(156 days)
No
The summary describes a hemostatic gauze and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended to control bleeding, which is a therapeutic function.
No
The device, CELOX Trauma Gauze, is indicated for controlling bleeding from injuries, not for diagnosing medical conditions.
No
The device is a physical gauze product intended to control bleeding, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding of lacerations, minor cuts, abrasions, and moderate to severe bleeding. This is a direct therapeutic action on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a gauze, which is a physical material used for wound care.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically stop bleeding, which is a treatment, not a diagnostic process.
N/A
Intended Use / Indications for Use
CELOX Trauma Gauze is intended to be available Over The Counter for the following indication.
Indications For OTC (Over The Counter) Use:
CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorbent Dressing Rx & OTC cleared in K070175 on July 25, 2007 for:
(Rx) 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.
Additionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).
(OTC) MedTrade Products AQUANOVA Super-Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.
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)
In vivo testing evaluated the efficacy of CELOX Trauma Gauze to provide hemostasis in femoral artery wound model. This data supports the effectiveness of the CELOX Trauma Gauze in achieving hemostasis in a femoral artery wound model.
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.
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 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 28, 2023
MedTrade Products Ltd. c/o Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GL United Kingdom
Re: K091795 Trade/Device Name: MedTrade Products CELOX Trauma Gauze OTC 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 November 20, 2009. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OSY.
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/7 description: The image shows the signature of Julie A. Morabito. The text "Sincerely," is written above the signature. The signature is followed by "-S", which likely indicates that it is a signed document. The signature is in a clear, legible font.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MedTrade Products Ltd. % Mr. Jonathan Ranfield Director, QA and RA Electra House, Crewe Business Park Crewe, Cheshire, CW1 6GI, United Kingdom
Re: K091795
Trade/Device Name: MedTrade Products CELOX Trauma Gauze OTC Regulation Number: Unclassified Regulation Name: NA Regulatory Class: Unclassified Product Code: FRO Dated: October 29, 2009 Received: November 2, 2009
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.
NOV 20 2009
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
2
Page 2 - Mr. Jonathan Ranfield
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
Mark McMullen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Ko91795
Device Name: MedTrade Products CELOX Trauma Gauze OTC
CELOX Trauma Gauze is intended to be available Over The Counter for the following indication.
Indications For OTC (Over The Counter) Use:
CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
Mark N. Millenson
(Division Sign-Oft) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surg.
and Restorative Devices
510(k) Number -
Prescription Use AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (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)
4
Page 1 of 1
Indications for Use
510(k) : ''' ' K091795
Device Name: MedTrade Products CELOX Trauma Gauze
Indications For Prescription Use:
CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.
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)
Daniel Krame for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091795
5
091795
page 1 of 2 Medtrade
2. 510(k) SUMMARY
Sponsor
MedTrade Products Limited Electra House Crewe Business Park Crewe Cheshire CW1 6GL വി
NOV 2 0 2009
Telephone: +44 1270 500019
Fax: +44 1270 500045
Registration Number: 9614493
Contact Person: Jonathan Ranfield
Date Summary was Prepared
June 12, 2009.
Device Information
Proprietary Name:
CELOX Trauma Gauze
CELOX Trauma Gauze OTC
Trauma Gauze Common Name:
Classification Name: Dressing, Unclassified
Predicate Device
MedTrade Products Limited: CELOX Hemostatic Granules On Sheet (K080097)
HemCon: ChitoGauze (K090026)
Device Description
CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorbent Dressing Rx & OTC cleared in K070175 on July 25, 2007 for:
(Rx) 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.
Additionally, AQUANOVA may be used for exudate absorption in oncology wounds (e.g. fungating cutaneous tumours, cutaneous metastases and Kaposi's sarcomas).
(OTC) MedTrade Products AQUANOVA Super-Absorbent OTC is indicated for minor burns, superficial cuts, lacerations and abrasions, and minor irritations of the skin.
Medtrade Products Ltd Medical Conne Bas ness back Linese Chester Chestill
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K091795
page 2 of 2
In vivo testing evaluated the efficacy of CELOX Trauma Gauze to provide hemostasis in femoral artery wound model. This data supports the effectiveness of the CELOX Trauma Gauze in achieving hemostasis in a femoral artery wound model. In addition the CELOX Trauma Gauze is substantially equivalent to other legally marketed chilosan based bandages with the same indications. With this 510(k) MedTrade is proposing to add the following indications to CELOX Trauma Gauze Rx and Celox Trauma Gauze OTC
CELOX Trauma Gauze Rx is indicated for temporary external use to control moderate to severe bleeding.
CELOX Trauma Gauze OTC is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
The predicate devices are indicated Rx for temporary external use to control moderate to severely bleeding wounds and OTC for temporary external use to control stop bleeding from minor wounds, minor cuts and minor abrasions. The CELOX Trauma Gauze is substantially equivalent to these predicate devices in that it has similar intended use and indications to the chitosan based predicate devices. The predicate devices are MedTrade Products Limited CELOX Hemostatic Granules On Sheet (K080097), cleared July 8, 2008 and HemCon: ChitoGauze (K090026), cleared March 31, 2009.
Indications for use
CELOX Trauma Gauze Rx is indicated for temporary external use to control moderate to severe bleeding.
CELOX Trauma Gauze OTC is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.