(195 days)
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 syringe via the polypropylene adapter. 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 document is a 510(k) Premarket Notification from the FDA for a device called PuraStat. It does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the typical sense of a diagnostic or AI-driven medical device evaluation.
The document states that the PuraStat device is identical to its predicate device (PuraStat-GI, K210098). Therefore, most performance data, including bench testing, animal testing, and biocompatibility testing, were referenced from the predicate device's filing.
However, there is an additional indication for PuraStat: "primary non-variceal gastrointestinal (GI) bleeding." To address this new indication, the submission references a clinical study found in the literature. This study evaluates the safety and effectiveness of PuraStat for this specific use, which can be interpreted as demonstrating the device's acceptable performance for this particular indication.
Based on the provided text, here's a breakdown of the requested information, focusing on the Branchi et al. Study which supports the additional indication:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it defines primary and secondary endpoints for the clinical study, and the reported results of these endpoints demonstrate the device's performance that was deemed acceptable by the FDA for the new indication.
| Acceptance Criteria (Study Endpoints) | Reported Device Performance (PuraStat) |
|---|---|
| Primary Endpoint: Achievement of hemostasis during the procedure (procedure success) | 94% of patients (74/79, 95% CI 88-99%) when used as primary application. |
| 75% of patients (24/32, 95% CI 59-91%) when used as secondary hemostatic product. | |
| Secondary Endpoint: Prevention of rebleeding (therapy success) at 3 days | 91% after primary use. |
| 87% in all study patients. | |
| Secondary Endpoint: Prevention of rebleeding (therapy success) at 7 days | 87% after primary use. |
| 81% in all study patients. | |
| Secondary Endpoint: Rebleeding rate at 30-day follow-up | 16% (18/111) overall. |
| 12% at 7 days and 16% at 30 days in the whole patient collective (specifically for patients with active oozing bleeding, where literature reports up to 50%). | |
| Risk and side effect profiles | No adverse events due to application of PuraStat or technical failures were reported. |
2. Sample size used for the test set and the data provenance
- Sample Size: 111 patients with gastrointestinal bleeding.
- Data Provenance: Retrospective and prospective. The study was a "prospective, consecutive open-label, multi-center study" conducted between July 2017 and December 2018 at 15 endoscopy departments in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number or qualifications of experts establishing ground truth within the Branchi et al. Study. The study design indicates a multi-center observational study, suggesting that treating physicians at each of the 15 endoscopy departments made the assessments of hemostasis and rebleeding. These would presumably be "experts" in gastrointestinal endoscopy, but no specific qualification (e.g., "radiologist with 10 years of experience") or number is detailed.
4. Adjudication method for the test set
The document does not specify an adjudication method (like 2+1, 3+1). The nature of the study (observational, multi-center) suggests that assessments were likely made by the treating clinicians at each site. There is no mention of independent adjudication of outcomes.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a hemostatic device, not an AI-driven diagnostic or assistive technology for human readers. Therefore, the concept of improving human readers with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, PuraStat is a physical hemostatic gel, not an algorithm. Its performance is always in a "human-in-the-loop" scenario, as it is applied by an endoscopist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the Branchi et al. Study was based on clinical outcomes and expert observation during and after endoscopic procedures:
- Procedure success (hemostasis): Assessed by the endoscopist during the procedure.
- Therapy success (prevention of rebleeding): Defined by the absence of clinical signs of gastrointestinal bleeding (hematemesis, melena, hematochezia) in association with cardiovascular stability or a stable hemoglobin level, assessed at 3 and 7 days after application.
- Adverse events: Recorded over 30 days post-procedure.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning. The Branchi et al. Study is a clinical trial evaluating the device's performance, not training an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this device.
§ 878.4456 Hemostatic device for intraluminal gastrointestinal use.
(a)
Identification. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must be demonstrated to be biocompatible.
(2) Performance data must support the sterility and pyrogenicity of the device.
(3) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(4) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The testing must evaluate the following:
(i) The ability to deliver the hemostatic material to the bleeding site;
(ii) The ability to achieve hemostasis in a clinically relevant model of gastrointestinal bleeding; and
(iii) Safety endpoints, including thromboembolic events, local and systemic toxicity, tissue trauma, gastrointestinal tract obstruction, and bowel distension and perforation.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be evaluated:
(i) Materials characterization of all components must demonstrate the device meets established specifications, which must include compositional identity and purity, characterization of impurities, physical characteristics, and reactivity with fluids.
(ii) Performance testing must demonstrate the mechanical integrity and functionality of the system used to deliver the device and demonstrate the device meets established specifications, including output pressure for propellant-based systems.
(6) Labeling must include:
(i) Information identifying and explaining how to use the device and its components; and
(ii) A shelf life.