Local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I - IV dermal ulcers (vascular, venous, pressure, and diabetic).

Device Description

The subject device is designed to contact the wound as a primary dressing and permit the passage of fluids. The dressing provides a protective moist environment for the wound passage of nulas. The aronamination in the dressing. The dressing. The subject device is an effective antimicrobial barrier dressing against the following organisms; Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, E. faecalis, Aspergillus niger and Escherichia coli. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in the subject device consists of a thin layer of metallic silver that provides effective protection of the dressing against microbial contamination. The contact wound dressings are made of flexible, sterile, non-adherent fabric offered in 1 or 4 layers. The wound dressings will be initially available in the following sizes and varieties: 2"x2", 4"x4", 4'x8'', 8"x8", 12"x48", 4" x 60" Elastic Wrap, 8" x 108" Elastic Wrap, Socks. The wound dressings are composed of a Nylon (polyamide) textile fiber substrate with metallic silver surface plating. The elastic wraps and socks also contain elastomer fiber. The wound dressings are made from MedTex P180 and Balingen. Both materials are silver plated Nylon (polyamide) textiles. The materials are identical with the exception that MedTex P180 is used for the stretch wraps and contains elastomer fiber. The raw material used on the device is silver nitrate. SWS 846 method 6010B (ICP) test method is used to determine purity. The purity of the silver in the dressing is 99.9% pure elemental silver, with a measured accuracy of 0.01%. It is anticipated the AgMed Tex material will be offered in additional sizes including contact wound dressings (2"x2", 4"x4", 4"x8", 4"x12", 10"x12", 8"x8", 8"x16", 16"x16", 4"x24", 4"x72", 12"x48"), stretch wrap wound dressing of different sizes (including 4"x24", 4"x60", 4"x72", 4"x108", 8"x108"), strips (in sizes such as 1"x3"). self-adhering bandages, and socks. The socks will use the same silver plated nylon textile material with elastomer fiber. The socks contain 6% silver. The self adhering bandages will include the same silver plated nylon textile material along with an adhesive tape. The adhesive tape will be the Avery Dennison medical grade adhesive tape or similar. Only medical grade, biocompatible, and latex free adhesive tapes will be used. Avery Dennison has these materials on file with FDA as a Drug Master File. The subject devices will be packaged in a standard pre-formed peelable pouch I he subject devices will be packaging. The pouches will be labeled and packed in a labeled SBS box. SBS boxes are commonly used in medical device packaging. The SBS boxes will be packed into corrugated master shipping boxes. The peelable pouches and SBS boxes are compatible with radiation sterilization. The subject devices are sterile single-use devices to be sterilized using a validated The baof of tiering cycle affording an SAL of 106. The devices are not to be reused, therefore cleaning and disinfection instructions are not applicable. The sterilization validation will be performed consistent with the ISO 11137 Standard - Sterilization of Vancation ++++ 0 - Requirements for validation and routine control - Radiation Sterilization. Method 1 will be employed to validate the sterilization process. Products will be sterilized at one of the Isomedix facilities. After sterilization the I roducts will be returned to Select Fabricators under quarantine and subjected to post sterility / final inspection prior to release and distribution. Seal strength testing will be done on a routine basis during raw material receipt, inprocess, and post-sterility processing. Seal strength testing (burst and creep to burst) will be performed using a TEST-A-PACK F100-2600 Seal Strength tester. Test will be applied per ASTM F-1140 or equivalent methods. The routine manufacturing inspection approam will also consist of visual inspection for package integrity. The packaging validation will include Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Inspections will be performed by SPC and/or ANSI/ASQ techniques. It is recommended the patient examine the wound every 24 hours and change the dressing as needed. The use of petroleum based materials, materials with the ingredient Papain, and materials with high protein content are not recommended for use with AgMed Tex wound dressings as they may inactivate the silver. The patients are warned against using the wearing the product during MR Imaging.

AI/ML Overview

While the provided text describes the device, its intended use, and claims of equivalence to a predicate device, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria, as outlined in your request.

Specifically, the document focuses on the regulatory submission (510(k) Summary) for a wound dressing, which primarily demonstrates substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against specific acceptance criteria.

Here's a breakdown of why many of your requested points cannot be extracted from this text:

Acceptance Criteria Table: No such table is present. The document states general claims about effectiveness.
Sample size for test set and data provenance: No information on a "test set" in the context of clinical or performance evaluation. The "laboratory tests" mentioned are for antimicrobial effectiveness.
Number of experts and qualifications for ground truth: Not applicable as no clinical or diagnostic "ground truth" establishment is described.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a wound dressing, not an imaging or diagnostic AI device.
Standalone (algorithm only) performance: Not applicable.
Type of ground truth: The "ground truth" mentioned refers to the effectiveness against microorganisms, not clinical outcomes in a structured study. It's based on "laboratory tests."
Sample size for training set: Not applicable; this device is a physical wound dressing and does not involve AI/machine learning training sets.
How ground truth for training set was established: Not applicable.

What the document does provide regarding performance:

The document states: "The device was found in laboratory tests to be effective in the reduction of several types of microorganisms including Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, E. faecalis, Aspergillus niger and Escherichia coli."

This indicates that some form of in-vitro antimicrobial testing was performed. However, it does not detail:

The specific method (e.g., zone of inhibition, quantitative reduction).
The acceptance criteria for "effective in the reduction."
The sample size of cultures or tests performed.
The statistical analysis, if any.

It also mentions "ISO 10993-1 biocompatibility testing." This is a standard safety test (biological evaluation of medical devices) and not a performance study in the way you've outlined.

In summary, based only on the provided text, I cannot complete your requested table and detailed study information because the context is a 510(k) submission showing substantial equivalence for a physical medical device (wound dressing), not a detailed performance study for a diagnostic or AI-driven device with specific acceptance criteria.

Summary

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OCT 27 2004

510 (k) Summary

K040518

Date Prepared [21 CFR 807.92(a)(1)]

March 1, 2004 (Amended on 10/19/04)

Submitter's Information [21 CFR 807.92(a)(1)]

Joseph M. Azary C/o Select Fabricators Inc. 543 Long Hill Avenue Shelton, CT 06484

Telephone: (203) 944-9320

Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Select Fabricators. Select Fabricators Inc. submitted the Initial Establishment Registration form (FDA 2891) to FDA and is awaiting the assignment of a registration number.

Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] Trade names are: Select Fabricators AgMed Tex© Wound Dressing Common Name: Silver Nylon Contact Wound Dressing, Contact Wound Dressing, Antimicrobial Wound Dressing Classification: Unclassified, Product Code: FRO

Predicate Device [21 CFR 807.92(a)(3)]

Silverlon Wound Dressing - K981299 .

The subject devices have all of the same indications as the predicate device. The material composition is identical. The subject device is offered in more of a variety of shapes and sizes including socks and self adhering bandages.

The sterilization method is the same as the predicate device.

The subject device exhibits 16%* silver and the predicate device exhibited 22% silver based on testing. The socks contain 6% silver (because the outside of the sock material does not have to be silver plated because it does not make contact with the patient).

Polymem Silver Wound Dressing - K031307 .

The Polymem Silver Wound Dressing is a silver wound dressing that has received clearance for indications for use similar to the AgMed Tex™ and Silverlon.

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KOYOSI8

Page 2 of 7

Description of the Device [21 CFR 807.92(a)(4)]

The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in the subject device consists of a thin layer of metallic silver that provides effective protection of the dressing against microbial contamination.

The contact wound dressings are made of flexible, sterile, non-adherent fabric offered in 1 or 4 layers. The wound dressings will be initially available in the following sizes and varieties:

. 2"x2"
4"x4" .
4'x8'' .
8"x8" .
12"x48" .
4" x 60" Elastic Wrap .
8" x 108" Elastic Wrap .
. Socks

The wound dressings are composed of a Nylon (polyamide) textile fiber substrate with metallic silver surface plating. The elastic wraps and socks also contain elastomer fiber. The wound dressings are made from MedTex P180 and Balingen. Both materials are silver plated Nylon (polyamide) textiles. The materials are identical with the exception that MedTex P180 is used for the stretch wraps and contains elastomer fiber. The raw material used on the device is silver nitrate. SWS 846 method 6010B (ICP) test method is used to determine purity. The purity of the silver in the dressing is 99.9% pure elemental silver, with a measured accuracy of 0.01%.

It is anticipated the AgMed Tex material will be offered in additional sizes including contact wound dressings (2"x2", 4"x4", 4"x8", 4"x12", 10"x12", 8"x8", 8"x16", 16"x16", 4"x24", 4"x72", 12"x48"), stretch wrap wound dressing of different sizes (including 4"x24", 4"x60", 4"x72", 4"x108", 8"x108"), strips (in sizes such as 1"x3"). self-adhering bandages, and socks.

The socks will use the same silver plated nylon textile material with elastomer fiber. The socks contain 6% silver.

The self adhering bandages will include the same silver plated nylon textile material along with an adhesive tape. The adhesive tape will be the Avery Dennison medical grade adhesive tape or similar. Only medical grade, biocompatible, and latex free

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KCYOSIP

Dise ? of-y

adhesive tapes will be used. Avery Dennison has these materials on file with FDA as a Drug Master File.

The subject devices will be packaged in a standard pre-formed peelable pouch I he subject devices will be packaging. The pouches will be labeled and packed in a labeled SBS box. SBS boxes are commonly used in medical device packaging. The SBS boxes will be packed into corrugated master shipping boxes. The peelable pouches and SBS boxes are compatible with radiation sterilization.

The subject devices are sterile single-use devices to be sterilized using a validated The baof of tiering cycle affording an SAL of 106. The devices are not to be reused, therefore cleaning and disinfection instructions are not applicable. The sterilization validation will be performed consistent with the ISO 11137 Standard - Sterilization of Vancation ++++ 0 - Requirements for validation and routine control - Radiation Sterilization. Method 1 will be employed to validate the sterilization process.

Products will be sterilized at one of the Isomedix facilities. After sterilization the I roducts will be returned to Select Fabricators under quarantine and subjected to post sterility / final inspection prior to release and distribution.

Seal strength testing will be done on a routine basis during raw material receipt, inprocess, and post-sterility processing. Seal strength testing (burst and creep to burst) will be performed using a TEST-A-PACK F100-2600 Seal Strength tester. Test will be applied per ASTM F-1140 or equivalent methods. The routine manufacturing inspection approam will also consist of visual inspection for package integrity. The packaging validation will include Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). Inspections will be performed by SPC and/or ANSI/ASQ techniques.

It is recommended the patient examine the wound every 24 hours and change the dressing as needed. The use of petroleum based materials, materials with the ingredient Papain, and materials with high protein content are not recommended for use with AgMed Tex wound dressings as they may inactivate the silver.

The patients are warned against using the wearing the product during MR Imaging.

Intended Use [21 CFR 807.92(a)(5)]

Local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I - IV dermal ulcers (vascular, venous, pressure, and diabetic).

Technological Characteristics [21 CFR 807.92(a)(6)]

Select Fabricators Inc. believes that the subject device is substantially equivalent to the predicate device. Both the subject device and predicate device are composed of similar silver plated nylon

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KO40518

xise Y of Y

textiles. Both the subject device and predicate device are sterilized using the same method and compliant with the same standards. The indications for use are identical.

Performance Data [21 CFR 807.92(b)(1)]

Silver has been safely used as an anti-microbial agent and in medical devices for many years. The device was found in laboratory tests to be effective in the reduction of several types of microorganisms including Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans, E. faecalis, Aspergillus niger and Escherichia coli.

The subject device has been subject to ISO 10993-1biocompatibility testing (for the materials that contact the patient).

Conclusion [21 CFR 807.92(b)(3)]

We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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Image /page/4/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" around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2004

Select Fabricators, Inc. c/o Mr. Joseph M. Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K040518

Trade/Device Name: Select Fabricators, Inc. AgMed Tex® Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: September 8, 2004 Received: September 9, 2004

Dear Mr. Azary:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreases) to the enactment date of the Medical Device Amendments, or to Conninered price to May 20, 1978, in easily accordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosmeter rest (110) that so device, subject to the general controls provisions of the Act. The 1 ou may, dicrororo, mainer of the Act include requirements for annual registration, listing of general controls pro reserving 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 If your device is elassinos (tional controls. Existing major regulations affecting your device can may be subject to back acceral 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 r touse of acribed a determination that your device complies with other requirements of the Act that I Drederal 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. Joseph M. Azary

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K040518 510(k) Number (if known):

Indications For Use:

Local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I - IV dermal ulcers (vascular, venous, pressure, and diabetic).

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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K040518

Regulation Number and Section

N/A