(129 days)
Not Found
Not Found
No
The document describes a wound gel and does not mention any AI or ML components.
Yes
The device is indicated for the management of various wounds and burns, which are conditions that require therapeutic intervention.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for the management of 1ª and 2 degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites," and "for the management of minor abrasions, cuts, lacerations and scalds." This indicates a therapeutic or management function rather than a diagnostic one. There is no mention of identifying, detecting, or assessing a condition.
No
The device description clearly states it is a "repeat use, amorphous hydrogel containing antimicrobial silver," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the management of wounds on the body (burns, ulcers, lacerations, etc.). This is a therapeutic application, not a diagnostic one.
- Device Description: The description confirms it's a "repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds." This further reinforces its therapeutic purpose.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the body (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Focus on Wound Management: The entire description revolves around treating and managing wounds, which is a clinical intervention, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing: the new products meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and the NIH Publication 99-4494. The products meet or exceed the USP Preservative Assurance Testing requirements for a repeat use product.
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.
Not Found
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
K083103
page 1 of 1
FEB 2 6 2009
510(k) Summary
Sponsor:
AcryMed, Inc. 9560 SW Nimbus Avenue Beaverton, OR 97008
Dressing Model #B
Contact Person:
Device Name
Dr. Bruce L. Gibbins; (503)-624-9830 ext 301 AcryDerm Antimicrobial Silver Gel Wound
Common Name:
Amorphous Hydrogel Gel Wound Dressing
Classification Product Code:
Classification Advisory Panel:
General and Plastic Surgery
Legally marketed device(s) for substantial equivalence comparison:
AcryDerm Silver Antimicrobial Wound Gel (AcryMed, Inc. Portland OR) AcryDerm Silver Antimicrobial OTC Wound Gel (AcryMed, Inc. Portland OR)
FRO
Description of Device: AcryDerm Antimicrobial Silver Gel Model #B is a repeat use, amorphous hydrogel containing antimicrobial silver for use in the management of wounds.
Intended use of the Device: Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1ª and 2ª degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Technological Characteristics: The AcryDerm Antimicrobial Silver Gel Wound Dressings incorporate proprietary stabilized silver salt to facilitate the action of antimicrobial ionic silver in the dressing and wound environment. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound.
Testing: the new products meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and the NIH Publication 99-4494. The products meet or exceed the USP Preservative Assurance Testing requirements for a repeat use product.
Manufacturing: The new antimicrobial gel product will be manufactured according to the product specifications and in accordance with good manufacturing practices to ensure the device is safe and effective for their intended uses.
Performance Standards: No performance standards are prescribed for the new product.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with its wings spread, clutching a staff entwined with a serpent, which is a symbol associated with medicine and healing.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AcryMed, Inc. % Bruce Gibbins, Ph.D Chief Technical Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008
FEB 2 6 2009
Re: K083103
Trade/Device Name: AcryDerm Antimicrobial Silver Gel Model #B, OTC: AcryDerm Wound Gel Model #B
Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2009 Received: February 17, 2009
Dear Dr. Gibbins:
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. Iisting 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.
2
Page 2 - Bruce Gibbins, 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 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,
H. A. Aims. for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K083103 510(k) Number (if known): _
. . . .
AcryDerm Antimicrobial Silver Gel Model #B Device Name:
Indications for Use: Under the supervision of a healthcare professional, AcryDerm Silver Antimicrobial Wound Gel Model #B is indicated for the management of 1* and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, (Division Sign-Off) | |
|---|---|
| ------------------------------------------ | -- |
Division of General, Restorative,
and Neurological Devices
| AcryDerm Silver Pre-market Notification 510(k) | |
|---|---|
| 510(k) Number | K083603 Page No. 4 |
2/26/2009
4
Page 10 of 10
Indications for Use
510(k) Number (if known):
OTC: AcryDerm Wound Gel Model #B Device Name:
Over the Counter Use: OTC: AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 2/25/2009
(Division Sign-Off) Division of General, Restorative, and Neurological Devices Page No. 5
510(k) Number K
AcryDerm Silver Pre-market Notification 510(k)