Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical and chemical properties of the dressing materials (silver, activated carbon fiber) and their mechanism of action (absorbing exudate, releasing silver ions). There is no mention of software, algorithms, data processing, or any characteristics typically associated with AI/ML. The performance studies are based on biocompatibility and antimicrobial efficacy testing, not algorithmic performance.

Therapeutic

Yes
The device is intended for the management of wounds and provides an antimicrobial barrier, directly contacting the wound to aid in healing and prevent infection, which aligns with the definition of a therapeutic device.

Diagnostic

No.

The device descriptions indicate that the BCT Antimicrobial Dressing and BCT Silver Bandage Dressings are used for the management of wounds and to provide an antimicrobial barrier by absorbing wound fluid and eliminating bacteria. They do not mention any function for diagnosing conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (polyethylene terphthalate non-woven, silver-coated activated carbon fiber cloth, polyethylene film, adhesive layer) and their physical mechanisms of action (absorbing wound fluid, silver ions acting locally, activated carbon fiber cloth absorbing toxins and odors). This is a physical medical device, not a software-only one.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is for the management of wounds and to provide an antimicrobial barrier by being applied topically and in direct contact with the wound. This is a therapeutic and protective function, not a diagnostic one.
Mechanism of Action: The device works by absorbing wound fluid and exudates and then the silver within the dressing acts locally to eliminate absorbed bacteria. This is a direct treatment/management mechanism, not a test or analysis of a sample to provide diagnostic information.
Device Description: The description focuses on the physical components of the dressing and how they interact with the wound and absorbed substances. There is no mention of analyzing a sample to provide information about a patient's condition.
Lack of Diagnostic Elements: There are no mentions of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing information for diagnosis, monitoring, or screening.

IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to directly interact with and manage a wound.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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) .

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

FRO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.

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.

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.

K022483

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

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 Dressing
BCT 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 under
Section 514 of the FD&C Act. Biocompatibility tests were done in
conformance 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.

Page 5 - 1 -

1

5. Legally Marketed Predicate Device(s)

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

6. 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.

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 & BCT
Silver 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 & BCT
Silver 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, pressure
ulcers, diabetic ulcers, acute wounds
such as 1st and 2nd degree burns and
surgical wounds. | ACTISORB Silver 220
Antimicrobial Binding. Dressing
provides an effective barrier to
bacterial penetration and for
adsorbing offending odor
resulting from wounds; the
binding properties of the
dressing trap bacteria, bacterial
toxins and odor. ACTISORB Silver
220 Antimicrobial Binding
Dressing may help reduce
infection in partial and full
thickness wounds, including:
• Pressure ulcers
• Venous ulcers
• Diabetic ulcers
• First and second-degree
burns
• Donor sites
• Surgical wounds

Bandage:
A. Rayon and Polyester composite absorbent layer
B. Activated carbon fiber cloth with silver (ACF-Ag)
C. Anti-adherent polyethylene film
D. Adhesive layer | | Dressing:
A. Nylon non-woven
B. Silver-containing Plain cloth (Charcoal activated carbon with silver)
C. Nylon non-woven |
| Sterilization | Same | | Gamma |

Table 5A - Comparison of Characteristics

2

.

:

. . . . . .

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

3

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.

4

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.

5

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

6

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)

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 )

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)