← Product Code FRO · K053256 # 3M TEGADERM SILVER (AG) MESH (K053256) _3M Company · FRO · Dec 16, 2005 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K053256 ## Device Facts - **Applicant:** 3M Company - **Product Code:** FRO - **Decision Date:** Dec 16, 2005 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use 3M™ Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary wound dressing over: - abrasions - ulcers - trauma wounds - surgical wounds - first and second degree burns - donor sites, ## Device Story Nonwoven dressing containing 8 mg/gm silver sulfate; acts as antimicrobial barrier. Porous, non-occlusive material conforms to wound base; wicks drainage. Silver ions released to reduce microorganisms (bacteria, yeast) in wound. Supplied sterile; custom-cut to fit wound. Used in clinical settings for wound management. Output is physical barrier and antimicrobial agent; aids healing by reducing microbial load. ## Clinical Evidence Bench testing only. Biocompatibility studies (cytotoxicity, intracutaneous irritation, skin sensitization) showed no deleterious effects. In vitro studies compared microbial reduction (gram-negative/positive bacteria, yeast) against Acticoat, demonstrating substantial equivalence. ## Technological Characteristics Nonwoven dressing containing 8 mg/gm silver sulfate. Porous, non-occlusive, conformable material. Supplied sterile. No electronic components or software. ## Predicate Devices - 3M™ Tegaderm™ Silver Nonwoven Dressing ([K040890](/device/K040890.md)) - Acticoat™ Silver Coated Dressing ([K955453](/device/K955453.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # Premarket Notification Summary #### Sponsor Information: . 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact Person: Amv E. Short Regulatory Manager Phone Number: (651) 737-6707 FAX Number: (651) 737-5320 ## Device Name: Common or Usual Name: Silver Dressing 3M™ Tegaderm™ Silver Nonwoven Dressing Proprietary Name: Also called 3M™ Tegaderm™ Ag Mesh Dressing with Silver Classification Name: Unclassified # Predicate Device: 3MTM Tegaderm™ Silver Nonwoven Dressing has predicates 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890) and Acticoat™ Silver Coated Dressing, aka Acticoat TM Burn Antimicrobial Dressing, manufactured by Smith & Nephew (originally cleared under K955453). #### Description of Device: . 3M™ Tegaderm™ Silver Nonwoven Dressing is a nonwoven dressing that contains (8 mg/gm of dressing) of silver sulfate. Silver ions released from the silver sulfate create an effective barrier. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base and wicks drainage into the dressing where in vitro studies show that the silver ions may reduce the number of microorganisms, including bacteria and yeast. {1}------------------------------------------------ # Indications for Use: 3MTM Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary wound dressing over: K 053256 - abrasions - ulcers - trauma wounds - surgical wounds - first and second degree burns - donor sites, ### Description of Safety and Substantial Equivalence: Safety Studies – A standard battery of biocompatibility studies was conducted: Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs. No deleterious effects were observed with 3M™ Tegaderm™ Silver Nonwoven Dressing : results were comparable to or better than those reported for Acticoat ™ Silver Coated Dressing. The results are those presented for the previously cleared device, 3MTM Tegaderm™ Silver Nonwoven Dressing, (K040890). Effectiveness -- 3M™ Tegaderm™ Silver Nonwoven Dressing was compared with Acticoat ™ Silver Coated Dressing in in vitro reduction studies aqainst a known number of microorganisms, such as gramnegative and gram-positive bacteria and yeast (Candida albicans). The results of this study demonstrated that 3MTM Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat ™ Silver Coated Dressing effectiveness. The results are those presented for 3MTM Tegaderm™ Silver Nonwoven Dressing (K040890) Substantial Equivalence – 3M ™ Tegaderm™ Silver Nonwoven Dressing with modified label, the previously cleared device (K040890) and Acticoat Silver Coated Dressing (aka, Acticoat TM Burn Antimicrobial Dressing) provide the same function and have the same indications for use. These characteristics, as well as the results of safety studies and effectiveness show the two products to be substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is composed of four wavy lines that converge at the bottom, resembling a staff with intertwined snakes, a symbol often associated with medicine and healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 6 2005 Amy E. Short Regulatory Manager 3M Health Care 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144-1000 Re: K053256 Trade/Device Name: 3M™ Tegadrem™ Silver Nonwoven Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 21, 2005 Received: November 22, 2005 Dear Ms. Short: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 310(t) premained is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use statuu in the choosure) to regars comment date of the Medical Device American so to commerce provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 rryour device is classified (600 a00 10) als. Existing major regulations affecting your device can may be subject to such additional controls. Existing major regulation FD may be subject to such additional controller Life. Barts 800 to 898. In addition, FDA may be found in the Oous an ents concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that i DTF 3185aanse or our device complies with other requirements of the Act that 1 177 has made a determinations administered by other Federal agencies. You must of any I cuch statutes and regulations and and limited to: registration and listing (21 comply with an the Not orequire Bart 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 forth in the quality systems (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) I ms letter will anow you to begin management of your device of your device to a legally {3}------------------------------------------------ #### Page 2-Amy E. Short Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be actised and termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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. 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/industry/support/index.html. Sincerely vours. Cbaubaua Buchund for Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use Statement K053256 510(k) Number (if known): Device Name: 3M™ Tegaderm™ Silver Nonwoven Dressing, also called 3M™ Tegaderm™ Ag Mesh Dressing with Silver ### Indications for Use: 3M™ Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary dressing over: - abrasions - - ulcers ﮯ - trauma wounds - surgical wounds - first and second degree burns - donor sites Prescription Use XX (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) Barbara Brigham Johnson (Division Sign-Division of General, Restorative, and Neurological Devices **510(k) Number** K053256 Page vi --- **Source:** [https://fda.innolitics.com/device/K053256](https://fda.innolitics.com/device/K053256) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com