dressing are equivalent to those of the predicate device, Acticoat® 7 Dressing. The design, materials, and manufacturing methods are similar to those of the predicate device and 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, while the predicate, Acticoat® 7 Dressing, consists of 3 layers of silver-coated HDPE alternating with two inner layers of absorbent polyester/rayon. Importantly, the skin-contacting materials in both the exSALT™ SD7 Wound Dressing and the predicate are the same. The absence of an extra layer of silver-coated HDPE in the exSALT™ SD7 dressing as compared to the predicate, does not affect the performance of the device as demonstrated by the results of physical, efficacy, and biocompatibility testing.
Silver is deposited on the exSALT™ SD7 Wound Dressing using an aqueous chemistry (emersion) approach, while physical vapor deposition (PVD) is used with the predicate. Both the PVD process and the emersion process produce oxidized silver species adherent to the substrate. This difference in application of the 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. Both the exSALT™ SD7 Wound Dressing and the predicate are sterilized by gamma irradiation.
b) Summary of Performance Data
The following performance tests were conducted on the exSALT™ SD7 Wound Dressing:
- . Absorptive Capacity
- . Moisture Content
- Drop Penetration �
- Adhesion .
Confidential
June 30, 2009
2
Response to FDA Request for Al
- Abrasion .
- Silver Content ●
- . Anti-microbial (Bacterial) Effectiveness
- Bactericidal Effectiveness ●
- . Biocompatibility
- � Biological Reactivity
Absorptive capacity, moisture content, adhesion characteristics were found to be substantially equivalent to the predicate.
While the amount of silver ion release from the exSALT™ SD7 Wound Dressing is less than that of Acticoat® 7 dressing over similar time periods, this does not affect the antimicrobial properties of the device. Antimicrobial effectiveness and bactericidal efficacy against Pseudomonas aeruginosa and Staphylococcus aureus were found to be the same when comparing the exSALT™ SD7 Wound Dressing and the predicate, tested under similar conditions.
The exSALT™ SD7 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™ SD7 Wound Dressing is substantially equivalent to the Acticoat® 7 Dressing.
June 30, 2009
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Exciton Technologies, Inc. % Intrinsik Health Sciences, Inc. Ms. Sandra Reis 6605 Hurontarioi Street Mississauga, Ontario L5T0A3 Canada
JUL. 30 2009
Re: K083870
Trade/Device Name: exSALT™ SD7 Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 30, 2009 Received: July 1, 2009
Dear Ms. Reis:
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.
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 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.
4
Page 2 - Ms. Sandra Reis
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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
exSALT™ SD7 Wound Dressing Indication for Use
510(k) Number: K083870
Device Name: exSALT™ SD7 Wound Dressing
Indication 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 (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 Keene for MXM
Confidential
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
June 30, 2009
510(k) Number K083870