The BCT Antimicrobial Dressing & BCT Silver Bandage Dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as:

Partial and full thickness wounds;
Pressure ulcers;
Diabetic ulcers;
Surgical wounds;
Acute wounds ( 1st and 2nd degree burns )

Device Description

BCT Antimicrobial Dressing consists of polyethylene terphthalate (PET) non-woven, silver-coated activated carbon fiber cloth and polyethylene (PE) film. BCT Silver Bandage contains the same ingredients, but includes an adhesive layer. The dressings and bandages contain 100 µg/cm² of silver and are available in several sizes to accommodate different wound sizes.

BCT Antimicrobial Dressing and BCT Silver Bandage absorbs wound fluid and exudates containing infectious organisms into the dressing fabric, where the silver exerts its antimicrobial action. The silver ions act locally within the dressing, eliminating the absorbed bacteria and pathogens.

The activated carbon fiber cloth in BCT Dressings absorbs bacterial toxins and offensive odors.

The dressings are individually packaged in a pouch. All dressings are sterile and are for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BCT Antimicrobial Dressing & BCT Silver Bandage, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (BCT Antimicrobial Dressing & BCT Silver Bandage)
Biocompatibility	Compliance with ISO 10993	Demonstrated through appropriate in vivo and in vitro tests; no additional safety risk over predicate device.
Antimicrobial Activity	> 4 log reduction in microbial population (AATCC Test Method 100-2004)	Greater than a 4 log reduction in microbial population. Comparable results to the predicate device.
Intended Use	Equivalent to predicate device (ACTISORB Silver 220)	Intended for management of partial/full thickness wounds, pressure ulcers, diabetic ulcers, surgical wounds, acute wounds (1st and 2nd degree burns).
Technological Characteristics	Similar to predicate device	Non-absorbable polymer materials, activated carbon fiber layer, similar size ranges, 100 µg/cm² silver content.
Sterilization	Gamma sterilization	Sterilized by Gamma (same as predicate device)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a separate "test set" for performance evaluation in the typical sense of clinical trials. The antimicrobial testing referenced AATCC Test Method 100-2004, which is a standardized lab test. The biocompatibility tests were "appropriate in vivo and in vitro tests" according to ISO 10993. These are lab-based tests, not human subject trials.
Data Provenance: The studies were non-clinical (lab-based). The sponsor is Bio-medical Carbon Technology Co., Ltd. from Taiwan. The AATCC and ISO standards are international standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies were non-clinical (biocompatibility and antimicrobial effectiveness) and did not involve expert-established ground truth in the context of diagnostic or interpretive performance. The "ground truth" for these tests are the established parameters and endpoints of the specified ISO and AATCC standards.

4. Adjudication Method for the Test Set

Not applicable. There was no human interpretation or adjudication involved in the non-clinical biocompatibility or antimicrobial effectiveness tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, not an AI-powered diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI" is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical wound dressing and does not involve any algorithm or AI component.

7. The Type of Ground Truth Used

For Biocompatibility: The "ground truth" is adherence to the requirements and established safety profiles outlined in ISO 10993 standards.
For Antimicrobial Activity: The "ground truth" is the quantitative reduction in microbial population as measured by AATCC Test Method 100-2004, with a specific criterion of "> 4 log reduction".

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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510(k) Summary

For

BCT Antimicrobial Dressing & BCT Silver Bandage

1. Submission Sponsor

Bio-medical Carbon Technology Co., Ltd. No. 8-1. Gongyecyu 12th Rd. Siehe Village, Situn Dist. Taichung City 40755, Taiwan Phone: +886-4-2355-4588 Fax: +886-4-2355-4587 Contact: Jui-Hsing Lin, Manager, R&D Center

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Dr. Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com

3. Date Prepared

January 17, 2014

4. Device Identification

Trade/Proprietary Name:	BCT Antimicrobial Dressing also marketed as KoCarbon Ag Antimicrobial DressingBCT Silver Bandage also marketed as KoCarbon Ag Silver Bandage
Common/Usual Name:	Antimicrobial Dressing
Classification Name:	Dressing, Wound, Drug
Classification Regulation:	Unclassified; 21 CFR § 878.4020*
Product Code:	FRO*
Classification Panel:	General and Plastic Surgery
Performance Standards:	No applicable performance standards have been established underSection 514 of the FD&C Act. Biocompatibility tests were done inconformance with relevant requirements of ISO 10993.

*A final classification for "Dressing" has not been implemented; however, a Class II classification has been proposed by the General and Plastic Surgery Devices Panel. At this time however, Classification Code FRO is unclassified.

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5. Legally Marketed Predicate Device(s)

K022483 – ACTISORB Silver 220 Antimicrobial Binding Dressing (Johnson & Johnson Medical, Ltd.)

6. Device Description

The activated carbon fiber cloth in BCT Dressings absorbs bacterial toxins and offensive odors.

The dressings are individually packaged in a pouch. All dressings are sterile and are for single use only.

7. Indication for Use Statement

The BCT Antimicrobial Dressing & BCT Silver Bandage dressings are intended for the management of wounds and to provide an antimicrobial barrier. These dressings are applied topically and are in direct contact with the wound. Both are intended to be used for indications such as:

Partial and full thickness wounds;
· Pressure ulcers;
. Diabetic ulcers;
. Surgical wounds;
Acute wounds (1st and 2nd degree burns) .

8. Substantial Equivalence Discussion

The BCT Antimicrobial Dressing & BCT Silver Bandage have similar indications for use and technological characteristics as Johnson's ACTISORB Silver 220. Both dressings and bandage are manufactured with non-absorbable polymer materials and an activated carbon fiber layer and are available in a similar range of sizes. The biocompatibility testing showed comparable safety profile of the BCT Antimicrobial Dressing & BCT Silver Bandage and the predicate Bench testing demonstrated that the devices are substantially equivalent for the management of wounds and to provide an antimicrobial barrier. See Table 5A for a comparison of characteristics.

Manufacturer	Bio-medical Carbon Technology Co.,Ltd.	Johnson & Johnson Medical, LTD.
Trade Name	BCT Antimicrobial Dressing & BCTSilver Bandage	ACTISORB Silver 220
510(k) Number	Pending	K022483
Product Code	FRO	FRO
Manufacturer	Bio-medical Carbon Technology Co.,Ltd.	Johnson & Johnson Medical, LTD.
Trade Name	BCT Antimicrobial Dressing & BCTSilver Bandage	ACTISORB Silver 220
Regulation Number	None	None
Regulation Name	Dressing, Wound, Drug	Dressing, Wound, Drug
Intended Use/Indications for Use	For the management of partial and full thickness dermal ulcers, pressureulcers, diabetic ulcers, acute woundssuch as 1st and 2nd degree burns andsurgical wounds.	ACTISORB Silver 220Antimicrobial Binding. Dressingprovides an effective barrier tobacterial penetration and foradsorbing offending odorresulting from wounds; thebinding properties of thedressing trap bacteria, bacterialtoxins and odor. ACTISORB Silver220 Antimicrobial BindingDressing may help reduceinfection in partial and fullthickness wounds, including:• Pressure ulcers• Venous ulcers• Diabetic ulcers• First and second-degreeburns• Donor sites• Surgical woundsACTISORB Silver 220 AntimicrobialBinding Dressing is suitable for useunder compression bandaging.
Antimicrobial ActivityMicrobes tested-	S. aureusE. coliC. albicansP. aeruginoseS. epidermidisS. saprophyticusMulti-drug resistant P. aeruginoseE. faecalisA. haemolyticusM. furfurP citrinumS. marcescensA. nigerT. rubrum	S. aureusE. coliC. albicansP. aeruginoseE. faeciumE. faecalis**
Zone of Inhibition	No well-defined zone of inhibition	No well-defined zone of inhibition
Duration	Same	7 days
Biocompatibility	Same	Biocompatibility established*
Key Factor	Same	Ag
Manufacturer	Bio-medical Carbon Technology, Co., Ltd.		Johnson & Johnson Medical, LTD.
Trade Name	BCT Antimicrobial Dressing & BCT Silver Bandage		ACTISORB Silver 220
Silver process	Same		Impregnation
Silver (Ag) content	100 µg/cm²		33 µg/cm²
Silver (Ag) contact wound directly?	Same		No
Non-invasive device	Same		Yes
Structure and materials	Dressing:A. Rayon and Polyester composite absorbent layerB. Activated carbon fiber cloth with silverC. Anti-adherent polyethylene filmBandage:A. Rayon and Polyester composite absorbent layerB. Activated carbon fiber cloth with silver (ACF-Ag)C. Anti-adherent polyethylene filmD. Adhesive layer		Dressing:A. Nylon non-wovenB. Silver-containing Plain cloth (Charcoal activated carbon with silver)C. Nylon non-woven
Sterilization	Same		Gamma

Table 5A - Comparison of Characteristics

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Stated in 510(k) Summary

**Stated in J.R. Furr, et al J Hosp Infection (1994) 27, 201-208

9. Non-Clinical Performance Data

The biocompatibility of BCT Antimicrobial Dressing and BCT Silver Bandage has been demonstrated through appropriate in vivo and in vitro tests on the dressings. The products have been assessed in accordance with ISO 10993 and do not introduce any additional safety risk over the predicate device ACTISORB* Silver 220 (K022483). Antimicrobial testing demonstrated greater than a 4 log reduction in microbial population under AATCC Test Method 100-2004. Testing demonstrated comparable results between BCT Antimicrobial Dressing and the ACTISORB 220 predicate device.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

Based on the indications for use, technological characteristics and performance test results, the BCT Antimicrobial Dressing & BCT Silver Bandage is substantially equivalent to the referenced predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wavy lines beneath it, possibly representing water or movement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 22, 2014

Bio-medical Carbon Technology Company Ltd. % Ms. Diane Sudduth Emergo Group 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K140147

Trade/Device Name: BCT Antimicrobial Dressing & BCT Silver Bandage Regulatory Class: Unclassified Product Code: FRO . Dated: January 17, 2014 Received: January 22, 2014

Dear Ms. Sudduth:

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 four of 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 that 1 Dr has made a and regulations administered by other Federal agencies. You must of any I outh 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic ford in the quality of the (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Diane Sudduth

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. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K140147

Device Name

BCT Antimicrobial Dressing & BCT Silver Bandage

Indications for Use (Describe)

- Partial and full thickness wounds;
- Pressure ulcers;
- Diabetic ulcers;
- Surgical wounds;

Acute wounds ( 1st and 2nd degree burns )

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)

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)

David Krause

Regulation Number and Section

N/A