(242 days)
PRO QR Powder is intended for use to stop minor bleeding and to absorb body fluid in traumatic superficial lacerations or wounds. Once exudation and bleeding have stopped, a protective dressing can be applied. It is intended to be distributed as a Professional Use (Non-Prescription) Device.
Components - The PRO QR product is composed of two main components: potassium iron oxyacid salt and a hydrophilic polymer.
Mechanism of Action - The PRO QR achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PRO QR (Quick Relief) Powder, based on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K070520 does not explicitly list numerical acceptance criteria or performance metrics in a typical table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sorbastace, K965034) based on shared intended use, satisfactory biocompatibility, high absorbency, and sterility.
However, based on the performance testing mentioned, we can infer some general performance goals:
| Acceptance Criteria (Inferred from testing and equivalence claims) | Reported Device Performance (as described in the 510(k) Summary) |
|---|---|
| Biocompatibility: No adverse biological reactions | Demonstrated satisfactory biocompatibility through Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Ames Mutagenicity tests. |
| Absorption Capability: Ability to absorb body fluids | "Highly absorbent for collecting body fluids" (stated for both subject and predicate device). Confirmed by "Absorption Study" in in-vitro testing. |
| Hemostasis (Stopping Minor Bleeding): Ability to stop minor bleeding in traumatic superficial lacerations/wounds | Achieves hemostasis by creating a physical barrier/seal to blood flow. Demonstrated performance in "A swine model of lethal, arterial extremity injury." |
| Mechanism of Action Equivalence: Similar mechanism to predicate (fluid dehydration and protein coagulation/agglomeration) | Both PRO QR and predicate arrest fluid/blood flow by fluid dehydration (polymeric component) and protein coagulation/agglomeration (aluminum oxyacid salt vs. potassium iron oxyacid salt). |
| Sterility: Sterile for single-use application | "Sterile, single use devices" (stated for both subject and predicate). |
| Safety: No new safety concerns due to composition differences | Composition differs from predicate, but "has been shown to be biocompatible... and raises no issue of safety or effectiveness." |
| Effectiveness: Effective for control of bleeding wounds and absorption of body fluids | "Safe and effective for the control of bleeding wounds, absorption of body fluids and performs in a manner equivalent to the predicate" based on testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document only mentions "A swine model of lethal, arterial extremity injury" for the animal study. It does not specify the sample size (number of animals or wounds) used in this model.
- Data Provenance: The animal study was conducted in a "swine model," indicating an animal study, not human data. The document does not specify the country of origin for the data. The study is prospective in nature, as it involves active animal experimentation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number or qualifications of experts used to establish a ground truth for the animal study. Animal model outcomes (e.g., successful hemostasis) would typically be assessed by veterinary or medical researchers, but specifics are absent here.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers evaluating medical images or data, which is not applicable to this device (a wound dressing powder).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the PRO QR Powder. "Standalone" performance generally refers to the performance of an AI algorithm operating independently. The PRO QR Powder is a physical medical device, not a software algorithm. Its performance is inherent in its physical properties and interaction with biological systems.
7. The Type of Ground Truth Used
For the animal study, the ground truth would have been physiological outcomes related to hemostasis and wound management, observed directly in the swine model (e.g., cessation of bleeding, time to hemostasis, blood loss measurements).
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. PRO QR Powder is a physical device, not an AI algorithm that undergoes training. The development and testing of such a device rely on material science, chemical properties, and biological studies, not machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8. There is no training set or associated ground truth for a physical medical device like PRO QR Powder.
N/A