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PuraStat is intended for hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. PuraStat is not indicated for arterial Forrest 1a bleeding.

PuraStat is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a hemostat. The gel is delivered to the intended application site(s) via a commercially available endoscopic catheter that is attached to the gel-filled syringe via the polypropylene adapter (Class 1 - 510k Exempt) also commercially available (Class 1, 510k Exempt). PuraStat is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation. Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraStat achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.

The provided text is a 510(k) summary for the PuraStat device. It states that the subject device (K242250) is identical to the predicate device (K222481) except for the final sterilization method. The document explicitly states that the "device is identical to the predicate device and has the same intended use."

Therefore, the performance data provided is to demonstrate equivalence to the predicate device, not to establish new performance criteria for the subject device. It relies on the predicate's performance to establish substantial equivalence.

Based on the provided information, I can answer some of your questions and explain why others cannot be answered from this specific document:

1. A table of acceptance criteria and the reported device performance

   • This document does not provide a table of acceptance criteria and reported device performance for the new device in the general sense of clinical performance or accuracy for an AI/diagnostic device.
   • Instead, it states, "The subject device is identical to the predicate device...an equivalence demonstration was performed following the final sterilization change. The bench testing and biocompatibility testing provided in this submission assess the equivalence demonstration."
   • The "acceptance criteria" here are to show that the change in sterilization does not alter the device's fundamental properties or safety, ensuring it performs identically to the predicate device. Specific numerical performance metrics for hemostasis are not detailed in this filing, as they would have been established and accepted for the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This information is not provided in this 510(k) summary. The testing mentioned (bench testing and biocompatibility) is related to the change in sterilization, not a clinical trial to establish new efficacy for the device's intended use.

3. 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 is not applicable and is not mentioned. The device is a hemostatic gel, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable as this is not an AI/diagnostic device based on expert interpretation.

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

   • Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • Not applicable. The device is a physical hemostatic gel, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable in the context of an AI/diagnostic ground truth. The "ground truth" for this filing is that the subject device, with its new sterilization, is functionally identical and safe compared to the predicate through bench and biocompatibility testing. Clinical efficacy would have been established for the predicate device, likely through clinical studies demonstrating hemostatic success (e.g., control of bleeding, resolution of bleeding events), which would have served as the "ground truth" for its performance.

8. The sample size for the training set

   • Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. This is not an AI device that requires a training set.

Summary of Relevant Information from the Document:

• Device Name: PuraStat
• Intended Use: Hemostasis of mild and moderate bleeding post ESD or EMR, as an adjunct, bridge, prophylactic or rescue therapy for intraprocedural venous bleeding or prophylactic therapy to prevent post procedure bleeding, and for primary non-variceal gastrointestinal (GI) bleeding. Not indicated for arterial Forrest 1a bleeding.
• Key Change from Predicate: Final sterilization method (replaced by gamma radiation sterilization).
• Performance Data Provided: Bench testing and biocompatibility testing to demonstrate equivalence between the subject device (with new sterilization) and the predicate device.
• Conclusion: The subject device is substantially equivalent to the predicate (K222481) as the change in sterilization does not raise any new questions of safety and effectiveness, and the device remains identical in material, formulation, manufacturing, and final product specifications. The performance of the predicate device is implicitly relied upon.

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