Predicate Devices

K12127

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and antimicrobial action of the dressing, with no mention of AI or ML.

Therapeutic

Yes
The device is a dressing indicated for the management of various types of wounds, including diabetic foot ulcers, pressure ulcers, surgical wounds, and burns, which falls under the scope of therapeutic applications aimed at facilitating healing and preventing infection.

Diagnostic

No

This device is a wound dressing designed for the management and healing of various types of wounds by providing a protective barrier and an antimicrobial environment. It does not perform any diagnostic functions like analyzing, detecting, or identifying diseases or conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it 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." This describes a physical medical device, 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 clearly states the device is for the management of various types of wounds. This is a therapeutic application, not a diagnostic one.
Device Description: The description details a dressing made of fibers and impregnated with substances to manage wounds. This is consistent with a wound care product, not a diagnostic test.
Performance Studies: The performance studies focus on the effectiveness of the dressing in wound healing, bacterial barrier properties, and reduction of bacterial growth within the dressing. These are all related to the therapeutic function of the dressing on the wound itself, not on analyzing a sample from the body to diagnose a condition.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

FRO

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).

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.

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

Over-the-Counter Use / general public; 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)

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.

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.

AQUACEL™ Ag EXTRA Hydrofiber™ Dressing, K12127

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

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.

1

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

2

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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4

Section 5 - 510(k) Summary

| Device: | AQUACEL™ Ag+ EXTRA Enhanced Hydrofiber™
Dressing with Silver and Strengthening Fiber |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Applicant: | ConvaTec Limited |
| Contact: | Justin Lovelace
Senior Regulatory Affairs Specialist
Telephone: 1-336-542-4745
Email: 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

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).

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.

5

Table 1: Device Composition

	Cellulose (Lyocell)		Ag+ Hydrofiber
	% w/w	g/m² of fabric	% w/w	g/m² of fabric
Aquacel Ag+
Available in
sizes:
5x5cm
10x12cm
15x15cm
20x30cm	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.

6

| | Aquacel Ag -K121275- (Predicate
Device) | Aquacel Ag+ (Subject Device) |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Composed of sodium
carboxymethylcellulose (HydrofiberTM)
and 1.2% ionic silver | Composed of sodium
carboxymethylcellulose (HydrofiberTM)
and 1.2% ionic silver with EDTA and
benzethonium chloride |
| Mode of
Action | 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. The silver in the dressing kills
wound bacteria held in the
dressing and provides an
antimicrobial barrier to protect
the wound bed. | 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. 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 (including
bacteria) or blood Forms a soft conformable gel Antimicrobial properties from
ionic silver May require a secondary dressing | 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 EDTA and BeCl improve the
preservative action of silver to
reduce bacterial growth within
the dressing |

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

7

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.

8

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).