(90 days)
Not Found
No
The summary describes a physical dressing with an antimicrobial gel pad and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a port dressing used to cover and protect catheter sites and secure devices to the skin, with an antimicrobial gel pad. Its primary function is to serve as a barrier and an antiseptic, not to treat a disease or condition for therapeutic purposes.
No
Explanation: The device is a dressing used to cover and protect catheter sites and secure devices, and it contains an antimicrobial agent. Its purpose is protective and preventive, not diagnostic.
No
The device description clearly describes a physical dressing with a gel pad containing Chlorhexidine Gluconate, indicating it is a hardware medical device, not software-only.
Based on the provided information, 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 secure devices to the skin. This is a physical barrier and securement function, not a diagnostic test performed on a sample from the body.
- Device Description: The device is a dressing with an antimicrobial gel pad. It's designed for external application to the skin and catheter sites.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies mentioned are bench testing and in vitro testing demonstrating antimicrobial effect. These are relevant to the device's function as a dressing with an antimicrobial component, not as a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
3 M Th Tegaderm™ CHG Chlorhexidine Gluconate I. V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.
Product codes
FRO
Device Description
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is used to cover and protect vascular access sites and to secure devices to the skin. The Chlorhexidine Gluconate I.V. Port Dressing is a two part system consisting of a bordered, transparent film cover dressing with an adhesive free window and an antimicrobial CHG Gel Device. The Chlorhexidine Gluconate I.V. Port Dressing is breathable and transparent, allowing continuous site observation.
The cover dressing provides an effective barrier against external contamination including fluids (waterproof), hacteria, and yeast.
The CHG gel pad device consists of an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel absorbs fluid.
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)
In vitro testing (time kill and zone of inhibition) demonstrates that the gel pad in the device has an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast.
Bench testing was collected to demonstrate substantial equivalence for this submission.
Clinical information provided supports the subject device, therefore, no additional clinical information was determined to be needed.
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
3M Company
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 5.10(k) Premarket Notification - Traditional
008 510k SUMMARY
Sponsor Information:
Applicant Name:
3M Company 3M Health Care Skin and Wound Care Division 3M Center 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, Minnesota 55144
Contact Person:
Phone Number: Fax Number: Email:
Joann Huehn Regulatory Affairs 651-733-9209 651-737-5320 jlhuehn1 @mmm.com
Date Prepared:
November 29, 2012
Device Name and Classification:
| Trade Name: | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate I.V. Port Dressing |
|------------------------|-----------------------------------------------------------------------------|
| Common or Usual Name: | I.V. Dressing with CHG |
| Classification Name: | Unclassified |
| Product Code: | FRO |
| Performance Standards: | Not Applicable |
| Predicate Device: | 3M™ Tegaderm™ CHG Dressing
(Chlorhexidine Gluconate Securement Dressing) |
Description of Device:
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is used to cover and protect vascular access sites and to secure devices to the skin. The Chlorhexidine Gluconate I.V. Port Dressing is a two part system consisting of a bordered, transparent film cover dressing with an adhesive free window and an antimicrobial CHG Gel Device. The Chlorhexidine Gluconate I.V. Port Dressing is breathable and transparent, allowing continuous site observation.
3M .
FEB 2 8 2013
p 112
1
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 510(k) Premarket Notification - Traditional
The cover dressing provides an effective barrier against external contamination including fluids (waterproof), hacteria, and yeast.
The CHG gel pad device consists of an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel absorbs fluid.
In vitro testing (time kill and zone of inhibition) demonstrates that the gel pad in the device has an antimicrobial effect against a variety gram-positive and gram-negative bacteria and yeast.
Indications for Use:
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is substantially equivalent to the predicate device, Tegaderm™ CHG Dressing (Chlorhexidine Gluconate Securement Dressing), cleared under K063458.
The Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is composed of the same or similar components, has same or similar performance, intended use and indications for use as the predicate device.
Non-Clinical Performance Data:
Bench testing was collected to demonstrate substantial equivalence for this submission.
Clinical Performance Data:
Clinical information provided supports the subject device, therefore, no additional clinical information was determined to be needed.
Non-Clinical and Clinical Conclusion:
Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing is safe for human use and acceptable for its intended use.
1223619
2
Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three intertwined lines representing health and well-being.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 28, 2013
3M Company % Ms. Joann Huehn Regulatory Affairs 3M Center, 2510 Conway Avenue, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K123679
Trade/Device Name: 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 29, 2012 Received: November 30, 2012
Dear Ms. Huehn:
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. 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 (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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3M Company
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Port Dressing 510(k) Premarket Notification - Traditional
3M Confidential
007_INDICATION FOR USE STATEMENT
510(k) Number (if known): To be Assigned
Device Name: 3M™ Tegaderm™ CHG Chlorhexidinc Gluconate I.V. Port Dressing
Indications for Use:
3 M Th Tegaderm™ CHG Chlorhexidine Gluconate I. V. Port Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering intravascular catheters and percutaneous devices.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Mark N. Melkerson , S 2013.02.28 13:26:08 =05 00'
(Division Sign-Off) Division of Surgical Devices 510(k) Number
Page 007-1