(182 days)
No reference devices were used in this submission.
No
The summary describes a wound dressing with antimicrobial properties due to silver content. There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis, treatment planning, or monitoring. The performance studies focus on clinical safety and feasibility of the dressing itself.
Yes
The device, Silverlon® Wound Contact, Burn Contact Dressings, is indicated for the management and healing of various types of wounds, including burns, abrasions, lacerations, and ulcers, by providing an antimicrobial barrier, reducing pain, and supporting the body's healing process, which aligns with the definition of a therapeutic device.
No
The provided text describes the device as a wound dressing for the management of various wounds, burns, and skin conditions. It treats or protects, but it does not diagnose.
No
The device description clearly states it is a physical wound dressing made of knitted nylon material plated with silver. It is a tangible, single-use product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Silverlon® Wound Contact, Burn Contact Dressings clearly indicates they are topical wound dressings. They are applied directly to the wound surface to provide an antimicrobial barrier, maintain a moist healing environment, and manage pain.
- Intended Use: The stated intended uses are for the local management of various types of wounds and burns. This is a direct treatment or management of the wound itself, not an analysis of a sample taken from the body.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze a biological sample or provide diagnostic information. Its function is entirely focused on the physical and antimicrobial properties of the dressing applied to the wound.
Therefore, the Silverlon® Wound Contact, Burn Contact Dressings fall under the category of wound care devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions, and lacerations.
RX Use
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury through dry desquamation.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
Product codes
FRO
Device Description
The Silverlon® Wound Contact, Burn Contact Dressings (WCD/BCD) are sterile, single use, single layer, non-adherent antimicrobial barrier wound dressings for up to seven day use. The dressings are comprised of Silverlon knitted nylon material plated with 99% elemental silver and 1% silver oxide. When Silverlon® dressings are moistened, the silver ions are activated, which kill wound bacteria held in the dressing which may help to reduce wound infection.
The dressings are used as primary dressings that conform to the wound surface. The dressings are available in several configurations (e.g., rectangular, chest/trunk aprons, face masks, wraps, and gloves) and sizes.
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
User:
OTC: Public
Prescription: Healthcare professional
Intended Use Environment:
OTC: Home use
Prescription: Healthcare facility
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
Non-Clinical Performance: The subject and primary predicate Silverlon® Wound Contact, Burn Contact Dressings are identical. Therefore, previously completed non-clinical bench testing remains valid and applicable to the subject device.
Pre-Clinical Performance: No additional animal studies were considered necessary or conducted specifically for the expanded indication for use up to seven days for radiation dermatitis and cutaneous radiation injury through dry desquamation.
Clinical Performance: Argentum Medical sponsored an open label, single site, single arm, unblinded, interventional clinical study to evaluate the safety and feasibility of Silverlon Burn Contact Dressings for the management of radiation dermatitis (RD) of patients receiving external beam radiation therapy (RT) for breast cancer (ClinicalTrials.gov Identifier: NCT04238728). Thirty (30) patients were enrolled and wore Silverlon® Burn Contact Dressings during prescribed RT and for two weeks post RT. The study sample size was not sufficiently powered to draw any statistical conclusions. The primary analyses demonstrated the safety of Silverlon® Burn Contact Dressings for management of RD as no adverse events related to the dressing were reported during or post RT. The secondary analyses demonstrated the feasibility of using Silverlon® Burn Contact Dressings for the management of RD for a period of 7 days during RT and for 2 weeks post-RT. The daily wear compliance was 99.9% and the average wear time was 22 hours/day. Of the 28 patients who completed a 90-day follow-up assessment, 100% would recommend Silverlon dressing to other patients.
Each clinical trial subject was matched with three historical patients within a four-year window of the clinical trial at the same study sites for a total of 90 patients. Matched patients received external radiation therapy for breast cancer and RD was managed with standard-of-care treatment (e.g. creams, lotions). Inclusion of historical patients was based solely on the eligibility criteria defined for the clinical study and matching was completed per pre-specified matching rules. The matching criteria included age (±10 years), race, ethnicity, BMI (±6), total prescribed radiation dose and fractionation dose (±5%), and total number of radiation treatment sessions (±5%).
Documented radiation dermatitis (RD) grades (either RTOG or CTCAE) were available for a subset (N=71) of the 90 matched cohort patients. RTOG scores were available for all clinical trial subjects.
Key results: RD grade 3 was observed in 2.8% of the matched cohort patients. No Silverlon clinical study patients were excluded from analysis nor withdrawn from the study due to a RTOG grade of 3 or more. The mean RD grade for the matched cohort was 1.41 (SD 0.69) with a range of 0-3, and for the clinical trial subjects was 1.27 (SD 0.52) with a range of 0-2.
The clinical trial results demonstrated that Argentum Medical's Silverlon Burn Contact Dressing (BCD) is a safe and feasible modality for the routine management of radiation dermatitis. The primary analyses showed no adverse events related to use of the Silverlon BCD. The secondary analyses demonstrated the feasibility of using Silverlon dressing as daily wear compliance during and two-weeks post RT was 99.9% with an average wear time of 22 hours per day. At the 90-day post RT follow-up, 100% of the patients surveyed stated they would recommend the use of the Silverlon dressing during RT to other patients. Additional analyses further showed that Silverlon dressings did not increase the severity of radiation dermatitis compared to the historical cohort.
Key Metrics
Daily wear compliance: 99.9%
Average wear time: 22 hours/day
Patient recommendation rate (90-day post-RT follow-up): 100%
Mean RD Grade (Matched Cohort): 1.41 (SD 0.69)
Mean RD Grade (Clinical Trial): 1.27 (SD 0.52)
Predicate Device(s)
Silverlon® Wound Contact, Burn Contact Dressings, K190343, HEALADEX®-P, K063517
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
October 26, 2022
Argentum Medical, Inc. Kathy Herzog Regulatory Consutlant 2571 Kaneville Ct Geneva. Illinois 60134
Re: K221218
Trade/Device Name: Silverlon Wound Contact, Burn Contact Dressings Regulatory Class: Unclassified Product Code: FRO Dated: September 28, 2022 Received: September 29, 2022
Dear Kathy Herzog:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Silverlon Wound Contact, Burn Contact Dressings
Indications for Use (Describe)
Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions, and lacerations.
RX Use
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury through dry desquamation.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact, Burn Contact Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
K221218 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
I. SUBMITTER
Argentum Medical, LLC 2571 Kaneville Court Geneva, IL 60134
Contact Person: Jim Fitzgerald Phone: 630-232-2507, ext. 119 JFitzgerald(@curasurgical.com
Date Prepared: October 26, 2022
II. DEVICE
| Trade/Proprietary Names: | Silverlon® Wound Contact, Burn Contact Dressings |
|---|---|
| Common Name: | Wound Dressing |
| Regulation Number: | Unclassified |
| Regulation Name: | NA |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Panel: | General & Plastic Surgery |
PREDICATE DEVICE III.
Silverlon® Wound Contact, Burn Contact Dressings, K190343 and HEALADEX®-P, K063517.
The predicate devices have not been subject to a design-related recall. No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The Silverlon® Wound Contact, Burn Contact Dressings (WCD/BCD) are sterile, single use, single layer, non-adherent antimicrobial barrier wound dressings for up to seven day use. The dressings are comprised of Silverlon knitted nylon material plated with 99% elemental silver and 1% silver oxide. When Silverlon® dressings are moistened, the silver ions are activated, which kill wound bacteria held in the dressing which may help to reduce wound infection.
4
The dressings are used as primary dressings that conform to the wound surface. The dressings are available in several configurations (e.g., rectangular, chest/trunk aprons, face masks, wraps, and gloves) and sizes.
V. INTENDED USE/INDICATIONS FOR USE
The Silverlon® Wound Contact, Burn Contact Dressings are indicated for the following:
Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions, and lacerations.
RX Use
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds, surgical wounds (donor and graft sites, incisions), first and second degree thermal burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites, and wound drain sites.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for decontaminated stable unroofed first and second degree mustard-induced vesicant injuries not requiring skin grafting.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for radiation dermatitis and cutaneous radiation injury through dry desquamation.
Silverlon® Wound Contact, Burn Contact Dressings are indicated for the management of infected wounds, as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Wound Contact Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Wound Burn Dressings are a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
A comparison of the subject Silverlon WCD/BCD to the primary and secondary predicate devices is provided in Table 1.
The subject, primary, and secondary predicate dressings all have the same intended use as wound dressings that provide a moist environment for wound healing. All of the dressings are sterile, single use dressings that are indicated for a variety of cutaneous wounds, including ulcers and first and second degree burns. The subject and secondary predicate dressings are both indicated to manage radiation-induced skin injury
5
The subject and primary predicate devices are identical and thus have identical technological characteristics. The expanded indications for use has no impact on the product design or technological characteristics.
The subject and secondary predicate, HEALADEX®-P, differ in construction and materials, however, these differences are not expected to raise different questions of safety and effectiveness as both devices are occlusive dressings and have the same principle of operation to allow exchange of oxygen and fluid through the dressing and provide a protective barrier to a wound.
| Feature | Silverlon WCD/BCD
(Subject Dressings) | Silverlon WCD/BCD
(Primary Predicate) | HEALADEX®-P*
(Secondary Predicate) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | K221218 | K190343 | K063517 |
| Classification | Unclassified | Same | Same |
| Product Code | FRO | Same | Same primary (FRO)
Subsequent code (KGN) |
| Dressing
Description | Sterile, single layer non-
adherent antimicrobial
barrier dressing | Same | Sterile, hydrogel island
wound dressing |
| Intended Use | Antimicrobial barrier
dressings | Same | Wound Dressing |
| Indications
for Use
(OTC) | Local management of
superficial wounds, minor
burns, abrasions, and
lacerations. | Same | Not applicable |
| Indications
for Use
(Prescription) | Silverlon® Wound
Contact, Burn Contact
Dressings are indicated
for use up to 7 days for
partial and full thickness | Same, except does not
include the new
indication for use of RD
and CRI as noted in | HEALADEX®-P Wound
Dressing provides a moist
environment that is
supportive of wound
healing. HEALADEX-P |
| Feature | Silverlon WCD/BCD
(Subject Dressings) | Silverlon WCD/BCD
(Primary Predicate) | HEALADEX®-P*
(Secondary Predicate) |
| | wounds including
traumatic wounds,
surgical wounds (donor
and graft sites, incisions),
first and second degree
thermal burns, as well as
dermal ulcers (stage I-IV
pressure sores, venous
stasis ulcers, arterial
ulcers, diabetic ulcers),
vascular access or
peripheral IV sites,
orthopedic external pin
sites, and wound drain
sites.
Silverlon® Wound
Contact, Burn Contact
Dressings are indicated
for use up to 7 days for
decontaminated stable
unroofed first and second
degree mustard-induced
vesicant injuries not
requiring skin grafting.
Silverlon® Wound
Contact, Burn Contact
Dressings are indicated
for the management of
infected wounds, as the
silver in the dressing
provides an antimicrobial
barrier that may be
helpful in managing these
wounds. In addition, the
moist wound healing
environment and control
of wound bacteria within
the Silverlon® Wound
Contact, Burn Contact
Dressings may help | bolded italic text for the
subject device | is indicated for dry, light
and moderately exudating
partial and full thickness
wounds such as:
First and second
degree burns Severe sunburns Superficial injuries,
superficial lacerations,
cuts, abrasions,
incisions/surgical
wounds, and skin tears HEALADEX-P dressing
should be used under
health care professional
direction for the
following indications:
Pressure ulcers, Stage
I-IV Lower extremity
ulcers Venous ulcers Arterial ulcers Ulcers of mixed
etiology Diabetic ulcers Donor sites and skin
grafts Burns caused by
radiation oncology
procedures |
| Feature | Silverlon WCD/BCD
(Subject Dressings) | Silverlon WCD/BCD
(Primary Predicate) | HEALADEX®-P*
(Secondary Predicate) |
| | reduce the risk of wound
infection and support the
body's healing process.
Silverlon® Wound
Contact, Burn Contact
Dressings may be used
for the management of
painful wounds.
Silverlon® Wound
Contact, Wound Burn
Dressings are a non-
adherent wound contact
layer that reduces pain
during dressing changes
and evaporation of
moisture in the dressing
may soothe the wound.
Silverlon® Wound
Contact, Burn Contact
Dressings are indicated
for use up to 7 days for
radiation dermatitis and
cutaneous radiation
injury through dry
desquamation. | | |
| Type of Use | OTC and Prescription | Same | Prescription |
| User | OTC: Public
Prescription: Healthcare
professional | OTC: Public
Prescription: Healthcare
professional | Healthcare professional |
| Intended Use
Environment | OTC: Home use
Prescription: Healthcare
facility | OTC: Home use
Prescription: Healthcare
facility | Healthcare environment |
| Principle of
Operation | The silver coated nylon
fabric permits the passage
of oxygen and fluids to
and from the wound and
when activated by | Same | The permeable moisture
vapor adhesive film
dressing sheet permits the
passage of oxygen and |
| Feature | Silverlon WCD/BCD
(Subject Dressings) | Silverlon WCD/BCD
(Primary Predicate) | HEALADEX®-P*
(Secondary Predicate) |
| | moisture, silver ions kill
wound bacteria held in
the dressings which may
help reduce infection. | | moisture vapor to and
from the wound. |
| Use | Single Use | Same | Same |
| Duration of
Use | Up to 7 days | Same | Not stated |
| Construction | Single layer | Same | Multi-layer |
| Materials | WCD Dressings: Nylon
and elastane substrate.
The nylon yarn is
circumferentially coated
with 99% metallic silver
and 1% silver oxide.
BCD, BWD, DS, SL,
ABG : Nylon and
elastane substrate. The
nylon yarn is
circumferentially coated
with 99% metallic silver
and 1% silver oxide. | Same. | Carboxymethylcellulose
and lyophilized
formulated porcine
plasma (hydrogel)
mounted on moisture
vapor permeable adhesive
film dressing sheet coated
with acrylic adhesive and
a polyurethane protective
film |
| Packaging | Tyvek film | Same | Foil pouch |
| Sterilization
Method | Ethylene oxide | Same | Not stated |
| Sterility
Assurance
Level (SAL) | 10-6 | Same | Not stated |
| Shelf Life | 5 years | 5 years | Not stated |
Table 1: Subject and Predicate Device Comparison
6
7
8
*Information for HEALADEX®-P is limited to that provided in the 510(k) Summary (K063517).
9
VII. PERFORMANCE DATA
Non-Clinical Performance
The subject and primary predicate Silverlon® Wound Contact, Burn Contact Dressings are identical. Therefore, previously completed non-clinical bench testing remains valid and applicable to the subject device.
Pre-Clinical Performance
No additional animal studies were considered necessary or conducted specifically for the expanded indication for use up to seven days for radiation dermatitis and cutaneous radiation injury through dry desquamation.
Clinical Performance
Argentum Medical sponsored an open label, single site, single arm, unblinded, interventional clinical study to evaluate the safety and feasibility of Silverlon Burn Contact Dressings for the management of radiation dermatitis (RD) of patients receiving external beam radiation therapy (RT) for breast cancer (ClinicalTrials.gov Identifier: NCT04238728). Thirty (30) patients were enrolled and wore Silverlon® Burn Contact Dressings during prescribed RT and for two weeks post RT. The study sample size was not sufficiently powered to draw any statistical conclusions.
The primary analyses demonstrated the safety of Silverlon® Burn Contact Dressings for management of RD as no adverse events related to the dressing were reported during or post RT.
The secondary analyses demonstrated the feasibility of using Silverlon® Burn Contact Dressings for the management of RD for a period of 7 days during RT and for 2 weeks post-RT. The daily wear compliance was 99.9% and the average wear time was 22 hours/day. Of the 28 patients who completed a 90-day follow-up assessment, 100% would recommend Silverlon dressing to other patients.
Each clinical trial subject was matched with three historical patients within a four-year window of the clinical trial at the same study sites for a total of 90 patients. Matched patients received external radiation therapy for breast cancer and RD was managed with standard-of-care treatment (e.g. creams, lotions). Inclusion of historical patients was based solely on the eligibility criteria defined for the clinical study and matching was completed per pre-specified matching rules. The matching criteria included age (±10 years), race, ethnicity, BMI (±6), total prescribed radiation dose and fractionation dose (±5%), and total number of radiation treatment sessions (±5%).
Documented radiation dermatitis (RD) grades (either RTOG or CTCAE) were available for a subset (N=71) of the 90 matched cohort patients. RTOG scores were available for all clinical trial subjects. The RT characteristics for these two groups with documented RD grades are shown in Table 2.
10
| RT Characteristic | Matched
Cohort
(N=71) | Clinical
Trial
(N=30) |
|----------------------------|-----------------------------|-----------------------------|
| RT Type, N (%) | | |
| 3D Conformal | 60 (96.8) | 25 (83.3) |
| IMRT | 2 (3.2) | 5 (16.7) |
| Bolus Use N (%) | | |
| Yes | 31 (43.7) | 1 (3.3) |
| No | 40 (56.3) | 29 (96.7) |
| Total Prescribed Dose (Gy) | | |
| Mean (SD) | 51.8 (4.94) | 50.85 (4.42) |
| Total # of Sessions | | |
| Mean (SD) | 22.4 (4.73) | 22.1 (4.60) |
Table 2: RT Characteristics: Matched Cohort vs. Silverlon Clinical Trial Subjects
A comparison of RD grades for these two groups is provided in Table 3. RD grade 3 was observed in 2.8% of the matched cohort patients. No Silverlon clinical study patients were excluded from analysis nor withdrawn from the study due to a RTOG grade of 3 or more. The mean RD grade for each group is provided in Table 4.
Table 3: RD Grade: Matched Cohort vs. Silverlon Clinical Trial Subjects
Image /page/10/Figure/4 description: The image contains a table and a bar graph that compares the RD Grade between a Matched Cohort (N=71) and a Silverlon Clinical Trial (N=30). The table shows the percentage of each RD Grade for both groups, with Grade 1 being the most common in both groups. The bar graph visually represents the same data, with blue bars representing the Matched Cohort and red bars representing the Silverlon Clinical Trial. The x-axis of the bar graph represents the RD Grade, and the y-axis represents the percentage.
*RTOG or CTCAE scale
*RTOG scale
| Table 4: Mean RD Grade: Matched Cohort vs. Clinical Trial Subjects | |
|---|---|
| -------------------------------------------------------------------- | -- |
| RD Grade | Matched Cohort
(N=71)* | Clinical Trial
(N=30)† |
|-----------|---------------------------|---------------------------|
| Mean (SD) | 1.41 (0.69) | 1.27 (0.52) |
| Range | 0-3 | 0-2 |
| 95% CI | [1.25, 1.57] | [1.07, 1.46] |
*RTOG or CTCAE scale
†RTOG scale
Six (6) of 30 study subjects (20%) used topical treatments in the RT field covered by the Silverlon dressing. Twenty of the 30 subjects (67%) used topical treatments in the RT field outside of the Silverlon dressing.
11
The clinical symptoms and pathology of skin injury from therapeutic radiation (such as seen in cancer patients) have similarities to lower severity CRI.12 Hence, the clinical results achieved with Silverlon® Burn Contact Dressings in the RD clinical study would be expected to be equivalent in management of CRI through dry desquamation.
The clinical trial results demonstrated that Argentum Medical's Silverlon Burn Contact Dressing (BCD) is a safe and feasible modality for the routine management of radiation dermatitis. The primary analyses showed no adverse events related to use of the Silverlon BCD. The secondary analyses demonstrated the feasibility of using Silverlon dressing as daily wear compliance during and two-weeks post RT was 99.9% with an average wear time of 22 hours per day. At the 90-day post RT follow-up, 100% of the patients surveyed stated they would recommend the use of the Silverlon dressing during RT to other patients. Additional analyses further showed that Silverlon dressings did not increase the severity of radiation dermatitis compared to the historical cohort. Furthermore, the radiation-induced skin injury symptoms (e.g. erythema, dry/moist desquamation and sensations such as tenderness, itchy, burning) assessed in the Silverlon clinical study are shared symptoms for radiation injuries termed either radiation dermatitis or cutaneous radiation injuries.
CONCLUSIONS VIII.
The subject Silverlon WCD/BCD have the same intended use and are identical product to the primary predicate Silverlon WCD/BCD. The clinical evaluation of the subject dressings for the management of RD in breast cancer patients undergoing external beam radiation treatment demonstrated the subject dressings do not raise different questions of safety and effectiveness compared to use of the primary predicate Silverlon WCD/BCD to manage cleared wound indications. The Silverlon WCD/BCD also have the same intended use as the secondary predicate, HEALDEX®-P, and both are indicated to manage radiation-induced skin injury (radiation dermatitis). The differences in dressing construction and materials of Silverlon WCD/BCD as compared to HEALADEX®-P are not expected to raise different questions of safety and effectiveness as both devices are occlusive dressings that have the same principle of operation. Therefore, the subject Silverlon WCD/BCD is as safe, and as effective, as the primary predicate Silverlon WCD/BCD (K190343) and the secondary predicate device HEALADEX®-P (K063517).
1 DiCarlo, A. L., Bandremer, A. C., Hollingsworth, B. A., Kasim, S., Laniyonu, A., Todd, N. F., .. & Rios, C. I. (2020). Cutaneous radiation injuries: Models, assessment and treatments. Radiation research, 194(3), 315-344.