FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Hemospray® Endoscopic Hemostat is a prescription use device consisting of a hemostatic agent and a delivery system. The hemostatic agent is (b) (4) | bentonite powder, a naturallysourced aluminum phyllosilicate clay. The delivery system is an endoscopic accessory used for spraying the powder onto the bleeding surface. The delivery device consists of a 220cm polyethylene application catheter, a handle with a pressurized CO2 cartridge, and a powder chamber containing approximately 20g of the Hemospray® material is propelled through the application catheter by release of CO2 from the cartridge located in the device handle. A trigger valve with an activation button allows the physician to control the amount of powder delivered to the affected area. Each actuation of Hemospray® delivers of CO2 and (b) gram of (b) (4) bentonite. Use of the complete 20-gram canister can produce a volume increase within the lumen of the bowel of 3 liters. In the presence of blood, the (b) (4) bentonite may swell 10-15% in volume.

The delivery system is offered in two configurations (i.e., two different outer diameters of the powder delivery catheter). The HEMO-7 version is used with a 2.8mm endoscope accessory channel, and the HEMO-10 version is used in a 3.7mm endoscope accessory channel.

AI/ML Overview

The Hemospray® Endoscopic Hemostat is designed for hemostasis of non-variceal gastrointestinal bleeding. The acceptance criteria for the device are derived from a combination of non-clinical, animal, and clinical studies, as well as literature reviews and post-market data. The studies aim to demonstrate the device's biocompatibility, sterility, shelf life, and its ability to achieve acute hemostasis while minimizing risks such as re-bleeding, perforation, and other adverse events.

Here's a breakdown of the acceptance criteria and the studies proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance (with supporting study reference)
Biocompatibility	Device materials (powder and catheter) must be non-cytotoxic, non-sensitizing, non-irritant, non-pyrogenic, non-hemolytic, and demonstrate no acute systemic toxicity, genotoxicity risks mitigated, and no local or systemic subchronic toxicity.	Hemospray® Powder: Non-cytotoxic, Non-sensitizer, Non-irritant, No acute systemic toxicity, Non-pyrogenic, Non-hemolytic, Genotoxicity risks mitigated, No local or systemic toxicity (Table 1, GLP Porcine Study Table 6).
Delivery Catheter: Non-cytotoxic, Non-sensitizer, Non-irritant (Table 2).
Shelf Life/Sterility	Sterilization validation (gamma irradiation), packaging validation (visual inspection, dye leak, burst testing), and device stability (visual inspection, functional testing) must pass.	All sterilization, packaging, and shelf life tests passed (Table 3).
MR Compatibility	Safety and compatibility in the MR environment must be evaluated for heating, migration, or image artifact.	"Hemospray® has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment." The safety is unknown, and the labeling includes a warning (page 4).
Performance - Bench	Output pressure below specified threshold to mitigate bloodstream entry risk, user can functionally set up and operate the device, handle does not rupture at working pressures, acceptable torque for detach/reattach and force for button press, consistent powder delivery without clogging/intermittence, and cartridge integrity after simulated shipping. Must show no significant pathological alterations or mucosal penetration in ex vivo tissue.	Output pressure: Passed. Functional testing: Passed. Rupture testing: Passed. Human Factors testing: Passed. Powder density: Passed. Cartridge integrity: Passed. Ex vivo tissue trauma: No significant pathological alterations; no mucosal penetration (Table 4).
Materials Characterization	Compositional identity and purity, water absorption, moisture content, bioavailable lead/arsenic levels within safe limits, and consistent particle size distribution for each lot.	Compositional identity and purity established (lot-to-lot acceptance criteria set). Free Swell Test and Moisture Content: Passed. Extraction in simulated gastric fluid for lead and arsenic: Passed. Particle Size Characterization: Results demonstrate consistent distribution (Table 5).
Performance - Animal	Assess hemostatic ability (effectiveness) and safety (gross and histologic assessment of regional and systemic effects, powder/treatment) in a clinically relevant animal model, including thromboembolic events, local/systemic toxicity, tissue trauma, GI tract obstruction, and bowel distension/perforation.	Acute hemostasis achieved in 6/6 treated animals. One control and two treatment animals had re-bleeding 8-10 days later. Histopathological evaluation showed no important differences between groups. No Hemospray® powder observed in local/regional tissue or lymph nodes, nor embedded in tissue layers (Table 6). The study stated it does not demonstrate safety/effectiveness in large area low-pressure bleeding or assess delayed re-bleeding.
Clinical Effectiveness	Achieve acute hemostasis in non-variceal GI bleeding (upper and lower), with acceptable rates of re-bleeding, adverse events, and mortality compared to standard of care.	Pilot Study: Acute hemostasis 95% (19/20 patients). Sustained hemostasis 89.5% (17/19). No treatment-related SAEs.
SEAL: Acute hemostasis 100% (89/89).
HALT: Initial hemostasis 96.8% (61/63), Successful hemostasis with Hemospray® alone 88.9% (56/63). Persistent bleeding 11.1%. Early recurrent bleed 7.1%.
APPROACH: Initial hemostasis 100% (50/50). Successful hemostasis with Hemospray® 98% (49/50).
Literature Review: Overall hemostasis 96% (509/532), Endoscopic hemostasis 97% (518/532). (Summarized in Table 25, Clinical Data).
Clinical Safety	Low incidence of device-related serious adverse events (SAEs), including perforation, bowel obstruction, aspirations, and device malfunction. Acceptable 30-day mortality.	Pilot Study: No treatment-related or procedure-related SAEs. No bowel obstruction.
SEAL: No unanticipated or serious adverse events attributed to Hemospray®.
HALT: Device-related SAEs 0% (0/63). 1 intra-operative perforation reported (patient died).
APPROACH: Hemospray® related adverse events 0% (0/50). No device-related adverse events.
Literature Review: 4 potential device-related adverse events (0.8%) (2 perforations, 2 aspiration pneumonias).
Complaint Data: 4 deaths (2 comorbidities, 1 perforation/sepsis, 1 device malfunction). Labeling and design changes implemented to mitigate risks. (Summarized in Table 25 and Table 26).

2. Sample Sizes and Data Provenance

Test Set (Clinical Data):
- Pilot Study: 20 patients. Hong Kong, China. Prospective.
- SEAL Registry: 89 evaluable patients (N=92 enrolled, 3 excluded). Canada, Denmark, England, France, Germany, Italy, Holland. Post-market, observational survey.
- HALT Study: 64 enrolled patients (interim report). EU and Canada. Post-market, single-arm study.
- APPROACH Study: 50 enrolled patients. Canada. Post-market, single-arm, prospective observational cohort study.
- Literature Review: 30 relevant studies, comprising 522 patients. Geographically diverse (Europe, Asia, Canada). Retrospective and prospective studies, case series, case reports, and registry-derived studies.
- Emergency Use: 5 critically ill patients. United States. Pre-market.
- Total Clinical Data (overall summary): 750 patients.
Training Set: Not explicitly stated for specific clinical studies, as many were observational or post-market with concurrent data collection. For the algorithm (if applicable, which is not the primary focus for a physical device in this context), this information would be separate. For the manufacturing/design aspects, non-clinical and bench testing would conceptually be "training data" for product development cycles.
- Biocompatibility: GLP porcine gastric bleeding animal study (subchronic toxicity and implantation).
- Performance - Animal: 6 Hemospray® treated animals, 3 sham control (total N=9). Porcine gastric bleeding model.

3. Number of Experts to Establish Ground Truth for Test Set & Qualifications

For the clinical studies (Pilot, HALT, APPROACH), the ground truth for outcomes like hemostasis, re-bleeding, and adverse events was established by treating physicians (endoscopists/gastroenterologists) at the respective clinical sites. The text doesn't specify the exact number or years of experience for individual experts, but it implies qualified medical professionals for each study. For example, the HALT study had 10 enrollment sites, meaning at least 10 primary investigators or teams. The APPROACH study had 4 clinical sites.
The SEAL Registry explicitly states that "all physician participants were trained on the use of the Hemospray® kit by Wilson-Cook Medical, Inc. personnel." This implies a level of qualification and standardized training for those assessing outcomes.
The overall literature review compiled data reported by clinician-authors in their respective publications.

4. Adjudication Method for the Test Set

The document does not explicitly detail a centralized adjudication method (e.g., 2+1, 3+1 structure with an independent committee) for the clinical studies. For single-center or multi-center, physician-reported outcomes, the assessment of hemostasis, re-bleeding, and adverse events would typically be performed by the local site investigators guided by the study protocol definitions.
For the SEAL Registry, "No queries or audits to identify and correct missing data were performed," indicating a lack of formal adjudication beyond initial reporting.
The HALT study mentions endoscopically-confirmed recurrent bleeds, suggesting a visual assessment by the clinician performing the endoscopy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies presented are primarily single-arm studies evaluating the performance of Hemospray® alone or in conjunction with other standard therapies.
The document does compare Hemospray® results to "Standard of Care per ASGE" in Table 20 (APPROACH study results) and generally discusses how Hemospray® "rivaled standard of care (SOC) with 63% initial hemostasis and 38% re-bleed rate" for patients on antithrombotic therapy. However, these are comparisons to historical or published SOC rates, not from a direct head-to-head MRMC study.
No effect size of human readers improving with AI vs. without AI assistance is provided, as this is a physical medical device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable as the Hemospray® Endoscopic Hemostat is a physical medical device. Performance is inherently tied to its application by a human operator (physician) in a clinical setting.

7. Type of Ground Truth Used

Clinical Studies (Pilot, HALT, APPROACH, Emergency Use): Clinician assessment and observation (endoscopic visualization) of bleeding cessation, re-bleeding, and adverse events, as defined by study protocols. Outcomes data (e.g., mortality).
Animal Study: Gross and histologic assessment of regional and systemic effects by veterinary pathologists/researchers.
Bench Studies: Objective measurements against predefined engineering specifications (e.g., pressure, density, functional checks).
Biocompatibility: Laboratory testing results based on ISO and ASTM standards.
Literature Review: Aggregated clinical outcomes reported in peer-reviewed publications.

8. Sample Size for the Training Set

Animal Study: 6 Hemospray® treated animals, 3 sham control (total N=9). While not a "training set" in the machine learning sense, this GLP porcine study served as crucial in vivo data for validating effectiveness and safety prior to widespread human use.
Biocompatibility: Various numbers for different tests (e.g., guinea pigs for sensitization, rabbits for pyrogenicity, cell lines for cytotoxicity). The "subchronic toxicity and implantation" was evaluated in the porcine animal study.
Non-clinical/Bench Studies: Performed on device prototypes and finished devices; specific sample sizes for each bench test are not always detailed but are implicit in the "Passed" results.
First-in-Human Pilot Study (20 patients): Could be considered early "training" or "feasibility" data for refining clinical protocols and understanding human safety.

9. How the Ground Truth for the Training Set was Established

Animal Study (Porcine Model): Ground truth for hemostasis was established by direct observation during the procedure and confirmed by follow-up. Safety endpoints (gross and histologic assessment of regional and systemic effects) were established by detailed pathological examination of tissues collected at termination by trained veterinary pathologists.
Biocompatibility Testing: Ground truth established according to standardized international (ISO, ASTM) and national (USP) testing protocols, which define specific biological responses (e.g., non-cytotoxic, non-irritant) under controlled laboratory conditions.
Bench Testing: Ground truth established through engineering specifications and predefined pass/fail criteria for physical and functional parameters of the device and its components, measured using calibrated equipment.

Summary

Regulation Number and Section

§ 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.