(537 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 (CRBSI), which are therapeutic effects.
No
This device is a securement dressing with antiseptic properties, intended to protect catheter sites and reduce infections. It does not diagnose any conditions or provide diagnostic information.
No
The device description clearly states it is a physical dressing with an integrated gel pad containing Chlorhexidine Gluconate, a chemical component. It is a tangible, physical medical device, not software.
Based on the provided information, the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is not an In Vitro Diagnostic (IVD) device.
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 catheter-related bloodstream infections. This is a direct therapeutic and protective function applied to the patient's body.
- 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 to the skin surface.
- Mechanism of Action: The mechanism of action is based on the physical barrier provided by the film and the antimicrobial activity of the CHG on the skin and within the dressing. It does not involve testing or analyzing samples taken from the body to provide diagnostic information.
- Performance Studies: The performance studies focus on the reduction of infections and colonization, which are clinical outcomes related to the device's protective and antimicrobial function, not diagnostic accuracy.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Tegaderm™ CHG dressing does not perform this function.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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, and yeast, and protects the I.V. 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.
Tegaderm™ CHG I.V. Securement dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
catheter sites (vascular 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Tests
- Suppression of regrowth over time
- 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.
Clinical Studies -- Randomized Controlled Clinical Trial
Study Type: randomized, multi-arm, controlled clinical trial
Sample Size: 1,879 subjects with 4,163 central venous and arterial catheters
Data Source: 11 hospitals in France (12 ICUs)
Key Results: The study found that the addition of 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing in institutions already following routine infection control techniques led to a reduction in catheter colonization and catheter-related infections.
The Timsit study defined a catheter-related bloodstream infection (CRBSI) as:
"CRBSI was a combination of (a) one or more positive peripheral blood cultures sampled immediately before or within 48 hours after catheter removal; (b) a positive quantitative catheter-tip culture positive (using the 1.000 CFU/ml threshold when vortexing technique was used or 100 CFU/ml threshold when sonication technique was used) for the same microorganisms (same species and same susceptibility pattern) or a blood-culture differential time-to-positivity of 2 hours or more; and (c) no other infectious focus explaining the positive blood cultures. In patients with blood cultures positive for coagulasenegative staphylococci, the same pulse-field gel electrophoresis patterns in the catheter tip and blood cultures was required for a diagnosis of CRBSI."
Utilizing this definition, a dressing containing CHG reduced the risk of CRBSI by 57% compared to dressings without CHG (control).
A re-analysis was conducted applying the Infectious Diseases Society of America (IDSA) 2009 guidelines for CRBSI, which is defined as:
"Catheter related Bacteremia or fungemia in a patient who has an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/ or hypotension), and no apparent source for bloodstream infection (with the exception of the catheter). One of the following should be present: a positive result of semiquantitative (>15 cfu per catheter segment) or quantitative (>10° cfu per catheter segment) catheter culture, whereby the same organism (species) is isolated from a catheter segment and a peripheral blood culture; simultaneous quantitative cultures of blood with a ratio of >3:1 cfu/mL of blood (catheter vs. peripheral blood); differential time to positivity (growth in a culture of blood obtained through a catheter hub is detected by an automated blood culture system at least 2 h earlier than a culture of simultaneously drawn peripheral blood of equal volume)."
The results of this re-analysis are provided in the Key Metrics section.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Timsit definition of CRBSI:
Control Group (non CHG dressing):
Patients with Infection: 2.2% (21/941)
Infections per 1000 Catheter Days: 1.29
Test Group (Tegaderm™ CHG I.V. Securement Dressing):
Patients with Infection: 0.96% (9/938)
Infections per 1000 Catheter Days: 0.52
Comparison:
Percent Reduction in Patients with Infections: 57%
Percent Reduction per 1000 Catheter Days: 60%
P-value: 0.020
IDSA 2009 guidelines re-analysis:
Control Group (non CHG dressing):
Patients with Infection: 1.7% (16/941)
Infections per 1000 Catheter Days: 0.94
Test Group (Tegaderm™ CHG I.V. Securement Dressing):
Patients with Infection: 0.85% (8/938)
Infections per 1000 Catheter Days: 0.46
Comparison:
Percent Reduction in Patients with Infections: 50%
Percent Reduction per 1000 Catheter Days: 51%
P-value: 0.095
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.
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.
No reference devices are used in this submission.
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
Image /page/0/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2017
3M Company Melissa Forth Regulatory Affairs Specialist 3M Center 2510 Conway Ave Bldg 275-5W-06 St. Paul, Minnesota 55144
Re: K153410
Trade/Device Name: 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 23, 2017 Received: February 24, 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 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 yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K153410
Device Name
3MTM 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 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.
| 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
3M Center 2510 Conway Ave, Bldg. 275-5W-06 St. Paul, MN 55144 U.S.A. 651 733 1110
Image /page/3/Picture/2 description: The image shows the 3M logo. The logo is red and consists of the number 3 followed by the letter M. The logo is simple and recognizable.
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: | (651) 737-5016 |
| Fax: | (651) 737-5320 |
| Email: | mjforth@mmm.com |
| Date Prepared: | May 10, 2017 |
II. DEVICE
| Trade Names: | 3M™ Tegaderm™ 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 Dressings 510(k) Premarket Notification - Traditional
III. PREDICATE DEVICE(S)
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing (K063458. K080620)
BIOPATCH Antimicrobial Dressing (K003229)
No reference devices are used in this submission.
IV. DEVICE DESCRIPTION
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
3MTM 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, and yeast, and protects the I.V. 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.
Tegaderm™ CHG I.V. Securement dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.
| 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 |
5
3M™ Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
| 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
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing
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.
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.
6
3M™ Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Intended Use and Indications for Use
The Intended Use of the subject and predicate devices is that they are antimicrobial dressings with CHG, indications for Use of the subject and the predicate devices are set forth in detail in the table directly below.
| 3M™ Tegaderm™ CHG Chlorhexidine
Gluconate I.V. Securement Dressing
(Submission Subject, K153410) | BIOPATCH Antimicrobial Dressing
(K003229) | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate
I.V. Securement Dressing
(K063458, K080620) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 I.V. catheters, other intravascular
catheters and percutaneous devices.
Tegaderm™ CHG Chlorhexidine Gluconate
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. | BIOPATCH containing Chlorhexidine Gluconate is
intended for use as a hydrophilic wound dressing
that is used to absorb exudate and to cover a wound
caused by the use of vascular and non-vascular
percutaneous medical devices such as: IV catheters,
central venous lines, arterial catheters, dialysis
catheters peripherally inserted coronary catheters,
mid-line catheters, drains, chest tubes, externally
placed orthopedic pins, and epidural catheters. It is
also intended to reduce local infections, catheter-
related blood stream infections (CRBSI), and skin
colonization of microorganisms commonly related
to CRBSI, in patients with central venous or arterial
catheters. | 3M™ Tegaderm™ CHG Dressings
(Chlorhexidine Gluconate I.V.
Securement Dressing) can be used to
cover and protect catheter sites and
to secure devices to skin. Common
applications include IV catheters,
other intravascular catheters and
percutaneous devices. |
The indications for use statement is different between the predicate device. Specifically, the subject device indications for use includes an indication expansion "to reduce vasular catheter-related bloodstream infections (CRBS) in patients with central venous or arterial catheters." This statement is not included in the predicate: 3M™ Tegadern I V. Securement Dressing. However, it performance characteristic associated with the same intended use of being an antimicrobial dressing with CHG. To support this portion of the indications, 3M has provided performance data to show that the T.V. Securement Dressings perform as claimed.
7
3M™ Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
In addition, the indications for use statement is different between the Tegadern™ CHG I.V. Securement Dressing and the BIOPATCH Antimicrobial Dressing predicate. The Tegaderm™ CHG I.V. Securement Dressing "to reduce vascular catheter colonization and catherer-related bloodstream infections (CRBS) in patients with catheters" is similar to BIOPATCH's indication "to reduce local infections, catheter-related blood stream infections (CRBS), and skin colonization commonly related to CRBSI, in patients with central venous or arterial catheres in the Indications do not affect the safety and effectiveness of the device, and again, as stated above, do not alter the intended therapeutic, drasmostic, or surgical use of the subject device.
Technology Comparison
The Tegadern™ CHG I.V. Securement Dressing and the BIOPATCH Antimicrobial Dressing have similar technological characteristics. Both devices contain the same antimicrobial, choconate (CHG). The minor differences in technological characteristics do not raise different questions of safety or effectiveness, as confirmed by the testing activities described in this submission.
| Characteristic | 3M™ Tegaderm™ CHG I.V
Securement Dressing
(Submission Subject, K153410) | BIOPATCH Antimicrobial
Dressing
(K003229) | 3M™ Tegaderm™ CHG
Chlorhexidine Gluconate
I.V. Securement Dressing
(K063458, K080620) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Antimicrobial
agent | CHG Chlorhexidine Gluconate (CHG)
Gel pad contains 2% w/w chlorhexidine
gluconate | CHG Chlorhexidine Gluconate
(CHG) contains chlorhexidine
gluconate
(no subsequent 510k filings) | CHG Chlorhexidine Gluconate (CHG)
Gel pad contains 2% w/w
chlorhexidine gluconate
(unchanged from original 510k
clearance) |
| Dressing
configuration | The Chlorhexidine Gluconate I.V.
Securement Dressing consists of a
transparent, semi-permeable adhesive
dressing and an integrated hydrophilic
gel pad containing 2% w/w
Chlorhexidine Gluconate (CHG). | A hydrophilic polyurethane
absorptive foam with
Chlorhexidine Gluconate (CHG).
A separate unspecified dressing
cover is needed. | 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). |
| Absorbent | Yes | Yes | Yes |
| Transparent | Yes | N/A (opaque) | Yes |
| Breathable | Yes | Yes | Yes |
8
3M™ Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
| Characteristic | 3MTM Tegaderm™ CHG I.V
Securement Dressing
(Submission Subject, K153410) | BIOPATCH Antimicrobial
Dressing
(K003229) | 3MTM Tegaderm™ CHG
Chlorhexidine Gluconate
I.V. Securement Dressing
(K063458, K080620) |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Broad spectrum,
continuous,
antimicrobial /
Broad spectrum
antifungal | Yes | Yes | Yes |
9
3MTM Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
VII. PERFORMANCE DATA
The following performance data are provided in support of the substantial equivalence determination for this indication expansion submission.
Performance Tests
The following performance testing was provided in this submission to support a determination of substantial equivalence to the predicate device.
- Suppression of regrowth over time ●
- 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.
Clinical Studies -- Randomized Controlled Clinical Trial
The proposed broadened indication for use for 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing is supported by a randomized, multi-arm, controlled clinical trial consisting of 1,879 subjects with 4.163 central venous and arterial catheters conducted at 11 hospitals in France (12 ICUs). This trial found that the addition of 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing in institutions already following routine infection control techniques led to a reduction in catheter colonization and catheter-related infections. The full study details are available in Timsit JF et al. Randomized controlled trial of chlorhexidine dressing and highly adhesive dressing for preventing catheter-related infections in critically ill adults. Am J Crit Care Med. 2012;186(12): 1272-1278.
The Timsit study defined a catheter-related bloodstream infection (CRBSI) as:
"CRBSI was a combination of (a) one or more positive peripheral blood cultures sampled immediately before or within 48 hours after catheter removal; (b) a positive quantitative catheter-tip culture positive (using the 1.000 CFU/ml threshold when vortexing technique was used or 100 CFU/ml threshold when sonication technique was used) for the same microorganisms (same species and same susceptibility pattern) or a blood-culture differential time-to-positivity of 2 hours or more; and (c) no other infectious focus explaining the positive blood cultures. In patients with blood cultures positive for coagulasenegative staphylococci, the same pulse-field gel electrophoresis patterns in the catheter tip and blood cultures was required for a diagnosis of CRBSI."
Utilizing the definition of CRBSI described in the Timsit et al. (2012) publication, the study authors found that a dressing containing CHG (i.e. Tegaderm CHG Securement Dressing), reduced the risk of CRBSI by 57% compared to dressings without CHG (control). The following results were obtained:
10
3MTM Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
| Control Group
(non CHG dressing) | Test Group
(Tegaderm™ CHG I.V.
Securement Dressing) | Comparison | P-value | | | |
|-------------------------------------|-----------------------------------------------------------|----------------------------|-----------------------------------------|--------------------------------------------------------|---------------------------------------------------|-------|
| Patients
with
Infection | Infections per
1000 Catheter
Days | Patients with
Infection | Infections per
1000 Catheter
Days | Percent
Reduction in
Patients with
Infections | Percent
Reduction per
1000 Catheter
Days | |
| 2.2%
(21/941) | 1.29 | 0.96%
(9/938) | 0.52 | 57% | 60% | 0.020 |
It should be noted that the Timsit definition differs from the CRBSI definition published by the Infectious Diseases Society of America (IDSA). See below for the IDSA definition. As a sensitivity analysis for the Timsit study results, the data was re-analyzed applying the Infectious Diseases Society of America (IDSA) 2009 guidelines, Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America. In a re-analysis of all 31 CRBSI cases, each subject was reviewed to determine whether they fully satisfied criteria for CRBSI per the IDSA Guidelines.
The IDSA 2009 guidelines use the following definition for CRBSI:
"Catheter related Bacteremia or fungemia in a patient who has an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/ or hypotension), and no apparent source for bloodstream infection (with the exception of the catheter). One of the following should be present: a positive result of semiquantitative (>15 cfu per catheter segment) or quantitative (>10° cfu per catheter segment) catheter culture, whereby the same organism (species) is isolated from a catheter segment and a peripheral blood culture; simultaneous quantitative cultures of blood with a ratio of >3:1 cfu/mL of blood (catheter vs. peripheral blood); differential time to positivity (growth in a culture of blood obtained through a catheter hub is detected by an automated blood culture system at least 2 h earlier than a culture of simultaneously drawn peripheral blood of equal volume)."
11
3MTM Tegaderm™ CHG Chlorhexidine Gluconate Dressings 510(k) Premarket Notification - Traditional
| Control Group
(non CHG dressing) | Test Group
(Tegaderm ™ CHG I.V.
Securement Dressing) | Comparison | | P-value | | |
|-------------------------------------|------------------------------------------------------------------------|----------------------------|-----------------------------------------|--------------------------------------------------------|---------------------------------------------------|-------|
| Patients with
Infection | Infections per
1000 Catheter
Days | Patients with
Infection | Infections per
1000 Catheter
Days | Percent
Reduction in
Patients with
Infections | Percent
Reduction per
1000 Catheter
Days | |
| 1.7%
(16/941) | 0.94 | 0.85%
(8/938) | 0.46 | 50% | 51% | 0.095 |
The following results were obtained from the re-analysis with the IDSA guidelines:
VIII. CONCLUSIONS
3MTM Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing has been shown to reduce the incidence of catheter-related bloodstream infection (CRBSI) and catheter colonization in a large, randomized, controlled clinical trial. The Timsit 2012 study supports the expanded indication statement requested by 3M.
The 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing remains substantially equivalent to 3M Company's currently cleared and marketed 3M™ Tegaderm™ CHG I.V. Securement Dressing, and is substantially equivalent to the BIOPATCH predicate. The differences proposed do not affect the safety and effectiveness of the device when used as labeled.