(326 days)
Not Found
Not Found
No
The summary describes a wound dressing with antimicrobial properties and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated for various types of acute and chronic wounds, which implies its use in treating health conditions or injuries, fitting the definition of a therapeutic device.
No
The device is described as a "Wound cover dressing" and "moist sheet wound dressing" intended for treating various types of wounds, not for diagnosing them.
No
The device description clearly states it is a "moist sheet wound dressing" and describes its physical composition and packaging, indicating it is a physical medical device, 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 clearly described as a "Wound cover dressing" for various types of acute and chronic wounds. This is a topical application for wound management.
- Device Description: The description details a "moist sheet wound dressing" with a "hydrophilic polyacrylate absorbent sheet containing silver halide." This is a physical barrier and absorbent material applied externally.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any analysis of biological specimens or diagnostic purposes.
The device is a wound dressing, which falls under the category of medical devices used for wound care, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
AcryDerm Silver Antimicrobial Barrier Wound Dressing is intended for use on partial and full thickness external wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and on acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for the treatment of third degree burns.
Wound cover dressing for the following wounds:
Acute Wounds such as:
- Surgical wounds .
- Lacerations ●
- Donor site wounds ●
- First and second degree burns ●
- Skin tears ●
- Abrasions ●
Chronic Wounds such as:
- . Pressure sores
- Diabetic ulcers ●
- Venous stasis ulcers .
- Arterial stasis ulcers .
Contra-indications
- . Not indicated for the treatment of third degree burns
Product codes
FRO
Device Description
AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches. The single use primaries will be packed, with a product insert, as 10 primaries per intermediate dispenser chipboard carton, and 5 intermediate cartons per case. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
510(k) Summary
| Contact Person: | Dr. Bruce L. Gibbins, Chairman & CTO |
|---|---|
| Date of preparation: | May 20, 1999 |
| Device Name (proprietary): | AcryDerm Silver Antimicrobial Barrier Wound Dressing |
| Common Name: | Moist wound dressing |
| Classification Name: | Hydrophilic wound dressing |
| Classification: | Unclassified |
Legally marketed device(s) for substantial equivalence comparison:
AcryDerm Advanced Wound Dressing, (AcryMed, Inc.) Arglaes Controlled Release Film Dressing (Maersk Medical Limited, UK)
Acticoat Silver Coated Dressing. (Westaim Biomedical Inc., NH)
Description of Device: AcryDerm Silver Antimicrobial Barrier Wound Dressing is a moist sheet wound dressing that contains silver halide that may help to reduce growth of microbial contaminants of the dressing. The base matrix is composed of a hydrophilic polyacrylate absorbent sheet containing silver halide and stabilizers. AcryDerm Silver Antimicrobial Barrier Wound Dressing will be supplied as sterile sheets of 2x2"; 4x4"; 4x8"; of 8x8" sizes, packaged in single use heat sealed medical grade foil pouches. The single use primaries will be packed, with a product insert, as 10 primaries per intermediate dispenser chipboard carton, and 5 intermediate cartons per case. Biocompatibility has been assessed according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).
Intended Use of the Device: AcryDerm Silver Antimicrobial Barrier Wound Dressing is intended for use on partial and full thickness external wounds such as pressure sores, arterial ulcers, diabetic ulcers, and venous stasis ulcers and on acute wounds such as draining surgical wounds, lacerations, donor site, and exudating first and second degree burns, and abrasions. It is not intended for the treatment of third degree burns.
Technological Characteristics: AcryDerm Silver Antimicrobial Barrier Wound Dressing is a sterile, single use unsupported synthetic absorbent polyacrylate hydrogel containing silver halide and stabilizers. The product carries the general classification name, "Hydrophilic wound dressing", as would apply to AcryDerm Advanced Wound Dressing (AcryMed, Inc.). The composition of AcryDerm Silver Antimicrobial Barrier Wound Dressing is substantially similar to the predicate device, AcryDerm Advanced Wound Dressing. The method of manufacturing of the product is similar, with the exception for the addition of the silver halide, to that used for the production of the predicate device, AcryDerm Advanced Wound Dressing. AcryDerm Silver Antimicrobial Barrier Wound Dressing contains silver that may control microbial contamination of the dressing similar to the silver in Arglaes Controlled Release Film Dressing (Maersk Ltd.) and Acticoat Silver Coated Dressing (Westaim Biomedical).
Manufacturing: AcryDerm Silver Antimicrobial Barrier Wound Dressing will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective for its intended use.
Page No. 2
Bruce Rollins 3-20-00
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing, ribbon-like shape at the bottom. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 2007
Bruce Gibbins, Ph.D. Chief Technology Officer AcryMed, Inc. 12232 SW Garden Place Portland, Oregon 97223
Re: K991818
Trade/Device Name: AcryDerm Silver Antimicrobial Barrier Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 20, 2000 Received: March 21, 2000
Dear Dr. Gibbins:
This letter corrects our substantially equivalent letter of April 17, 2000.
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.
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 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 vours,
Milla N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: AcryDerm Silver Antimicrobial Dressing_
Indications For Use:
Wound cover dressing for the following wounds:
Acute Wounds such as:
- Surgical wounds .
- Lacerations ●
- Donor site wounds ●
- First and second degree burns ●
- Skin tears ●
- Abrasions ●
Chronic Wounds such as:
- . Pressure sores
- Diabetic ulcers ●
- Venous stasis ulcers .
- Arterial stasis ulcers .
Contra-indications
- . Not indicated for the treatment of third degree burns
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
inver R. lochner.
(Division Sign f
Division of Ge
Restorative Devices
510(k) Numbe K991818
Prescription Use
(Per 21 CFR 801.109)
OR
i
Over-The-Counter Use
(Optional Format 1-2-96)
26