(155 days)
No
The device description and performance studies focus on the antimicrobial properties and biocompatibility of a wound gel, with no mention of AI or ML technologies.
No
The device is described as a wound filler for minor skin injuries, which functions as an antimicrobial barrier rather than providing therapeutic treatment for a disease or condition.
No
Explanation: The device is an antimicrobial wound gel intended for treating existing wounds, not for diagnosing medical conditions. Its performance studies focus on antimicrobial barrier activity and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a "moist amorphous gel wound filler" supplied in "collapsible blind ended heat sealed co-laminate tubes," indicating it is a physical 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 topical application to intact and broken skin and dermal injuries. This is a direct treatment or management of a wound, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a wound gel containing antimicrobial silver. This is a therapeutic product applied externally.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. The performance studies focus on antimicrobial activity and biocompatibility, which are relevant to a topical wound treatment.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.
Product codes
FRO
Device Description
AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.
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)
The antimicrobial barrier activity of the new product has been established by the Kirby-Bauer zone of inhibition test. In addition, the new product conforms with the USP Preservative Challenge Test performed against the strains of organisms specified in the USP Preservative Challenge Test protocol. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
Antimicrobial barrier activity has been demonstrated by Kirby-Bauer zone of inhibition assays against a broad spectrum of bacteria and fungi including: Staphylococcus epidermitis, E. coli, Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), Candida albicans, and Enterococcus faecium, Klebsiella pneumoniae (3 strains), Candida parapsilosis, Candida galbrata , Bacillus subtilis, Enterobacter cloacae (2 strains), Enterococcus faecalis (2 strains), Aspergillus niger, Serratia marcescens, Citrobacter diversus, Citrobacter kasseri, Staphylococcus saprophyticus, Epidermophyton sp., Microsporum sp., and Tricophyton sp. The silver antimicrobial wound gel has been shown by in vitro serial transfer testing to maintain a barrier function for more than 3 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc., OR), SilverMed Antimicrobial Silver Hydrogel (Argentis Biomedical, Tx), Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., Ca)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K070333
page 1 of 2
510(k) Summary
| Contact Person: | Bruce L. Gibbins, PhD | |
|---|---|---|
| Date of preparation: | January 26, 2007 | JUL 10 2007 |
| Device Name (proprietary): | AcryDerm OTC Silver Antimicrobial Wound Gel | |
| Common Name: | Moist antimicrobial wound filler | |
| Classification Name: | Hydrophilic wound dressing | |
| Classification: | Unclassified |
Legally marketed device(s) for substantial equivalence comparison:
AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc., OR)
SilverMed Antimicrobial Silver Hydrogel (Argentis Biomedical, Tx)
Silver Shield Antimicrobial Skin and Wound Gel (Anacapa Tech., Inc., Ca)
Description of Device: AcryDerm Silver Antimicrobial OTC Wound Gel is a moist amorphous gel wound filler that contains antimicrobial silver. It is supplied in collapsible blind ended heat sealed co-laminate tubes fitted with screw caps.
Intended Use of the Device: AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrap and minor surgical procedures.
Technological Characteristics: AcryDerm Silver Antimicrobial OTC Wound Gel is a repeatuse antimicrobial barrier amorphous gel wound cover that contains ionic silver. Antimicrobial barrier activity has been demonstrated by Kirby-Bauer zone of inhibition assays against a broad spectrum of bacteria and fungi including: Staphylococcus epidermitis, E. coli, Pseudomonas aeruginosa, Staphylococcus aureus (MRSA), Candida albicans, and Enterococcus faecium, Klebsiella pneumoniae (3 strains), Candida parapsilosis, Candida galbrata , Bacillus subtilis, Enterobacter cloacae (2 strains), Enterococcus faecalis (2 strains), Aspergillus niger, Serratia marcescens, Citrobacter diversus, Citrobacter kasseri, Staphylococcus saprophyticus, Epidermophyton sp., Microsporum sp., and Tricophyton sp. The silver antimicrobial wound gel has been shown by in vitro serial transfer testing to maintain a barrier function for more than 3 days.
Manufacturing: AcryDerm Silver Antimicrobial OTC Wound Gel will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe, effective, and correctly labeled for its intended use.
Performance testing: The antimicrobial barrier activity of the new product has been established by the Kirby-Bauer zone of inhibition test. In addition, the new product conforms with the USP Preservative Challenge Test performed against the strains of organisms specified in the USP
Vlio
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Preservative Challenge Test protocol. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
Purpose for this Submission
This application is being made in order to gain clearance to market a previously cleared product for Over The Counter (OTC) distribution. The product AcryDerm Silver Antimicrobial Wound Gel received clearance to market (K011994) and has been in continuous distribution since 2002 as a prescription only product. The complaint history, biocompatibility, safety, and performance in a wound healing study show that it would be safe for wider and more direct access of this product by patients. Clearance to OTC distribution is respectfully sought in this application.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right. To the left of the symbol is text arranged in a circular fashion, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AcryMed, Inc. % Bruce Gibbons, PhD Chief Technology Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008
JUL 1 0 2007
Re: K070333
Trade/Device Name: AcryDerm Silver Antimicrobial OTC Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: June 5, 2007 Received: June 20, 2007
Dear Dr. Gibbons:
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 (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.
3
Page 2 - Bruce Gibbons, PhD
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
For Pels R
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Rum
Dip O.A
7/10/07
Enclosure
4
| 510(k) NUMBER (IF KNOWN): | K070333 |
|---|---|
| DEVICE NAME: | AcryDerm Silver Antimicrobial OTC Wound Gel |
INDICATIONS FOR USE:
AcryDerm Silver Antimicrobial OTC Wound Gel is intended for use on intact and broken skin and dermal injuries such as minor laceration, cuts, burns, scrapes and minor surgical procedures wounds.
Prescription use (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1)
of
Page
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
pation (ODE) Office of Device Concurrence of CDRH,
(Division. Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ LG T 6333