(223 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and antimicrobial effectiveness of a silver-impregnated wound dressing, with no mention of AI or ML.
No.
The device is a wound dressing used for various types of wounds, which falls under wound care products rather than therapeutic devices designed for specific medical treatments or interventions beyond basic wound management.
No
The device is described as a wound dressing for treatment, not for diagnosis. Its intended use is to cover various types of wounds and reduce bacteria.
No
The device description clearly states it is a physical dressing made of cotton nonwoven mesh containing silver oxide, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing applied externally to treat various types of wounds. IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a physical dressing containing silver oxide, designed for direct application to a wound. This is consistent with a topical medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the 3M™ Tegaderm™ Silver Nonwoven Dressing is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
3M™ Tegaderm™ Silver Nonwoven Dressing is a cotton nonwoven mesh dressing which contains silver oxide. It is available as rectangle or square dressings of various sizes.
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)
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 Tegaderm Silver Dressing; results were comparable to or better than those reported for Acticoat Silver Coated Dressing.
Effectiveness - 3M Tegaderm Silver Dressing was compared with Acticoat Silver Coated Dressing in in vitro reduction studies against a known number of gram-negative and gram-positive bacteria.. The dressings were also tested against Candida albicans. The results of this study demonstrated that Tegaderm Silver Dressing was equivalent to Acticoat Silver Coated Dressing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Acticoat™ Silver Coated Dressing, aka Acticoat Burn Antimicrobial Dressing, manufactured by Smith & Nephew.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
3MTM Tegaderm™ Silver Dressing K040890 Response to May 18, 2004 Request
2 2004
Section 4: Modified 510(k) Summary Page
The indications for use presented in the Premarket Notification Summary of the original 510(k) have been modified. The updated summary pages are presented below:
Premarket Notification Summary
1. Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Amy E. Short
Regulatory Specialist |
|-----------------|---------------------------------------|
| Phone Number: | (651) 737-6707 |
| FAX Number: | (651) 737-5320 |
2. Device Name:
| Common or Usual Name: | Silver Nonwoven Dressing |
|---|---|
| Proprietary Name: | 3M™ Tegaderm™ Silver |
| Classification Name: | Unclassified |
3. Predicate Device:
Acticoat™ Silver Coated Dressing, aka Acticoat Burn Antimicrobial Dressing, manufactured by Smith & Nephew.
র্ব. Description of Device:
3M™ Tegaderm™ Silver Nonwoven Dressing is a cotton nonwoven mesh dressing which contains silver oxide. It is available as rectangle or square dressings of various sizes.
1
3M™ Tegaderm™ Silver Dressing K040890 Response to May 18, 2004 Request
Indications for Use: ડાં
3MTM Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary wound dressing over:
- abrasions 1
- ulcers -
- trauma wounds -
- surgical wounds -
- first and second degree burns -
- donor sites 1
Description of Safety and Substantial Equivalence: ર.
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 Tegaderm Silver Dressing; results were comparable to or better than those reported for Acticoat Silver Coated Dressing.
Effectiveness - 3M Tegaderm Silver Dressing was compared with Acticoat Silver Coated Dressing in in vitro reduction studies against a known number of gram-negative and gram-positive bacteria.. The dressings were also tested against Candida albicans. The results of this study demonstrated that Tegaderm Silver Dressing was equivalent to Acticoat Silver Coated Dressing
Substantial Equivalence - Tegaderm Silver Dressing and Acticoat Silver Coated Dressing (aka, Acticoat 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/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2004
Ms. Amy E. Short Regulatory Specialist 3M Health Care 3M Center Building 275-5W-06 St. Paul, Minnesota 55144
Re: K040890
Trade/Device Name: 3M™ Tegaderm™ Silver Nonwoven Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 30, 2004 Received: August 31, 2004
Dear Ms. Short:
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 (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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with cation. The FDA finding of substantial equivalence of your device to a legally promance noticated 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 11 you a 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 vours.
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
4
Indications for Use
510(k) Number (if known): K040890
3M™ Tegaderm™ Silver Nonwoven Dressing Device Name:
Indications For Use:
3M™ Tegaderm™ Silver Nonwoven Dressings are indicated for use as a primary wound dressing over:
- abrasions -
- ulcers -
- trauma wounds ﮯ
- surgical wounds 1
- 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_4040890
Page 1 of
Page 4 of 37