(686 days)
EndoClot® PHS is used for hemostasis of nonvariceal gastrointestinal bleeding, excluding Forrest Ia classification of bleeding.
EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS) is a sterilized single use medical device that is composed of Absorbable Modified Polymer (AMP®) particles in a PE bellow and an EndoClot® Applicator (K162197). The device contains no human or animal components. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch.
The provided text describes the 510(k) premarket notification for the EndoClot® Polysaccharide Hemostatic System (EndoClot® PHS), seeking substantial equivalence to predicate devices, primarily Hemospray®. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) study. The performance data presented are for the medical device itself, demonstrating its physical and biological equivalence to the predicate, rather than the performance of an algorithm or human readers.
Therefore, many of the requested criteria related to AI/ML device performance, expert ground truth establishment, adjudication methods, and MRMC studies, cannot be extracted from this document.
However, I can provide information based on the device's performance tests and studies, framed as acceptance criteria and proof of meeting them:
Acceptance Criteria and Device Performance for EndoClot® PHS
The EndoClot® PHS is a medical device intended for hemostasis of nonvariceal gastrointestinal bleeding. The studies presented aim to demonstrate that the proposed device is substantially equivalent to its predicate devices (Hemospray® and EndoClot® Applicator) by meeting specific performance, biocompatibility, and safety criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the properties of EndoClot® PHS were evaluated and compared to the predicate device Hemospray®. The acceptance criteria were implicitly set as being "similar to or better than" the predicate device.
| Acceptance Criteria Category | Specific Metric/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Performance | Pressure of Gas Source | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate |
| Spray Pattern | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate | |
| Delay Time | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate | |
| Powder Feeding Rate | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate | |
| Water Absorbency | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate | |
| pH | Similar to or better than predicate (Hemospray®) | Similar to or better than predicate | |
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Systemic Toxicity, Genotoxicity, Hemocompatibility, Endotoxins | In accordance with FDA guidance and recognized international standards (e.g., ISO10993) to demonstrate safety | All tests indicated substantial equivalence to the predicate |
| Chemical Characterization | (Specific parameters not detailed) | In accordance with FDA guidance and recognized international standards (e.g., ISO10993) to demonstrate safety | Met standards, indicating substantial equivalence to the predicate |
| Sterility | (Specific parameters not detailed) | In accordance with recognized international standards (e.g., ISO11737-2) | Met standards, indicating substantial equivalence to the predicate |
| In Vivo Animal Study | Efficacy and Safety in Swine Model for GI Bleeding Control | Demonstrate efficacy and safety comparable to predicate (Hemospray®) in a swine model | Results demonstrated substantial equivalence to the predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the performance tests (e.g., number of units tested for spray pattern, pressure). For the in vivo animal study, it specifies a "swine model" but does not give the number of animals used. The provenance of the data is from testing conducted by the manufacturer (EndoClot Plus Co., Ltd. and their correspondent Med-wheat Shanghai) to support their 510(k) submission. The type of study is prospective testing of the device's physical, chemical, biological, and functional properties. The country of origin for the submitter is China (Shanghai).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of device and studies described. The "ground truth" here is objective physical, chemical, and biological measurements, and observed hemostatic performance in an animal model, rather than expert interpretation of medical images or patient outcomes for an AI algorithm.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are device performance tests and animal studies, not interpretative studies requiring human expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. This type of study is relevant for AI/ML diagnostic or interpretative devices where human performance with and without AI assistance is evaluated. The EndoClot® PHS is a medical device for direct therapeutic intervention, not an AI/ML algorithm.
6. Standalone (Algorithm Only) Performance
This is not applicable as the device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" used for this device evaluation consisted of:
- Objective physical measurements: For parameters like gas source pressure, spray pattern, delay time, powder feeding rate, water absorbency, and pH.
- Adherence to standardized biological safety tests: Biocompatibility, sterility, and chemical characterization tests following ISO and FDA guidelines.
- Observed physiological outcomes: In the in vivo swine model, the ability of the device to achieve hemostasis when applied to gastrointestinal bleeding. This can be considered a form of "outcomes data" in an animal model.
- Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is the demonstration that the proposed device performs "similar to or better than" the legally marketed predicate device.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as it refers to an AI/ML context that is not relevant to 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.