Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and antimicrobial properties of a wound dressing, with no mention of AI or ML.

Therapeutic

Yes
The device is described as an "Antimicrobial Transparent Thin Film Dressing" intended to "cover and protect a wound" and "inhibits microbial growth within the dressing and prevents external contamination," which are functions consistent with therapeutic intervention for wound care.

Diagnostic

No.
The device is a ChloraDerm™ Antimicrobial Transparent Thin Film Dressing, which is used to cover and protect wounds and inhibit microbial growth. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical dressing made of film and adhesive containing an antimicrobial agent. There is no mention of software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Description and Intended Use: The ChloraDerm dressing is applied externally to the skin to cover and protect wounds caused by medical devices. It inhibits microbial growth within the dressing and prevents external contamination. It does not analyze any bodily fluids or tissues.

Therefore, the function and application of the ChloraDerm dressing clearly fall outside the scope of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FRO

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 days.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Surface of 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)

Test Type: Physical Performance
Test Description: Water Vapor Transmission Rate, Flammability, Synthetic Blood Penetration, Viral Penetration, Tear Resistance, Tensile Elongation, Recovery/Elongation to Break, Primary Release, Peel Adhesion/Shear Adhesion
Results: The ChloraDerm passed all functional testing and met all product specification requirements in addition to demonstrating equivalent performance to that of the predicate device.

Test Type: Antimicrobial Efficacy
Test Description: Zone of Inhibition/Activity, Spectrum, In vitro Kill Time
Results: The ChloraDerm demonstrated that it had adequate antimicrobial activity that was equivalent to that of the predicate device.

Test Type: Analytical
Test Description: p-Chloroaniline (PCA) Content
Results: The test results from zero-time and accelerated aged samples demonstrated that no detectable levels of p-chloroaniline were observed in the ChloraDerm. However, p-chloroaniline was detected in all of the Covalon 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K121819, K973036

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.

Not Found

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

Regulation Number and Section

N/A

Summary

0

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

1

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

2

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)

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.

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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

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.

PRODUCT 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.

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 Antimicrobial
Transparent Thin Film
Dressings	Covalon SurgiClearTM
Antimicrobial Clear Silicone
Adhesive Dressing with
Chlorhexidine and Silver	3MTM TegadermTM Transparent
Dressing	Substantial Equivalence
Rationale
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 salts
in the adhesive	None	Antimicrobial Efficacy Testing-
All acceptance criteria were met
and the device performed as
intended establishing
antimicrobial effectiveness.
Physical Performance Testing-
All acceptance criteria were met
and the device performed as
intended.
Adhesive	Acrylic-based pressure sensitive
adhesive	Silicone-based pressure sensitive
adhesive	Acrylic-based pressure sensitive
adhesive
Design Features	Transparent for site visibility,
Framed Delivery System	Transparent for site visibility,
Pull away release tabs for
delivery	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 Part
Numbers	The dimensional differences raise
no new issues of safety or
efficacy.
Feature	Sterility	Target Microbes		Substantial Equivalence
Rationale
entrotech life sciences inc.
ChloraDerm™ Antimicrobial
Transparent Thin Film
Dressings	Gamma	Gram-positive bacteria,
Gram-negative bacteria and
yeast including:
• Methicillin-Resistant
Staphylococcus aureus
(MRSA)
• Methicillin-Resistant
Staphylococcus epidermidis
(MRSE)
• Vancomycin-Resistant
Enterococcus faecalis (VRE)
• Multiple Drug-Resistant
Enterococcus faecium (MDR)
• Enterococcus faecium
• Pseudomonas aeruginosa
• Escherichia coli
• Serratia marcescens
• Candida albicans
• Candida tropicalis
• Candida parapsilosis
Covalon SurgiClear™
Antimicrobial Clear Silicone
Adhesive Dressing with
Chlorhexidine and Silver	Ethylene Oxide	Gram-positive bacteria,
Gram-negative bacteria and yeast
including:
• Methicillin-Resistant
Staphylococcus aureus (MRSA)
• Methicillin-Resistant
Staphylococcus epidermidis
• Vancomycin-Resistant
Enterococcus faecalis (VRE)
• Klebsiella pneumoniae
• Pseudomonas aeruginosa
• Enterobacter cloacae
• Candida albicans
• Candida tropicalis		Sterilization validation
performed, ensures a SAL of 10-6
as per device specifications.
3M™ Tegaderm™ Transparent
Dressing	Radiation			Antimicrobial Efficacy Testing-
All acceptance criteria were met
and the device performed as
intended establishing
antimicrobial effectiveness.
			Not specified on IFU

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510(k) SUMMARY (CONT.

7

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
Physical
Performance	Water Vapor Transmission Rate
Flammability
Synthetic Blood Penetration
Viral Penetration
Tear Resistance
Tensile Elongation
Recovery/Elongation to Break
Primary Release
Peel Adhesion/Shear Adhesion	The ChloraDerm passed all functional testing and
met all product specification requirements in
addition to demonstrating equivalent performance to
that of the predicate device.
Antimicrobial
Efficacy	Zone of Inhibition/Activity
Spectrum
In vitro Kill Time	The ChloraDerm demonstrated that it had adequate
antimicrobial activity that was equivalent to that of
the predicate device.
Analytical	p-Chloroaniline (PCA) Content	The test results from zero-time and accelerated aged
samples demonstrated that no detectable levels of
p-chloroaniline were observed in the ChloraDerm.
However, p-chloroaniline was detected in all of the
Covalon 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.

8

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.