Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a wound dressing with antimicrobial properties and physical characteristics for fluid management. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on biocompatibility, bench testing of physical properties, antimicrobial effectiveness, and animal wound healing models.

Therapeutic

Yes.
The device is a dressing for treating acute and chronic wounds, which is a therapeutic purpose.

Diagnostic

No

The device is a wound dressing designed for treatment and management of various types of wounds by absorbing exudate and providing antimicrobial efficacy; it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical wound dressing made from fibers and containing silver and LAE, not software.

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 and treatment of various types of wounds by absorbing exudate and providing antimicrobial efficacy within the dressing. This is a therapeutic application, not a diagnostic one.
Device Description: The device is a wound dressing made of fibers with added silver and LAE. Its function is to interact with the wound environment, not to analyze a sample from the body to provide diagnostic information.
Lack of Diagnostic Elements: There is no mention of the device being used to test a sample (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
Performance Studies: The performance studies focus on biocompatibility, physical properties, antimicrobial effectiveness within the dressing, and wound healing performance. These are all related to the device's function as a wound dressing, not as a diagnostic tool.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The product is indicated for use on moderate to highly exuding acute and chronic wounds such as:

· Diabetic ulcers
· Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology)
· Pressure injuries (stage 2-4)
Traumatic wounds
· Partial thickness (second degree) burns
· Donor sites
· Post-operative surgical wounds
· Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

Product codes

FRO

Device Description

Biatain Fiber Ag is a soft, sterile, primary wound dressing made mainly from non-woven gelling carboxymethyl cellulose (CMC) fibers. In addition, non-gelling bicomponent (BiCo) fibers are incorporated to obtain strength and integrity of the products both in dry and gelled condition. Ionic silver (Ag+) is added for antimicrobial efficacy within the dressing, and ethyl lauroyl arginate (LAE) is added as combined surfactant and chelator within the dressing.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Under the supervision of a healthcare professional

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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility: A biocompatibility evaluation, in accordance with ISO 10993-1:2018, has been conducted and concludes that the dressings have a safe toxicological profile for their intended use. The battery of testing included the following tests:

. Cytotoxicity
. Irritation
. Sensitization
Acute systemic toxicity ●
Sub-acute systemic toxicity .
. Pyrogenicity
. Implantation

Testing of physical/mechanical properties has been conducted on key performance parameters:

Absorption capacity .
. Fluid retention capacity
. Wet strength (gelled condition)
. Lateral shrinkage upon absorption
Volume expansion upon absorption ●
Lateral spreading of fluid .

Bench Testing:
Antimicrobial Effectiveness within the Dressing: The preservative action of silver and LAE reduces bacterial growth within the dressing. This was confirmed by in vitro tests. ≥4 log reduction (AATCC 100) antimicrobial effectiveness against 9 organisms, 3 Gram positive bacteria, 4 Gram negative bacteria, 1 yeast, and 1 mold for up to 7 days within the dressing.

Animal Study: A full thickness wound healing model in porcine study was conducted to evaluate local tissue effects and wound healing performance of a wound dressing containing silver (Biatain Fiber Ag). The study demonstrated that Biatain Fiber Ag and the predicate device did not hinder the wound healing process.

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.

K173675

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

Not Found

Regulation Number and Section

N/A

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 22, 2024

Coloplast Corp. Laura Kelly Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, Minnesota 55411

Re: K231953

Trade/Device Name: Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x 12 cm / 4 in x 5 in); Biatain Fiber Ag (33574 - 15 cm x 15 cm / 6 in x 6 in); Biatain Fiber Ag (33576 - 2.5 cm x 46 cm / 1 in x 18 in); Biatain Fiber Ag (33578 - 20 cm x 30 cm / 8 in x 12 in)

Regulatory Class: Unclassified Product Code: FRO Dated: February 22, 2024 Received: February 22, 2024

Dear Laura Kelly:

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 (the 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 available 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.

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

2

For comprehensive regulatory information about medical devices and radiation-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-regulatory-

assistance/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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K231953

Device Name Biatain Fiber Ag

Indications for Use (Describe)

The product is indicated for use on moderate to highly exuding acute and chronic wounds such as:

· Diabetic ulcers
· Leg ulcers (arterial ulcers, venous ulcers and leg ulcers of mixed etiology)
· Pressure injuries (stage 2-4)
Traumatic wounds
· Partial thickness (second degree) burns
· Donor sites
· Post-operative surgical wounds

· Exudate absorption in oncology wounds, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma

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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4

TRADITIONAL 510(k) SUMMARY

| Submitted by: | Coloplast A/S
Holtedam 1
3050
Humlebaek
Denmark |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Laura Kelly
Principal Regulatory Affairs Specialist
Coloplast Corp.
1601 West River Road North
Minneapolis MN 55411
Phone: +1 (612) 940-9983
Email: uslke@coloplast.com |
| Date of Summary: | March 22, 2024 |
| SUBJECT DEVICE | |
| Trade or Proprietary
Name: | Biatain Fiber Ag |
| Classification Name: | Dressing, Wound, Drug |
| Device Classification: | Unclassified |
| Product Code: | FRO |
| Review Panel: | General & Plastic Surgery |
| Predicate Device: | K173675, AQUACELTM Ag+ EXTRA Enhanced
HydrofiberTM Dressing with Silver and Strengthening Fiber |
| Device Description: | Biatain Fiber Ag is a soft, sterile, primary wound dressing
made mainly from non-woven gelling carboxymethyl
cellulose (CMC) fibers. In addition, non-gelling
bicomponent (BiCo) fibers are incorporated to obtain
strength and integrity of the products both in dry and
gelled condition. Ionic silver (Ag+) is added for
antimicrobial efficacy within the dressing, and ethyl
lauroyl arginate (LAE) is added as combined surfactant
and chelator within the dressing. |

5

| | Subject device
Biatain Fiber Ag (K231953) | Predicate device
AQUACEL Ag+ EXTRA (K173675) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The product is indicated for use on moderate
to highly exuding acute and chronic wounds
such as:
Diabetic ulcers Leg ulcers (arterial ulcers, venous ulcers
and leg ulcers of mixed etiology) Pressure injuries (stage 2-4) Traumatic wounds Partial thickness (second degree) burns Donor sites Post-operative surgical wounds Exudate absorption in oncology wounds,
such as fungoides-cutaneous tumors,
fungating carcinoma, cutaneous metastasis,
Kaposi's sarcoma, and angiosarcoma Prescription use only. | Over-the-Counter Use:
AQUACELTM Ag+ EXTRA Enhanced HydrofiberTM
Dressing with Silver and Strengthening Fiber may be
used for the management of:
Abrasions Lacerations Minor cuts Minor scalds and burns Prescription Use:
Under the supervision of a healthcare professional:
AQUACELTM Ag+ EXTRA Enhanced HydrofiberTM
Dressing with Silver and Strengthening Fiber may be
used for the management of:
Wounds as an effective barrier to bacterial
penetration of the dressing as this may help
reduce infection; Partial thickness (second degree) burns; Diabetic
foot ulcers, leg ulcers, (venous stasis ulcers,
arterial ulcers and leg ulcers of mixed etiology)
and pressure ulcers/sores (partial & full
thickness); Surgical wounds left to heal by secondary
intention such as dehisced surgical incisions; Surgical wounds that heal by primary intent such
as dermatological and surgical incisions (e.g.,
orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such as
wounds that have been mechanically or
surgically debrided and donor sites; Oncology wounds with exudate, such as
fungoides-cutaneous tumors, fungating
carcinoma, cutaneous metastasis, Kaposi's
sarcoma, and angiosarcoma; Management of painful wounds; Infected wounds |
| Components | Composed of sodium carboxymethyl
cellulose (CMC) fibers with bicomponent
(BiCo) fibers and 0.63% (w/w) ionic silver
with ethyl lauroyl arginate (LAE).
The device is reinforced with BiCo fibers
embossed to create a hexagon pattern. | Composed of sodium carboxymethylcellulose
(HydrofiberTM) and 1.2% ionic silver with
EDTA and benzethonium chloride. |
| Mode of
action | The dressing absorbs exudate and forms a
gel. The gelled dressing retains exudate,
thereby maintaining a moist wound
environment to support the healing process.
The dressing aids in the removal of
unnecessary material from the wound
(autolytic debridement). | The dressing absorbs wound fluid and creates a
soft, conformable gel, which maintains a moist
wound environment to support the healing
process.
The dressing aids in the removal of unnecessary
material from the wound (autolytic debridement)
without damaging newly formed tissue. |
| | When the wound exudate is absorbed by the
Biatain Fiber Ag dressing, the free ionic
silver exerts its activity by killing the
microorganisms held within the dressing. | The silver preservative in the dressing reduces
the growth of microorganisms within the
dressing. The silver preservative in the dressing kills
wound bacteria held in the dressing and provides
an effective barrier to bacterial penetration of the
dressing. |
| Characteristics | Sterile. Absorbs exudate. Forms a conformable gel The preservative action of ionic silver
reduces bacterial growth within the
dressing. Should be used with a secondary dressing
depending on the clinical condition of the
wound. | Sterile. Absorbs exudate (including bacteria) or blood. Forms a soft conformable gel. Ionic silver within the dressing functions as a
preservative to reduce bacterial growth within
the dressing. May require a secondary dressing. |

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

6

The differences in technological characteristics of the subject device do not raise additional questions of safety and effectiveness.

PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility:

A biocompatibility evaluation, in accordance with ISO 10993-1:2018, has been conducted and concludes that the dressings have a safe toxicological profile for their intended use. The battery of testing included the following tests:

. Cytotoxicity
. Irritation
. Sensitization
Acute systemic toxicity ●
Sub-acute systemic toxicity .
. Pyrogenicity
. Implantation

Testing of physical/mechanical properties has been conducted on key performance parameters:

Absorption capacity .
. Fluid retention capacity
. Wet strength (gelled condition)
. Lateral shrinkage upon absorption
Volume expansion upon absorption ●
Lateral spreading of fluid .

Bench Testing:

7

| Antimicrobial
Effectiveness within the
Dressing: | The preservative action of silver and LAE reduces bacterial
growth within the dressing. This was confirmed by in vitro
tests. |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ≥4 log reduction (AATCC 100) antimicrobial effectiveness
against 9 organisms, 3 Gram positive bacteria, 4 Gram
negative bacteria, 1 yeast, and 1 mold for up to 7 days
within the dressing. |
| Animal Study: | A full thickness wound healing model in porcine study was
conducted to evaluate local tissue effects and wound healing
performance of a wound dressing containing silver (Biatain
Fiber Ag). The study demonstrated that Biatain Fiber Ag
and the predicate device did not hinder the wound healing
process. |
| CONCLUSION | Based on the identical indications for use, principles of
operations, technological characteristics, and performance
testing, Biatain Fiber Ag is as safe and as effective as the
predicate device, ConvaTec's AQUACELTM Ag+ EXTRA
Enhanced HydrofiberTM Dressing with Silver and
Strengthening Fiber (K173675). |