(265 days)
Prescription Use: Zeolite Hemostatic Gauze is intended for temporary external use to control traumatic bleeding.
Over-The-Counter Use: Zeolite Hemostatic Gauze is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
The Zeolite Hemostatic Gauze consists of zeolite and gauze. Zeolite Hemostatic Gauze is provided in a sterile dressing format that conforms readily to the wound. It is available in four types, which are P (Sheet), J (Rolled), Z (Folded) and L (Cubed). The difference between each type is the dressing shape. Each type is available in a range of different sizes.
This FDA 510(k) summary provides information for a medical device called "Zeolite Hemostatic Gauze" (K211570). The document asserts substantial equivalence to a predicate device, QuikClot® eXTM (K072474), and references another device, QuikClot (K013390).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from various standards and internal specifications, as indicated by the non-clinical test conclusions. The reported device performance is presented as meeting these requirements.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Performance | Water Absorption ≥ 300% | Water absorption ≥300% |
| Hydration Temperature Rise ≤ 1.0°C | Hydration temperature rise ≤1.0°C. Maximum exothermic temperature of the proposed device is 0.5℃. | |
| Zeolite Content ≥ 10% | Zeolite amount ≥10% | |
| Sterile Barrier Packaging | Integrity of Seals (ASTM F1886/F1886M: 2016) | Test result showed that the device package can maintain its integrity. |
| Seal Strength (ASTM F88/F88M: 2015) | Test result showed that the device package can maintain its integrity. | |
| Dye Penetration (ASTM F1929: 2015 / F3039: 2015) | Test result showed that the device package can maintain its integrity. | |
| Leak Detection by Bubble Emission/Vacuum Leak (ASTM D3078-02 (Reapproved 2021)el) | Test result showed that the device package can maintain its integrity. | |
| Packaging Resistance Bacteria Performance (DIN 58953-6-2010) | Test result showed that the device package can maintain its integrity. | |
| Sterilization & Shelf Life | Bacterial Endotoxins Test (USP ). Endotoxin limit did not exceed 20 EU/device. | Endotoxin limit did not exceed 20EU/device. |
| Shelf Life Evaluation (Water absorption, zeolite content, and heat release, package tests on aging samples) | Shelf life test result showed that the device can maintain its performance during the claimed shelf life. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5: 2009) | The results for the biocompatibility testing showed that the proposed device is biocompatible (No Cytotoxicity, No intracutaneous reactivity, No Sensitization, No Acute Systemic Toxicity, No pyrogen). |
| Sensitization (ISO 10993-10: 2010) | The results for the biocompatibility testing showed that the proposed device is biocompatible. | |
| Irritation (ISO 10993-10: 2010) | The results for the biocompatibility testing showed that the proposed device is biocompatible. | |
| Systemic Toxicity (ISO 10993-11: 2017) | The results for the biocompatibility testing showed that the proposed device is biocompatible. | |
| Pyrogen Test (USP ) | The results for the biocompatibility testing showed that the proposed device is biocompatible. | |
| Hemostatic Effectiveness | In vivo testing to support the indications for use. (No specific quantitative acceptance criteria are provided in the summary, but the predicate device serves as the benchmark for substantial equivalence in effectiveness). | A in vivo testing using pig as a model is conducted on the subject device and predicate device to supports the indications for use of the subject device. |
Study Details Proving Device Meets Acceptance Criteria
-
Sample Size used for the test set and the data provenance:
- Physical performance testing: "Three discrete batches of subject device were tested." No further details on the number of units per batch or the provenance (country, retrospective/prospective) are provided beyond the manufacturer being in China.
- Sterile barrier packaging testing: No specific sample size is provided beyond stating "sterile barrier packaging testing were performed." Provenance is assumed to be from the manufacturer in China.
- Sterilization and shelf life testing: No specific sample size is provided for these tests, except for "aging samples" for shelf life. Provenance is assumed to be from the manufacturer in China.
- Biocompatibility testing: No specific sample sizes for in vitro tests (cytotoxicity, sensitization, irritation, systemic toxicity) are provided. Provenance is assumed to be from the manufacturer in China.
- Animal Study: 16 animals were selected for hemostatic testing: 8 for the subject device and 8 for the predicate device. The model used was a pig. Provenance is not specified beyond the manufacturer being in China, implying the study was conducted there. The study is prospective in nature as it involves active testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For physical performance, sterile barrier packaging, sterilization, shelf life, and biocompatibility, the acceptance criteria are based on established international and national standards (e.g., ASTM, ISO, USP, DIN). The "ground truth" here is the adherence to these standard specifications demonstrated through validated test methods, rather than expert interpretation of data. No external experts are mentioned for establishing ground truth for these tests.
- For the animal study, the "ground truth" for hemostatic effectiveness is the measured outcome in the pig model. The document does not specify if external experts were used to establish the ground truth (e.g., blinded assessment of bleeding time/volume) or the qualifications of those who evaluated the results.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method is mentioned for any of the non-clinical tests or the animal study. Test results are reported directly against the specified standards or internal criteria.
-
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:
- No MRMC or human reader study was mentioned. This device is a passive hemostatic gauze, not an AI-assisted diagnostic or therapeutic device that would involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical hemostatic gauze, not an algorithm. Performance testing (physical, biocompatibility, sterilization, and animal study) represents the "standalone" performance of the physical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical Performance, Sterile Barrier, Sterilization, Shelf-life: Ground truth is defined by published industry standards and specifications (e.g., ASTM, ISO, USP, DIN) and the results obtained from validated testing methods.
- Biocompatibility: Ground truth is established by the results of tests conducted according to ISO 10993 series and USP standards, indicating the absence of adverse biological responses.
- Animal Study: The ground truth for hemostatic efficacy is derived from direct observation and measurement of bleeding control in a live animal model (pig). This is a form of outcomes data within the controlled environment of an animal study.
-
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical product whose performance is evaluated through conventional non-clinical and pre-clinical testing.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
N/A