(157 days)
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.
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.
This document is a 510(k) Pre-market Notification for a medical device called the "3M™ Tegaderm™ CHG Chlorhexidine Gluconate Gel Pad". It is a submission to the FDA seeking clearance to market the device, claiming substantial equivalence to a previously cleared predicate device.
Here's an analysis of the provided text in relation to your request:
Based on the provided text, the device is not an AI/ML device, therefore, much of the requested information (sample sizes for training/test sets, ground truth establishment for AI, MRMC studies, details on expert readers/adjudication) is not applicable. The device is a medical dressing with an antiseptic agent.
My analysis will focus on the information relevant to a non-AI medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list "acceptance criteria" in a quantitative manner as one might find for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, for this type of device, "acceptance criteria" are implied by successful completion of standard performance and biocompatibility tests, demonstrating that the device functions as intended and is safe. The "reported device performance" refers to the outcomes of these tests.
| Test Description | Reported Device Performance / Outcome |
|---|---|
| In vitro Direct Time Kill | Demonstrates antimicrobial effect (log reduction) against a variety of gram-positive and gram-negative bacteria, mold, and yeast. |
| Absorption | The CHG Gel Pad absorbs fluid. |
| Moisture Vapor Transmission Rate | (Result not explicitly stated, but implies the test was performed and met expectations for breathability) |
| Biocompatibility | Provided data from predicate device (K123679), concluding the device meets biocompatibility requirements. Categorized as a surface contacting device with breached/compromised skin contact of prolonged duration per ISO 10993-1 and FDA Guidance. |
| Adherence (Subject device) | The subject standalone CHG Gel Pad does adhere. |
| Securement (Subject device) | Not intended to provide securement. |
| Transparency (Subject device) | Transparent, allowing continuous site observation. |
| Breathability (Subject device) | Breathable. |
| CHG Content (Subject device) | Contains 2% w/w Chlorhexidine Gluconate (CHG). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not specify discrete "sample sizes" for the in vitro tests beyond stating that testing was performed. For in vitro laboratory tests, samples usually refer to a certain number of product units tested, which is not detailed here. Clinical data from human subjects is absent because this is a 510(k) submission based on substantial equivalence and non-clinical testing.
- Data Provenance: The in vitro tests were conducted internally by 3M Company, presumably in a laboratory setting. There is no mention of country of origin of the data in the context of clinical trials (as there are none) or whether the data is retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is not an AI/ML device relying on expert-labeled data for its performance evaluation. The "ground truth" for this device's performance is established by the direct measurement of physical and chemical properties in laboratory settings (e.g., direct measurement of CHG concentration, fluid absorption, bacterial kill rates).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. Adjudication methods are typically used in clinical trials or for ground truth establishment in AI/ML performance evaluation involving human interpretation, which is not the case here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as the device is not an AI/ML device. MRMC studies are used to evaluate diagnostic accuracy and the impact of AI assistance on human readers, which is entirely outside the scope of this medical dressing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is derived from:
- Direct physical and chemical measurements: Examples include the measured concentration of Chlorhexidine Gluconate, measured fluid absorption capacity, and measured moisture vapor transmission rate.
- Microbiological assays: For the in vitro direct time kill studies, the "ground truth" refers to the confirmed reduction in microbial counts based on standardized microbiological testing protocols.
- Biocompatibility standards: Compliance with ISO 10993-1 and FDA Guidance based on established toxicological principles and testing.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML device and therefore does not have a "training set" in that context. The device's characteristics are inherent to its manufacturing and materials.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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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
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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.
N/A