(337 days)
The Hemostatic Xerogel Sponge is a hemostatic dressing for the external, temporary control of severely bleeding wounds.
The proposed device, Hemostatic xerogel sponge, is available in three models for different size. The Hemostatic Xerogel Sponge is a irradiation sterilized, single used device, and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 2 years.
The document describes non-clinical performance data for the Hemostatic Xerogel Sponge to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Testing | ||
| Water Absorption | Not less than 20 times the weight of the sample before liquid absorption. | Meets the acceptance criteria. |
| Density | Product density ≥ 0.2 g/cm³ (specified based on product technique requirements) | Meets the acceptance criteria. |
| Package Integrity | (Implicitly meets criteria through successful testing for shelf-life claims) | |
| Simulated Distribution | Verified through ASTM D4169:2016 and associated integrity testing. | Successfully performed. |
| Package Integrity (Seal) | Verified through ASTM F88/F88-15 seal strength test. | Successfully performed. |
| Package Integrity (Dye) | Verified through ASTM F1929-15 dye penetration test. | Successfully performed. |
| Accelerated Aging | Verified through associated package integrity testing for shelf-life claims. | Successfully performed. |
| Sterilization Testing | ||
| EO Residue | Not to exceed the limit of ISO 10993-7. | Did not exceed the limit of ISO 10993-7. |
| ECH Residue | Not to exceed the limit of ISO 10993-7. | Did not exceed the limit of ISO 10993-7. |
| Endotoxin Limit | Not to exceed 20 EU/device (USP ). | Did not exceed 20 EU/device. |
| Animal Study (In Vivo) | Demonstrates substantial equivalence to the predicate device in hemostatic function. | Subject device demonstrated substantial equivalence to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- For physical testing (water absorption, density), the document does not specify the exact number of samples tested, only referring to "samples" and "each sample."
- For package integrity testing, the document does not specify the number of packages or tests performed.
- For sterilization testing (EO/ECH residue, endotoxin), the document does not specify the number of devices tested.
- For the animal study, the document does not explicitly state the number of animals used, only that "A new in vivo testing using swine femoral artery as a model is conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is Solaplus Biotech Co., Ltd. located in Wenzhou, China, and the designated submission correspondent is Mid-Link Consulting Co., Ltd in Shanghai, China, it is reasonable to infer the studies were conducted in China, likely prospectively for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The studies described are non-clinical engineering and animal studies, not human clinical trials or expert-adjudicated performance evaluations in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies are non-clinical and do not involve human interpretation or adjudication for establishing ground truth.
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
- No, an MRMC comparative effectiveness study was not done. The device is a physical medical device (hemostatic sponge), not an AI diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
- For physical testing (water absorption, density): The ground truth is based on direct measurement against predefined quantitative physical property specifications.
- For package integrity testing: The ground truth is based on established engineering standards for package performance (e.g., seal strength, dye penetration).
- For sterilization testing: The ground truth is based on chemical residue limits (ISO 10993-7) and biological contamination limits (USP ).
- For the animal study: The ground truth for effectiveness is the direct observation of hemostasis in the swine femoral artery model, compared to the performance of the predicate device.
8. The sample size for the training set
- This information is not applicable. The document describes the performance of a physical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as above.
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