(188 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the treatment and management of various types of wounds, including burns, ulcers, and surgical wounds, which are therapeutic applications.
No
The device is described as a wound dressing for treatment and management of various types of wounds and for exudate absorption and minor bleeding control. It does not perform any diagnostic function.
No
The device description clearly states it is a "soft pad woven dressing" made of physical materials (chitosan, chitosan derivatives, and structural materials), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a wound dressing for various types of wounds and for controlling minor bleeding. This is a topical application for wound management, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "soft pad woven dressing" made of chitosan and structural materials. This aligns with the description of a wound dressing, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Using reagents or calibrators
The device's function is to absorb exudate, manage bleeding, and provide a protective covering for wounds, which are all functions of a wound dressing, not an IVD.
N/A
Intended Use / Indications for Use
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.
Additionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).
Product codes (comma separated list FDA assigned to the subject device)
QSY
FRO
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 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 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.
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
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Not Found
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.
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
N/A
0
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.
1
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.
2
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
3
3/: E
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
4
Page 2 of 2
2
Indications for Use
510(k) Number K070175
Device Name: MedTrade Products AQUANOVA Super-Absorbent Dressing
Indications for Use:
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. AQUANOVÀ 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).
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)
5
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.
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.
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.
l 그
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K070175 Page 2 og 3
COMPARATIVE FEATURES
| Characteristic | MedTrade
Products
AQUANOVA
Super-Absorbent
Dressing | Scion Cardio-
Vascular Inc.
Clo-sur P.A.D. | Convatecs
Aquacel
Hydrofibre
Wound Dressing | MedTrade
Products
CELOX Topical
Hemostatic
Granules |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemistry | Absorbent
chitosan, a
material consisting
of cellulostic
polymer, poly-N-
acetylglucosamine | Absorbent
chitosan. | N/A - As sodium
carboxymethylcell
ulose based. | Absorbent
chitosan, a
material consisting
of cellulostic
polymer, poly-N-
acetylglucosamine |
| Physical
Composition | Soft absorbent
pad | Soft absorbent
pad | Soft Absorbent
pad | N/A - Absorbent
granules |
| Indications For
Use | Under the
supervision of a
healthcare
professional
AQUANOVA may
be used for
wounds such as
leg ulcers (Stages
I-IV), diabetic
ulcers, surgical
wounds (post-
operative, 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. | A topical
haemostat that
provides an
optimal wound
healing
environment with
exudates
management. | Under the
supervision of a
healthcare
professional
Aquacel may be
used for wounds
such as leg ulcers
(Stages I-IV),
diabetic ulcers,
surgical wounds
(post-operative,
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. Aquacel
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.
Aquacel can be
used in the control
of minor bleeding. | N/A for
professional use
as used as an
emergency
haemostat.
However, OTC
version is for
lacerations, minor
cuts and minor
bleeding the same
as AQUANOVA. |
| Characteristic | MedTrade
Products
AQUANOVA
Super-Absorbent
Dressing | Scion Cardio-
Vascular Inc.
Clo-sur P.A.D. | Convatecs
Aquacel
Hydrofibre
Wound Dressing | MedTrade
Products
CELOX Topical
Hemostatic
Granules |
| | AQUANOVA
Super-Absorbent
OTC is indicated
for minor burns,
superficial cuts,
lacerations and
abrasions, and
minor irritations of
the skin. | | Aquacel OTC is
indicated for the
exudates
management of
abrasions,
lacerations, minor
cuts, minor scalds
and minor burns –
taken from 510K
as no OTC
commercial
packaging could
be found. | |
| Packaging | Paper Pouch | Unknown from
510K summary or
internet
information | Paper/Poly Pouch | Foil Pouch |
| Sterilisation
Method | Gamma Irradiation | Unknown from
510K summary or
internet
information | Gamma Irradiation | Gamma Irradiation |
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