(182 days)
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.
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.
The provided text describes the performance data for Silverlon Wound Contact, Burn Contact Dressings but does not specify acceptance criteria or present the information in a clear "acceptance criteria vs. reported performance" table format. The study aims to demonstrate safety and feasibility, and to show non-inferiority in terms of radiation dermatitis severity compared to historical controls.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format for the clinical study. Instead, it focuses on demonstrating safety and feasibility, and comparing radiation dermatitis grades with a historical cohort.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Safety | No adverse events related to the dressing were reported during or post RT (Radiation Therapy). |
| Feasibility | Daily wear compliance was 99.9%.Average wear time was 22 hours/day.100% of 28 patients completing 90-day follow-up would recommend the dressing. |
| Effectiveness (Radiation Dermatitis Grades) | The mean RD grade for the Silverlon clinical trial group was 1.27 (SD 0.52), range 0-2 (RTOG scale).The mean RD grade for the matched cohort (standard-of-care) was 1.41 (SD 0.69), range 0-3 (RTOG or CTCAE scale).No Silverlon clinical study patients were excluded or withdrawn due to an RTOG grade of 3 or more, whereas RD grade 3 was observed in 2.8% of the matched cohort. |
| Equivalence to Predicate | Compared to the primary predicate, the subject device is identical for existing indications and the expanded indications have no impact on product design or technological characteristics.Compared to the secondary predicate, differences in construction/materials are not expected to raise different safety/effectiveness questions as both are occlusive dressings with the same principle of operation. |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Study): 30 patients were enrolled in the interventional clinical study.
- Sample Size (Matched Cohort): 90 historical patients were matched (3 historical patients per clinical trial subject). For the comparison of RD grades, a subset of 71 matched cohort patients had documented RD grades.
- Data Provenance: The interventional clinical study was an open label, single site, single arm, unblinded study. The text does not explicitly state the country of origin, but it is implied to be within the US due to FDA submission. The historical data for the matched cohort was from the "same study sites" within a four-year window of the clinical trial.
- Retrospective/Prospective:
- The Silverlon study data is prospective (interventional clinical study).
- The matched cohort data is retrospective (historical patients).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts used to establish the ground truth or their qualifications. The "documented radiation dermatitis (RD) grades (either RTOG or CTCAE)" imply that these were assigned clinically, likely by treating physicians or radiation oncologists, but no details on their number or specific expertise are provided.
4. Adjudication method for the test set
The document does not describe any specific adjudication method for determining the RD grades for either the clinical trial subjects or the matched cohort. The grades were "documented," suggesting standard clinical assessment.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study is for a wound dressing, not an AI or imaging device with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical wound dressing, not an algorithm.
7. The type of ground truth used
The ground truth for the radiation dermatitis grades was based on clinical assessment using standardized scales (RTOG or CTCAE scale) as documented in patient records.
8. The sample size for the training set
This section is not applicable as the document describes a physical medical device (wound dressing) and a clinical trial. There is no mention of an algorithm or a training set for an AI model.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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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
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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
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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.
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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.
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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
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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) |
| DressingDescription | Sterile, single layer non-adherent antimicrobialbarrier dressing | Same | Sterile, hydrogel islandwound dressing |
| Intended Use | Antimicrobial barrierdressings | Same | Wound Dressing |
| Indicationsfor Use(OTC) | Local management ofsuperficial wounds, minorburns, abrasions, andlacerations. | Same | Not applicable |
| Indicationsfor Use(Prescription) | Silverlon® WoundContact, Burn ContactDressings are indicatedfor use up to 7 days forpartial and full thickness | Same, except does notinclude the newindication for use of RDand CRI as noted in | HEALADEX®-P WoundDressing provides a moistenvironment that issupportive of woundhealing. HEALADEX-P |
| Feature | Silverlon WCD/BCD(Subject Dressings) | Silverlon WCD/BCD(Primary Predicate) | HEALADEX®-P*(Secondary Predicate) |
| wounds includingtraumatic wounds,surgical wounds (donorand graft sites, incisions),first and second degreethermal burns, as well asdermal ulcers (stage I-IVpressure sores, venousstasis ulcers, arterialulcers, diabetic ulcers),vascular access orperipheral IV sites,orthopedic external pinsites, and wound drainsites.Silverlon® WoundContact, Burn ContactDressings are indicatedfor use up to 7 days fordecontaminated stableunroofed first and seconddegree mustard-inducedvesicant injuries notrequiring skin grafting.Silverlon® WoundContact, Burn ContactDressings are indicatedfor the management ofinfected wounds, as thesilver in the dressingprovides an antimicrobialbarrier that may behelpful in managing thesewounds. In addition, themoist wound healingenvironment and controlof wound bacteria withinthe Silverlon® WoundContact, Burn ContactDressings may help | bolded italic text for thesubject device | is indicated for dry, lightand moderately exudatingpartial and full thicknesswounds such as:First and seconddegree burns Severe sunburns Superficial injuries,superficial lacerations,cuts, abrasions,incisions/surgicalwounds, and skin tears HEALADEX-P dressingshould be used underhealth care professionaldirection for thefollowing indications:Pressure ulcers, StageI-IV Lower extremityulcers Venous ulcers Arterial ulcers Ulcers of mixedetiology Diabetic ulcers Donor sites and skingrafts Burns caused byradiation oncologyprocedures | |
| Feature | Silverlon WCD/BCD(Subject Dressings) | Silverlon WCD/BCD(Primary Predicate) | HEALADEX®-P*(Secondary Predicate) |
| reduce the risk of woundinfection and support thebody's healing process.Silverlon® WoundContact, Burn ContactDressings may be usedfor the management ofpainful wounds.Silverlon® WoundContact, Wound BurnDressings are a non-adherent wound contactlayer that reduces painduring dressing changesand evaporation ofmoisture in the dressingmay soothe the wound.Silverlon® WoundContact, Burn ContactDressings are indicatedfor use up to 7 days forradiation dermatitis andcutaneous radiationinjury through drydesquamation. | |||
| Type of Use | OTC and Prescription | Same | Prescription |
| User | OTC: PublicPrescription: Healthcareprofessional | OTC: PublicPrescription: Healthcareprofessional | Healthcare professional |
| Intended UseEnvironment | OTC: Home usePrescription: Healthcarefacility | OTC: Home usePrescription: Healthcarefacility | Healthcare environment |
| Principle ofOperation | The silver coated nylonfabric permits the passageof oxygen and fluids toand from the wound andwhen activated by | Same | The permeable moisturevapor adhesive filmdressing sheet permits thepassage of oxygen and |
| Feature | Silverlon WCD/BCD(Subject Dressings) | Silverlon WCD/BCD(Primary Predicate) | HEALADEX®-P*(Secondary Predicate) |
| moisture, silver ions killwound bacteria held inthe dressings which mayhelp reduce infection. | moisture vapor to andfrom the wound. | ||
| Use | Single Use | Same | Same |
| Duration ofUse | Up to 7 days | Same | Not stated |
| Construction | Single layer | Same | Multi-layer |
| Materials | WCD Dressings: Nylonand elastane substrate.The nylon yarn iscircumferentially coatedwith 99% metallic silverand 1% silver oxide.BCD, BWD, DS, SL,ABG : Nylon andelastane substrate. Thenylon yarn iscircumferentially coatedwith 99% metallic silverand 1% silver oxide. | Same. | Carboxymethylcelluloseand lyophilizedformulated porcineplasma (hydrogel)mounted on moisturevapor permeable adhesivefilm dressing sheet coatedwith acrylic adhesive anda polyurethane protectivefilm |
| Packaging | Tyvek film | Same | Foil pouch |
| SterilizationMethod | Ethylene oxide | Same | Not stated |
| SterilityAssuranceLevel (SAL) | 10-6 | Same | Not stated |
| Shelf Life | 5 years | 5 years | Not stated |
Table 1: Subject and Predicate Device Comparison
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*Information for HEALADEX®-P is limited to that provided in the 510(k) Summary (K063517).
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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.
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| RT Characteristic | MatchedCohort(N=71) | ClinicalTrial(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.
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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.
N/A