For Over-the-Counter Use: AQUACELTM Ag+ EXTRA Enhanced Hydrofiber™ Dressing with Silver and Strengthening Fiber may be used for the management of: Abrasions, Lacerations, Minor cuts, Minor scalds and burns. Under the supervision of a healthcare professional: AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™ 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.

Device Description

AQUACEL™ Ag+ EXTRA™ Enhanced Hydrofiber™ dressing with Silver and Strengthening Fiber is a soft, sterile dressing made from two layers of 1.2% ionic silver impregnated sodium carboxymethylcellulose fiber with added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride and stitched together with strengthening fibers. The two Hydrofiber™ layers are nominally 77gsm (grams per square meter) weight each. Aquacel Ag+ also includes added Ethylenediaminetetraacetic Acid Disodium Salt (EDTA) and Benzethonium Chloride (BECL).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (Device Name: K173675). The notification aims to establish substantial equivalence to a predicate device, AQUACEL Ag EXTRA Hydrofiber Dressing (K121275).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML device performance (e.g., target specificity, sensitivity, or AUC values). Instead, it focuses on demonstrating equivalence to a predicate device through various tests.

The core "acceptance criteria" for this 510(k) submission appear to be:

Biocompatibility: The device must be safe for its intended use, as demonstrated by standard biocompatibility testing.
Performance (Bench): The device must exhibit physical properties and preservative action comparable to or improved upon the predicate device, especially regarding antimicrobial efficacy and wound management characteristics.
Performance (Animal Study): The device must not hinder the wound healing process and should perform comparably to the predicate device in a relevant in vivo model.
Substantial Equivalence: Overall, the device must be shown to be as safe and effective as the predicate device, despite the addition of new components (EDTA and BECL).

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (ISO 10993-1:2009)	Concluded to have a safe toxicological profile for intended use, based on testing including Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Genotoxicity, Subchronic Toxicity, and Toxicological Risk Assessment.
Bench Performance - Physical Properties (Moisture retention, gelling, absorption, tensile strength, dry fabric properties)	"Shared technological characteristics with the predicate device... and the corresponding physical properties... make Aquacel Ag+ suitable for the management of a variety of wounds." (Implies comparable performance)
Bench Performance - Preservative Action / Antimicrobial Efficacy (in vitro) (Reduce bacterial growth within dressing, effective barrier to penetration)	"Confirmed by in vitro tests." Demonstrated to kill a broad spectrum of micro-organisms (MRSA, VRE, S. epidermidis, S. pyogenes, P. aeruginosa, K. pneumoniae, A. baumannii, E. coli, C. krusei, A. brasiliensis) within the dressing for up to 7 days. EDTA and BeCl improve the preservative action of silver.
Animal Study - Effect on wound healing (Rate of epithelialization, white cell infiltrate, granulation tissue formation, no detrimental effects)	"No differences in rate of epithelialization, white cell infiltrate or granulation tissue formation between any of the treatment groups." "No detrimental effects on healing of wounds managed with Aquacel Ag+ and the predicate device... as compared to the control were observed." "Demonstrated that both materials examined (Aquacel Ag+ and the predicate Aquacel Ag) did not hinder the wound healing process."
Overall Substantial Equivalence	"...demonstrate that the Aquacel Ag+ is substantially equivalent to ConvaTec's previously cleared Aquacel Ag (K121275)." (Based on comparison of indications, materials, technology, product specifications, and the results of all testing).

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

Test Set (Animal Study): The text mentions a "porcine model" but does not specify the exact number of animals or wounds used in the study.
Data Provenance: The animal study was conducted using a porcine model, which is a common pre-clinical model for wound healing. The location of the study is not specified, but it's a prospective experimental study.
Test Set (In vitro studies): No specific sample sizes (e.g., number of bacterial cultures or dressing samples) are given for the in vitro tests. These are laboratory-derived data.

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

This information is not provided in the document. For non-AI/ML medical devices like wound dressings, "ground truth" is typically established through objective measurements (e.g., bacterial count reduction in vitro, histological analysis in animal models) rather than expert consensus on images or clinical cases.

4. Adjudication Method for the Test Set:

Not applicable/Not provided. As noted above, the "ground truth" for this type of device study is based on objective laboratory and animal model measurements, not on human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, this was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This document describes a wound dressing, not an AI/ML diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a medical product (wound dressing), not an algorithm or AI system. Its performance is inherent in the physical and chemical properties of the dressing itself.

7. The Type of Ground Truth Used:

In vitro studies: Objective laboratory measurements of bacterial growth reduction, bacterial penetration, moisture retention, gelling, absorption, tensile strength, and dry fabric properties.
Animal study: Objective measurements of biological outcomes in a porcine model, such as rate of epithelialization, white cell infiltrate, and granulation tissue formation, likely derived from histological analysis or direct observation/measurement.

8. The Sample Size for the Training Set:

Not applicable. This is a physical wound dressing, not an AI/ML device that requires a training set. The "training" in this context would be the research and development phase involving materials science and biological testing to optimize the dressing's composition and manufacturing.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 20, 2018

ConvaTec Limited Justin Lovelace Senior Regulatory Affairs Specialist First Avenue. Deeside Industrial Park Flintshire, CH5 2NU, United Kingdom

Re: K173675

Trade/Device Name: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber Regulatory Class: Unclassified Product Code: FRO Dated: November 29, 2017 Received: November 30, 2017

Dear Justin Lovelace:

We have reviewed vour 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 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)	K173675
Device Name	AQUACEL TM Ag+ EXTRA Enhanced Hydrofiber TM Dressing with Silver and Strengthening Fiber
Indications for Use (Describe)
For Over-the-Counter Use:

AQUACELTM Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber may be used for the management of:

Abrasions
Lacerations
Minor cuts
Minor scalds and burns

Under the supervision of a healthcare professional:

AQUACELTM Ag+ EXTRA Enhanced 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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Section 5 - 510(k) Summary

Device:	AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™Dressing with Silver and Strengthening Fiber
Applicant:	ConvaTec Limited
Contact:	Justin LovelaceSenior Regulatory Affairs SpecialistTelephone: 1-336-542-4745Email: Justin.Lovelace@convatec.com
Date:	July 19, 2018
Trade Name:	AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™Dressing with Silver and Strengthening Fiber
Classification Name:	Dressing, Wound, Drug
Device Class:	Unclassified
Product Code:	FRO
Predicate Device:	AQUACEL™ Ag EXTRA Hydrofiber™ Dressing, K12127

Device Description

Based on in vitro testing, the silver preservative in the dressing kills microorganisms held within the dressing (these include bacteria, yeasts and mold) and provides an effective barrier to bacterial penetration of the dressing. This dressing absorbs wound fluid and creates a soft gel that conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). A moist wound environment supports the body's healing process. The silver preservative in the dressing provides an effective barrier to bacterial penetration of the dressing as this may help reduce infection.

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Table 1: Device Composition

	Cellulose (Lyocell)		Ag+ Hydrofiber
	% w/w	g/m² of fabric	% w/w	g/m² of fabric
Aquacel Ag+Available insizes:5x5cm10x12cm15x15cm20x30cm	17	29	83	144

Indications for Use

Over-the-Counter Use:

AQUACELTM Ag+ EXTRA Enhanced Hydrofiber™ 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:

AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™ 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

The intended use and indications for use are unchanged from the predicate, AQUACEL™ Ag EXTRA Hydrofiber™ Dressing (the cleared Aquacel Ag), K121275.

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	Aquacel Ag -K121275- (PredicateDevice)	Aquacel Ag+ (Subject Device)
Components	Composed of sodiumcarboxymethylcellulose (HydrofiberTM)and 1.2% ionic silver	Composed of sodiumcarboxymethylcellulose (HydrofiberTM)and 1.2% ionic silver with EDTA andbenzethonium chloride
Mode ofAction	The dressing absorbs wound fluidand creates a soft, conformablegel, which maintains a moistwound environment to supportthe healing process. The dressing aids in the removalof unnecessary material from thewound (autolytic debridement)without damaging newly formedtissue. The silver in the dressing killswound bacteria held in thedressing and provides anantimicrobial barrier to protectthe wound bed.	The dressing absorbs wound fluidand creates a soft, conformablegel, which maintains a moistwound environment to supportthe healing process. The dressing aids in the removalof unnecessary material from thewound (autolytic debridement)without damaging newly formedtissue. The silver preservative in thedressing reduces the growth ofmicroorganisms within thedressing The silver preservative in thedressing kills wound bacteriaheld in the dressing andprovides an effective barrier tobacterial penetration of thedressing.
Characteristics	Sterile Absorbs exudate (includingbacteria) or blood Forms a soft conformable gel Antimicrobial properties fromionic silver May require a secondary dressing	Sterile Absorbs exudate (includingbacteria) or blood Forms a soft conformable gel Ionic silver within the dressingfunctions as a preservative toreduce bacterial growthwithin the dressing May require a secondary dressing EDTA and BeCl improve thepreservative action of silver toreduce bacterial growth withinthe dressing

The materials of construction, and fundamental scientific technology of the Aquacel Ag+ remain equivalent to those of the predicate device (K121275).

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Biocompatibility Testing:

A biocompatibility evaluation, in accordance with ISO 10993-1:2009, 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
Systemic Toxicity
Genotoxicity
Subchronic Toxicity
Toxicological Risk Assessment ●

Performance Testing - Bench:

Pre-clinical data demonstrate that the Aquacel Ag+ is an effective dressing. The shared technological characteristics with the predicate device (and other Hydrofiber™ dressings) and the corresponding physical properties (as demonstrated in-vitro via moisture retention, gelling, absorption, tensile strength and dry fabric properties) make Aquacel Ag+ suitable for the management of a variety of wounds.

The preservative action of silver, EDTA and BeCl within the dressing reduce bacterial growth within the dressing and provide an effective barrier to bacterial penetration of the dressing was confirmed by in vitro tests.

. Kill a broad spectrum of micro-organisms within the dressing as demonstrated in vitro (tested against Methicillin Resistant Staphylococcus aureus (MRSA): USA300 (Heath Protection Agency (HPA) Reference: H045260142), Vancomycin Resistant Enterococcus faecalis (NCTC 12201), Staphylococcus epidermidis (NCTC 11047), Streptococcus pyogenes (NCTC 10872), Pseudomonas aeruginosa (NCTC 8506), Klebsiella pneumoniae (NCTC13465), Acinetobacter baumannii (NCTC 13421), Escherichia coli (NCIMB 10544), Candida krusei (NCPF 3876), and Aspergillus brasiliensis (NCPF 2275)
. The preservative action of silver, EDTA and BeCl within the dressing will continue to reduce bacterial growth within the dressing and provide an effective barrier to bacterial penetration of the dressing for up to 7 days (as demonstrated by in vitro studies).

Animal Study:

A study was conducted to evaluate the effect of Aquacel Ag+ on deep partial thickness wound healing using a porcine model. In conclusion, the study authors found no differences in rate of epithelialization, white cell infiltrate or granulation tissue formation between any of the treatment groups. No detrimental effects on healing of wounds managed with Aquacel Ag+ and the predicate device (Aquacel Ag – K121275) as compared to the control were observed. The study demonstrated that both materials examined (Aquacel Ag+ and the predicate Aquacel Ag) did not hinder the wound healing process.

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Conclusion:

While establishing substantial equivalence to the predicate device, ConvaTec evaluated the indications for use, materials of construction, technology, and product specifications of the device. The only difference between the two devices is the addition of EDTA and BECL. The results of biocompatibility testing, performance testing and animal testing demonstrate that the Aquacel Ag+ is substantially equivalent to ConvaTec's previously cleared Aquacel Ag (K121275).

Regulation Number and Section

N/A