(62 days)
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.
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.
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.
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