FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

QuikClot 1st Response™ and QuikClot ACS+™ are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy.

AI/ML Overview

This document ([K061767](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K061767](https://510k.innolitics.com/search/K061767).pdf)) is a 510(k) summary for the QuikClot 1st Response™ & QuikClot ACS+™ devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance against a clinical endpoint. Therefore, the information provided below is extracted from the 510(k) summary regarding the studies conducted to support substantial equivalence, particularly focusing on the safety improvement and non-inferiority in efficacy.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Parameter / Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	All component materials and the finished device must pass ISO Standard 10993-1:1997.	All component materials and the finished device passed ISO Standard 10993-1:1997.
Heat Reduction (Safety)	Eliminate the risk of burns to caregivers and patients.	In-vitro: Peak temperature reduced from 190°F (predicate device) to 90°F (device modification) when mixed with an excess of water.
In-vivo (preclinical animal wound model): Caregivers experienced a peak temperature of 106°F and agreed that the risk of burns was eliminated, describing the heat generated as "warm."
Clotting Efficacy (Non-inferiority)	Maintain clotting efficacy not inferior to the predicate device.	In-vitro: Both the predicate device zeolite and the reformulated zeolite took less than 3 minutes to form a clot, while whole blood without zeolite took longer than 6 minutes. (Demonstrates efficacy comparable to predicate and superior to no treatment).
In-vivo Efficacy (Non-inferiority)	Demonstrate substantial equivalence to the predicate device in in-vivo models.	In-vivo testing in various swine models was used to demonstrate substantial equivalence to the predicate device. (Specific quantitative results are not provided in the summary, but the conclusion states substantial equivalence was demonstrated).

2. Sample Size Used for the Test Set and Data Provenance

Heat Reduction Studies:
- In-vitro: "an excess of zeolite was mixed with water." No specific numerical sample size is given for the in-vitro heat test.
- In-vivo (preclinical animal wound model): "Care givers that evaluated the product in a preclinical animal wound model..." While an animal model is mentioned, the exact number of animals or trials within this model is not specified.
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. It is retrospective data as it supports a 510(k) submission.
Clotting Time Studies:
- In-vitro: No specific numerical sample size for the samples tested (e.g., number of blood samples, replicates) is given for the in-vitro clotting time test. It compares "the zeolite formulation used in the predicate device," "the reformulated zeolite," and "whole blood without zeolite."
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.
In-vivo Efficacy Studies:
- "In-vivo testing in various swine models..." No specific numerical sample size (number of swine or trials) is provided.
- Data Provenance: The document does not specify the country of origin for these studies. It implies they are part of the manufacturer's pre-clinical testing. Retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Heat Reduction (In-vivo): "Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated."
- Number of Experts: Not specified beyond "Care givers" (plural).
- Qualifications: Referred to as "Care givers." No specific qualifications (e.g., type of medical professional, years of experience) are provided.
Other Studies (Biocompatibility, Clotting Time, In-vivo Efficacy): The document does not describe the use of human experts to establish "ground truth" for the test sets in these studies in the way a clinical trial might, but rather relies on objective measurements (temperature, clotting time) or expert interpretation of animal model outcomes, which is inherent in pre-clinical research.

4. Adjudication Method for the Test Set

Heat Reduction (In-vivo): For the in-vivo heat assessment, it states "Care givers...agreed that the risk of burns was eliminated." This implies a consensus or agreement among the unspecified number of caregivers. It does not describe a formal adjudication method like 2+1 or 3+1.
Other studies: Adjudication methods are not applicable nor described for the objective measurements in the other pre-clinical tests.

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 document describes pre-clinical testing for a device modification, focusing on safety (heat reduction) and non-inferiority in efficacy in lab and animal models, not on human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical medical product (hemostatic dressing), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Biocompatibility: Demonstrated by passing ISO Standard 10993-1:1997. The ground truth is adherence to the standard's requirements, likely via lab testing and analysis by qualified personnel.
Heat Reduction:
- In-vitro: Objective temperature measurements. The ground truth is the peak temperature recorded.
- In-vivo: Direct observation and subjective feedback ("warm," "risk of burns eliminated") from "Care givers" in a preclinical animal model.
Clotting Efficacy: Objective measurement of clotting time in a controlled in-vitro setting. The ground truth is the time to clot formation.
In-vivo Efficacy: Outcomes from "various swine models." The specific endpoints for "substantial equivalence" are not detailed but would typically involve measures of blood loss, time to hemostasis, or survival rates compared to the predicate device in controlled injury models.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for this physical medical device.

Summary

Regulation Number and Section

N/A