(89 days)
Not Found
No
The 510(k) summary describes a hemostatic gauze with a physical mechanism of action and does not mention any AI or ML components.
No
The device is indicated for temporary external use to control bleeding and acts as a physical barrier, not for treating or rehabilitating a disease or condition.
No
The device is indicated for temporary external use to control bleeding and uses a physical barrier to stop the flow of blood, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is composed of chitosan and acts as a delivery system for granules, indicating it is a physical medical device, not software.
Based on the provided text, 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" or "bleeding of lacerations, minor cuts, and abrasions." This describes a device used directly on a wound to stop bleeding, which is a therapeutic or wound care application, not a diagnostic one.
- Mechanism of Action: The mechanism of action involves forming a "physical barrier or seal to stop the flow of blood." This is a physical action to control bleeding, not a process of analyzing a sample (like blood, urine, or tissue) to diagnose a condition or provide information about a patient's health status.
- Device Description: The device is composed of chitosan and acts as a delivery system for granules that form a seal. This aligns with a hemostatic device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
In summary, the description clearly points to a hemostatic device used for wound care, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
CELOX Rapid Gauze is indicated for temporary external use to control moderate to severe bleeding.
CELOX Rapid Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
Components – CELOX Rapid is composed of chitosan
Mechanism of Action - CELOX Gauze achieves its principle intended action (hemostasis) by acting as a delivery system for the Celox Granules creating a physical barrier or seal to stop the flow of blood. When in contact with a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, the CLO. C Granules heat bonded on to the CELOX Rapid quickly form a strong seai that completely covers the wound.
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)
Biocompatibility Testing:
Biocompatibility has been reviewed in accordance with ISO10993 and FDA Blue Book memo G95-1.
To support:
To Control Moderate To Severe Bleeding, Works in Hypothermic Conditions, No Heat Generated in Use, Reduces Blood Loss, previously provided and cleared under (K080097).
In Vitro Testing to support:
- Rapid Packing
- High Volume Gauze Strip
- Promotes Rapid Wound Adhesion
Animal Studies
Animal Study 1 - The efficacy of Celox Rapid Gauze in a femoral artery wound model. To support
- Stops bleeding fast
- Rapidly controls bleeding
Clinical Study - Not Applicable.
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
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July 28, 2023
Medtrade Products Limited c/o Jonathan Ranfield Quality and Regulatory Director Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Re: K110386 Trade/Device Name: CELOX Rapid 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 May 10, 2011. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtrade Products Limited % Mr. Jonathan Ranfield Quality and Regulatory Director Electra House, Crewe Business Park Crewe, Cheshire CWI 6GL United Kingdom ·
MAY 1 0 201
Re: K110386
Trade/Device Name: CÊLOX Rapid Gauze Product Code: FRO Dated: February 3, 2011 Received: February 10, 2011
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 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
2
Page 2 - Mr. Jonathan Ranfield
Enclosure
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.lda.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 vours.
Hy B. n h
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
KIJO386 510(k) Number (if known):
Device Name: CELOX Rapid Gauze
Indications For Prescription Use:
CELOX Rapid Gauze is indicated for temporary external use to control moderate to severe bleeding.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sig Division of ! and Restorati
510(k) Number K110386
Page 1 of 1
4
Indications for Use
510(k) Number (if known): K
Device Name: CELOX Rapid Gauze
Indications For OTC (Over The Counter) Use:
CELOX Rapid Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K. B. Dake for nxn.
(Division Sign-Off)
AND/OR
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K110386
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Image /page/5/Picture/0 description: The image shows the text "K110386 Page 1 of 3" in the upper left corner. To the right of the text is the word "Medtrade" in a bold, sans-serif font. A curved line extends from below the word "Medtrade" to the right, creating a logo-like effect.
SECTION 2:
510(k) SUMMARY
Innovative Medical Products
2.1 Sponsor
Medtrade Products Limited Electra House Crewe Business Park Crewe Cheshire CW1 6GL nk
Telephone: +44 1270 500019
Fax: +44 1270 500045
Registration Number: 9614493
Contact Person: Jonathan Ranfield Quality & Regulatory Director
2.2 Date Summary was Prepared
February 3, 2011.
2.3 Device Information
Proprietary Name: CELOX Rapid Z-Fold Gauze
Common Name: CELOX Rapid
Classification Name: Dressing, Unclassified
5.4 Predicate Device
Medtrade Products Limited: CELOX Hemostatic Granules on Sheet (K080097)
5.5 Device Description
Components – CELOX Rapid is composed of chitosan
Mechanism of Action - CELOX Gauze achieves its principle intended action (hemostasis) by acting as a delivery system for the Celox Granules creating a physical barrier or seal to stop the flow of blood. When in contact with a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, the CLO. C Granules heat bonded on to the CELOX Rapid quickly form a strong seai that completely covers the wound.
6
K 110386
page 2 of 3
5.6 Intended Use
CELOX Rapid Gauze (Rx) is indicated for temporary external use to control moderate to severe bleeding.
CELOX Rapid Gauze (OTC) is indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
5.7 Substantial Equivalence
CELOX Rapid Gauze is identical in manufacturing route, packaging and irradiation. as CELOX Hemostatic Granules on Sheet K080097 cleared on July 9, 2008.
CELOX Rapid Gauze has substantially equivalent indications to CELOX Hemostatic Granules on Sheet K080097 in that they are indicated for temporary external use to control moderate to severe bleeding (Rx) and temporary external use to control bleeding of lacerations, minor cuts, and abrasions (OTC).
CELOX Rapid Gauze uses the same safe and effective technology as CELOX Hemostatic Granules on Sheet K080097. The subject device and predicate devices are made from materials which have demonstrated satisfactory biocompatibility, are sterile, single use devices.
5.7 Performance Testing
Biocompatibility Testing:
Biocompatibility has been reviewed in accordance with ISO10993 and FDA Blue Book memo G95-1.
To support:
To Control Moderate To Severe Bleeding, Works in Hypothermic Conditions, No Heat Generated in Use, Reduces Blood Loss, previously provided and cleared under (K080097).
Image /page/6/Figure/13 description: The image contains a collection of characters from different languages. There are characters from Gujarati, Arabic, and Telugu. The characters are arranged vertically in the image. The image is black and white.
In Vitro Testing to support:
- Rapid Packing
- High Volume Gauze Strip
- Promotes Rapid Wound Adhesion
Animal Studies
Animal Study 1 - The efficacy of Celox Rapid Gauze in a femoral artery wound model. To support
- Stops bleeding fast
- Rapidly controls bleeding
Clinical Study - Not Applicable.
5.8 Conclusion
CELOX Rapid Gauze induces hemostasis by the absorption of water in the blood to form a robust gel plug the same as CELOX Hemostatic Granules on Sheet (K080097) predicate device.
CELOX Rapid Gauze has been shown in testing to provide rapid haemorrhage control in a swine model of lethal arterial extremity.
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K110886
page 3 of 3
Medtrade Products believes that, as a result of the biocompatibility testing in vitro testing, and non-clinical animal testing, CELOX Rapid Gauze is safe and effective as an id the control of temporary external bleeding associated with moderate to severe bleeding and the control of minor external bleeding of laceration, minor cuts and abrasions.