(62 days)
No
The device description and performance studies focus on the chemical and physical properties of the hemostatic agent, with no mention of AI or ML.
Yes
This device is intended for the temporary treatment and control of bleeding, which is a therapeutic action.
No
This device is designed to control bleeding (hemostasis) by forming a physical barrier, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states that CELOX PRO is composed of physical components (chitosan, polymer, poly-N-acetyIglucosamine) and functions as a topical dressing, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CELOX PRO 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 that is applied externally to a wound to physically stop bleeding.
- Mechanism of Action: The mechanism of action describes the formation of a "physical barrier or seal to stop the flow of blood" when applied to a wound. This is a physical interaction with the wound itself, not an analysis of a biological sample in vitro.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on the analysis of a sample.
- Using reagents or assays to detect or measure substances in a sample.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. CELOX PRO does not perform any such analysis. It is a topical hemostatic agent.
N/A
Intended Use / Indications for Use
CELOX 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.
CELOX PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
CELOX PRO for minor external bleeding from wounds and procedures (OTC) 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.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
Components - CELOX PRO is composed of chitosan, polymer, poly-N-acetylglucosamine.
Mechanism of Action – CELOX Pro achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. CELOX PRO quickly forms a strong seal 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-
Identical to CELOX Hemostatic Granules, previously provided and reviewed and cleared under (K061071).
In vitro Testing
To support: No Heat Generated in Use, Promoting Rapid Coagulation & Heparinized Blood and Works in Hypothermic Conditions, identical to CELOX Hemostatic Granules, previously provided and cleared under (K061071).
To support: Promoting Rapid Coagulation & Warfarin / Coumadin Blood identical to CELOX topical Hemostatic Granules in Soluble Bag, previously provided and cleared under K072328
Animal Studies
Animal Study 1 - Preliminary study of CELOX severe topical arterial bleeding model Protocol & Report to establish method.
Animal Study 2 - CELOX PRO Severe topical arterial bleeding model Protocol & Report full study.
CELOX Hemostatic Granules (have been shown in testing to be equivalent to, if not better than, the QuikClot Powder predicate device in rapid haemorrhage control in a swine model of lethal arterial extremity. (Portsmouth Paper)
Safety and efficacy was also demonstrated for bleeding control in minor external bleeding from surgical procedures using a swine model.
CELOX Hemostatic Granules OTC have been shown in testing to repeatedly control minor external bleeding from surgical procedures swine model.
CELOX Hemostatic Granules have been shown in testing to repeatedly control external bleeding when the animal model has been heparinised.
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
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.
MedTrade Products Limited c/o Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs Electra House, Crewe Business Park Crewe, Cheshire CWI 6GL United Kingdom
July 28, 2023
Re: K093593 Trade/Device Name: CELOX PRO 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 January 20, 2010. 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.
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
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, which is a common emblem associated with health and medical services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 20 2010
MedTrade Products Limited % Mr. Jonathan Ranfield Director, QA/RA Electra House, Crewe Business Park Crew, Cheshire CW1 6GL United Kingdom
Re: K093593
Trade/Device Name: CELOX Pro Regulatory Class: Unclassified Product Code: FRO Dated: November 11, 2009 Received: November 19, 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.
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 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.
2
Page 2 - Mr. Jonathan Ranfield
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 vours.
Saibao trup
Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K093593 510(k) Number (if known):
Device Name: CELOX PRO
CELOX 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.
CELOX PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Caunter 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 Kane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093593
Page 1 of 1
4
Indications for Use
KO93593 510(k) Number (if known):
Device Name: CELOX PRO
CELOX PRO for minor external bleeding from wounds and procedures (OTC) 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.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (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 Keane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
AND/OR
510(k) Number K093593
Page 1 of 1
5
SECTION 2:
510(k) SUMMARY
- 2.1 Sponsor
MedTrade Products Limited Electra House Crewe Business Park Crewe Cheshire CW1 6GL UK
Innovative Medical Products
K09.3593
page 1/3
JAN 2 0 2010
Telephone: +44 1270 500019
Fax: +44 1270 500045
Registration Number: 9614493
Contact Person: Jonathan Ranfield Director, Quality Assurance & Regulatory Affairs
2.2 Date Summary was Prepared
November 11, 2009.
2.3 Device Information
Proprietary Name: CELOX PRO for Minor External Bleeding from Wounds and Procedures
CELOX PRO for Moderate to Severe External Bleeding Wounds
Common Name: Hemostatic Granules Wound Dressing
Classification Name: Dressing, Unclassified
5.4 Predicate Device
e
MedTrade Products Limited: CELOX Topical Hemostatic Granules (K061079)
Biolife, L.L.C; PRO QR (Quick Relief) Powder (K080210)
Medafor, Inc.; HemaDerm (K021678)
5.5 Device Description
Components - CELOX PRO is composed of chitosan, polymer, poly-N-acetyIglucosamine.
Mechanism of Action – CELOX Pro achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. CELOX PRO quickly forms a strong seal that completely covers the wound.
Image /page/5/Picture/26 description: The image shows the number 10 with a smiley face inside of the zero. The number one is a simple line that is slanted to the left. The zero is a circle with two dots for eyes and a curved line for a mouth.
Image /page/5/Picture/27 description: The image shows a circular logo with text around the perimeter. The text includes "CEPREI No. I MD 600441 ISO 13485: 2016". Inside the circle is a triangular shape with a smaller circle at the top. The logo appears to be a certification mark, possibly related to quality management systems.
6
5.6 Intended Use
K093593 page 2/3
CELOX PRO for minor external bleeding from wounds and procedures (Rx) is intended 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.
CELOX PRO for moderate to severe external bleeding wounds (Rx) is intended for temporary external treatment for controlling moderate to severe bleeding.
CELOX PRO for minor external bleeding from wounds and procedures is intended for OTC 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.
5.7 Substantial Equivalence
CELOX PRO has substantially equivalent indications to the PRO QR (K080210) and HemaDerm (K021678) predicates 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. CELOX PRO uses the same safe and effective technology as CELOX Topical Hemostatic Granules (K061079). The subject device and predicate devices are made from materials which have demonstrated satisfactory biocompatibility, are highly absorbent for collecting body fluids, and are sterile, single use devices.
5.8 Performance Testing
Biocompatibility Testing-
Identical to CELOX Hemostatic Granules, previously provided and reviewed and cleared under (K061071).
In vitro Testina
To support: No Heat Generated in Use, Promoting Rapid Coagulation & Hepranized Blood and Works in Hypothermic Conditions, identical to CELOX Hemostatic Granules, previously provided and cleared under (K061071).
To support: Promoting Rapid Coagulation & Warfarin / Coumadin Blood identical to CELOX topical Hemostatic Granules in Soluble Bag, previously provided and cleared under K072328
Animal Studies
Animal Study 1 - Preliminary study of CELOX severe topical arterial bleeding model Protocol & Report to establish method.
Animal Study 2 - CELOX PRO Severe topical arterial bleeding model Protocol & Report full study.
Clinical Study - Not Applicable.
5.9 Conclusion
CELOX PRO induces hemostasis by the absorption of water in the blood to form a robust gel plug the same as CELOX Topical Hemostatic Granules (K061079) predicate device.
CELOX Hemostatic Granules (have been shown.in testing to be equivalent to, if not better than, the QuikClot Powder predicate device in rapid haemorrhage control in a swine model of lethal arterial extremity. (Portsmouth Paper)
//
7
K 093593 page 3/3
external bleeding
Safety and efficacy was also demonstrated for bleeding control in minor external bleeding from surgical procedures using a swine model.
CELOX Hemostatic Granules OTC have been shown in testing to repeatedly control minor external bleeding from surgical procedures swine model.
CELOX Hemostatic Granules have been shown in testing to repeatedly control external bleeding when the animal model has been heparinised.
MedTrade Products believes that, as a result of the biocompatibility testing in vitro testing, and non-clinical animal testing, CELOX PRO is safe and effective as an aid in the control of temporary external bleeding associated with moderate to severe bleeding. CELOX PRO is substantially equivalent to the predicate devices, CELOX, PRO QR and HemaDerm.