(157 days)
No
The device is a physical dressing with an antiseptic agent, and the description focuses on its material properties and antimicrobial activity, with no mention of software, algorithms, or data processing.
Yes.
The device contains Chlorhexidine Gluconate, an antiseptic agent with antimicrobial and antifungal activity, and is intended to cover and protect catheter sites, which suggests a therapeutic purpose to prevent infection.
No
The device is described as a gel pad used to cover and protect catheter sites and percutaneous devices, and it contains an antiseptic agent. Its function is protective and antimicrobial, not to diagnose a condition or disease.
No
The device description clearly indicates it is a physical gel pad containing a chemical antiseptic, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to "cover and protect catheter sites," including "intravascular catheters and percutaneous devices." This describes a device applied externally to the body to protect a medical site.
- Device Description: The description focuses on the physical properties of the gel pad (breathable, transparent, absorbs fluid) and the presence of an antiseptic agent (Chlorhexidine Gluconate) for antimicrobial activity. It describes a topical application for site protection.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples or diagnostic purposes.
- Performance Studies: The performance studies mentioned (in vitro Direct Time Kill, Absorption, Moisture Vapor Transmission Rate) are related to the physical and antimicrobial properties of the dressing, not diagnostic testing.
- Biocompatibility: The focus on biocompatibility is typical for devices that come into contact with the body, not necessarily for IVDs which primarily interact with samples.
In summary, the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad is a medical device intended for external application to protect catheter sites, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad can be used to cover and protect catheter sites. Common applications include covering intravascular catheters and percutaneous devices.
Product codes
FRO
Device Description
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate (CHG Gel Pad) is used to cover and protect vascular and non-vascular percutaneous medical devices. The CHG Gel Pad is breathable and transparent, allowing continuous site observation.
The CHG Gel Pad contains 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The CHG Gel Pad absorbs fluid. In vitro testing (log reduction) demonstrates that the CHG Gel Pad has an antimicrobial effect against a variety of gram-positive and gram-negative bacteria, mold, and yeast.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Catheter sites, intravascular catheters, and percutaneous devices.
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 device substantial equivalence was verified through the following tests:
- in vitro Direct Time Kill
- Absorption
- Moisture Vapor Transmission Rate
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 4, 2020
3M Company Hilary Hovde Regulatory Affairs Specialist Bldg. 275-5W-06 St. Paul, Minnesota 55144
Re: K200835
Trade/Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad Regulatory Class: Unclassified Product Code: FRO Dated: May 1, 2020 Received: April 29, 2020
Dear Hilary Hovde:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200835
Device Name
3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad
Indications for Use (Describe)
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad can be used to cover and protect catheter sites. Common applications include covering intravascular catheters and percutaneous devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad
3M Company 3M Health Care 2510 Conway Ave. 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Preparation Date: September 1, 2020
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Device Name and Classification
| Trade Name: | 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad |
|---|---|
| Common/Usual Name: | Dressing, Wound, Drug |
| Device Classification: | Unclassified |
| Product Code: | FRO |
Predicate Device
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing, K123679
Reference Device
BIOPATCH® Antimicrobial Dressing, K003229
Indications for Use
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad can be used to cover and protect catheter sites. Common applications include covering intravascular catheters and percutaneous devices.
Description of Device
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate (CHG Gel Pad) is used to cover and protect vascular and non-vascular percutaneous medical devices. The CHG Gel Pad is breathable and transparent, allowing continuous site observation.
The CHG Gel Pad contains 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The CHG Gel Pad absorbs fluid. In vitro testing (log reduction) demonstrates that the CHG Gel Pad has an antimicrobial effect against a variety of gram-positive and gram-negative bacteria, mold, and yeast.
Comparison of Technological Characteristics with the Predicate and Reference Devices
The predicate device, 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing. K123679, contains the identical CHG Gel Pad and a cover dressing whereas the subject device contains only the CHG Gel Pad which may be used with or without a cover dressing. The CHG Gel Pad is identical to the predicate device gel pad, therefore both devices are transparent, breathable, absorbent, and contain Chlorhexidine gluconate (CHG). Both devices are intended to cover and protect catheter sites and other percutaneous devices. Although the
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subject standalone CHG Gel Pad does adhere, it is not intended to provide securement and may be used with or without a cover dressing.
Substantial Equivalence and Summary of Studies
The difference between the subject and predicate device has been evaluated through performance and biocompatibility tests to provide evidence of substantial equivalence for the 3MTM Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad.
The device substantial equivalence was verified through the following tests:
- in vitro Direct Time Kill ●
- Absorption
- . Moisture Vapor Transmission Rate
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad is categorized as a surface contacting device, with breached or compromised skin contact of prolonged duration in accordance with ISO 10993-1 and FDA Guidance, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The biocompatibility data from predicate device, K123679, were provided in the current submission to address biocompatibility.
Conclusion
Based on the intended use, technological characteristics, performance data, and non-clinical tests performed, the subject device is substantially equivalent to the 3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing (cleared under K123679), Unclassified, product code FRO and does not raise new questions of safety or effectiveness.