(15 days)
No reference devices are used in this submission.
No
The device description and performance studies focus on the physical and chemical properties of the dressing and its antimicrobial agent, with no mention of AI or ML.
Yes
The device is intended to reduce vascular catheter colonization and catheter-related bloodstream infections, indicating a therapeutic purpose.
No
This device is a securement dressing with antiseptic properties, intended to protect catheter sites and reduce infections, not to diagnose a medical condition.
No
The device description clearly outlines a physical dressing with an integrated gel pad containing Chlorhexidine Gluconate, indicating it is a hardware-based medical device, not software-only.
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, secure devices to skin, and reduce vascular catheter colonization and CRBSIs. This is a direct interaction with the patient's body and the medical device (catheter).
- Device Description: The device is a dressing with an integrated gel pad containing an antiseptic. It acts as a physical barrier and delivers an antimicrobial agent topically.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The "in vitro testing" mentioned is related to the performance of the dressing itself (antimicrobial effect, barrier testing), not a diagnostic test on a patient sample.
IVD devices are typically used to test samples like blood, urine, tissue, etc., outside of the body to gain information about a patient's health status. This device is applied directly to the patient's skin and catheter site.
N/A
Intended Use / Indications for Use
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.
Product codes
FRO
Device Description
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.
Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria. viruses* and yeast, and protects the IV site.
In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.
*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.
Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
catheter sites, skin
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)
Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device. No biocompatibility, animal studies or clinical studies were needed to support this change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices are used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
3M Company Melissa Forth Regulatory Affairs Specialist 3M Center. 2510 Conwav Ave. Bldg 275-5W-06 St. Paul, Minnesota 55144
Re: K171908
Trade/Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2017 Received: June 26, 2017
Dear Melissa Forth:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
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) K171908
Device Name
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
Indications for Use (Describe)
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.
| 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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510(k) Summary
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92.
I. SUBMITTER
| Applicant Name: | 3M Health Care
3M Center
2510 Conway Ave, Bldg. 275-5W-06
St. Paul, MN 55144-1000 |
|--------------------------|--------------------------------------------------------------------------------------------|
| Contact Person: | Melissa J. Forth
Regulatory Affairs Specialist |
| Phone:
Fax:
Email: | (651) 737-5016
(651) 737-5320
mjforth@mmm.com |
| Date Prepared: | June 22, 2017 |
| II. DEVICE | |
| Trade Name: | 3MTM TegadermTM CHG Chlorhexidine Gluconate
I.V. Securement Dressing |
| Common or Usual
Name: | Antimicrobial I.V. Securement Dressing |
| Classification: | Unclassified |
| Product Code: | FRO |
| Classification
Name: | Dressing, wound, drug |
4
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification
III. PREDICATE DEVICE
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458, K080620, K153410)
No reference devices are used in this submission.
IV. DEVICE DESCRIPTION
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.
Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria. viruses* and yeast, and protects the IV site.
In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.
*In vitro testing shows that the transparent film of the Tegaderm™ CHG dressing provides a viral barrier from viruses 27 nm in diameter or larger while the dressing remains intact without leakage.
Tegaderm™ CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
| Catalog
Number | Device Name | Dressing Size | Average Amount of
CHG per Dressing
(mg based on gel pad size) |
|-------------------|--------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------|
| 1657 | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 8.5 cm x 11.5 cm
(3-1/2 X 4-1/2 in) | 45 mg |
| 1658 | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 10 cm X 12 cm
(4 X 4-3/4 in) | 45 mg |
| 1659 | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 10 cm x 15.5 cm
(4 X 6-1/8 in) | 78 mg |
The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.
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3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification - Special 510(k): Device Modification
| Catalog
Number | Device Name | Dressing Size | Average Amount of
CHG per Dressing
(mg based on gel pad size) |
|-------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------------------------------------------------------------|
| 1660 | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 7 cm x 8.5 cm
(2 3/4 in. x 3 3/8 in.) | 15 mg |
| 1877* | 3M™ PICC / CVC Securement
Device + Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 8.5 cm x 11.5 cm
(3 1/2 x 4 1/2 in) | 45 mg |
| 1879* | 3M™ PICC / CVC Securement
Device + Tegaderm™ CHG
Chlorhexidine Gluconate I.V.
Securement Dressing | 10 cm x 15.5 cm
(4 x 6 1/8 in) | 78 mg |
- Note: Catalog numbers 1877 and 1879 are convenience kits. The 3M™ PICC / CVC Securement Device portion of the kit is a US Class I device.
V. INDICATIONS FOR USE
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing and covering I.V. catheters, other intravascular catheters and percutaneous devices.
Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | 3M™ Tegaderm™ CHG
I.V. Securement Dressing
(Submission Subject) | 3M™ Tegaderm™ CHG
I.V. Securement Dressing
(K063458, K080620, K153410) |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No changes.
Same intended use as predicate
device. | 3M™ Tegaderm™ CHG Chlorhexidine
Gluconate I.V. Securement Dressing can be used
to cover and protect catheter sites and to secure
devices to skin. |
| Indications for
Use | No changes.
Same Indications for Use as
predicate device. | 3M™ Tegaderm™ CHG Chlorhexidine
Gluconate I.V. Securement Dressing can be used
to cover and protect catheter sites and to secure
devices to skin. Common applications include
securing and covering I.V. catheters, other
intravascular catheters and percutaneous devices. |
| Characteristic | 3MTM TegadermTM CHG
I.V. Securement Dressing | 3MTM TegadermTM CHG
I.V. Securement Dressing |
| | (Submission Subject) | (K063458, K080620, K153410) |
| | | TegadermTM CHG I.V. Securement Dressing is
intended to reduce vascular catheter colonization
and catheter-related bloodstream infections
(CRBSI) in patients with central venous or
arterial catheters. |
| Operating
Principle | No change.
Same operating principle as
predicate. | Catheter securement device. |
| Antimicrobial
agent | No change.
Same as predicate device. | CHG Chlorhexidine Gluconate (CHG)
Gel pad contains 2% w/w chlorhexidine
gluconate (CHG) or 15-78 mg CHG per pad
(depending on dressing size). |
| Technology
description | No change.
Same as predicate device. | The Chlorhexidine Gluconate I.V. Securement
Dressing consists of a transparent adhesive
dressing and an integrated hydrophilic gel pad
containing 2% w/w Chlorhexidine Gluconate
(CHG). The gel pad absorbs fluid. |
| Absorbent | No change.
Same as predicate device. | Yes |
| Transparent | No change.
Same as predicate device. | Yes |
| Breathable | No change.
Same as predicate device. | Yes |
| Secures | No change.
Same as predicate device. | Yes |
| Broad spectrum,
continuous,
antimicrobial /
Broad spectrum
antifungal | No change.
Same as predicate device. | In vitro testing (log reduction and barrier testing)
demonstrates that the TegadermTM CHG gel pad
in the TegadermTM CHG I.V. Securement
Dressing has an antimicrobial effect against, and
is a barrier to, a variety of gram-positive and
gram-negative bacteria, and yeast in the dressing. |
| Suppresses
re-growth of
microorganisms | No change.
Same as predicate device. | Yes |
| Reduces vascular
catheter
colonization | No change.
Same as predicate device. | Yes |
| Reduces catheter-
related
bloodstream
infection (CRBSI) | No change.
Same as predicate device. | Yes |
6
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing 510(k) Premarket Notification – Special 510(k): Device Modification
7
VII. SUMMARY OF PERFORMANCE (NON-CLINICAL TESTING) DATA
Non-clinical testing of the subject device for viral barrier performance at the end of shelf-life was performed. The device's performance is substantially equivalent to the predicate device. No biocompatibility, animal studies or clinical studies were needed to support this change.