(285 days)
Rx Indications for Use: For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc. OTC Indications for Use: For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.
Procellera Composite Antibacterial Wound Dressing is a three-layer dressing comprising a broadspectrum antibacterial contact layer (Procellera), a polyester-based absorbent layer, and a polyurethane semi-occlusive outer adhesive layer to keep the dressing in place and help maintain a moist wound environment. The dressing is offered in various shapes and elbow/shoulder dressings are prescription use only, while the square, rectangular and round shaped dressings are for both prescription and over-the-counter use. Embedded in the dressing are microcell batteries made of elemental zinc applied in a dot-matrix pattern to a polyester substrate. In the presence of a conductive medium such as wound exudate, water-based wound hydrogels, saline, or water, microcurrents are generated at the dressing surface due to its inherent design. Silver and zinc in the dressing help to preserve it and minimize or prevent the growth of bacteria within the dressing. Procellera Composite Antibacterial Wound Dressing may be used with other common wound treatment products such as sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to local clinical protocols.
The provided document is a 510(k) summary for a medical device (Procellera Composite Antibacterial Wound Dressing) and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of acceptance criteria and device performance in the way a clinical trial or a more extensive performance study might.
Based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets and then report corresponding device performance against those targets (e.g., "Device must achieve X% sensitivity; device achieved Y% sensitivity").
Instead, the acceptance for this 510(k) submission is implicitly based on demonstrating that the new device is substantially equivalent to legally marketed predicate devices through a comparison of technological characteristics, intended use, and safety/performance data. The performance is assessed by showing compliance with relevant standards and established methods, implying that meeting these standards is the "acceptance criteria" for the device's characteristics.
Here's an interpretation of the implied acceptance criteria and reported performance:
| Characteristic | Implied Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance/Evidence |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993: Biological Evaluation of Medical Devices standard. | "Procellera Composite Antibacterial Wound Dressing was tested in accordance with applicable parts of the ISO 10993: Biological Evaluation of Medical Devices standard and found to be biocompatible. Additional tests recommended by FDA guidance Use of International Standard ISO 10993-1 were also performed. Testing included: cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity and implantation." |
| Antibacterial Effectiveness | Demonstrated broad-spectrum antibacterial effectiveness within the dressing (as per AATCC TM 100 or equivalent). | "Procellera Composite Antibacterial Wound Dressing was tested per AATCC TM 100: Assessment of Antibacterial Finishes on Textile Materials and demonstrated broad-spectrum antibacterial effectiveness within the dressing." |
| Intended Use | Identical to primary predicate device. | "The intended use... of Procellera Composite Antibacterial Wound Dressing are identical to the primary predicate single layer Procellera Antimicrobial Wound Dressing cleared under K160783 and its predecessors." |
| Wound Contact Layer | Identical to primary predicate device. | "The wound contact layer of the subject device is identical to the Procellera Antimicrobial Wound Dressing." |
| Antibacterial Technology | Identical to primary predicate device. | "The antibacterial technology... of Procellera Composite Antibacterial Wound Dressing are identical to the primary predicate single layer Procellera Antimicrobial Wound Dressing cleared under K160783 and its predecessors." |
| Materials | Comparable composition to predicate devices, with new materials evaluated. | New materials evaluated through standardized test methods (implicitly showing no new safety/effectiveness questions). See "Substantial Equivalence Comparison of Key Characteristics" table for comparison. |
| Configuration | Comparable to predicate devices (multi-layered like secondary predicate, contact layer like primary). | Comparisons provided in the "Substantial Equivalence Comparison of Key Characteristics" table. |
| Sterility | Provided sterile by irradiation. | "Provided sterilized by irradiation (gamma)." (Comparable to predicates.) |
| Duration of Use | Up to 7 days. | "Up to 7 days." (Identical to predicate devices.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size for a test set" in the context of clinical data. The studies conducted are primarily benchtop and in-vitro (biocompatibility, antibacterial effectiveness) rather than human clinical trials.
- Biocompatibility testing: This typically involves a range of in-vitro and in-vivo tests using animal models or cell cultures, adhering to ISO 10993 standards. Specific sample sizes for these tests are not provided but are assumed to follow standard regulatory guidelines for such testing.
- Antibacterial effectiveness testing (AATCC TM 100): This is an in-vitro laboratory test. The number of samples tested is not specified but would follow the methodology of the standard.
There is no mention of human subject data, and therefore no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the studies described. The ground truth for biocompatibility and antibacterial effectiveness is established by the standardized methods and accepted scientific principles of those tests, not by expert consensus on clinical cases.
4. Adjudication Method for the Test Set
This is not applicable. There is no mention of a human-read test set requiring adjudication in this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical characteristics and compliance with benchtop/in-vitro standards, not on human reader performance with or without AI assistance. This device is a wound dressing, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not a software/AI device, so this concept is not applicable.
7. The type of ground truth used
For the safety and performance data presented:
- Biocompatibility: Ground truth is established by adherence to ISO 10993 series standards and FDA guidance, meaning the biological response observed (e.g., lack of cytotoxicity, irritation) is the "ground truth" relative to the standard's criteria.
- Antibacterial effectiveness: Ground truth is established by the quantifiable reduction in bacterial growth as measured by the AATCC TM 100 method.
There is no clinical "ground truth" (pathology, expert consensus, outcomes data) derived from human subjects for this submission.
8. The sample size for the training set
This is not applicable. The device is a physical wound dressing, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
December 10, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Vomaris Wound Care, Inc. Charmaine Sutton Head of Regulatory and Quality 1911 East Fifth Street Tempe, Arizona 85281
Re: K180533
Trade/Device Name: Procellera Composite Antibacterial Wound Dressing (also Helix Composite Antibacterial Wound Dressing and Jumpstart Composite Antibacterial Wound Dressing) Regulatory Class: Unclassified Product Code: FRO Dated: September 7, 2018 Received: September 10, 2018
Dear Charmaine Sutton:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lixim Diu
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K180533
Device Name
Procellera Composite Antibacterial Wound Dressing (also Helix Composite Antibacterial Wound Dressing and Jumpster Composite Antibacterial Wound Dressing)
Indications for Use (Describe)
Rx Indications for Use:
For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.
OTC Indications for Use:
For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary for Procellera® Composite Antibacterial Wound Dressing
Prepared December 7, 2018
Submitter
| Manufacturer: | Contact Person: |
|---|---|
| Vomaris Wound Care, Inc. | Charmaine Sutton |
| 1911 East Fifth Street | Head of Regulatory and Quality |
| Tempe, AZ 85281 | (480) 921-4948 Ext. 2253 |
| 480-921-4948 | e-mail: regulatory@vomaris.com |
General Information
| Trade Name: | Procellera Composite Antibacterial Wound Dressing(also Helix Composite Antibacterial Wound Dressing andJumpstart Composite Antibacterial Wound Dressing) |
|---|---|
| Common / Usual Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Product Code and Classification: | FRO, Unclassified |
| Primary Predicate Device: | Procellera Antimicrobial Wound Dressing(K160783, K130350, K081977, K060237) |
| Secondary Predicate Device: | Silverlon Island Wound Dressing (K143001) |
Intended Use
For professional use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and fullthickness wounds such as pressure ulcers, venous ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.
For over-the-counter use, Procellera Composite Antibacterial Wound Dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.
Device Description
Procellera Composite Antibacterial Wound Dressing is a three-layer dressing comprising a broadspectrum antibacterial contact layer (Procellera), a polyester-based absorbent layer, and a polyurethane semi-occlusive outer adhesive layer to keep the dressing in place and help maintain a moist wound environment. The dressing is offered in various shapes and elbow/shoulder dressings are prescription use only, while the square, rectangular and round shaped dressings are for both prescription and over-the-counter use.
{4}------------------------------------------------
Embedded in the dressing are microcell batteries made of elemental zinc applied in a dot-matrix pattern to a polyester substrate. In the presence of a conductive medium such as wound exudate, water-based wound hydrogels, saline, or water, microcurrents are generated at the dressing surface due to its inherent design. Silver and zinc in the dressing help to preserve it and minimize or prevent the growth of bacteria within the dressing.
Procellera Composite Antibacterial Wound Dressing may be used with other common wound treatment products such as sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to local clinical protocols.
Technological Characteristics
Procellera Composite Antibacterial Wound Dressing is a multi-layer wound dressing with built-in polyester-based absorbent and polyurethane adhesive layers to keep it in place and help maintain a moist wound environment. The wound contact layer of the subject device is identical to the Procellera Antimicrobial Wound Dressing. Elemental silver and elemental zinc are bound to the surface of a polyester substrate in a well-characterized dot matrix pattern. In the presence of a conductive medium, such as wound exudate, water-based wound hydrogels, saline, or water, microcurrents are generated at the surface of the device, and this occurs because it is inherent to the design.
Safety and Performance Data
Procellera Composite Antibacterial Wound Dressing was tested in accordance with applicable parts of the ISO 10993: Biological Evaluation of Medical Devices standard and found to be biocompatible. Additional tests recommended by FDA guidance Use of International Standard ISO 10993-1 were also performed. Testing included: cytotoxicity, intracutaneous irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity and implantation.
Procellera Composite Antibacterial Wound Dressing was tested per AATCC TM 100: Assessment of Antibacterial Finishes on Textile Materials and demonstrated broad-spectrum antibacterial effectiveness within the dressing.
Substantial Equivalence Discussion
The intended use, wound contact layer and antibacterial technology of Procellera Composite Antibacterial Wound Dressing are identical to the primary predicate single layer Procellera Antimicrobial Wound Dressing cleared under K160783 and its predecessors. The composite configuration with multiple functional layers is equivalent to the secondary predicate Silverlon Island Wound Dressing. The impact of the new materials in Procellera Composite Antibacterial Wound Dressing were evaluated through standardized test methods. The tests raised no new questions of safety or effectiveness. Key characteristics of the subject and predicate devices are compared in the table below. Procellera Composite Antibacterial Wound Dressing is substantially equivalent to the legally marketed predicate devices.
{5}------------------------------------------------
Table: Substantial Equivalence Comparison of Key Characteristics
| Subject Device | Primary Predicate | Secondary Predicate | |
|---|---|---|---|
| Procellera Composite | Procellera | Silverlon | |
| Antibacterial | Antimicrobial | Island | |
| Wound Dressing | Wound Dressing | Wound Dressing | |
| (K180533) | (K160783) | (K143001) | |
| Vomaris Wound Care, Inc. | Vomaris Wound Care, Inc. | Argentum Medical, LLC. | |
| Phoenix, AZ, USA | Phoenix, AZ, USA | Geneva, IL, USA | |
| Indicationsfor Use (Rx) | Intended for the management of wounds to provide a moist wound environment and indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc. | Intended for the management of wounds to provide a moist wound environment and indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc. | Under the supervision of a healthcare professional Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions), and partial to full thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). Silverlon® Island Wound Dressings and Silverlon® Wound Pad 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® Island Wound Dressing and Silverlon® Wound Pad Dressing may help reduce the risk of wound infection and support the body's healing process. Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressings may be used for the management of painful wounds. Silverlon® Island Wound Dressings and Silverlon® Wound Pad Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may soothe the wound. |
{6}------------------------------------------------
| Subject Device | Primary Predicate | Secondary Predicate | ||||
|---|---|---|---|---|---|---|
| Procellera CompositeAntibacterialWound Dressing(K180533)Vomaris Wound Care, Inc.Phoenix, AZ, USA | ProcelleraAntimicrobialWound Dressing(K160783)Vomaris Wound Care, Inc.Phoenix, AZ, USA | SilverlonIslandWound Dressing(K143001)Argentum Medical, LLC.Geneva, IL, USA | ||||
| Indicationsfor Use (OTC) | Intended for the managementof wounds to provide a moistwound environment andindicated for superficialwounds such as minor cuts,scrapes, irritations, abrasions,blisters, etc. | Intended for the management ofwounds to provide a moist woundenvironment and indicated forsuperficial wounds such as minorcuts, scrapes, irritations,abrasions, blisters, etc. | Local management of superficialwounds, minor burns, abrasionsand lacerations. | |||
| Materials | Procellera polyester substratecontaining elemental silver andelemental zinc.Absorbent polyester- basedmaterial.Outer polyurethane layer withacrylate adhesive. | Procellera polyester substratecontaining elemental silver andelemental zinc. | Knitted continuous nylon fibercoated with metallic silver.Absorbent laminate pad.Polyester layer with acrylicadhesive.Polyethylene / HDPE films. | |||
| Configuration | Multi-layered; primary layerthat contacts the wound bed,followed by an absorbentlayer, then an adhesive tapelayer. | Single layer that contacts thewound bed. Used in combinationwith secondary dressing(s)selected by the user to absorb andfix the dressing in place. | Multi-layered; primary layer thatcontacts the wound bed,followed by an absorbent layer,then an adhesive tape layer. Twofilms are used to bond thesefunctional layers together. | |||
| Sterility | Provided sterilized byirradiation (gamma). | Provided sterilized by irradiation(e-beam). | Provided sterile. | |||
| Shapes andSizes (inches) | SquareRectangularRoundKneeElbow /Shoulder | 4 x 45 x 64.5 x 104 D, 2.5 D6 x 11.54.2 x 7.54.4 x 9.6 | SquareRectangular | 1 x 1, 2 x 2,3 x 3, 4 x 4,8 x 8,12 x 121.5 x 8,1.5 x 10,2 x 5, 4 x 8 | SquareRectangular | 4 x 46 x 64 x 64 x 104 x 124 x 14 |
| Durationof Use | Up to 7 days | Up to 7 days | Up to 7 days | |||
| Safety | Biocompatiblein compliance withISO 10993 | Biocompatiblein compliance withISO 10993 | Biocompatiblein compliance withISO 10993 | |||
| PerformanceCharacteristics | Antibacterial effectiveness(AATCC TM 100)Fluid managementConformabilityAdhesion | Antimicrobial effectiveness(AATCC TM 100) | Antimicrobial effectiveness(Kirby-Bauer; ASTM E2315)Fluid managementConformabilityAdhesion |
N/A