For professional use. Procellera® antimicrobial 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, diabetic ulcers, first and second degree burns, surgical incisions, donor and recipient graft sites, etc.

For over-the-counter use, Procellera® antimicrobial 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, blisters, etc.

Device Description

Procellera® is a single layer, broad-spectrum antimicrobial wound dressing: it consists of a polyester substrate containing elemental silver and elemental zinc bound to the surface by a biocompatible binder in a well-characterized dot matrix pattern.

In the presence of a conductive fluid, such as wound exudate or moisture, a small amount of current is produced at the surface of the device, due to its inherent design. The device is self-contained and has no accessories.

Procellera® contains Silver and Zinc as preservatives to the dressing, to minimize or prevent the growth of microorganisms within the dressing, not at the wound site, and to help preserve the dressing.

Procellera® is a primary contact layer dressing and it should be used under a secondary dressing or bandage, which keeps it in place and helps maintain a moist wound environment. Procellera® may be used with other common wound treatment products such as, sutures, staples, liquid skin adhesives, or steri-strips as an adjunct to the local clinical protocols.

AI/ML Overview

This document is a 510(k) premarket notification for the Procellera Antimicrobial Wound Dressing, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs for performance, number of experts for ground truth, and training set details are not explicitly present in the provided text.

Based on the information provided, here's an attempt to answer your questions:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, etc.) typically seen for diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied by the demonstration of:

Substantial Equivalence: The primary objective is to show the device is as safe and effective as legally marketed predicate devices.
Biocompatibility: Meeting ISO 10993 standards.
Antimicrobial Efficacy (in-vitro within the dressing): Previously cleared for prescription use.
Voltage Potential: Generation of sustained, measurable voltage.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices	Concluded to be as safe, as effective, and performs as well as the predicate devices (Procellera® K130350, Procellera® K081977, CMBTM Antimicrobial Dressing K060237), which are identical to the current device prior to labeling for OTC use.
Biocompatibility	Tested per ISO 10993 and found to be biocompatible (including cytotoxicity, irritation, sensitization, pyrogenicity, and 28-day subcutaneous implantation).
Broad-Spectrum in-vitro Antimicrobial Efficacy	Previously submitted to FDA and resulted in clearance for prescription use with an antimicrobial claim. Silver and zinc in the dressing inhibit growth of microorganisms within the dressing. The same data applies to OTC use as products are identical.
Sustained Voltage Generation (Device Mechanism)	Voltage potential testing confirmed that a sustained, measurable voltage is generated on the surface of the device for up to 30 days when immersed in a conductive fluid. (Note: Device use is for up to 7 days, or longer by clinician discretion, and safety beyond 28 days not studied).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "in-vitro antimicrobial efficacy testing" and "voltage potential testing." These are laboratory/benchtop tests, not clinical studies involving human patient samples. Therefore, the concept of "sample size for a test set" in the context of human data is not applicable here. The "data provenance" would be laboratory data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable. The evaluations are based on laboratory testing (in-vitro efficacy, biocompatibility, voltage potential), not expert interpretation of clinical data where a ground truth would be established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies with expert reviewers, which is not the type of study described here.

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 MRMC study was done, as this device is a wound dressing, not an AI-assisted diagnostic tool or an imaging device that involves human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation in this context is based on:

Laboratory measurements/standards: For biocompatibility (ISO 10993), in-vitro antimicrobial efficacy (presumably against standard microbial cultures), and electrical properties (voltage measurement).
Predicate devices: The "ground truth" for substantial equivalence is the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning model. The studies described are performance tests of the physical device.

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for this type of device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care or protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2016

Vomaris Innovations, Inc. Mr. Timothy Joiner Head Of Quality And Regulatory 1911 E. 5th St Tempe, Arizona 85281

Re: K160783

Trade/Device Name: Procellera Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 26, 2016 Received: July 28, 2016

Dear Mr. Joiner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160783

Device Name Procellera Antimicrobial Wound Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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."

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160783

Device Name Procellera Antimicrobial Wound Dressing

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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.

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."

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VOMARIS

Vomaris Innovations, Inc. 1911 East Fifth Street, Tempe, AZ 85281 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948

510(k) Summary for Procellera® Device

Date: July 11, 2016

Device Name: Procellera®

Trade Name: Procellera® Antimicrobial Wound Dressing

Common Name: Wound Dressing

Product Code: FRO

Predicate Device(s):

Procellera® Antimicrobial Wound Dressing (K130350)
Procellera® Antimicrobial Wound Dressing (K081977)
o CMBTM Antimicrobial Dressing (K060237)

Reference Device(s):

K062212, Silver Shield Antimicrobial Skin and Wound Gel
K070333, AcryDerm OTC Silver Antimicrobial Wound Gel
K083103, AcryDerm Antimicrobial Silver Wound Gel ●

Device Description:

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Vomaris Innovations, Inc. 1911 East Fifth Street, Tempe, AZ 85281 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948

Intended Use:

For professional use, Procellera® antimicrobial 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.

Technological Characteristics:

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 fluid, such as wound exudate or moisture, a small amount of current is produced at the surface of the device, and it occurs because it is inherent to its design.

Performance Data:

Performance data was gathered through in-vitro antimicrobial efficacy testing and voltage potential testing.

Broad-Spectrum in-vitro antimicrobial efficacy testing previously submitted to FDA resulted in clearance of Procellera® Antimicrobial Wound Dressing for prescription use

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Vomaris Innovations, Inc. 1911 East Fifth Street, Tempe, AZ 85281 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948

with an Antimicrobial claim. Silver and zinc in the dressing inhibit growth of microorganisms within the dressing. Neither the silver nor zinc preservatives provide any antimicrobial action in or on the wound.

The same data and results are applicable to Procellera® Antimicrobial Wound Dressing for OTC use as the products are identical and indistinguishable prior to labeling.

Voltage potential testing confirmed that a sustained, measurable voltage is generated on the surface of the device for up to 30 days when immersed in a conductive fluid. However, Procellera may only be left in place for up to 7 days (or longer, at the discretion and instruction of the treating clinician) and the safety of daily Procellera use for longer than 28 days has not been studied.

Biocompatibility Data:

Procellera® Antimicrobial Wound Dressing was tested per ISO 10993 and found to be biocompatible. Testing included: cytotoxicity, irritation, sensitization, pyrogenicity, and 28-day subcutaneous implantation.

Conclusion:

Based on the information provided herein, we conclude that Procellera® Antimicrobial Wound Dressing is as safe, as effective, and performs as well as the predicate devices, which are identical, and thus is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

Contact:

Timothy Joiner Director, Quality Assurance & Regulatory Affairs 1911 East Fifth Street, Tempe, Arizona, 85281 480-921-4948 Timothy.Joiner@Vomaris.com

Regulation Number and Section

N/A