(152 days)
Not Found
No
The description focuses on the material composition and physical properties of the dressing, with no mention of AI or ML capabilities.
Yes.
The device is used for the management of various types of wounds, aiming to aid in healing and inhibit bacterial growth, which clearly falls under therapeutic uses.
No
Explanation: The device is described as a super-absorbent dressing for wound management and healing, not for diagnosing conditions. Its function is to absorb wound fluid, inhibit bacterial growth, and create a moist healing environment.
No
The device description clearly states it is a "soft, sterile, nonwoven pad or ribbon dressing" composed of physical materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a wound dressing for managing various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and function of the dressing in absorbing wound fluid, creating a moist environment, and inhibiting bacterial growth. These are all related to wound treatment and management.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to diagnose a condition, monitor a disease, or determine a patient's health status.
- Anatomical Site: The anatomical sites listed are all external wounds and ulcers, which are treated topically. IVDs typically involve analyzing internal samples or bodily fluids.
In summary, the AQUANOVA Ag Super-Absorbent Dressing is a therapeutic device intended for wound care, not a diagnostic device used for in vitro testing.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds lS and 200 degree burns, diabetic foot ulcers, venous sta arterial ulcers and leg ulcers of mixed aetiology and pressure ulocity venous stass unclises and surgical wounds and donor sites.
Product codes
FRO
Device Description
AQUANOVA Ag Super-Absorbent Dressing (Silver containing Antibacterial Dressing) is a soft, sterile, nonwoven pad or ribben dressing is composed of Chitosan, Oressing) is a soft, sterile, nonmaterials with the addition of inse . The dressing is composed of Chitosan derivalive materials with the addition of innic silver ions present in the dressing help to information in the dressing help to inhibit bacterial growth in the dressing. The dressing and relise the probective in the dressmy new to mhbit acterial cohesive gel that intimately conforms and of wound find and dacenta and creates a soft, conducive to wound healing and aids in the removal of non-viable tissue from the wound (autolytic debridement). the moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the AQUANOVA Ag Dressings support the body's healing process.
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
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 product was evaluated through standard that news innibility tests (ISO 10993) and found to be acceptable. Antibacterial effectiveness was established through testing with appropriate organisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the Medtrade logo. Above the logo is the text "K100693 page 1 of 2". The Medtrade logo is a stylized text logo with a curved line underneath.
Innovative Medical Products
3, 8-2-2-2007 100 100 2017/2
30 cm ..
12:31:31
510(k) SUMMARY
AQUANOVA Ag Super-Absorbent Dressing
- Submitter: Medtrade Products Electra House Crewe Business Park Crewe, Cheshire, CW1 6GL. UK
Tel: +44 (0)1270 500019 Fax: +44 (0)1270 500045
Contact: Jonathan Ranfield. Quality & Regulatory Director E-mail: Jonathan Ranfield@Medtrade.co.uk
Date Prepared: March 1, 2010.
- Device:
AQUANOVA Ag Super Absorbent Dressing Silver containing Antibacterial Dressing
Common/Usual Name: AQUANOVA Ag AQUANOVA Ag Antibacterial Dressing AQUANOVA Ag Super Absorbent Antibacterial Dressing AQUANOVA Ag Silver Antibacterial Dressing AQUANOVA Ag Super Absorbent Gelling Dressing
AQUANOVA Ag Super Absorbent Gelling Dressing with Silver
Classification Name: Dressing, Wound, Drug
Device Class: Unclassified
Product Code: FRO
- Predicate Device: AQUANOVA K070175 (Medtrade Products) AQUACEL Ag K080383 (ConvaTec) AQUANOVA Ag Super-Absorbent Dressing is substantially equivalent to:
MedTrade Products AQUANOVA Ag Super-Absorbent Dressing (Silver Impregnated Antibacterial Dressing)
is identical to the legally marketed ModTrade Products AQUANDMAC is identical to the legally nations and child cressing (Silver impregnated Antibacherial Dressing (KD70175 cleared July 27, 2007) in product design, composition and processing, it is a super absorbent Dressing (K070175,
is soft, sterile, non-woven nad or ribbon dressing, it is a is soft, sterile, non-woven pad or ribbon and processing, it s'a super absorbent polymer, which in the relief.
materials with the difference being the oddition of intosan der materials with the difference being the addition of ionic Silver.
Convatec's AQUACEL Ag Hydro fibre Wound Dressing (K080383, cleared May 2, 2008), as both products are highly absorbent polysaccharides derived polymers with the addition of ionic silver as an Antibacterial.
Therefore, the technological characteristics of the subject device are substantially equivalent to those of the predicate device and the indications of the subject device are substantially equivalent to those of the
device as they are hoth even shocked of the subject device are substa device as they are both super-absorbent dressings with the addition of ionic silver, both products gel in the presence of fluids to absorb arge quantities of exudate and produce a moist wound healing environment. Both dressings have the same indications for use.
4. Device Description:
AQUANOVA Ag Super-Absorbent Dressing (Silver containing Antibacterial Dressing) is a soft, sterile, nonwoven pad or ribben dressing is composed of Chitosan, Oressing) is a soft, sterile, nonmaterials with the addition of inse . The dressing is composed of Chitosan derivalive materials with the addition of innic silver ions present in the dressing help to information in the dressing help to inhibit bacterial growth in the dressing. The dressing and relise the probective in the dressmy new to mhbit acterial cohesive gel that intimately conforms and of wound find and dacenta and creates a soft,
AUG 1 0 2010
1
K100693
page 2 of 2
conducive to wound healing and aids in the removal of non-viable tissue from the wound (autolytic debridement). the moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the AQUANOVA Ag Dressings support the body's healing process.
Chitosan is a material consisting of cellulostic polymer, poly-N-acetyl glucosamine. 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 species 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 biomedical 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 wet integrity studies have demonstrated that the dressing remains intact for removal from the wound.
5. Intended Use:
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of Onder and full thickness wounds 18 and 200 degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.
6. Technological Characteristics:
The composition of AQUANOVA Ag is identical to the legally marketed MedTrade Products AQUANOVA The ochipotition of NQ27, 2007 in product design, composition and processing. Furthermore, AQUANOVA Ku is substantially equivalent to AQUACEL Ag K080383, cleared May 2, 2008, as both products are highly Ag is oubstantially of iread polymers with the addition of ionic silver as an Antibacterial ingredient absolbent polyoutonandoo don't on the dressing. The product was evaluated through standard that news innibility tests (ISO 10993) and found to be acceptable. Antibacterial effectiveness was established through testing with appropriate organisms.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 0 2010
Medtrade Products % Mr. Jonathan Ranfield Quality and Regulatory Director Electra House Crewe Business Park Crewe, Cheshire, SW1 6GL United Kingdom
Re: K100693
Trade/Device Name: AQUANOVA Ag Super Absorbent Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 04, 2010 Received: August 06, 2010
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 indivetions 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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Fedral Food, Drug and Cosmetic Act (Act) that do not require approval of a premarket a proval 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 libility warranties. We remind you; however, that device labeling must be truthful and not miledding.
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 (ran he 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
3
Page 2 - Mr. Jonathan Ranfield
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) K100693
Device Names: AQUANOVA Ag Super-Absorbent Dressing Silver containing Antibacterial Dressing
Indications for Use:
Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 15 and 2001 and new York of the management
of partial and full thickness wounds 15 and 200 degree burns, diabetic foot ulcers, venous sta arterial ulcers and leg ulcers of mixed aetiology and pressure ulocity venous stass unclises and surgical wounds and donor sites.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
00 (6)
AUG 1 0 2010
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krasnofsky MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100693
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