(243 days)
Not Found
No
The device description focuses on the material composition and antimicrobial properties of a wound dressing, with no mention of AI or ML technology.
Yes
The device is intended for the local management of various types of wounds, including burns, incisions, and ulcers, which are conditions that require therapeutic intervention for healing. It also claims to provide an "effective antimicrobial barrier," which directly contributes to the therapeutic process by preventing infection.
No
Explanation: The device is a wound dressing designed for local management of various types of wounds, providing a protective moist environment and an antimicrobial barrier. It facilitates healing rather than diagnosing a condition.
No
The device description clearly details a physical wound dressing made of nylon fabric with metallic silver plating. It discusses materials, sizes, sterilization, packaging, and physical properties, indicating it is a tangible 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 for the local management of various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a wound dressing designed to provide a protective environment and act as an antimicrobial barrier. It physically interacts with the wound for treatment purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status or disease. Its function is to aid in wound healing and prevent microbial contamination of the dressing itself.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is applied in vivo (on the body) for therapeutic purposes.
N/A
Intended Use / 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).
Product codes
FRO
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.
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)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
KOYOSI8
Page 2 of 7
Description of the Device [21 CFR 807.92(a)(4)]
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
2
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
3
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.
4
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.
5
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
6
Indications for Use
K040518 510(k) Number (if known):
Select Fabricators Inc. AgMed Tex© Wound Dressing Device Name:
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