(260 days)
No
The device description and performance studies focus on the material properties and physical mechanism of action (chitosan-based hemostatic granules forming a gel). There is no mention of any computational analysis, algorithms, or learning processes.
Yes
The device is intended to control moderate to severe bleeding, which is a therapeutic function.
No
Explanation: The device is a hemostatic gauze used to control bleeding, which is a therapeutic function, not a diagnostic one. It does not provide information about a patient's condition or disease state.
No
The device is a physical gauze product coated with hemostatic granules and includes a radiopaque strip. It is 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." This describes a therapeutic action applied directly to a wound on the body.
- Device Description: The description details a "hemostatic gauze for external use" that works by forming a "gel-like plug at the site of bleeding." This is a physical interaction with the wound.
- Mechanism of Action: The mechanism involves the chitosan granules absorbing blood and water to create a physical seal at the bleed site. This is a direct interaction with the wound, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a hemostatic agent applied directly to a wound for therapeutic purposes.
N/A
Intended Use / Indications for Use
Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Product codes
QSY
Device Description
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip.
Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.
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)
Non-Clinical Performance Data:
The following Performance data was obtained via in-vitro testing carried out on both the subject device and the predicate devices, in line with Medtrade products Ltd Design Control process, in support of the modification to the indications of use from the primary predicate device.
- pH
- Wet Tensile and Elongation
- Absorbency
- Blood Immobilisation
All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. Comparison testing was performed on the secondary predicate device to support the devices being comparable.
In-vivo Animal Studies:
In-vivo studies included within this submission confirm that Celox Rapid X-ray Gauze can perform as intended under anticipated conditions of use and demonstrates efficacy in achieving hemostasis in various swine wound models with varying severities of bleeds. The gauze is easily removed following hemostasis being achieved and is readily detectable if inadvertently left.
Biocompatibility Testing:
Biocompatibility testing requirements has been assessed and evaluated to demonstrate compliance / in accordance with:
- ISO10993-1 Biological evaluation of medical devices. Part 1- Evaluation and testing within a risk management process.
- FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
- USP Pyrogenicity Test
- USP Medical Devices Bacterial Endotoxin and Pyrogen Tests
- FDA guidance Pyrogen and Endotoxins Testing: Questions and Answers
As per standard guidance ISO 10993-1:2020 classification and FDA Biocompatibility guidance the subject device meets the requirements as a "Surface Contact medical device that contacts breached and compromised skin, for a prolonged duration >24 hours to
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, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
November 17, 2023
Medtrade Products Ltd. Mina Patel Regulatory Affairs Manager Electra House, Crewe Business Park Crewe. CW1 6GL United Kingdom
Re: K230589
Trade/Device Name: Celox Rapid X-Ray Gauze Regulatory Class: Unclassified Product Code: QSY Dated: October 26, 2023 Received: October 27, 2023
Dear Mina Patel:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K230589
Device Name CELOX Rapid X-Ray Gauze
Indications for Use (Describe)
Celox Rapid X-Ray detectable Z-fold hemostatic Gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicate for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
This Traditional 510(k) Premarket Notification is to provide the basis for determining substantial equivalence of the Medtrade Products Ltd Celox Rapid X-Ray Gauze to the predicate device Celox Rapid Gauze presented below:
| Submitter: | Medtrade Product Ltd
Electra House, Crewe Business Park
Crewe, Cheshire
CW1 6GL
United Kingdom
Telephone: + 44 (0)1270 500019
Facsimile: + 44 (0)1270 500045 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Contact: | Miss Kelsey Gomes
Senior Regulatory Affairs Specialist |
| Primary Contact: | Ms. Mina Patel
Regulatory Affairs Manager |
| Date prepared: | 26 October 2023 |
| 510(k) Type: | Traditional |
Device Information:
| Common Name: | Dressing – Hemostat |
|---|---|
| Trade/Proprietary Name: | CELOX Rapid X-Ray Gauze |
| OMNI-STAT Rapid X-Ray Gauze | |
| Celox Rapid X-Ray detectable Z-Fold Hemostatic Gauze | |
| Classification Panel: | General and Plastic Surgery |
| Product Code: | QSY |
| Classification Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
4
Predicate / Reference Device/s:
| Predicate 1 Device | Primary Predicate |
|---|---|
| Device Name: | CELOX Rapid Gauze |
| Company: | Medtrade Products Ltd |
| 510(k) Number: | K110386 |
| Product Code: | QSY |
| Predicate 2 Device | Secondary Predicate |
| Device Name: | Prometheus ChitoGauze XR Pro |
| Company: | HemCon Medical Technologies |
| 510(k) Number: | K153582 |
| Product Code: | QSY |
| Reference 1 Device | Reference Device |
| Device Name: | Celox Hemostatic Granules on Sheet |
| Company Name: | Medtrade Products Ltd |
| 510(k) Number: | K080097 |
| Product Code: | QSY |
Description of the Device:
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. Celox Rapid X-ray Gauze will be packaged in a tear-pouch for the pre-hospital market and a peel pouch for the hospital market and is available by prescription only. The subject device is a modification to the legally marketed predicate device Celox Rapid Gauze, with the inclusion of an x-ray detectable strip.
Celox Rapid X-Ray Gauze achieves its principle intended action (hemostasis) whereby the chitosan - hemostatic granules laminated to the gauze absorb blood and water creating a gelling action physically sealing the bleed site. As the water is absorbed, blood components are also amalgamated, in combination with manual pressure to the wound forming a gel coagulum at the site of bleeding. The device may be left in place for up to 72 hours. An additional standard gauze may be used if required.
5
Intended Use and Indications for Use:
Intended Use
Temporary topical external hemostat to control bleeding.
Indications for use
Prescription (Rx) Use:
Celox Rapid X-Ray detectable Z-fold hemostatic gauze is indicated for temporary external use to control moderate to severe bleeding. May also be indicated for temporary external use to control bleeding of lacerations, minor cuts, and abrasions.
Substantial Equivalence
Celox Rapid X-Ray Gauze has substantially equivalent indications for use, design principles, mechanisms of action and performance characteristics to the legally marketed primary predicate device Celox Rapid Gauze. The intended use of the subject device and primary predicate device are equivalent. The device is substantially equivalent in materials and performance characteristics, the addition of the radiopaque x-ray detectable strip does not alter the safety and performance of the device.
6
Comparison of Technological Characteristics with the Primary Predicate Device:
Table 1: Technological characteristics comparison of the subject device, and secondary predicate devices
| Category | Celox Rapid X-Ray Gauze
(Subject Device) | Celox Rapid Gauze
(Primary Predicate Device) | ChitoGauze XR Pro
(Secondary Predicate Device) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K230589 | K110386 | K153582 |
| Product Code | QSY | QSY | QSY |
| Classification | Unclassified | Unclassified | Unclassified |
| Regulatory Class | Unclassified | Unclassified | Unclassified |
| For single use | Yes | Yes | Yes |
| Shelf-life | 5 years | 5 years | Unknown |
| Intended Use | Temporary topical hemostat to control
bleeding | Temporary topical hemostat to control
bleeding | HemCon ChitoGauze® XR Pro is a
hemostatic dressing for the external,
temporary control of severely bleeding
wounds |
| Indications for Use | Celox Rapid X-Ray detectable z-fold
hemostatic gauze is indicated for
temporary external use to control
moderate to severe bleeding. May also
be indicated for temporary external
use to control bleeding of lacerations,
minor cuts, and abrasions. | Celox Rapid Gauze is a dressing
indicated for temporary external use to
control moderate to severe bleeding. | Prometheus ChitoGauze® XR PRO is a
hemostatic dressing for the external,
temporary control of severely bleeding
wounds |
| Design | Celox Rapid X-Ray Gauze is a
chitosan-based hemostatic gauze
stitch bonded with an x-ray detectable
strip using viscose Tencel, presented
in a sealed trilaminate foil pouch. Th
gauze materials consist of chitosan
hemostatic granules bonded using a
hot melt adhesive onto both sizes of
the non-woven base gauze and cut to
size. | Celox Rapid Gauze is a chitosan-based
hemostatic gauze presented in a sealed
trilaminate foil pouch. The gauze materials
consist of chitosan hemostatic granules
bonded using a hot melt adhesive onto
both sides of the non-woven base gauze
and cut to size. | Prometheus ChitoGauze® XR PRO is
composed of standard polyester/rayon
blend nonwoven medical gauze with a
radiopaque filament that is coated with
chitosan. The dressing is z-folded to the
appropriate size and vacuum sealed in a
pre-printed foil pouch. |
7
| Material/
Chemical
Composition | A proprietary chitosan formulation in
granular form heat bonded and coated
on to both sides of a non-woven
viscose-based gauze, stitch bonded
with an x-ray detectable strip using a
viscose (Tencel) thread. | A proprietary chitosan formulation in
granular form heat bonded and coated on
to both sides of a non-woven viscose-
base gauze. | A chitosan covered standard non-woven
base gauze with a radiopaque filament
strip. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Size | Various:
3in x 2ft, 3in x 5ft, 1in x 5ft Ribbon. | Various:
Range from 1in x 1in" to 3in" x 10ft. | 3in x 4yd (7.5cmx 3.7m) |
| Method of
sterilisation | Gamma Irradiation in accordance with
ISO 11137 | Gamma Irradiation in accordance with
ISO 11137 | Gamma Irradiation in accordance with
ISO 11137 |
| For Prescription
Use (Rx only) | Prescription use only | Prescription and OTC use | Prescription use only |
8
Performance Data
Non-Clinical Performance Data
The following Performance data was obtained via in-vitro testing carried out on both the subject device and the predicate devices, in line with Medtrade products Ltd Design Control process, in support of the modification to the indications of use from the primary predicate device.
- pH
-
- Wet Tensile and Elongation
-
- Absorbency
-
- Blood Immobilisation
All testing completed on both the subject device and primary predicate device meet the defined acceptance criteria. Comparison testing was performed on the secondary predicate device to support the devices being comparable.
In-vivo Animal Studies
In-vivo studies included within this submission confirm that Celox Rapid X-ray Gauze can perform as intended under anticipated conditions of use and demonstrates efficacy in achieving hemostasis in various swine wound models with varying severities of bleeds. The qauze is easily removed following hemostasis being achieved and is readily detectable if inadvertently left.
Biocompatibility Testing
Biocompatibility testing requirements has been assessed and evaluated to demonstrate compliance / in accordance with:
-
ISO10993-1 Biological evaluation of medical devices. Part 1- Evaluation and testing within a risk management process.
-
FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
-
USP Pyrogenicity Test
-
USP Medical Devices Bacterial Endotoxin and Pyrogen Tests
-
FDA guidance Pyrogen and Endotoxins Testing: Questions and Answers
As per standard quidance ISO 10993-1:2020 classification and FDA Biocompatibility guidance the subject device meets the requirements as a "Surface Contact medical device that contacts breached and compromised skin, for a prolonged duration >24 hours to