MedTrade Products AQUANOVA Super-Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.

Under the supervision of a healthcare professional AQUANOVA may be used for wounds such as leg ulcers (Stages I-IV), diabetic ulcers, surgical wounds (postoperative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have been left to heal by secondary intention.

AQUANOVA may also be used for the local management of wounds that are prone to bleeding such as wounds that have been surgically or mechanically debrided, donor sites, and traumatic wounds. AQUANOVA can be used in the control of minor bleeding.

Aditionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).

Device Description

MedTrade Products AQUANOVA Super-Absorbent is a mixture of chitosan, chitosan derivatives and structural materials to produce a soft pad woven dressing.

Chitosan is a material consisting of cellulostic polymer, poly-N-acetylglucosamine. A similar chitosan material has been self-affirmed as a GRAS (Generally Recognised As Safe) food ingredient in accordance with 21 CFR s 170.30. The GRAS report refers to safety studies in human beings and several apecies of animals. The studies sited represent research on the safety and use of chitosan, which have been published over a period of decades by scientists from around the world. This large body of scientific literature satisfies the requirement in 21 CFR s 170.30 (a), that a general recognition of safety requires common knowledge about the substance throughout the scientific community. Several bornedical applications of chitosan have already been reported.

Chitosan has many advantages due to its non-toxicity and biodegradability without damaging the environment. It is a biocompatible material that breaks down slowly in to a harmless product, glucosamine that can be absorbed completely by the body. However, no product will be available to break down as with integrity studies have demonstrated that the dressing remains intact for removal from the wound.

Med Trade Products AQUANOVA Super-Absorbent Dressings are provided in sterile single use pouches. Pouches will be provided in a carton with an information leaflet.

AI/ML Overview

The provided document is a 510(k) premarket notification letter for MedTrade Products AQUANOVA Super-Absorbent Dressing. This type of regulatory document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and performance data for a new device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for a study is not available within this document. The document primarily identifies predicate devices and compares general features.

Here's a breakdown of why the requested information cannot be found in this document:

Acceptance Criteria and Reported Device Performance: This document does not present specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for the AQUANOVA device itself. Instead, it argues that AQUANOVA is substantially equivalent to existing predicate devices based on its chemistry, physical composition, and intended uses.
Sample Size and Data Provenance (Test Set): No test set or related performance study is described.
Number of Experts and Qualifications (Ground Truth for Test Set): Not applicable as there's no test set described.
Adjudication Method (Test Set): Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
Standalone Performance (Algorithm Only): Not applicable as this is a physical medical device, not an AI algorithm.
Type of Ground Truth Used: Not applicable.
Sample Size for the Training Set: Not applicable as this is not an AI/ML device requiring a training set.
How Ground Truth for the Training Set was Established: Not applicable.

The document highlights the following in lieu of a detailed study:

Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to three predicate devices:
- Scion Cardio-Vascular Inc. Clo-sur P.A.D. (K032986)
- Convated's Aquacel Hydrofibre Wound Dressing (K982116)
- MedTrade Products Celox Topical Hemostatic Granules (Not explicitly given a K-number, but listed as a predicate)
Comparative Features: A table is provided comparing the AQUANOVA dressing to these predicate devices based on:
- Chemistry: All use chitosan as an absorbent, except Aquacel which uses sodium carboxymethylcellulose.
- Physical Composition: AQUANOVA and the first two predicates are soft absorbent pads; Celox is absorbent granules.
- Indications For Use: Similar indications are highlighted between AQUANOVA and Convatec's Aquacel for both professional and OTC use, and between AQUANOVA OTC and Celox OTC for minor wounds/bleeding.
- Packaging: Paper Pouch for AQUANOVA, Paper/Poly Pouch for Aquacel, Foil Pouch for Celox, Unknown for Clo-sur P.A.D.
- Sterilisation Method: Gamma Irradiation for AQUANOVA, Aquacel, and Celox, Unknown for Clo-sur P.A.D.
Chitosan Safety: The document references that a similar chitosan material has been self-affirmed as GRAS (Generally Recognized As Safe) food ingredient, citing scientific literature for safety studies in humans and animals. This addresses the biocompatibility and safety aspect rather than performance in a clinical study.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a stylized depiction of a human figure, while the FDA logo features the agency's acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The logos are placed side by side.

June 11, 2023

MedTrade Products, Ltd. c/o Jonathan D. Ranfield Director, Quality Assurance & Regulatory Affairs Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom

Re: K070175

Trade/Device Name: MedTrade Products AQUANOVA Super-Absorbent Dressing Regulatory Class: Unclassified Product Code: QSY

Dear Jonathan D. Ranfield:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 25, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.

Image /page/0/Picture/8 description: The image shows the closing of a letter from Julie A. Morabito, Ph.D., Assistant Director at the Center for Devices and Radiological Health. Morabito is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works at OHT4: Office of Surgical and Infection Control Devices. The letter is from the Office of Product Evaluation and Quality.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2007

Medtrade Products, Ltd. % Mr. Jonathan D. Ranfield Director, QA/RA Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom

Re: K070175

Trade/Device Name: MedTrade Products AQUANOVA Super-Absorbent Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2007 Received: July 16, 2007

Dear Mr. Ranfield:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 -- Mr. Jonathan D. Ranfield

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a logally marketed predicate device results in a classification for your device and thus, perceits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,
Mark A. Milherson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 2

Indications for Use

510(k) Number K070175

Device Name: MedTrade Products AQUANOVA Super-Absorbent Dressing

MedTrade Products AQUANOVA Super-Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.

Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Of (Division Sign-On) Restorative, Division of Neurological Devices

510(k) Number

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Page 2 of 2

Indications for Use

510(k) Number K070175

Device Name: MedTrade Products AQUANOVA Super-Absorbent Dressing

Indications for Use:

Aditionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Safety & Effectiveness MedTrade Products AQUANOVA Super-Absorbent Dressing

JUL 2 5 2007

Classification Name: 878 -- General and Plastic Surgery - FRO (Dressing)

Contact_ Jonathan Ranfield - Director, Quality Assurance & Regulatory Affairs

Prepared: January 31st 2007

Description: MedTrade Products AQUANOVA Super-Absorbent is a mixture of chitosan, chitosan derivatives and structural materials to produce a soft pad woven dressing.

Med Trade Products AQUANOVA Super-Absorbent Dressings are provided in sterile single use pouches. Pouches will be provided in a carton with an information leaflet.

MedTrade Products AQUANOVA Super-Absorbent Dressing is substantially equivalent to:

. Scion Cardio-Vascular Inc. Clo-sur P.A.D. K032986. It is similar to AQUANOVA in that it is a soft pad that provides an optimal wound-healing environment with exudates management. The manufacturers of Clo-sur P.A.D. also make antibacterial claims that MedTrade do not wish to make for AQUANOVA.
Convated's Aquacel Hydrofibre Wound Dressing K982116. It is similar in intended use to . AQUANOVA, both products gel in the presence of fluids to absorb large quantities of exudate and produce a moist wound healing environment. Both dressings have the same indications for use. Aquacel is based on sodium carboxymethycellulose technology.
Med Trade Products Celox Topical Hemostatic Granules. It is similar to AQUANOVA in absorbing large quantities of fluid to form a gel. It is also manufactured from chitosan. The product issues in the product is diffirent from AQUANOVA in its intended use for the professional market and the physical form (granules compared to a soft pad for AQUANOVA).

A table of comparative features may be found below.

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K070175 Page 2 og 3

COMPARATIVE FEATURES

Characteristic	MedTradeProductsAQUANOVASuper-AbsorbentDressing	Scion Cardio-Vascular Inc.Clo-sur P.A.D.	ConvatecsAquacelHydrofibreWound Dressing	MedTradeProductsCELOX TopicalHemostaticGranules
Chemistry	Absorbentchitosan, amaterial consistingof cellulosticpolymer, poly-N-acetylglucosamine	Absorbentchitosan.	N/A - As sodiumcarboxymethylcellulose based.	Absorbentchitosan, amaterial consistingof cellulosticpolymer, poly-N-acetylglucosamine
PhysicalComposition	Soft absorbentpad	Soft absorbentpad	Soft Absorbentpad	N/A - Absorbentgranules
Indications ForUse	Under thesupervision of ahealthcareprofessionalAQUANOVA maybe used forwounds such asleg ulcers (StagesI-IV), diabeticulcers, surgicalwounds (post-operative, donorsites,dermatological),burns (first andsecond degree),and themanagement ofsurgical ortraumatic woundswhich have beenleft to heal bysecondaryintention.AQUANOVA mayalso be used forthe localmanagement ofwounds that areprone to bleedingsuch as woundsthat have beensurgically ormechanicallydebrided, donorsites, andtraumatic wounds.AQUANOVA canbe used in thecontrol of minorbleeding.	A topicalhaemostat thatprovides anoptimal woundhealingenvironment withexudatesmanagement.	Under thesupervision of ahealthcareprofessionalAquacel may beused for woundssuch as leg ulcers(Stages I-IV),diabetic ulcers,surgical wounds(post-operative,donor sites,dermatological),burns (first andsecond degree),and themanagement ofsurgical ortraumatic woundswhich have beenleft to heal bysecondaryintention. Aquacelmay also be usedfor the localmanagement ofwounds that areprone to bleedingsuch as woundsthat have beensurgically ormechanicallydebrided, donorsites, andtraumatic wounds.Aquacel can beused in the controlof minor bleeding.	N/A forprofessional useas used as anemergencyhaemostat.However, OTCversion is forlacerations, minorcuts and minorbleeding the sameas AQUANOVA.
Characteristic	MedTradeProductsAQUANOVASuper-AbsorbentDressing	Scion Cardio-Vascular Inc.Clo-sur P.A.D.	ConvatecsAquacelHydrofibreWound Dressing	MedTradeProductsCELOX TopicalHemostaticGranules
	AQUANOVASuper-AbsorbentOTC is indicatedfor minor burns,superficial cuts,lacerations andabrasions, andminor irritations ofthe skin.		Aquacel OTC isindicated for theexudatesmanagement ofabrasions,lacerations, minorcuts, minor scaldsand minor burns –taken from 510Kas no OTCcommercialpackaging couldbe found.
Packaging	Paper Pouch	Unknown from510K summary orinternetinformation	Paper/Poly Pouch	Foil Pouch
SterilisationMethod	Gamma Irradiation	Unknown from510K summary orinternetinformation	Gamma Irradiation	Gamma Irradiation

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Regulation Number and Section

N/A