Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Device Description

Modern Medical Antimicrobial Wound Dressing is made up of darker viscose polyester layer and a lighter layer of non-woven cloth. The darker layer contains nano silver ions (0.5 mg per g) about 1-100 nm in diameter, these provide a barrier protection against microbes. The lighter layer is designed to protect the wound surface. Modern Medical Antimicrobial Burn Dressing is totally made of unwoven cloth. The thicker and stronger texture also contains silver ions (2.6 mg per g) in order to form an effective barrier against microbes. It is intended to be applied directly onto the wound and cover with conventional methods.

AI/ML Overview

The provided text describes the Modern Medical Antimicrobial Wound Dressing and Modern Medical Antimicrobial Burn Dressing. This is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria and device performance. Therefore, detailed information on acceptance criteria and a study proving device performance in the manner requested (e.g., sample sizes, expert qualifications, HRMC studies, standalone performance with ground truth) is not present in the provided document.

Instead, the document focuses on demonstrating the safety and effectiveness of the device through various performance tests and biocompatibility assessments rather than a direct clinical performance study comparing against specified acceptance criteria for diagnostic or treatment accuracy.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:
No cytotoxicity	Studies show dressings are safe.
No skin sensitization	Studies show dressings are safe.
No skin irritation	Studies show dressings are safe.
No acute toxicity	Studies show dressings are safe.
No mutagenicity (Ames Test)	Studies show dressings are safe.
No chromosomal aberration (In Vitro Mammalian Chromosome Aberration Test)	Studies show dressings are safe.
No gene mutation (In vitro Mammalian Cell Gene Mutation Test)	Studies show dressings are safe.
Antimicrobial Effectiveness:
Effective against microbial contamination (barrier protection)	Antimicrobial Preservatives Effectiveness test based on USP 51 performed.
Antimicrobial activity demonstrated	Antimicrobial Activity Assessment of Antimicrobial Medical Dressing test using AATCCC Test Method 147 performed.
Material/Design Functionality:
First aid management for minor abrasions, cuts, scrapes, scalds, and burns.	Devices function as first aid management.
Silver ions provide effective barrier against microbial contamination.	Silver ions (0.5 mg/g for Wound, 2.6 mg/g for Burn) provide barrier protection against microbes.

Note: The document states "The studies show that the dressings, Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are safe and effective for their intended use." This is a general statement of compliance rather than specific quantitative performance metrics against pre-defined numerical acceptance criteria.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the document. The performance assessments listed (biocompatibility and antimicrobial effectiveness tests) are typically laboratory-based tests. The document does not specify human clinical trial sample sizes or data provenance (country, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable/not provided. The listed tests are laboratory assays (e.g., cytotoxicity, skin irritation, antimicrobial efficacy). These tests have defined protocols and endpoints according to standards (ISO, USP, AATCCC), and their results are interpreted by technical experts in those fields, but it's not a "ground truth" establishment in the sense of clinical expert consensus for image or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like "2+1" are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The listed tests are not set up in this manner.

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

This information is not applicable/not provided. This device is a wound dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This device is a physical wound dressing and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance assessments are established by the pre-defined endpoints and methodologies of the international and national standards described:

Biocompatibility: ISO 10993 (Parts 1, 3, 11) - These standards define methods for evaluating biological risks, and the "ground truth" is adherence to the safety limits and observations specified within these protocols (e.g., absence of cytotoxicity, irritation, sensitization).
Antimicrobial Effectiveness: United States Pharmacopoeia (USP 51) and American Association of Textile Chemists & Colorists (AATCCC Test Method 147) - These standards prescribe specific bacterial or fungal challenge tests and measure the reduction in microbial population. The "ground truth" is meeting the specified reduction criteria defined in these standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. This device is not an AI algorithm that requires a training set or associated ground truth.

Summary

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050842

510 (K) SUMMARY

AUG 0 2 2006

1. Submitter's Name & Address:

Modern Medical Equipment Manufacturing Ltd

5F,Gold King Ind.Bldg.	Or	1705 Dabney Rd.
35 Tai Lin Pai Rd.		Richmond
Kwai Chung		VA 23230
Hong Kong		USA

Contact Person & Tel Nos: Mr. Bob Stillman (Account Manager) Phone : (1) 804-353-7160 (1) 804-353-7161 Fax : E-Mail : Bob Stillman@modernmedical.com.hk

Date summary was prepared : November 17, 2005

2. Device Name :

Proprietary Name:	Modern Medical Antimicrobial Wound DressingModern Medical Antimicrobial Burn Dressing
Common /Usual name:	Dressing
Classification Name:	Dressing

3. Identification of Predicate Device for which Substantial Equivalence is claimed : Predicate device for which Substantial Equivalence is claimed is identified as : Silverlon Contact Wound Dressing (K023612) of Argentum International LLC

Device Description: 4.

Explanation of how the device functions: the devices Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing when placed in contact with wounds act as first aid management for minor abrasions, cuts, scrapes, scalds and burns.

Scientific concepts that form the basis for the device : the silver ions contained in the fabric of the dressings provide effective barrier against microbial contamination. The silver ions on the devices give rise to an antimicrobial barrier and hence protection against microbes

Significant physical and performance characteristics of the device (e.g. device design, material used, and physical properties):

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510 (K) SUMMARY

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microbes . The lighter layer is designed to protect the wound surface. Modern Medical Antimicrobial Burn Dressing is totally made of unwoven cloth. The thicker and stronger texture also contains silver ions (2.6 mg per g) in order to form an effective barrier against microbes. It is intended to be applied directly onto the wound and cover with conventional methods.

5. Intended use including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended:

The devices Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are intended for the general population as first aid management for minor abrasions, cuts, scrapes, scalds and burns. The dressings should not be applied onto patients with a known sensitivity to silver. The dressing is not compatible with Magnetic Resonance Imaging and should not be in contact with electrodes or conductive gels during electronic measurements.

Summary of the technological characteristics of the device compared to the 6. predicate device :
Substantial equivalence to the predicate device can be shown by: the technological characteristics of the application of silver, antimicrobial properties of silver, first aid management for wounds, nature of materials allowing wrapping around burnt wounds and adherence onto the wounded surface.

7. Assessment of Performance Data :

Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing were subjected to :

the biocompatibility tests on: cytotoxicity, skin sensitization, skin irritation tests in a) accordance with ISO10993-Part 1 Biological Evaluation of Medical Devices;
Acute Toxicity Test in accordance with ISO 10993-Part 11 : b)
Ames Test, In Vitro Mammalian Chromosome Aberration Test, In vitro Mammalian c) Cell Gene Mutation Test in accordance with ISO 10993-Part 3;
d) Antimicrobial Preservatives Effectiveness test based on the United States Pharmacopoeia 23 Method 51 (USP 51) ;
e) Antimicrobial Activity Assessment of Antimicrobial Medical Dressing test using the American Association of Textile Chemists & Colorists (AATCCC Test Method 147).

The studies show that the dressings, Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2006

Modern Medical Equipment Mfg., LTD % E&M Engineering, Inc. Mr. Robert Stillman Account Manager 1705 Dabney Road Richmond, Virginia 23230

Re: K050842

Trade/Device Name: Modern Medical Antimicrobial Wound Dressing Modern Medical Antimicrobial Burn Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 7. 2006 Received: June 16, 2006

Dear Mr. Stillman:

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 (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 - Mr. Robert Stillman

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,

Huber Lemercier

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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KOTO842

Indications for Use

510(k) Number (if known): K050842

Device Name: Modern Medical Antimicrobial Wound Dressing

Modern Medical Antimicrobial Burn Dressing

Indications for Use:

Modern Medical Antimicrobial Wound Dressing & Modern Medical Antimicrobial Burn Dressing are used for first aid management of minor abrasions, cuts, scrapes, scalds and burns.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Leuer
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K050842

Regulation Number and Section

N/A