(327 days)
Not Found
No
The 510(k) summary describes a hydrogel dressing with antimicrobial properties and does not mention any AI or ML components. The performance studies focus on biocompatibility and antimicrobial effectiveness, not algorithmic performance.
Yes
The device is indicated for the management of various wounds and skin irritations, promoting healing and delivering antimicrobial silver to inhibit microbial growth, which aligns with the definition of a therapeutic device.
No
The device is a moist hydrogel dressing intended for wound management and treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "moist hydrogel dressing" and mentions physical properties like "high moisture content gel" and "Stabilizers". It also describes physical containers (1.5 oz and 3 oz). This indicates a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SilverMed™ Antimicrobial Hydrogel is a topical dressing applied directly to wounds and skin. Its function is to manage wounds by providing moisture, delivering antimicrobial silver, and absorbing exudate. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes the management of various types of wounds and skin irritations, which are external applications.
- Device Description: The description focuses on the physical properties of the hydrogel and its application to the wound surface.
- Performance Studies: The performance studies mentioned are related to biocompatibility and antimicrobial effectiveness on the wound, not diagnostic testing of bodily fluids or tissues.
Therefore, the SilverMed™ Antimicrobial Hydrogel falls under the category of a wound dressing or topical antimicrobial device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SilverMed™ Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Product codes
FRO
Device Description
The Argentis SilverMedIM Antimicrobial Hydrogel is a moist hydrogel dressing designed to deliver antimicrobial silver that inhibits the growth of microbial contaminants. The high moisture content gel absorbs destructive components of wound exudate while promoting healthy tissue healing. Stabilizers prevent discoloration and staining from the dressing.
The product is available in 1.5 oz and 3 oz containers.
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
Under the supervision of a healthcare professional
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
SilverMed™ Antimicrobial Hydrogel has been subjected to in vitro and in vivo biocompatibility testing (ISO Modified Intracutaneous study, the ISO Intracutaneous Reactivity test and the ISO Delayed Hypersensitivity study) and cytotoxicity testing (ISO Agar Diffusion Diffusion (Direct)). These tests support the safe use of SilverMed™ Antimicrobial Hydrogel in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard USP Antimicrobial Effectivencss Test .
The performance data testing exceeds the requirements as set forth by the USP. The biocompatibility testing and performance testing performed for the device also demonstrated that the device is safe and effective for the indications of use.
Key Metrics
Not Found
Predicate Device(s)
K932291, K011994, K062212, K061227, K071703
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 1 6 2008
2. 510(k) Summary
2.1 Submitter's Name and Address
| Contact Person: | Argentis Biomedical Inc
11005 Indian Trail #102
Dallas, Texas 75229 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Toni Miller PhD
LEC Associates LLC
26 Chestnut Ridge Rd #12
Montvale NJ 07645
1 201 615 1212
Fax: 1.201.785.0322
Email: tfmiller@lecassociates.com |
2.2 Datc Prepared 12 September 2008
2.3 Device Name
| Trade Name: | SilverMed TM Antimicrobial Hydrogel |
|---|---|
| Common: | Moist antimicrobial wound gel |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and or Biologic |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
2.4 Predicate Devices 807.92(a)(3)
SilverMed ™ Antimicrobial Silver Hydrogel is substantially equivalent to the following hydrogels:
| • Eutra Gel For Wound Dressing | K932291 |
|---|---|
| • SilvaSorb Silver Antimicrobial Wound Gel or | |
| AcryDerm Silver Antimicrobial Wound Dressing | K011994 |
| • Silver Shield™ Antimicrobial Skin and | |
| Wound Gel | K062212 |
| • Hydrolyzed Collagen Gel with Silver | K061227 |
| • Elta Silver Antimicrobial Wound Gel | K071703 |
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2.5 Device Description
The Argentis SilverMedIM Antimicrobial Hydrogel is a moist hydrogel dressing designed to deliver antimicrobial silver that inhibits the growth of microbial contaminants. The high moisture content gel absorbs destructive components of wound exudate while promoting healthy tissue healing. Stabilizers prevent discoloration and staining from the dressing.
The product is available in 1.5 oz and 3 oz containers.
2.6 Assessment of Performance Data and Safety
SilverMed™ Antimicrobial Hydrogel is substantially equivalent to several silver hydrogel wound dressings: SilvaSorb Silver Antimicrobial Wound Gel/AKA AcryDerm Silver Antimicrobial Wound Dressing (K011994), Silver Shield™ Antimicrobial Skin and Wound Gel (K062212), Hydrolyzed Collagen Gel with Silver (K061227) and most recently Elta Silver Gel™ Advanced Ionic-Silver Wound Gel (K071703) and to Eutra Gel For Wound Dressing (K932291) except that this dressing does not contain antimicrobial silver.
SilverMed™ Antimicrobial Hydrogel has been subjected to in vitro and in vivo biocompatibility testing (ISO Modified Intracutaneous study, the ISO Intracutaneous Reactivity test and the ISO Delayed Hypersensitivity study) and cytotoxicity testing (ISO Agar Diffusion Diffusion (Direct)). These tests support the safe use of SilverMed™ Antimicrobial Hydrogel in contact with breached or compromised skin. In vitro Antimicrobial testing was assessed by the standard USP Antimicrobial Effectivencss Test .
2.7 Statement of Intended Use
SilverMed™ Antimicrobial.Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
These indications are identical or substantially equivalent to its predicates.
2.8 Technological Characteristics and Substantial Equivalence
SilverMed™ Antimicrobial Hydrogel is an amorphous gel wound filler that controls wound moisture levels through dual function of donation and absorption. Antimicrobial
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3/2
action is conferred by its content of stabilized antimicrobial silver. The product carries the general classification name "Dressing, Wound and Burn, Hydrogel w/Drug and or Biologic". It is substantially identical to the predicate device Eutra Gel For Wound Dressing (K932291) in form and function except that its' preservative system has been replaced by antimicrobial silver technology. SilverMed™ Antimicrobial Hydrogel is substantially similar to the predicates SilvaSorb Silver Antimicrobial Wound Gel/AKA AcryDerm Silver Antimicrobial
Wound Gel (K011994), Silver Shield™ Antimicrobial Skin and Wound Gel (K062212), Hydrolyzed Collagen Gel with Silver (K061227) and Elta Silver Antimicrobial Wound Gel (K071703) in its active component of antimicrobial silver, in its hydrogel configuration and in its function.
The indications of use, technological properties and performance testing for SilverMedIM Antimicrobial Hydrogel are substantially equivalent to those of the predicate devices. The performance data testing exceeds the requirements as set forth by the USP. The biocompatibility testing and performance testing performed for the device also demonstrated that the device is safe and effective for the indications of use.
K073019 SilverMed Antimicrobial Hydrogel (Sept2008) tfiller@lecassociates.com 1 201 615 1212
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
SEP 1 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Argentis Biomedical Incorporated % LEC Associates, LLC Toni Miller, Ph.D. President 26 Chestnut Ridge Road #12 Montvale, New Jersey 07645
Re: K073019
Trade/Device Name: SilverMed Antimicrobial Hydrogel Regulation Number: Unclassified Product Code: FRO Dated: August 17, 2008 Received: October 14, 2008
Dear Dr. Miller:
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.
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Page 2 – Toni Miller, Ph.D.
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 ventures (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 M. Milliman
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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510(k) Number:
- Indications for Use Statement
SilverMed Antimicrobial Hydrogel Device Name:
Indications for use:
SilverMed™ Antimicrobial Hydrogel is indicated for the management of minor burns, superficial cuts, lacerations, abrasions and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Prescription Use X (Part 21 CFR 801 Subpart D) And/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEAS DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
D.M. m/
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Concurrence of CDRH, Office of Device Evaluation (ODE)