(162 days)
PuraStat-GI 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.
PuraStat-GI 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-GI 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-GI achieves hemostatic effects by forming a hydrogel matrix barrier that blocks the flow of blood at the site of application.
The provided text describes a 510(k) premarket notification for the device PuraStat-GI, a hemostatic device for intraluminal gastrointestinal use.
It details bench testing, animal studies, and clinical studies of the device. However, it does not explicitly state specific acceptance criteria (e.g., "The device must achieve hemostasis in X% of cases with Y% confidence interval"). Instead, it presents reported device performance and implies that these results demonstrate substantial equivalence to a predicate device, thereby meeting the FDA's requirements for market clearance.
Therefore, the response below will present the reported device performance from the provided text and note the absence of explicitly stated numerical acceptance criteria.
Acceptance Criteria and Study Details for PuraStat-GI
While the document does not explicitly list specific numerical "acceptance criteria" that the device must meet (e.g., "hemostasis rate must be >X%"), it presents the performance data of PuraStat-GI from three clinical studies, alongside a comparison to a predicate device in bench and animal testing, to demonstrate substantial equivalence. The implied acceptance is that the device's performance is comparable to or better than established benchmarks in terms of safety and effectiveness for its intended use.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
| Performance Metric | Implied Acceptance Criterion (Comparable to predicate/clinically acceptable) | Reported PuraStat-GI Performance (from Clinical Studies) |
|---|---|---|
| Hemostasis Rate | High rate of initial hemostasis for mild to moderate GI bleeding | Subramaniam (2019): 75% |
| de Nucci (2020): 90% | ||
| Subramaniam (2020): 92.6% | ||
| Delayed Bleed Rate | Low incidence of delayed bleeding post-endoscopic resection | Subramaniam (2019): 3% |
| Subramaniam (2020): 4.3% | ||
| Re-bleed Rate | Low incidence of re-bleeding post-acute GI bleeding | de Nucci (2020): 10% |
| Mortality | 0% or very low | All studies reported: 0% |
| Adverse Events | No adverse events related to device use | No adverse events related to PuraStat-GI in 223 patients |
Note: The acceptance criteria are "implied" based on the presentation of data to support device clearance, rather than explicit numerical targets defined in the document.
2. Sample Size Used for the Test Set and Data Provenance
The provided text details three clinical studies that serve as the "test set" for human performance data for PuraStat-GI:
- Subramaniam (2019): N=100 patients
- de Nucci (2020): N=77 patients
- Subramaniam (2020): N=46 patients
Total clinical patients: 223 patients.
Data Provenance: The document states these are "results of three clinical studies of the use of PuraStat® that have been reported in the literature." This indicates these were likely retrospective analyses of previously conducted and published clinical trials. The specific countries of origin for these studies are not specified in the provided document.
Additionally, a GLP gastrointestinal mucosal defect study was conducted in a porcine model with a comparative side-by-side assessment against the predicate device. The sample size for this animal study is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used to establish ground truth in the clinical studies, nor their specific qualifications. Typically, clinical study results (like hemostasis success, re-bleed rates, and adverse events) are determined by the treating physicians and study investigators, who are medical professionals specializing in endoscopy and gastroenterology, but their specific roles in "ground truth" establishment are not detailed here.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical studies presented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical studies presented solely evaluate the performance of PuraStat-GI itself. There is no mention of human readers (clinicians) assessing cases with and without AI assistance, as would be typical for an MRMC study comparing AI-assisted performance to human-only performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical studies presented, along with the animal and bench testing, represent "standalone" performance of the PuraStat-GI device. The device is a physical hemostatic agent, not an AI algorithm. Its performance metrics (hemostasis rate, re-bleed rate, etc.) are a direct measure of the device's efficacy without human-in-the-loop assistance in the sense of an AI diagnostic. The human "in the loop" delivers the device, but the device's hemostatic action is independent.
7. The Type of Ground Truth Used
The ground truth for the clinical studies appears to be based on clinical outcomes and physician assessment during and after endoscopic procedures. This includes:
- Observation of hemostasis during endoscopy.
- Follow-up for delayed bleeding or re-bleeding events.
- Reporting of adverse events.
For the animal study, the ground truth was also based on direct observation of hemostasis and re-bleeding rates in the porcine model.
8. The Sample Size for the Training Set
The document does not mention a training set for PuraStat-GI. PuraStat-GI is a medical device (hemostatic gel), not a machine learning or AI algorithm that typically requires a training set. The clinical studies, animal studies, and bench tests are for validation and performance assessment, not for training.
9. How the Ground Truth for the Training Set Was Established
As PuraStat-GI is not an AI algorithm, there is no "training set" in the conventional sense, and thus no ground truth was established for a training set. The development of the device itself would have involved extensive research and pre-clinical testing, but these are not referred to as a "training set" in the context of this document.
§ 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.