(253 days)
Not Found
No
The summary describes a dressing with antimicrobial properties and securement features, with no mention of AI or ML technology.
Yes
The device is intended to cover and protect catheter sites and secure devices to the skin, and it contains chlorhexidine gluconate (CHG), a broad-spectrum antimicrobial/antifungal agent, indicating a therapeutic function of inhibiting microbial growth.
No
Explanation: The device is a dressing intended to cover and protect catheter sites and secure devices to the skin. Its function is to provide physical protection and antimicrobial effect, not to diagnose a condition or disease.
No
The device is a physical dressing with antimicrobial properties, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cover and protect catheter sites and to secure devices to the skin." This is a topical application for wound care and device securement, not for analyzing samples from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical properties of the dressing (polyurethane film, adhesive, CHG) and its function in covering and protecting the skin and securing devices. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The clinical study described focuses on wear performance and securement of the dressing on healthy subjects, not on the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing diagnostic information about a patient's health status.
In summary, the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are medical devices used for wound care and device securement, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.
Product codes
FRO
Device Description
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are similar dressings with one provided as a film dressing and the latter provided as a film dressing with a soft cloth border. Performance data supports both product configurations.
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing consists of a polyurethane film coated with a transparent chlorhexidine gluconate (CHG) acrylic adhesive. CHG, a broad spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.
The transparent film is breathable, allowing oxygen and moisture vapor exchange, yet is impermeable to external contaminants. including fluids (waterproof), bacteria, viruses* and yeast. The dressing must remain intact to protect the IV site from external contaminants.
3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices.
In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.
- In vitro testing shows that the film of the dressing provides a barrier to viruses 27 nm in diameter or larger while the dressing remains intact without leakage. These results have not been studied with regard to prevention of viral infection. No clinical study has been conducted regarding the ability of the dressing to prevent viral infections.
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
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing was conducted in accordance with International Organization for Standardization ISO-10993, Biological Evaluation of Medical Devices and FDA's guidance. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016. 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are characterized as a surface contacting device for use on breached or compromised skin for prolonged duration (less than 30 days). The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Pyrogenicity
- Acute System Toxicity and Subacute/Subchronic Toxicity
- Implantation
Bench Testing
Bench testing for 3M™ Tegaderm™ Antimicrobial Transparent Dressing was conducted in support of substantial equivalence to the predicate devices. The bench testing included the following tests:
- Tensile and Elongation*
- Moisture Vapor Transmission Rate*
- Waterproof*
- Amount of CHG within the device throughout the use life through Release Kinetics*
- Barrier Performance
- Antimicrobial activity spectrum (Time kill)*
*Studies conducted in comparison with the predicate device.
Clinical Study
Study Type: Randomized, controlled, open-label study
Sample Size: 24 healthy subjects
Key Results: A Mixed Model ANOVA was used to analyze wear/lift of the dressing. At 72 hours (3 days), all dressings remained on the arms for both the subject and predicate device. At 168 hours (7 days), the subject device remained on the arms and three of the predicate devices had been removed due to excess lift
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 20, 2017
3M Company, 3M Health Care Maria Ruiz Regulatory Affairs Specialist 3M Center, 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, Minnesota 55144
Re: K170754
Trade/Device Name: 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 25, 2017 Received: October 26, 2017
Dear Maria Ruiz:
We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170754
Device Name
3M™ Tegadern™ Antimicrobial Transparent Dressing, 3M™ Tegadem™ Antimicrobial I.V. Advanced Securement Dressing
Indications for Use (Describe)
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510K SUMMARY
I. SUBMITTER
3M Company 3M Health Care 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144
| Phone: | 651-736-2733 |
|---|---|
| Fax: | 651-737-5320 |
| E-Mail: | meruiz@mmm.com |
| Contact Person: | Maria Ruiz |
| Regulatory Affairs Specialist |
Date Prepared: March 10, 2017
II. DEVICE
| Name of Device: | 3M™ Tegaderm™ Antimicrobial Transparent Dressing
and 3M™ Tegaderm™ Antimicrobial I.V. Advanced
Securement Dressing |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Common or Usual Name: | Dressing, Wound, Drug |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
III. PREDICATE DEVICE
BD ChloraShield™ I.V. Dressing with CHG Antimicrobial (K113836, originally cleared September 24, 2012 under the device name Benehold CHG Transparent Film Dressing)
DEVICE DESCRIPTION IV.
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are similar dressings with one provided as a film dressing and the latter provided as a film dressing with a soft cloth border. Performance data supports both product configurations.
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3MTM Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing consists of a polyurethane film coated with a transparent chlorhexidine gluconate (CHG) acrylic adhesive. CHG, a broad
4
spectrum antimicrobial/antifungal agent known to inhibit microbial growth has been formulated into the acrylic adhesive.
The transparent film is breathable, allowing oxygen and moisture vapor exchange, yet is impermeable to external contaminants. including fluids (waterproof), bacteria, viruses* and yeast. The dressing must remain intact to protect the IV site from external contaminants.
3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is bordered, notched and reinforced with soft cloth tape and is designed to provide securement around catheters and other devices.
In vitro testing (time kill) demonstrates that the 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing has an antimicrobial effect against a variety of gram-positive bacteria, gramnegative bacteria, yeast and mold in the dressing.
- In vitro testing shows that the film of the dressing provides a barrier to viruses 27 nm in diameter or larger while the dressing remains intact without leakage. These results have not been studied with regard to prevention of viral infection. No clinical study has been conducted regarding the ability of the dressing to prevent viral infections.
INDICATIONS FOR USE V.
3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing is intended to be used to cover and protect catheter sites and to secure devices to the skin. Common applications include covering and securing IV catheters, other intravascular catheters and percutaneous devices.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The technological principle for the subject device and the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial, are that they are both transparent dressings containing chlorhexidine gluconate (CHG) in the adhesive. They are both intended to cover and protect catheter sites and secure devices to the skin.
The subject device and predicate device have similar technological elements which include:
5
- Operational principle .
- Device is transparent ●
- Device is provided with an adhesive containing Chlorhexidine Gluconate (CHG) ●
- Device is breathable .
- Device is conformable ●
- Device is waterproof ●
- . Device is a barrier to viruses
The minor differences do not raise different questions of safety and effectiveness. The following technological differences exist between the subject device and the predicate device:
- . Sterilization method
- . Concentration of CHG
- . Absorption
PERFORMANCE DATA VII.
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing was conducted in accordance with International Organization for Standardization ISO-10993, Biological Evaluation of Medical Devices and FDA's guidance. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16, 2016. 3M™ Tegaderm™ Antimicrobial Transparent Dressing and 3M™ Tegaderm™ Antimicrobial I.V. Advanced Securement Dressing are characterized as a surface contacting device for use on breached or compromised skin for prolonged duration (less than 30 days). The battery of testing included the following tests:
- Cytotoxicity .
- . Sensitization
- Irritation ●
- Pyrogenicity ●
6
- Acute System Toxicity and Subacute/Subchronic Toxicity .
- Implantation ●
Bench Testing
Bench testing for 3M™ Tegaderm™ Antimicrobial Transparent Dressing was conducted in support of substantial equivalence to the predicate devices. The bench testing included the following tests:
- . Tensile and Elongation*
- Moisture Vapor Transmission Rate* .
- Waterproof* ●
- Amount of CHG within the device throughout the use life through Release Kinetics* ●
- Barrier Performance .
- Antimicrobial activity spectrum (Time kill)* ● *Studies conducted in comparison with the predicate device.
Clinical Study
A randomized, controlled, open-label study on 24 healthy subjects was conducted to assess wear performance at three (3) and seven (7) days with the subject device and the predicate device, BD ChloraShield™ I.V. Dressing with CHG Antimicrobial. A Mixed Model ANOVA was used to analyze wear/lift of the dressing. At 72 hours (3 days), all dressings remained on the arms for both the subject and predicate device. At 168 hours (7 days), the subject device remained on the arms and three of the predicate devices had been removed due to excess lift