(64 days)
K100693, K0917953
AQUANOVA Ag K100693, CELOX Trauma Gauze K0917953
No
The description focuses on the material composition and physical properties of the gauze for wound healing and bacterial inhibition, with no mention of AI or ML.
Yes
The device is indicated for temporary external use to control moderate to severe bleeding, and for the management of various types of wounds, all of which are conditions that therapeutic devices address to promote healing or alleviate symptoms.
No
This device is a trauma gauze designed to control bleeding, manage wounds, and inhibit bacterial growth, supporting the healing process. Its function is therapeutic and not diagnostic.
No
The device is described as a physical gauze dressing composed of materials like Chitosan, Chitosan derivatives, structural woven gauze, and Ionic Silver. It is a tangible product used for wound management and bleeding control, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary external use to control moderate to severe bleeding" and for the "management of partial and full thickness wounds," burns, ulcers, and surgical wounds. This describes a device applied directly to the body for therapeutic purposes.
- Device Description: The description details a "soft, sterile, non-woven gauze dressing" composed of materials like Chitosan and Ionic Silver, designed to absorb wound fluid, inhibit bacterial growth in the dressing, and support wound healing. This is a description of a wound care product.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The provided information does not mention any testing of samples or diagnostic purposes.
The device is clearly intended for direct application to wounds and bleeding sites for therapeutic and wound management purposes, which falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd 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.
Product codes
QSY, FRO
Device Description
CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-OLLOA Antibaterial Trauma Guazo (Silver Seneses of Chitosan, Chitosan derivatives and structural woven gouze areooing. This aroosing to. The silver ions present in the dressing help to inhibit materials with the adultion of forlis envor. The dressing absorbs high amounts of wound fluid and bacteria buttonal grown in the drooming to the wound surface, maintains a maintains a moist and orcales a son, concerne gol that method healing and aids in the removal of non-viable tissue wound chviloritient while to obliagnt). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.
Chitosan is a material consisting of polysaccharide polymer, poly-N-acetylglucosanine. A similar Gilliosan is a material consisting of polysdomands polyment poly in against of the material in accordance with 21 CFR s 170.30. The GRAS report refers to safety studies in human beings and in accordance with 2 PCPK S 170.30. The Order research on the safety and use of chilosan, and Sevelal species of animals. The studies sited ropression (connaround the world. This large which have been published over a pensa quirement in 21 CFR s 170.30 (a), that a general bout of scientific fitere ballenoo the rowledge about the substance throughout the scientific reoogmition of balley requently applications of chitosan have already been reported.
Chitosan has many advantages due to its non-toxicity and biodegradability without anaging the Onlinesan nas many duringgou ado to no no nowly in to a harmless product, glucosamine that can be absorbed completely by the body.
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
Not Found
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 biocompatibility tests (ISO polymers with the addition of lone sires and) and through testing with appropriate organisms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AQUANOVA Ag K100693, CELOX Trauma Gauze K0917953
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 28, 2023
Medtrade Products Ltd. c/o Jonathan Ranfield Quality & Regulatory Director Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom
Re: K102965
Trade/Device Name: CELOX Trauma Gauze Ag, CELOX Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma Gauze Ag, Omni-Stat Hemostatic Antibacterial Trauma Gauze Regulatory Class: Unclassified Product Code: QSY
Dear Jonathan 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 December 8, 2010. 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.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 8 2010
Medtrade Products Ltd. % Mr. Jonathan Ranfield Quality and Regulatory Director Electra House, Crewe Business Park Crewe, Cheshire SW1 6GL United Kingdom
Re: K102965
Trade/Device Name: MedTrade Products CELOX Antibacterial Trauma Gauze Regulatory Class: Unclassified Product Code: FRO Dated: September 24, 2010 Received: October 05, 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 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
2
Page 2 - Mr. Jonathan Ranfield
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.
Sincerely yours.
erely yours,
for
N.K.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use
DEC - 8 2010
K 102965 510(k)
Device Name: MedTrade Products CELOX Antibacterial Trauma Gauze
Indications For Prescription Use:
CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness wounds 1st and 2nd 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.
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) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
4
K102965
page 1 of 2
Image /page/4/Picture/1 description: The image shows the logo for Medtrade. The word "Medtrade" is written in a simple, sans-serif font. A curved line starts below the "M" and extends over the word, ending below the "e", creating a semi-circular shape around the name. The logo is simple and clean, with a focus on the company name.
Innovative Medical Products
DEC - 8 2010
510(k) SUMMARY
CELOX Antibacterial Trauma Gauze
- Submitter: MedTrade Products Limited Electra House Crewe Business Park Crewe, Cheshire, CW1 6GL. UK
Telephone: +44 1270 500019 Fax: +44 1270 500045
Contact Person: Jonathan Ranfield, Quality & Regulatory Director E-mail: Jonathan Ranfield@Medtrade.co.uk
Registration Number: 9614493
Date Prepared: September 24, 2010
- Device:
CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing)
Common / Usual Name: CELOX Trauma Gauze Ag CELOX Hemostatic Antibacterial Trauma Gauze Omni-Stat Antibacterial Trauma Gauze Omni-Stat Trauma Gauze Ag Omni-Stat Hemostatic Antibacterial Trauma Gauze
Dressing, Wound, Drug Classification Name:
- Predicate Device:
AQUANOVA Ag K100693 (Medtrade Products) CELOX Trauma Gauze K0917953 (Medtrade Products)
CELOX Antibacterial Trauma Gauze is substantially equivalent in raw materials and manufacturing route to Predicate Device, AQUANOVA Ag Super Absorbent Dressing cleared in K100693 on August 10, 2010.
And identical to Predicate Device, CELOX Trauma Gauze cleared in K091795 on November 20, 2009, with the difference being the addition of ionic Silver as the antibacterial agent.
It also has the same intended use and indications to the above predicate devices.
Therefore, the technological characteristics of the subject device are substantially equivalent to those of the predicate device and the indications for use of the subject device are substantially equivalent to the prodicate device as they are hoth super-absorbent dressings with the addition of ionic silver, 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.
4. Device Description
CELOX Antibacterial Trauma Gauze (Silver containing Antibacterial Dressing) is a soft, sterile, non-OLLOA Antibaterial Trauma Guazo (Silver Seneses of Chitosan, Chitosan derivatives and structural woven gouze areooing. This aroosing to. The silver ions present in the dressing help to inhibit materials with the adultion of forlis envor. The dressing absorbs high amounts of wound fluid and bacteria buttonal grown in the drooming to the wound surface, maintains a maintains a moist and orcales a son, concerne gol that method healing and aids in the removal of non-viable tissue wound chviloritient while to obliagnt). The moist wound healing environment and the ability to inhibit bacterial growth in the dressing provided by the CELOX Antibacterial Gauze support the body's healing process.
Medtrade Products Ltd Electra House, Crewe Business Park, Crewe, Cheshire CW1 6GL T: +44 (0) 1270 500019 F: +44 (0) 1270 500045
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K102965
page 2 of 2
10
Chitosan is a material consisting of polysaccharide polymer, poly-N-acetylglucosanine. A similar Gilliosan is a material consisting of polysdomands polyment poly in against of the material in accordance with 21 CFR s 170.30. The GRAS report refers to safety studies in human beings and in accordance with 2 PCPK S 170.30. The Order research on the safety and use of chilosan, and Sevelal species of animals. The studies sited ropression (connaround the world. This large which have been published over a pensa quirement in 21 CFR s 170.30 (a), that a general bout of scientific fitere ballenoo the rowledge about the substance throughout the scientific reoogmition of balley requently applications of chitosan have already been reported.
Chitosan has many advantages due to its non-toxicity and biodegradability without anaging the Onlinesan nas many duringgou ado to no no nowly in to a harmless product, glucosamine that can be absorbed completely by the body.
5. Intended Use:
5. Intended Use.
CELOX Antibacterial Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
CELOX Antibacterial Trauma Gauze may be used for the management of partial and full thickness and log CELOX Antibacterial Trauma Gauze may be tuota stasis ulcers, arterial uicers and leg wounds T and 2 uegree burns, diabelle roof also, vollabord, vollal and full thickness), surgical wounds and donor sites.
6. Technological Characteristics:
- Technological Characterial Trauma Gauze is substantially equivalent on Meditade Products AQUANOVA CELOX Antibacterial Trauma Gauze is Sabolant design, composition and processing.
Ag, K1000693, cleared August 10, 2010 in product design, composition polyagescride Ag, K 1000693, Cleared August 16, 2016 in product is a highly absorbent polysaccharde derived Furthermore, CECOX Antibacterial Tradine Guaze a natibacterial ingredient that helps inhibit hets (JSO polymers with the addition of lone sires and and biocompatibility tests (ISO
growth in the dressing. The product was evaluated through to through tosting growth in the dressing. The product was evaluation through standard becompanisy of the with appropriate organisms.