The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. ChloraDerm may also be used to cover and secure primary dressings. ChloraDerm inhibits microbial growth within the dressing and prevents external contamination.

Device Description

The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings ("ChloraDerm") are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. The ChloraDerm may also be used to cover and secure primary dressings. The ChloraDerm inhibits microbial growth within the dressing and prevents external contamination. ChloraDerm consists of a transparent, thin plastic film coated with an acrylic-based pressure sensitive adhesive containing chlorhexidine as an antimicrobial agent. The ChloraDerm dressing is a single-use device, intended to be used for up to 7 davs.

AI/ML Overview

This document describes the 510(k) premarket notification for the "ChloraDerm™ Antimicrobial Transparent Thin Film Dressing" and provides information about its substantial equivalence to predicate devices, supported by various tests.

Here's an analysis of the provided text to extract the requested information:

1. A table of acceptance criteria and the reported device performance

The document lists various tests performed and states that the device "passed all functional testing and met all product specification requirements." However, it does not provide specific numerical acceptance criteria (e.g., "Water Vapor Transmission Rate > X g/m²/24hr") or exact reported numerical performance values for the ChloraDerm. Instead, it indicates that the ChloraDerm's performance was equivalent to, or did not raise new safety/effectiveness issues compared to, the predicate devices.

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Physical Performance	Meet product specification requirements and demonstrate equivalent performance to predicate device (3M™ Tegaderm™ Transparent Dressings)	Passed all functional testing and met all product specification requirements. Demonstrated equivalent performance to the predicate device.
Water Vapor Transmission Rate	(Implicit: within acceptable range comparable to predicate)	Passed functional testing.
Flammability	(Implicit: conform to safety standards)	Passed functional testing.
Synthetic Blood Penetration	(Implicit: effective barrier against blood penetration)	Passed functional testing.
Viral Penetration	(Implicit: effective barrier against viral penetration)	Passed functional testing.
Tear Resistance	(Implicit: sufficient resistance comparable to predicate)	Passed functional testing.
Tensile Elongation	(Implicit: sufficient elasticity comparable to predicate)	Passed functional testing.
Recovery/Elongation to Break	(Implicit: sufficient recovery/elasticity comparable to predicate)	Passed functional testing.
Primary Release	(Implicit: appropriate release characteristics)	Passed functional testing.
Peel Adhesion/Shear Adhesion	(Implicit: appropriate adhesion strength comparable to predicate)	Passed functional testing.
Antimicrobial Efficacy	Adequate antimicrobial activity equivalent to predicate device (Covalon SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with Chlorhexidine and Silver)	ChloraDerm demonstrated adequate antimicrobial activity that was equivalent to that of the predicate device. All acceptance criteria were met and the device performed as intended establishing antimicrobial effectiveness.
Zone of Inhibition/Activity Spectrum	(Implicit: demonstrate inhibition against target microbes)	Demonstrated adequate antimicrobial activity.
In vitro Kill Time	(Implicit: demonstrate effective microbial reduction within a specified timeframe)	Demonstrated adequate antimicrobial activity.
Analytical	For p-Chloroaniline (PCA) Content: No detectable levels of p-chloroaniline in ChloraDerm (zero-time and accelerated aged samples).	Test results from zero-time and accelerated aged samples demonstrated that no detectable levels of p-chloroaniline were observed in the ChloraDerm. (Note: PCA was detected in the Covalon SurgiClear samples, but this is a predicate device, not the device under review.)
Biocompatibility	Meet established biocompatibility standards.	Testing conducted; results implicitly acceptable to support substantial equivalence.
Shelf life	Demonstrate stability and effectiveness over intended shelf life.	Testing conducted; results implicitly acceptable to support substantial equivalence.
Packaging	Ensure sterility and integrity of the device until use.	Testing conducted; results implicitly acceptable to support substantial equivalence.
Sterilization Validation	Achieve a Sterility Assurance Level (SAL) of 10^-6 as per device specifications.	Performed, ensures a SAL of 10^-6 as per device specifications.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (number of units tested) for any of the performance, antimicrobial efficacy, or analytical tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. These details are typically part of a comprehensive test report but are not included in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a medical dressing, not an AI/imaging device requiring expert interpretation for "ground truth" establishment in the typical sense of diagnostic accuracy. The ground truth for its performance would be established by objective measurements in a laboratory setting (e.g., measuring peel adhesion, inhibitory zones for bacteria, chemical composition). Therefore, the concept of "experts" establishing a clinical "ground truth" for a test set, as might be done for an imaging AI, does not apply directly here. The "experts" involved would be relevant laboratory personnel and possibly a clinical team for biocompatibility/shelf-life, but their numbers and specific qualifications are not mentioned in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human readers (e.g., radiologists) interpret data, and discrepancies need to be resolved. The testing described here is primarily bench (physical, chemical, microbiological) and biocompatibility, which typically relies on established protocols and measurement standards rather than human interpretive adjudication.

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

Not applicable. This is not an AI-assisted diagnostic or imaging-interpretation device. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through objective laboratory measurements and standardized test methods against predefined specifications and comparisons to predicate devices:

Physical Performance: Measured values for properties like water vapor transmission rate, tear resistance, adhesion strength, flammability, and penetration against synthetic blood/viruses.
Antimicrobial Efficacy: Measured zones of inhibition and in vitro kill times against specified microbial strains.
Analytical (PCA Content): Chemical analysis to determine the presence and quantity of a specific compound.
Biocompatibility: Results of standardized biocompatibility tests (e.g., ISO 10993 series).
Sterilization Validation: Demonstrated achievement of a specific Sterility Assurance Level (SAL).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling 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

November 7, 2014

Entrotech Life Sciences Incorporated % Ms. Valerie Defiesta-Ng Experien Group, LLC 755 North Mathilda Avenue, Suite 100 Sunnyvale, California 94085

Re: K140389

Trade/Device Name: ChloraDerm™ Antimicrobial Transparent Thin Film Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 8, 2014 Received: October 9, 2014

Dear Ms. Defiesta-Ng:

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

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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. 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" (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 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

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140389

Device Name

ChloraDerm™ Antimicrobial Transparent Thin Film Dressings

Indications for Use (Describe)

ChloraDerm™ may also be used to cover and secure primary dressings.

ChloraDerm™ inhibits microbial growth within the dressing and prevents external contamination.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Notification K140389

GENERAL INFORMATION

Applicant:

entrotech life sciences inc. 409 Illinois Street San Francisco, CA 94158 U.S.A. Phone: 510-384-0657 Fax: 800-580-0161

Contact Person:

Valerie Defiesta-Ng Regulatory Consultant Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 408-400-0856 Fax: 408-400-0865

Date Prepared: October 7th, 2014

DEVICE INFORMATION

Trade Name: ChloraDerm™ Antimicrobial Transparent Thin Film Dressings

Generic/Common Name: Wound Dressing, Antimicrobial

Classification: Antimicrobial Dressing, Unclassified

Product Code: FRO

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PREDICATE DEVICE(S)

Covalon SurgiClear™ Antimicrobial Clear Silicone Adhesive Dressing with o Chlorhexidine and Silver ("SurgiClear") (K121819)
3M™ Tegaderm™ Transparent Dressings ("Tegaderm") (K973036) ●

INDICATIONS FOR USE

PRODUCT DESCRIPTION

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the ChloraDerm are substantially equivalent to the predicate devices. Table 5.1 lists the technological characteristics of the ChloraDerm and the predicate device and provides the rationale to support a determination of substantial equivalence. Any differences in the technological characteristics of the device do not affect the safety and effectiveness of the device.

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510(k) SUMMARY (CONT.

Table










Equivalence






Substantial




Table 5.1:

Table 5.1: Substantial Equivalence Table
Feature	entrotech life sciences inc.ChloraTMDerm AntimicrobialTransparent Thin FilmDressings	Covalon SurgiClearTMAntimicrobial Clear SiliconeAdhesive Dressing withChlorhexidine and Silver	3MTM TegadermTM TransparentDressing	Substantial EquivalenceRationale
510(k) Number	K140389	K121819	K973036	--
Instruction for Use	Single Use	Single Use	Single Use	N/A (Same)
Duration of Use	Up to 7 days	Up to 7 days	Up to 7 days	N/A (Same)
Anatomical Site	Surface of skin	Surface of skin	Surface of skin	N/A (Same)
Physical Composition	Polyurethane film	Polyurethane film	Polyurethane film	N/A (Same)
Antimicrobial Agent	Chlorhexidine in the adhesive	Chlorhexidine and Silver saltsin the adhesive	None	Antimicrobial Efficacy Testing-All acceptance criteria were metand the device performed asintended establishingantimicrobial effectiveness.Physical Performance Testing-All acceptance criteria were metand the device performed asintended.
Adhesive	Acrylic-based pressure sensitiveadhesive	Silicone-based pressure sensitiveadhesive	Acrylic-based pressure sensitiveadhesive
Design Features	Transparent for site visibility,Framed Delivery System	Transparent for site visibility,Pull away release tabs fordelivery	Transparent for site visibility,Framed Delivery System	N/A (Same)
Dimensions	1624CH: 2-3/8" x 2-3/4"1626CH: 4" x 4-3/4"	TWBD1017: 1.6" x 2.8"TWBD1018: 1.6" x 5"TWBD1019: 4" x 4.8"TWBD1021: 1.6" x 1.6"TWBD1023: 2.5" x 8"TWBD1024: 2.6" x 10"TWBD1025: 2.5" x 12"	Multiple sizes/Multiple PartNumbers	The dimensional differences raiseno new issues of safety orefficacy.
Feature	Sterility	Target Microbes		Substantial EquivalenceRationale
entrotech life sciences inc.ChloraDerm™ AntimicrobialTransparent Thin FilmDressings	Gamma	Gram-positive bacteria,Gram-negative bacteria andyeast including:• Methicillin-ResistantStaphylococcus aureus(MRSA)• Methicillin-ResistantStaphylococcus epidermidis(MRSE)• Vancomycin-ResistantEnterococcus faecalis (VRE)• Multiple Drug-ResistantEnterococcus faecium (MDR)• Enterococcus faecium• Pseudomonas aeruginosa• Escherichia coli• Serratia marcescens• Candida albicans• Candida tropicalis• Candida parapsilosis
Covalon SurgiClear™Antimicrobial Clear SiliconeAdhesive Dressing withChlorhexidine and Silver	Ethylene Oxide	Gram-positive bacteria,Gram-negative bacteria and yeastincluding:• Methicillin-ResistantStaphylococcus aureus (MRSA)• Methicillin-ResistantStaphylococcus epidermidis• Vancomycin-ResistantEnterococcus faecalis (VRE)• Klebsiella pneumoniae• Pseudomonas aeruginosa• Enterobacter cloacae• Candida albicans• Candida tropicalis		Sterilization validationperformed, ensures a SAL of 10-6as per device specifications.
3M™ Tegaderm™ TransparentDressing	Radiation			Antimicrobial Efficacy Testing-All acceptance criteria were metand the device performed asintended establishingantimicrobial effectiveness.
			Not specified on IFU

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510(k) SUMMARY (CONT.

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SUBSTANTIAL EQUIVALENCE

The indications for use of the ChloraDerm is identical to that of the Covalon SurgiClear predicate device. All three devices are intended to cover and protect wounds caused by percutaneous medical devices and are also to be used as a secondary dressing to cover and secure a primary dressing.

The ChloraDerm is similar to the Tegaderm in its physical performance and to the SurgiClear in its antimicrobial efficacy. Available performance data support the determination of substantial equivalence in terms of both device physical performance and antimicrobial efficacy and confirmed that any differences in the technological characteristics between the ChloraDerm and the predicate devices do not raise any new issues of safety or effectiveness. Thus, the ChloraDerm is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing including head comparison testing with the predicate devices was conducted on the ChloraDerm to support a determination of substantial equivalence to the predicate devices. The following table lists the non-clinical testing performed and the results for each test.

Test Type	Test Description	Results
PhysicalPerformance	Water Vapor Transmission RateFlammabilitySynthetic Blood PenetrationViral PenetrationTear ResistanceTensile ElongationRecovery/Elongation to BreakPrimary ReleasePeel Adhesion/Shear Adhesion	The ChloraDerm passed all functional testing andmet all product specification requirements inaddition to demonstrating equivalent performance tothat of the predicate device.
AntimicrobialEfficacy	Zone of Inhibition/ActivitySpectrumIn vitro Kill Time	The ChloraDerm demonstrated that it had adequateantimicrobial activity that was equivalent to that ofthe predicate device.
Analytical	p-Chloroaniline (PCA) Content	The test results from zero-time and accelerated agedsamples demonstrated that no detectable levels ofp-chloroaniline were observed in the ChloraDerm.However, p-chloroaniline was detected in all of theCovalon SurgiClear samples evaluated

In addition to the above performance testing, entrotech conducted Biocompatibility, Shelf life, Packaging and Sterilization Validation testing on the ChloraDerm.

The collective results of the performance testing demonstrate that the materials chosen, manufacturing processes, and design of the ChloraDerm meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the ChloraDerm does not raise new questions of safety or effectiveness when compared to the predicate devices.

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CONCLUSION

The entrotech life sciences inc. ChloraDerm is substantially equivalent to the Covalon SurgiClear and 3M Tegaderm dressings. The indications for use of the ChloraDerm is identical to that of the Covalon SurgiClear predicate device. The product performance testing demonstrated that ChloraDerm is as safe, as effective and performs as well as the predicate devices in terms of intended use, safety and technological characteristics, and patient populations. The key difference between the devices is the presence and/or choice of antimicrobial agent that is incorporated into the adhesive. The difference in antimicrobial agent between the subject device and the SurgiClear predicate device raises no issue of safety and effectiveness. Additionally, the difference in physical performance between the subject device and the 3M Tegaderm product raises no issues of safety and effectiveness. The information contained in this 510(k) premarket notification demonstrates the substantial equivalence of the ChloraDerm to the SurgiClear and to the Tegaderm.

Regulation Number and Section

N/A