(169 days)
No
The device description and performance studies focus on the physical and chemical properties of the wound dressing (silver and zinc content, voltage generation) and its antimicrobial efficacy in vitro. There is no mention of AI, ML, image processing, or data analysis related to wound assessment or treatment decisions.
Yes
The device is intended for the management of wounds and provides a moist wound environment, which are therapeutic actions. It is used to treat partial and full-thickness wounds, including pressure ulcers, diabetic ulcers, and burns, indicating a therapeutic purpose.
No
Explanation: The device is described as an antimicrobial wound dressing intended for the management of wounds to provide a moist wound environment. Its function is to cover and protect wounds and inhibit microbial growth within the dressing, not to identify or characterize a disease or condition.
No
The device description clearly states it is a physical wound dressing made of polyester containing elemental silver and zinc. It is a tangible product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds to provide a moist wound environment and is indicated for various types of wounds. This is a therapeutic or wound care application, not a diagnostic one.
- Device Description: The device is a wound dressing designed to be applied directly to the wound. It contains silver and zinc as preservatives within the dressing to inhibit microbial growth on the dressing itself, not to diagnose or test for microorganisms in the wound or the patient.
- Lack of Diagnostic Function: The description focuses on the physical properties of the dressing and its ability to generate a small current in the presence of fluid. This current is related to the device's design and potential mechanism of action as a wound dressing, not for diagnosing a condition or analyzing a sample from the body.
- Performance Studies: The performance studies mentioned are in-vitro antimicrobial efficacy testing (related to the preservation of the dressing) and voltage potential testing (related to the device's physical properties). These are not diagnostic performance studies (like sensitivity, specificity, etc.).
- No Mention of Sample Analysis: IVD devices typically involve the analysis of samples taken from the human body (blood, urine, tissue, etc.) to provide information about a person's health. This device is applied to the wound itself and does not involve the collection or analysis of such samples for diagnostic purposes.
In summary, the Procellera® antimicrobial wound dressing is a therapeutic device intended for wound management, not a diagnostic device used to test for or diagnose a condition.
N/A
Intended Use / Indications for 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, 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, irritations, abrasions, blisters, etc.
Product codes
FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (partial and full-thickness, superficial)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use; Over-the-counter use
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
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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
2
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)
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.
| 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."
3
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)
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.
| 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."
4
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:
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.
5
Vomaris Innovations, Inc. 1911 East Fifth Street, Tempe, AZ 85281 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948
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.
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.
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, irritations, abrasions, blisters, 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
6
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