(58 days)
The COOK Hemospray device is intended for hemostasis of non-variceal bleeds in the GI (gastrointestinal) tract. It is for prescription use only.
Hemospray is an inert, bentonite powder developed for endoscopic hemostasis. The powder is delivered by use of a carbon dioxide powered delivery system and through a catheter inserted through the working channel of an endoscope which provides access to the bleed. Each device contains approximately 20g of powder.
This document is a 510(k) Premarket Notification for a medical device called the Hemospray Endoscopic Hemostat. The submission primarily addresses a minor design change to an existing predicate device to correct a failure mode related to the activation knob. Because the changes are focused on a revised manufacturing process and an improved safety feature (the activation knob's tensile strength) rather than a change in the therapeutic mechanism or intended use, many of the typical acceptance criteria for AI/ML-based devices, such as those related to diagnostic performance or multi-reader studies, are not applicable here.
Therefore, I cannot populate the table and sections as requested for an AI/ML device's acceptance criteria and study proving performance. This document concerns a physical medical device and primarily focuses on mechanical performance and safety, not on the performance of a software algorithm.
However, I can extract information related to the device's functional acceptance criteria as demonstrated through bench testing for the design modification.
Here's how I can interpret and present the available information in the context of your request, focusing on the specific modification made to the physical device:
1. A table of acceptance criteria and the reported device performance
Note: The acceptance criteria and performance data provided relate to the mechanical integrity of the modified activation knob, not to an AI/ML algorithm's diagnostic or therapeutic performance.
| Acceptance Criteria (for the modified activation knob) | Reported Device Performance |
|---|---|
| Tensile strength of the red activation knob > Established Design Specification | All tested samples had tensile strength greater than the established design specification. |
| Functionality as intended (post-modification) | Bench testing demonstrated the subject device met the established performance requirement to fulfill the intended use, and performs as intended. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of units, but "All tested samples" implies a complete test of the sample set prepared.
- Data Provenance: The testing was "bench testing" conducted by the manufacturer, Wilson-Cook Medical, Inc., located in Winston-Salem, North Carolina. This is prospective testing performed for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This study is not evaluating a diagnostic or AI/ML device requiring clinical expert ground truth for image interpretation or diagnosis. It focuses on the mechanical performance of a device component. The "ground truth" for the new design specification was established based on a human factors study evaluating the maximum force a user could apply.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described, as the evaluation is based on objective physical measurements (tensile strength) against a defined design specification, rather than subjective interpretations.
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
- Not applicable. This study is not an MRMC study and does not involve AI assistance. It evaluates a mechanical design change to a physical hemostatic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This study does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the new tensile strength design specification was established based on a human factors study that evaluated the maximum force a user could apply to the red activation knob during use. The success of the device was then determined by objective mechanical testing to confirm that the component met this established design specification.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; therefore, there is no "training set." The human factors study provided data to establish the design specification.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML algorithm. The design specification (which could be considered a form of "ground truth" for the mechanical test) was established through a "human factors study that evaluated the maximum force a user could apply to the red activation knob during use."
§ 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.