(244 days)
No
The device description focuses on the physical and chemical properties of the hemostatic gauze and its mechanism of action, with no mention of AI or ML.
Yes
The device is indicated for controlling bleeding from wounds and procedures, which is a therapeutic purpose.
No
The device is a hemostatic gauze intended to stop bleeding by providing a physical barrier and promoting clot formation. It does not perform any diagnostic function such as detecting, analyzing, or interpreting medical conditions.
No
The device description clearly states it is a physical gauze product with hemostatic granules and adhesive, 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 clearly states the device is a "temporary topical dressing for bleeding control associated with minor wounds" and for "temporary external treatment for controlling moderate to severe bleeding." This describes a device applied externally to the body to manage bleeding, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description focuses on the physical mechanism of action (physical barrier, absorbing water, concentrating platelets) to stop bleeding. It does not mention any analysis of biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Being used in a laboratory setting.
The device is a hemostatic gauze, which is a type of medical device used to control bleeding. Its function is purely mechanical and physical in stopping blood flow.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.
Product codes
QSY, FRO
Device Description
CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet (510(k) # K080097) in product composition (raw materials), manufacturing processes and product performance. The device consists of a chitosan Haemostatic granules (CELOX PRO 510(k) # K093593) adhered onto a base fabric (non-woven gauze) using a hot melt adhesive.
CELOX Gauze PRO achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the CELOX Gauze PRO directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding and reduce the risk of re-bleeding.
In addition because CELOX Gauze PRO absorbs water from blood, platelets are concentrated, resulting in activation of platelets to help stop bleeding and reduce the risk of re-bleeding
CELOX Gauze PRO is an effective solution that reduces time to haemostasis, even for patients on anticoagulants such as warfarin and heparin.
The CELOX Gauze Pro is packed in a three layer laminate pouch of polyester, aluminium and LDPE. The pouch provide an integral barrier that maintains dressing sterility post irradiation yet allows easy opening and aseptic dressing removal by the end user.
The CELOX Gauze PRO is available in various sizes ranging from 1" x 1" to 3″ x 10ft.
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
Under the supervision of a healthcare professional
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)
Performance data for the CELOX Gauze PRO has been established using in-vivo testing and bench testing.
The biocompatibility of CELOX Gauze PRO has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). Sterilisation validation has been performed in compliance with harmonised standards (ISO 11137-1 - Sterilization of healthcare products - Radiation -Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices).
The biocompatibility and performance testing for the CELOX Gauze PRO has demonstrated that the device is safe and effective for the indications of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023 Medtrade Products Ltd. Claire Ryan Head Of Regulatory and QA Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom Re: K113560 Trade/Device Name: CELOX Gauze PRO/CELOC PRO Hemostatic Gauze/OMNI-STAT Gauze/OMNI-STAT Hemostatic Gauze Regulatory Class: Unclassified Product Code: QSY
Dear Claire Ryan:
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 August 1, 2012. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is facing right and is composed of thick, curved lines. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2012
Medtrade Products, Limited % Ms. Claire Ryan Head of Regulatory & QA Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Re: K113560
Trade/Device Name: CELOX Gauze PRO/CELOC PRO Hemostatic Gauze/OMNI-STAT Gauze/OMNI-STAT Hemostatic Gauze
Regulatory Class: Unclassified Product Code: FRO Dated: June 21, 2012 Received: June 25, 2012
Dear Ms. Ryan:
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
2
Page 2 - Ms. Claire Ryan
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark L. Miller
Mark N. Melkerson Director Division of Surgical, Orthoped and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K113560
Device Name: CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze
Indications for Use:
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
Under the supervision of a healthcare professional CELOX Gauze PRO / CELOX PRO Hemostatic Gauze / OMNI-STAT Gauze / OMNI-STAT Hemostatic Gauze for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ﮨﮯ ﺍ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kureta, mm
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K113560
4
INDICATIONS FOR USE
510(k) Number (if known): K113560
Device Name: CELOX Gauze PRO (OTC)
Indications for Use:
CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ X (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)
Dail Kune famm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_1
5
Section 5 - Traditional 510(k) Notification:- Summary
1 2012 AUG
(113560 P
This Traditional 510(k) notification is to provide substantial equivalence for Medtrade Products CELOX Gauze PRO, which is substantially equivalent to currently marketed device intended for wound care.
| Submitted by:- | Medtrade Product Ltd
Electra House, Crewe Business Park
Crewe, Cheshire
CW1 6GL
United Kingdom |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:- | Mrs Claire Ryan
Head of Regulatory and QA
Telephone: + 44(0)1270 500019
Fax:- + 44(0)1270 500045
Email: claire.ryan@medtrade.co.uk |
| Date prepared:- | 26th March 2012 |
| Proprietary Name: | CELOX Gauze PRO |
| Common Name:- | CELOX Gauze PRO (Prescription)
CELOX Gauze PRO OTC
CELOX PRO Hemostatic Gauze (Prescription)
OMNI-STAT Gauze (Prescription)
OMNI-STAT Hemostatic Gauze (Prescription)
OMNI-STAT Granules on Gauze (Prescription) |
| Trade Names:- | Not yet defined |
| Product Code:- | FRO |
| Classification Name:- | Dressing, Wound, Drug |
| Classification:- | Unclassified |
Legally marketed device(s) for substantial equivalence comparison:-CELOX Hemostatic Granules on Sheet, 510(k) # K080097 and CELOX PRO 510(k) # K093593, manufactured by Medtrade Products Ltd.
Device Description :-
CELOX Gauze PRO is identical to CELOX Hemostatic Granules on Sheet (510(k) # K080097) in product composition (raw materials), manufacturing processes and product performance. The device consists of a chitosan Haemostatic granules (CELOX PRO 510(k) # K093593) adhered onto a base fabric (non-woven gauze) using a hot melt adhesive.
S'4 page 1
6
K113560 page 2/3
CELOX Gauze PRO achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the CELOX Gauze PRO directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding and reduce the risk of re-bleeding.
In addition because CELOX Gauze PRO absorbs water from blood, platelets are concentrated, resulting in activation of platelets to help stop bleeding and reduce the risk of re-bleeding
CELOX Gauze PRO is an effective solution that reduces time to haemostasis, even for patients on anticoagulants such as warfarin and heparin.
The CELOX Gauze Pro is packed in a three layer laminate pouch of polyester, aluminium and LDPE. The pouch provide an integral barrier that maintains dressing sterility post irradiation yet allows easy opening and aseptic dressing removal by the end user.
The CELOX Gauze PRO is available in various sizes ranging from 1" x 1" to 3″ x 10ft.
Indications for use:
Under the supervision of a healthcare professional CELOX Gauze PRO for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
Under the supervision of a healthcare professional CELOX Gauze PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
CELOX Gauze PRO (OTC) is indicated for use as a temporary topical dressing for minor cuts, minor abrasions, minor lacerations and minor burns.
Manufacturing :-
CELOX Gauze PRO is manufactured according to the product specifications and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971 to identify possible failure mode during manufacturing and design. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode.
CELOX Gauze PRO meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use.
CELOX Gauze PRO are terminally sterilised by gamma irradiation to a sterility assurance level (SAL) of 10-6.
7
K 113560 page 3/3
Testing:-
Performance data for the CELOX Gauze PRO has been established using in-vivo testing and bench testing.
The biocompatibility of CELOX Gauze PRO has been demonstrated to be in compliance with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). Sterilisation validation has been performed in compliance with harmonised standards (ISO 11137-1 - Sterilization of healthcare products - Radiation -Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices).
The biocompatibility and performance testing for the CELOX Gauze PRO has demonstrated that the device is safe and effective for the indications of use.
Statement of Substantial Equivalence:-
The indication for use and performance testing for the CELOX Gauze PRO is substantially equivalent to the predicate device: CELOX Hemostatic Granules on Sheet, 510(k) # K080097 and CELOX PRO 510(k) # K093593 manufactured by Medtrade Products Ltd in that they are indicated for topical application as an aid in the control of temporary external bleeding associated with minor to severely bleeding wounds.