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)

• K Number: K231953
• 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)
• Manufacturer: Coloplast Corp.
• Date Cleared: 2024-03-22 ( 266 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K173675
• Predicate For: N/A

Intended 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

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.

AI/ML Overview

The provided text is a 510(k) summary for the Biatain Fiber Ag wound dressing. This document describes the device, its indications for use, comparison with a predicate device, and performance data to support its substantial equivalence. However, it does not contain information about an AI/ML-enabled medical device study, nor does it describe acceptance criteria and performance in the context of AI/ML algorithms.

Therefore, I cannot provide details on the following, as they are not present in the document:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for AI/ML.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document details the performance data for a traditional wound dressing:

1. Performance Data Provided (Related to a traditional wound dressing):

Test Category	Acceptance Criteria/Method	Reported Device Performance
Biocompatibility	Conformance with ISO 10993-1:2018	Concluded that the dressings have a safe toxicological profile for their intended use. Battery of tests included: Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Sub-acute systemic toxicity, Pyrogenicity, Implantation.
Physical/Mechanical Properties	Not explicitly stated "acceptance criteria" values, but testing was 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. (No specific numerical results provided in the summary).
Antimicrobial Effectiveness within the Dressing	≥4 log reduction (AATCC 100) antimicrobial effectiveness against specified organisms for up to 7 days.	Confirmed by in vitro tests. Achieved ≥4 log reduction (AATCC 100) 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	Wound healing performance not hindered.	A full thickness wound healing model in porcine study demonstrated that Biatain Fiber Ag and the predicate device did not hinder the wound healing process.

Summary of Device and Study Type:

The document describes performance data for the Biatain Fiber Ag, which is a wound dressing, not an AI/ML device. The studies listed are standard performance tests for such a product to demonstrate its safety and effectiveness in its intended use, particularly for absorbency, wet strength, and antimicrobial properties.

Summary

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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.

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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.

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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 ([e-mail]) or phone [phone] 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

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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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TRADITIONAL 510(k) SUMMARY

Submitted by:	Coloplast A/SHoltedam 13050HumlebaekDenmark
Contact Person:	Laura KellyPrincipal Regulatory Affairs SpecialistColoplast Corp.1601 West River Road NorthMinneapolis MN 55411Phone: [phone]Email: [e-mail]
Date of Summary:	March 22, 2024
SUBJECT DEVICE
Trade or ProprietaryName:	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 EnhancedHydrofiberTM Dressing with Silver and Strengthening Fiber
Device Description:	Biatain Fiber Ag is a soft, sterile, primary wound dressingmade mainly from non-woven gelling carboxymethylcellulose (CMC) fibers. In addition, non-gellingbicomponent (BiCo) fibers are incorporated to obtainstrength and integrity of the products both in dry andgelled condition. Ionic silver (Ag+) is added forantimicrobial efficacy within the dressing, and ethyllauroyl arginate (LAE) is added as combined surfactantand chelator within the dressing.

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	Subject deviceBiatain Fiber Ag (K231953)	Predicate deviceAQUACEL Ag+ EXTRA (K173675)
Indications forUse	The product is indicated for use on moderateto highly exuding acute and chronic woundssuch as:Diabetic ulcers Leg ulcers (arterial ulcers, venous ulcersand 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 HydrofiberTMDressing with Silver and Strengthening Fiber may beused 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 HydrofiberTMDressing with Silver and Strengthening Fiber may beused for the management of:Wounds as an effective barrier to bacterialpenetration of the dressing as this may helpreduce infection; Partial thickness (second degree) burns; Diabeticfoot ulcers, leg ulcers, (venous stasis ulcers,arterial ulcers and leg ulcers of mixed etiology)and pressure ulcers/sores (partial & fullthickness); Surgical wounds left to heal by secondaryintention such as dehisced surgical incisions; Surgical wounds that heal by primary intent suchas dermatological and surgical incisions (e.g.,orthopedic and vascular); Traumatic wounds; Wounds that are prone to bleeding, such aswounds that have been mechanically orsurgically debrided and donor sites; Oncology wounds with exudate, such asfungoides-cutaneous tumors, fungatingcarcinoma, cutaneous metastasis, Kaposi'ssarcoma, and angiosarcoma; Management of painful wounds; Infected wounds
Components	Composed of sodium carboxymethylcellulose (CMC) fibers with bicomponent(BiCo) fibers and 0.63% (w/w) ionic silverwith ethyl lauroyl arginate (LAE).The device is reinforced with BiCo fibersembossed to create a hexagon pattern.	Composed of sodium carboxymethylcellulose(HydrofiberTM) and 1.2% ionic silver withEDTA and benzethonium chloride.
Mode ofaction	The dressing absorbs exudate and forms agel. The gelled dressing retains exudate,thereby maintaining a moist woundenvironment to support the healing process.The dressing aids in the removal ofunnecessary material from the wound(autolytic debridement).	The dressing absorbs wound fluid and creates asoft, conformable gel, which maintains a moistwound environment to support the healingprocess.The dressing aids in the removal of unnecessarymaterial from the wound (autolytic debridement)without damaging newly formed tissue.
	When the wound exudate is absorbed by theBiatain Fiber Ag dressing, the free ionicsilver exerts its activity by killing themicroorganisms held within the dressing.	The silver preservative in the dressing reducesthe growth of microorganisms within thedressing. The silver preservative in the dressing killswound bacteria held in the dressing and providesan effective barrier to bacterial penetration of thedressing.
Characteristics	Sterile. Absorbs exudate. Forms a conformable gel The preservative action of ionic silverreduces bacterial growth within thedressing. Should be used with a secondary dressingdepending on the clinical condition of thewound.	Sterile. Absorbs exudate (including bacteria) or blood. Forms a soft conformable gel. Ionic silver within the dressing functions as apreservative to reduce bacterial growth withinthe dressing. May require a secondary dressing.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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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:

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AntimicrobialEffectiveness within theDressing:	The preservative action of silver and LAE reduces bacterialgrowth within the dressing. This was confirmed by in vitrotests.
	≥4 log reduction (AATCC 100) antimicrobial effectivenessagainst 9 organisms, 3 Gram positive bacteria, 4 Gramnegative bacteria, 1 yeast, and 1 mold for up to 7 dayswithin the dressing.
Animal Study:	A full thickness wound healing model in porcine study wasconducted to evaluate local tissue effects and wound healingperformance of a wound dressing containing silver (BiatainFiber Ag). The study demonstrated that Biatain Fiber Agand the predicate device did not hinder the wound healingprocess.
CONCLUSION	Based on the identical indications for use, principles ofoperations, technological characteristics, and performancetesting, Biatain Fiber Ag is as safe and as effective as thepredicate device, ConvaTec's AQUACELTM Ag+ EXTRAEnhanced HydrofiberTM Dressing with Silver andStrengthening Fiber (K173675).

Regulation Number and Section

N/A