(162 days)
Prescription Use: Zeolite Hemostatic Cotton is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Cotton is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
The Zeolite Hemostatic Cotton consists of zeolite and cotton. It is provided in a sterile dressing format that conforms readily to the wound. There are 15 models of Zeolite Hemostatic Cotton, and the size ranges from 0.1g to 10g. The difference between each model is weight.
The provided document, K223495, is a 510(k) Premarket Notification for the Zeolite Hemostatic Cotton. It details non-clinical tests conducted to demonstrate the device's substantial equivalence to a legally marketed predicate device (K211570, Zeolite Hemostatic Gauze).
It's important to note that this submission does not include clinical study data (as explicitly stated in Section 6: "No clinical study is included in this submission."). Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document refer to non-clinical performance testing and biocompatibility assessments, not to AI-driven diagnostic or assistive technologies, nor to comparative effectiveness studies involving human readers and AI. The device described is a medical device for managing bleeding, not an AI software/device.
Given this context, I will address your points where applicable based on the provided document, acknowledging that many of your questions are geared towards AI/software medical devices or clinical trials, which are not present here.
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The acceptance criteria and reported performance are based on physical performance testing, sterile barrier packaging testing, sterilization and shelf-life testing, and biocompatibility testing.
Here's a table summarizing the acceptance criteria and reported performance specifically from the "Non-Clinical Test Conclusion" section (Section 5) of the document:
Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Test Category | Specific Test / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Performance | Water Absorption | ≥10g | Test results all meet the requirements (implies ≥10g) |
| Zeolite Content | Not less than 10% | Test results all meet the requirements (implies ≥10%) | |
| Hydration Temperature Rise | ≤3.0℃ | Test results all meet the requirements (implies ≤3.0℃) | |
| Sterile Barrier & Shelf-Life | Visual Inspection (ASTM F1886/F1886M) | Pass (integrity of seals) | Test results show device package can maintain integrity for 3 years |
| Seal Strength (ASTM F88/F88M) | Pass (seal integrity) | Test results show device package can maintain integrity for 3 years | |
| Dye Penetration Test (ASTM F3039) | Pass (no leakage) | Test results show device package can maintain integrity for 3 years | |
| Vacuum Leak (ASTM D3078) | Pass (no leaks) | Test results show device package can maintain integrity for 3 years | |
| Sterility (ISO 11737-2) | Sterile | Test results show device package can maintain integrity for 3 years | |
| Endotoxin Limit (USP ) | Did not exceed 20 EU/10g | Did not exceed 20 EU/10g | |
| Shelf-Life Evaluation (Appearance, Water Absorption, Zeolite Content, Heat Release, Package Integrity) | Maintain performance meet acceptance criteria for 3 years | Accelerated stability test results showed device maintains performance for 3 years | |
| Biocompatibility | Cytotoxicity | No Cytotoxicity | No Cytotoxicity (biocompatible) |
| Sensitization | No Sensitization | No Sensitization (biocompatible) | |
| Intracutaneous Reactivity | No Intracutaneous Reactivity | No Intracutaneous Reactivity (biocompatible) | |
| Acute Systemic Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity (biocompatible) | |
| Pyrogen Testing (USP ) | No Pyrogenicity | No Pyrogen (biocompatible) |
Responses to Specific Questions (based on the provided document):
-
A table of acceptance criteria and the reported device performance:
(See Table 1 above) -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document mentions "Three discrete batches of subject device were tested for water absorption, Zeolite content, and heat release." For other tests (e.g., packaging integrity, biocompatibility), the sample sizes are not explicitly stated within the public summary, but it's implied that sufficient samples were tested to meet the requirements of the listed ISO and ASTM standards.
- Data Provenance: The tests were non-clinical, likely performed in laboratories affiliated with the manufacturer or their testing partners. The manufacturer is Hangzhou Zeo-Innov Life Technology Co., Ltd. in China. The data would be prospective, as these are tests performed on newly manufactured devices for regulatory submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable. The "ground truth" here is defined by meeting predefined engineering, material science, and biological safety standards (e.g., specific thresholds for absorption, temperature, endotoxins, or qualitative assessments like "no cytotoxicity"). These are determined by lab analyses and standard protocols, not by expert consensus on clinical interpretation. There are no human "experts" establishing "ground truth" in the sense of clinical diagnoses in this context.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies where human readers interpret data, often with conflicting interpretations requiring a tie-breaker. This document focuses on non-clinical laboratory testing where results are quantitative or qualitative against established thresholds, not subjective interpretations requiring adjudication.
-
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:
- This is not applicable. The document explicitly states: "No clinical study is included in this submission." This device is not an AI-assisted diagnostic tool, and no MRMC study was performed or required for its 510(k) clearance based on substantial equivalence to a predicate hemostatic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This device is a physical medical product (hemostatic cotton), not an algorithm or software. Therefore, there is no "standalone performance" of an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" is based on pre-defined quantitative and qualitative performance specifications outlined in recognized international and national standards (e.g., ASTM, ISO, USP). For example, water absorption must be ≥10g, or certain biocompatibility tests must show "no cytotoxicity." This is a technical ground truth based on scientific and engineering principles rather than clinical outcomes or expert consensus.
-
The sample size for the training set:
- This is not applicable. This device is a physical product, not an AI/ML model that requires a training set.
-
How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical medical device.
In summary: The provided FDA 510(k) summary for the Zeolite Hemostatic Cotton focuses entirely on non-clinical testing (physical properties, packaging, sterilization, biocompatibility) to demonstrate substantial equivalence. It explicitly states that no clinical studies were performed. Therefore, questions pertaining to AI/ML, human reader studies, clinical ground truth establishment, or training sets are not relevant to this document. The "acceptance criteria" discussed are for the device's physical and biological performance as per established standards for medical devices of this type.
N/A