(136 days)
No
The device description and performance studies focus on the material properties and antimicrobial efficacy of the dressing, with no mention of AI or ML.
Yes
The device is described as an "antimicrobial dressing" used for various types of wounds, aiming to help with the healing process by maintaining a moist wound environment and likely preventing infection, which aligns with the definition of a therapeutic device.
No
The provided text describes an antimicrobial wound dressing used for treatment, not for diagnosing medical conditions. Its intended use is to act as an antimicrobial barrier and help maintain a moist wound healing environment.
No
The device description clearly states it is a physical dressing made of woven polyester containing silver and zinc, indicating it is a hardware 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 for treating wounds topically as an antimicrobial barrier. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a dressing containing silver and zinc, designed to interact with wound exudate. This is a physical/chemical interaction with the wound environment, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status or disease.
- Performance Studies: The performance studies focus on antimicrobial activity in vitro and biocompatibility, which are relevant to a therapeutic device, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dressing does not fit that description.
N/A
Intended Use / Indications for Use
The CMB Antimicrobial Dressing is an effective barrier to bacterial penetration. It is intended for professional use only. The dressing is for use on moderately to heavily exuding partial and full-thickness wounds including decubitus ulcers, venous stasis ulcers, surgical wounds, first- and second-degree burns, grafts and donor sites.
As an antimicrobial barrier, place over partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.
The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.
Product codes
FRO
Device Description
The CMB Antimicrobial dressing is a single layer dressing consisting of a woven adsorbent polyester containing elemental silver and zinc. In the presence of exudate, the dressing can be used with an appropriate secondary barrier to help maintain a moist wound healing 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
professional use only.
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
Antimicrobial performance was tested in vitro.
Biocompatibility tests performed on the CMB Antimicrobial Dressing included cytotoxicity, irritation, sensitization, pyrogenicity and systemic injection. An independent laboratory performed the testing and test results are on file.
Key Metrics
Not Found
Predicate Device(s)
Acticoat Antimicrobial Dressing (K955453), Hydrocolloid with Zinc Wound Dressing (K973855), Absorbent Antimicrobial Wound Dressing (K033814)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K060237
CMB Antimicrobial Dressing
510(K) Summary of Safety and Effectiveness
.
| 510(k) Summary
of Safety &
Effectiveness | The CMB Antimicrobial Dressing is an effective barrier to
bacterial penetration. It is intended for professional use only.
The dressing is for use on moderately to heavily exuding partial
and full-thickness wounds including decubitus ulcers, venous
stasis ulcers, surgical wounds, first- and second-degree burns,
grafts and donor sites. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device Name: | CMB Antimicrobial Dressing |
| Predicate Device Names: | Acticoat Antimicrobial Dressing
(K955453)
Hydrocolloid with Zinc Wound
Dressing (K973855)
Absorbent Antimicrobial Wound
Dressing (K033814) |
| Device
Description | The CMB Antimicrobial dressing is a single layer dressing
consisting of a woven adsorbent polyester containing elemental
silver and zinc. In the presence of exudate, the dressing can be
used with an appropriate secondary barrier to help maintain a
moist wound healing environment. |
| Intended Use | As an antimicrobial barrier, place over partial and full-
thickness wounds such as: pressure ulcers, venous ulcers,
diabetic ulcers, burns and donor and recipient graft sites. |
| Indications
Statement | The CMB Antimicrobial Dressing is indicated for professional
use only as an antimicrobial barrier for partial and full-
thickness wounds such as: pressure ulcers, venous ulcers,
diabetic ulcers, burns and donor and recipient graft sites. |
| Technological
Characteristics | Technologically, the CMB Antimicrobial Dressing and
predicate devices are the similar in that they all contain a
fabric/gauze/pad component and an antimicrobial component.
The difference is that two antimicrobial components, silver and
zinc are included in the CMB dressing |
| Performance
Data | Antimicrobial performance was tested in vitro.
Biocompatibility tests performed on the CMB Antimicrobial
Dressing included cytotoxicity, irritation, sensitization,
pyrogenicity and systemic injection. An independent
laboratory performed the testing and test results are on file. |
| Conclusions | Based on the 510(k) summaries and the 510(k) statements (21
CFR 807) and the information and performance data provided
herein, we conclude that the CMB Antimicrobial Dressing is
substantially equivalent to the existing legally marketed
devices under the Federal Food, Drug and Cosmetic Act. |
| Contact | Debbie Koeneman, M.S.
Silverleaf Medical Products, Inc.
1100 E. University Drive, Suite 101
Tempe, AZ 85281 |
| Date | June 1, 2006 |
:
1
CMB Antimicrobial Dressing 510(K) summary of Safety and Effectiveness continued,
:
:
.
:
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
JUN 15 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Silverleaf Medical Products, Inc. % Ms. Debbie Koeneman, M.S. Director, Regulatory Affairs 1100 E. University, Suite 101 Tempe, Arizona 85281
Re: K060237 Trade/Device Name: CMB Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 2, 2006 Received: June 5, 2006
Dear Ms. Koeneman:
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 (?1 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. 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
3
Page 2 - Ms. Angelika Scherp
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.
Hubert Lenoir
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
510(k) Number (if known): K060237
Device Name: CMB Antimicrobial Dressing
Indications for Use:
The CMB Antimicrobial Dressing is indicated for professional use as an antimicrobial barrier for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns and donor and recipient graft sites.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| or | |
| Over-The- Counter Use |
(Optional Format 1-2-99)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices510(k) Number_K060237