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510(k) Data Aggregation
(230 days)
Nexpowder™ is used for hemostasis of nonvariceal gastrointestinal bleeding.
The Nexpowder is used for hemostasis of non-variceal gastrointestinal bleeding. It is a prescription only, single-use device provided with a powder pre-packaged in a vial, and a delivery system, which consists of a spray body, a connector and a delivery catheter is inserted through an endoscope's working channel to deliver the powder to the intended hemostasis target site. Nexpowder is almost identical to the currently marketed device (K202929) and has the same technological characteristics and mechanism of action, but differs in the indications for use, where the subject device is also indicated for lower GI bleeding.
Here's a breakdown of the acceptance criteria and study information for the Nexpowder™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which implies that the Nexpowder™ should perform comparably to the predicate for the expanded indications. The reported performance is primarily about showing comparability.
| Performance Aspect | Acceptance Criteria (Implied / Indirect) | Reported Device Performance |
|---|---|---|
| Hemostasis for lower GI | Comparable safety and effectiveness to the predicate device (Hemospray for lower GI bleeding) | Clinical data from a prospective study and retrospective studies (Korea and EU) for 260 lower GI cases demonstrated results comparable to Hemospray's De-Novo authorization (DEN170015), supporting the lower GI indication expansion. |
| Overall Safety & Effectiveness | Safety and effectiveness previously established for Nexpowder (K202929) for upper GI, with no new questions of safety/effectiveness arising from changes. | The device's safety and effectiveness (including powder chemical characteristics, delivery method, and energy source) were previously established in K202929. The expanded indication does not alter the intended use, and minor modifications were determined not to significantly affect safety or efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 260 lower GI cases.
- Data Provenance: Clinical data was collected:
- Outside the United States (OUS)
- Prospective study conducted in Korea.
- Retrospective studies conducted in Korea.
- Aggregated data collected in the European Union (EU).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not specify the number of experts used to establish ground truth for the clinical studies, nor does it detail their qualifications (e.g., "radiologist with 10 years of experience"). It generally refers to "clinical data" without providing these specifics.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. This device is a physical hemostatic device, not an AI/software device, so an MRMC study would generally not be applicable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as Nexpowder™ is a physical medical device (hemostatic powder and delivery system), not an algorithm or software. There is no "algorithm only" performance to be assessed.
7. Type of Ground Truth Used
The "ground truth" for the clinical studies would be clinical outcomes related to hemostasis of non-variceal gastrointestinal bleeding. This would involve medical assessment of whether bleeding was successfully stopped using the device.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This is a physical medical device, not an AI/software product, so the concept of a training set as often discussed in AI studies is not applicable here. The "training" for the device would be its prior development and testing, including the clinical data supporting its previous clearance (K202929).
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" in the AI sense is not applicable. For the development and prior clearance (K202929) of Nexpowder, the "ground truth" would have been established through a combination of:
- Pre-clinical testing: Laboratory and animal studies to demonstrate the hemostatic properties and safety of the powder and delivery system.
- Clinical studies (for K202929): Data from human trials (likely for upper GI bleeding) to establish safety and effectiveness, similar to the type of clinical outcome data described above for the lower GI indication expansion.
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