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.

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.

AI/ML Overview

This document is a 510(k) summary for the CELOX PRO hemostatic granules, indicating FDA clearance based on substantial equivalence to predicate devices. It does not contain details of specific acceptance criteria or a study proving the device meets those criteria in the format requested. Instead, it references prior clearances for similar products and animal studies to justify its safety and effectiveness.

Therefore, many of the requested fields cannot be directly extracted or are explicitly stated as "Not Applicable" for a clinical study.

Here's a breakdown based on the provided text, indicating where information is present or absent:

Acceptance Criteria and Device Performance Study Details for CELOX PRO

1. Table of Acceptance Criteria and Reported Device Performance
This information is NOT available in the provided document. The document details that the device is "substantially equivalent" to predicate devices based on safety and effectiveness, but it does not list specific numerical acceptance criteria (e.g., stopping bleeding within X seconds in Y% of cases) nor a head-to-head performance study against such criteria.

2. Sample size used for the test set and the data provenance
This information is NOT explicitly detailed for a single test set proving specific acceptance criteria.

Sample Size: The document refers to "animal studies" (Animal Study 1 and Animal Study 2) but does not provide specific sample sizes (number of animals) for these studies.
Data Provenance: The animal studies were likely conducted to support regulatory submission, but the country of origin is not specified. The studies are described as "preliminary study of CELOX severe topical arterial bleeding model Protocol & Report to establish method" and "CELOX PRO Severe topical arterial bleeding model Protocol & Report full study." Another study mentions a "swine model of lethal arterial extremity" (Portsmouth Paper). These are prospective animal studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as the evaluation was based on animal models of bleeding, not human expert interpretation of data. The ground truth would be direct observation of hemostasis in the animal model.

4. Adjudication method for the test set
Not applicable, as the evaluation was based on animal models of bleeding, not human expert interpretation of data requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a hemostatic agent, not an AI or imaging diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (hemostatic granules), not an algorithm.

7. The type of ground truth used

Animal Studies: Direct observation of hemostasis (cessation of bleeding) in animal models (specifically, swine models for arterial bleeding and surgical procedures).
Biocompatibility Testing: Likely laboratory tests to assess material compatibility with biological systems.
In vitro Testing: Laboratory experiments to demonstrate properties like "No Heat Generated in Use," "Promoting Rapid Coagulation," "Heparinized Blood," "Hypothermic Conditions," and "Warfarin / Coumadin Blood."

8. The sample size for the training set
Not applicable. This is a medical device, and the concept of a "training set" for AI algorithms does not apply.

9. How the ground truth for the training set was established
Not applicable. See point 8.

Summary of available information regarding performance:

The claim of safety and effectiveness for CELOX PRO relies on:

Substantial Equivalence: It has substantially equivalent indications to previously cleared devices (PRO QR, K080210; HemaDerm, K021678).
Shared Technology: It uses the "same safe and effective technology" as CELOX Topical Hemostatic Granules (K061079), which was previously cleared.
Biocompatibility Testing: Identical to CELOX Hemostatic Granules (K061071).
In vitro Testing: Identical to CELOX Hemostatic Granules (K061071) for various conditions (no heat, rapid coagulation in heparinized/hypothermic blood) and identical to CELOX topical Hemostatic Granules in Soluble Bag (K072328) for rapid coagulation in warfarin/Coumadin blood.
Animal Studies:
- One preliminary study to establish the method for a severe topical arterial bleeding model.
- One full study using a severe topical arterial bleeding model (swine model).
- Mention of CELOX Hemostatic Granules being "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).
- Demonstration of safety and efficacy for bleeding control in minor external bleeding from surgical procedures using a swine model.
- Demonstration of repeated control of minor external bleeding from surgical procedures (swine model) and external bleeding in heparinized animal models by CELOX Hemostatic Granules OTC.

The document concludes that based on biocompatibility, in vitro, and non-clinical animal testing, CELOX PRO is safe and effective and substantially equivalent to its predicate devices.

Summary

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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

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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.

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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

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Indications for Use

K093593 510(k) Number (if known):

Device Name: CELOX PRO

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

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Indications for Use

KO93593 510(k) Number (if known):

Device Name: CELOX PRO

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

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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

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.

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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.

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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)

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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.

Regulation Number and Section

N/A