For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.
For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

Device Description

Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design. In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

AI/ML Overview

The provided 510(k) summaries for Procellera™ (both professional and over-the-counter use) do not describe specific acceptance criteria in terms of quantitative performance metrics, nor do they detail a study designed to prove the device meets such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing - K060237) based on technological characteristics and general performance data relevant to safety and biocompatibility.

Here's an analysis based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated as Quantitative Metrics. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar technological characteristics and acceptable performance in areas of safety and effectiveness.	Technological Equivalence to Predicate Device: "Procellera™ and the predicate device (CMB™ Antimicrobial Wound Dressing) are identical. Procellera™ is the same device as the predicate CMB™." Performance Data Categories: Antimicrobial testing Animal testing Bench testing Biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, 28-day subcutaneous implantation)

Acceptance Criteria

Reported Device Performance

Not Explicitly Stated as Quantitative Metrics. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar technological characteristics and acceptable performance in areas of safety and effectiveness.

Technological Equivalence to Predicate Device: "Procellera™ and the predicate device (CMB™ Antimicrobial Wound Dressing) are identical. Procellera™ is the same device as the predicate CMB™." Performance Data Categories: Antimicrobial testing Animal testing Bench testing Biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, 28-day subcutaneous implantation)

Detailed Breakdown of Study Information (Based on Available Text):

The provided text describes the type of performance data gathered, but does not detail the specifics of studies that would allow for the reconstruction of a typical acceptance criteria table and performance comparison as requested for a diagnostic or AI device.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "antimicrobial, animal, bench and biocompatibility testing" but does not provide sample sizes, study designs (prospective/retrospective), or data provenance for these tests.
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):
- Not applicable. The tests described are laboratory and animal-based performance tests (e.g., biocompatibility, antimicrobial activity), not studies requiring expert interpretation of diagnostic data to establish ground truth in the way a clinical study for a diagnostic algorithm would.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies involving human observers and their interpretations, not to the types of performance tests described (e.g., in vitro antimicrobial assays, biocompatibility tests).
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:
- Not applicable. This device is a wound dressing, not a diagnostic algorithm or an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its clearance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is a wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data mentioned would be established by the standard scientific and regulatory protocols for the specific tests performed:
  - Antimicrobial testing: Likely based on standardized microbiological assays (e.g., bacterial reduction, zone of inhibition) with objective measurements.
  - Animal testing: Likely based on objective physiological responses and observations in animal models.
  - Bench testing: Objective measurements against predefined physical or chemical properties.
  - Biocompatibility testing: Compliance with ISO 10993 standards, using objective measurements of cellular response, systemic effects, and local tissue reactions. The "ground truth" here is the adherence to these accepted standards.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm is involved.

Summary of Device Acceptance:

The acceptance of Procellera™ for marketing was based on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing, K060237) under the 510(k) pathway. This means the FDA concluded that Procellera™ is as safe and effective as the predicate device. The evidence provided for this conclusion consisted of:

Identical Technological Characteristics: The Procellera™ is explicitly stated to be "the same device as the predicate CMB™."
Performance Data: General categories of testing were conducted (antimicrobial, animal, bench, and various biocompatibility tests following established guidelines). These tests are aimed at supporting the safety and effectiveness claim by demonstrating the device performs as expected for a wound dressing and does not pose undue risks.

The 510(k) summaries do not present quantitative acceptance criteria or detailed results from specific studies in a format typically seen for devices that require complex performance metrics (e.g., sensitivity, specificity for diagnostic devices). Instead, the regulatory pathway relies on the direct comparison to an already cleared device and general safety assessments.

Summary

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081977 page 101

Procellera™ (for Professional Use) 510(k) Summary of Safety and Effectiveness

Procellera™ is a single layer dressing consisting of the worker 510(K) Summary absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder.

For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

Procellera™ New Device Name:

CMB Antimicrobial Dressing (K060237) Predicate Device Name:

Device Description Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polvester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design.

In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

For professional use, Procellera™ antimicrobial wound dressing is Indications indicated for partial and full-thickness wounds such as: pressure Statement ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

Technologically, Procellera™ and the predicate device (CMB™ Technological Antimicrobial Wound Dressing) are identical. Procellera™ is the Characteristics same device as the predicate CMB™.

A small amount of current is produced and it occurs because it is inherent to the design.

Performance Performance data were gathered via antimicrobial, animal, bench and biocompatibility testing. Biocompatibility tests performed on the Data cytotoxicity, irritation, sensitization. Procellera™: included 28 day subcutaneous pvrogenicity, systemic injection, and implantation.

Based on the 510(k) summaries and the 510(k) statements (21 CFR Conclusions 807) and the information and performance data provided herein, we conclude that the Procellera™ is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

Contact

Jeffry Skiba Vomaris Innovations Inc. 3100 W Ray Rd, Suite 148 Chandler, AZ 85226 Phone: 480-921-4948 Fax: 480-921-0948

Date

November 19, 2008

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Procellera™ (for Over The Counter Use)

510(k) Summary of Safety and Effectiveness

510(K) Summary Procellera™ is a single laver dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder.

For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

Procellera™ New Device Name:

Predicate Device Name: CMB Antimicrobial Dressing (K060237)

Device Description Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multifilament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design.

In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.

over-the-counter use, Procellera™ wound dressing is Indications For indicated for minor cuts, scrapes, irritations, and abrasions. Statement

Technologically, Procellera™ and the predicate device (CMB™ Technological Antimicrobial Wound Dressing) are identical. Procellera™ is the Characteristics same device as the predicate CMB™.

A small amount of current is produced and it occurs because it is inherent to the design.

Performance Data

Performance data were gathered via antimicrobial, animal, bench and biocompatibility testing. Biocompatibility tests performed on the Procellera™: included cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, and 28 day subcutaneous implantation.

Conclusions

Based on the 510(k) summaries and the 510(k) statements (21 CFR 807) and the information and performance data provided herein, we conclude that the Procellera™ is substantially equivalent to the existing legally marketed devices under the Federal Food, Drug and Cosmetic Act.

Contact

Jeffry Skiba Vomaris Innovations Inc. 3100 W Ray Rd, Suite 148 Chandler, AZ 85226 Phone: 480-921-4948 Fax: 480-921-0948

Date

November 19, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of a bird-like figure.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 1 2008

Vomaris Innovations, Inc. % Mr. Jeff Skiba President 3100 W Ray Road, Suite 148 Chandler, Arizona 85226

Re: K081977

Trade/Device Name: Procellera™ Regulatory Class: Unclassified Product Code: FRO Dated: October 23, 2008 Received: October 24, 2008

Dear Mr. Skiba:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Mr. Jeff Skiba

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known):

K081977

Device Name:

Procellera™

Indications for Use:

· For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X or

Over-The-Counter Use

(Optional Format 1-2-96)
Nul Reeds

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

081 લે ની 510(k) Number

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Statement of Indications for Use

510(k) Number (if known):

K081977

Device Name:

Procellera™

Indications for Use:

For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use.

(Optional Format 1-2-96)

xm (Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

N/A