Predicate Devices

K160783, K130350, K081977, K060237, K143001

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical and chemical properties of the wound dressing and the generation of microcurrents. There is no mention of AI, ML, or any computational processing of data for decision-making or analysis.

Therapeutic

Yes.
The device is a wound dressing intended for the management of various partial and full-thickness wounds, including pressure ulcers, diabetic ulcers, and burns, as well as superficial wounds like cuts and scrapes, which are therapeutic medical conditions.

Diagnostic

No

The device is a wound dressing intended for the management of wounds to provide a moist wound environment. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical wound dressing with multiple layers, embedded microcell batteries, and materials like polyester, polyurethane, zinc, and silver. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, 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.
Device Description: The description clearly states that Procellera Composite Antibacterial Wound Dressing is a wound dressing applied externally to the skin to manage wounds. It works by providing a moist wound environment and generating microcurrents in the presence of wound exudate.
Intended Use: The intended use is for the management of various types of wounds, which is a topical application, not an in vitro test.

The device is a wound care product, not a diagnostic test performed on a sample outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FRO

Device Description

Procellera Composite Antibacterial Wound Dressing is a three-layer dressing comprising a broad-spectrum 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.

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)

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.

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.

K160783, K130350, K081977, K060237, K143001

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

Regulation Number and Section

N/A

Summary

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

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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)

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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 and
Jumpstart 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.

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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
Indications
for 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.

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Subject Device	Primary Predicate	Secondary Predicate
Procellera Composite
Antibacterial
Wound Dressing
(K180533)
Vomaris Wound Care, Inc.
Phoenix, AZ, USA	Procellera
Antimicrobial
Wound Dressing
(K160783)
Vomaris Wound Care, Inc.
Phoenix, AZ, USA	Silverlon
Island
Wound Dressing
(K143001)
Argentum Medical, LLC.
Geneva, IL, USA
Indications
for Use (OTC)	Intended for the management
of wounds to provide a moist
wound environment and
indicated for superficial
wounds such as minor cuts,
scrapes, irritations, abrasions,
blisters, etc.	Intended for the management of
wounds to provide a moist wound
environment and indicated for
superficial wounds such as minor
cuts, scrapes, irritations,
abrasions, blisters, etc.	Local management of superficial
wounds, minor burns, abrasions
and lacerations.
Materials	Procellera polyester substrate
containing elemental silver and
elemental zinc.
Absorbent polyester- based
material.
Outer polyurethane layer with
acrylate adhesive.	Procellera polyester substrate
containing elemental silver and
elemental zinc.	Knitted continuous nylon fiber
coated with metallic silver.
Absorbent laminate pad.
Polyester layer with acrylic
adhesive.
Polyethylene / HDPE films.
Configuration	Multi-layered; primary layer
that contacts the wound bed,
followed by an absorbent
layer, then an adhesive tape
layer.	Single layer that contacts the
wound bed. Used in combination
with secondary dressing(s)
selected by the user to absorb and
fix the dressing in place.	Multi-layered; primary layer that
contacts the wound bed,
followed by an absorbent layer,
then an adhesive tape layer. Two
films are used to bond these
functional layers together.
Sterility	Provided sterilized by
irradiation (gamma).	Provided sterilized by irradiation
(e-beam).	Provided sterile.
Shapes and
Sizes (inches)	Square
Rectangular
Round
Knee
Elbow /
Shoulder	4 x 4
5 x 6
4.5 x 10
4 D, 2.5 D
6 x 11.5
4.2 x 7.5
4.4 x 9.6	Square