(89 days)
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.
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.
The provided text describes the 510(k) submission for the CELOX Rapid Gauze device. It compares the device to its predicate, CELOX Hemostatic Granules on Sheet (K080097), and outlines performance testing that supports its substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of formal "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not explicitly stated or provided in this 510(k) summary. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific quantifiable performance targets against a clinical ground truth.
Instead, the performance reported is framed in terms of supporting claims for the device.
| Claim/Performance Area | Reported Device Performance |
|---|---|
| Biocompatibility | Reviewed in accordance with ISO10993 and FDA Blue Book memo G95-1. (Implied: Satisfactory). |
| Control of Bleeding | Rx Use: Temporary external use for moderate to severe bleeding. (Supported by predicate and animal studies).OTC Use: Temporary external use for lacerations, minor cuts, and abrasions. (Supported by predicate). |
| Hypothermic Conditions | Works in Hypothermic Conditions (previously provided and cleared under K080097). |
| Heat Generation | No Heat Generated in Use (previously provided and cleared under K080097). |
| Blood Loss Reduction | Reduces Blood Loss (previously provided and cleared under K080097). |
| Rapid Packing | Supported by In Vitro Testing. |
| High Volume Gauze Strip | Supported by In Vitro Testing. |
| Rapid Wound Adhesion | Promotes Rapid Wound Adhesion (supported by In Vitro Testing). |
| Stopping Bleeding Fast | Supported by Animal Study 1 (femoral artery wound model). "Stops bleeding fast." |
| Rapid Bleeding Control | Supported by Animal Study 1 (femoral artery wound model). "Rapidly controls bleeding." |
| Haemorrhage Control (main claim) | "CELOX Rapid Gauze has been shown in testing to provide rapid haemorrhage control in a swine model of lethal arterial extremity." (Implied: effective and comparable to predicate based on mechanism of action and prior clearance). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The primary "test set" for efficacy assessment appears to be an animal study (Animal Study 1): "The efficacy of Celox Rapid Gauze in a femoral artery wound model."
- Sample Size: The precise number of animals used in Animal Study 1 is not specified in the provided text. It only mentions a "swine model of lethal arterial extremity."
- Data Provenance: The origin of the data (e.g., country) is not specified. The study is likely prospective, as it's an efficacy study for a new device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable: This type of study (animal model for hemostasis) typically does not involve human expert readers establishing ground truth in the same way an imaging study would. The ground truth for hemostatic efficacy in an animal model is established by direct observation and measurement of bleeding cessation and blood loss during the experiment by the study's researchers/veterinarians.
4. Adjudication Method for the Test Set
- Not Applicable: Given that the primary efficacy data comes from an animal study and in vitro tests, a "2+1, 3+1" adjudication method is not relevant. The assessment of endpoints in these studies would be based on predefined objective criteria applied by the study investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is typically for evaluating diagnostic imaging devices with multiple human readers, often comparing AI-assisted performance to unassisted performance. The CELOX Rapid Gauze is a hemostatic device, not a diagnostic imaging AI algorithm.
6. Standalone (Algorithm Only) Performance
- Not Applicable: The CELOX Rapid Gauze is a physical medical device (hemostatic gauze), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant. Its performance is its direct physical action.
7. Type of Ground Truth Used
- Animal Outcomes/Physiological Response: For the animal study, the ground truth was the direct observation and measurement of hemostasis (cessation of bleeding) and control of hemorrhage in the swine model, along with potentially other physiological parameters like blood loss, under experimental conditions.
- Biocompatibility Standards: For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO10993 and FDA Blue Book memo G95-1).
- In Vitro Metrics: For in vitro tests (Rapid Packing, High Volume Gauze Strip, Promotes Rapid Wound Adhesion), the ground truth would be precise laboratory measurements using established protocols.
8. Sample Size for the Training Set
- Not Applicable: As the CELOX Rapid Gauze is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning. The device's design and mechanism of action are based on scientific principles of chitosan's hemostatic properties.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: Since there is no training set as defined for AI algorithms, this question is not relevant. The "ground truth" for the device's development would stem from extensive research into material science, hemostasis, and preclinical testing over many years, culminating in its predicate device.
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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
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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
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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
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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
7
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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.
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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).
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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.
N/A