(136 days)
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.
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.
The provided text describes the CMB Antimicrobial Dressing, a device primarily for wound care. There is very limited information about specific acceptance criteria or details of a study that proves the device meets particular criteria. The document is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a novel device.
However, based on the limited information provided, here's an attempt to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria with corresponding performance results. It only mentions types of tests performed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Antimicrobial effectiveness | Tested in vitro |
| Biocompatibility (Cytotoxicity) | Tested, results on file |
| Biocompatibility (Irritation) | Tested, results on file |
| Biocompatibility (Sensitization) | Tested, results on file |
| Biocompatibility (Pyrogenicity) | Tested, results on file |
| Biocompatibility (Systemic Injection) | Tested, results on file |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the in vitro or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the information provided. The studies mentioned (antimicrobial performance, biocompatibility) are laboratory tests, not clinical studies requiring expert interpretation of results to establish a "ground truth" in the way it's described for image analysis or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Laboratory tests typically involve established protocols and readouts, not adjudications of subjective interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was mentioned. The device is a wound dressing, not an AI-powered diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical wound dressing, not an algorithm. The "antimicrobial performance" was tested in vitro, which can be considered a standalone test for the device's inherent property.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the in vitro antimicrobial performance, the ground truth would be established by standard microbiological methods, such as colony counts or zone of inhibition measurements, which quantify bacterial reduction or inhibition. For biocompatibility tests, the ground truth is established by standard toxicology and biological evaluation methods (e.g., cell viability assays for cytotoxicity, skin reaction scores for irritation/sensitization). These are objective measurements against established scientific standards, not expert consensus or pathology in the clinical sense.
8. The sample size for the training set
Not applicable. The CMB Antimicrobial Dressing is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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K060237
CMB Antimicrobial Dressing
510(K) Summary of Safety and Effectiveness
.
| 510(k) Summaryof Safety &Effectiveness | The CMB Antimicrobial Dressing is an effective barrier tobacterial penetration. It is intended for professional use only.The dressing is for use on moderately to heavily exuding partialand full-thickness wounds including decubitus ulcers, venousstasis 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 WoundDressing (K973855)Absorbent Antimicrobial WoundDressing (K033814) |
| DeviceDescription | The CMB Antimicrobial dressing is a single layer dressingconsisting of a woven adsorbent polyester containing elementalsilver and zinc. In the presence of exudate, the dressing can beused with an appropriate secondary barrier to help maintain amoist 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. |
| IndicationsStatement | The CMB Antimicrobial Dressing is indicated for professionaluse 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. |
| TechnologicalCharacteristics | Technologically, the CMB Antimicrobial Dressing andpredicate devices are the similar in that they all contain afabric/gauze/pad component and an antimicrobial component.The difference is that two antimicrobial components, silver andzinc are included in the CMB dressing |
| PerformanceData | Antimicrobial performance was tested in vitro.Biocompatibility tests performed on the CMB AntimicrobialDressing included cytotoxicity, irritation, sensitization,pyrogenicity and systemic injection. An independentlaboratory performed the testing and test results are on file. |
| Conclusions | Based on the 510(k) summaries and the 510(k) statements (21CFR 807) and the information and performance data providedherein, we conclude that the CMB Antimicrobial Dressing issubstantially equivalent to the existing legally marketeddevices under the Federal Food, Drug and Cosmetic Act. |
| Contact | Debbie Koeneman, M.S.Silverleaf Medical Products, Inc.1100 E. University Drive, Suite 101Tempe, AZ 85281 |
| Date | June 1, 2006 |
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CMB Antimicrobial Dressing 510(K) summary of Safety and Effectiveness continued,
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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
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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
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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
N/A