(140 days)
Not Found
No
The device description focuses on the material composition and the generation of microcurrent through the interaction of silver, zinc, and wound exudate. There is no mention of AI, ML, image processing, or data analysis for diagnosis or treatment. The performance studies described are related to voltage generation and biocompatibility, not algorithmic performance.
Yes
The device is intended for the management of wounds and provides a moist wound environment, indicating it has a direct therapeutic effect on the body.
No
The device is described as a wound dressing intended for the management of wounds by providing a moist wound environment and producing microcurrent. Its function is to treat or manage wounds, not to diagnose conditions.
No
The device description clearly states it is a "single layer dressing" consisting of a "polyester substrate containing elemental silver and elemental zinc," which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for managing wounds and providing a moist wound environment. It is applied directly to the wound.
- Device Description: The description details a physical dressing with elemental silver and zinc that produces a microcurrent in the presence of fluid. This mechanism is related to wound healing and preservation of the dressing, not to diagnosing a condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are designed to provide information about a patient's health status through in vitro testing.
The device is a therapeutic wound care product, not a diagnostic tool.
N/A
Intended Use / Indications for Use
For over-the-counter use, Procellera® 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.
For prescription 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/or recipient graft sites, etc.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Procellera® is a single layer 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, and it occurs because it is inherent to its design. The device is self-contained and has no accessories.
Silver and zinc in the dressing produce microcurrent which helps the dressing to be preserved and to minimize or prevent growth of microorganisms within 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.
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)
Voltage potential testing was performed in-house and 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.
The device was tested per ISO 10993 and found to be biocompatible. Testing included: cytotoxicity, irritation, sensitization, pyrogenicity, and 28-day subcutaneous implantation.
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.
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
N/A
0
Vomaris Innovations, Inc. 3100 W. Ray Rd, Suite 148, Chandler, AZ 85226 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948
510(k) Summary for Procellera® Device for Over-The-Counter Use
510(k) # K130350
JUL 2 2013
Device Name: Procellera® Wound Dressing
Trade Name: Procellera®
Common Name: Wound Dressing
Product Code: FRO
Predicate Devices: Procellera® wound dressing (K081977) CMB™ dressing (K060237)
Device Description:
Procellera® is a single layer 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, and it occurs because it is inherent to its design. The device is self-contained and has no accessories.
Silver and zinc in the dressing produce microcurrent which helps the dressing to be preserved and to minimize or prevent growth of microorganisms within 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.
Intended Use:
For over-the-counter use, Procellera® 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.
1
Vomaris Innovations. Inc. 3100 W. Ray Rd. Suite 148. Chandler. AZ 85226 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948
Technological Characteristics:
Procellera® device is identical to the device cleared under 510(k) K060237 and K081977.
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:
Voltage potential testing was performed in-house and 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.
Biocompatibility Data
The device 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® device 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:
Jeffry B. Skiba - CTO Vomaris Innovations, Inc. 3100 W. Ray Rd. Suite 148, Chandler, AZ 85226 Phone: 480-921-4948 Fax: 480-921-0948
Date: June 19th , 2013
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 2, 2013
Vomaris Innovations. Inc. % Mr. Jeff Skiba Chief Technology Officer 3100 West Ray Road, Suite 148 Chandler, Arizona 85226
Re: K130350
Trade/Device Name: Procellera Antimicrobial Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 12, 2013 Received: April 22, 2013
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Jeff Skiba
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
FOR Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Vomaris Innovations, Inc. 3100 W. Ray Rd, Suite 148, Chandler, AZ 85226 www.procellera.com Phone: 480-921-4948 Fax: 480-921-0948
Indications for Use - Procellera® Prescription Use Device
510(k) Number: K130350
Device Name: Procellera® Antimicrobial Wound Dressing
Indications for Use:
For prescription 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/or recipient graft sites, etc.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130350
Page __ of
5
Indications for Use - Procellera® Over-The-Counter Use Device
510(k) Number: K130350
Device Name: Procellera® Wound Dressing
Indications for Use:
For over-the-counter use, Procellera® 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130350
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