(250 days)
Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.
The provided document is a 510(k) summary for a medical device called "Multi-Band Ligator." It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices.
Here's an analysis of the acceptance criteria and the study information as requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for each test. Instead, it describes the purpose or goal of each test and then generally states that the device "meets the related requirements" or "complied with the Indication for Use."
| Acceptance Criteria (Implied from Description) | Reported Device Performance |
|---|---|
| Device integrity, cleanliness, and hygiene (Appearance) | Confirmed as integrity, cleanliness, and hygiene. |
| Device functions comply with Indication for Use (Functional performance) | Confirmed to comply with the Indication for Use. |
| pH, Total heavy metals, Potassium permanganate reductive substance, Evaporative residues, Ultraviolet Absorbance meet related requirements (Chemical properties) | Confirmed to meet related requirements. |
| Loop Hardness, Tensile strength, Tensile elongation, Tensile deformation meet technical requirements (Mechanical performance of the Loop) | Confirmed to meet the company's technical requirements. |
| Trigger cord Tensile strength (Tensile strength) | Confirmed. |
| Irrigation adapter connection firmness, Inner surface, and Luer connector (Physical properties of Irrigation adapter) | Conformed. |
| Barrel tightness; no leakage (Leakage of the barrel) | Confirmed no leakage. |
| Shelf life of 2 years | Successfully tested according to ASTM F 1980-16 for 2 years. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneously irritation per ISO 10993) | Test results verify biocompatibility criteria fulfilled. |
| Functional performance compared to predicate device | Performance comparison testing conducted; subject device found to have substantially equivalent functional performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for any of the bench tests (e.g., how many units were tested for appearance, functional performance, chemical properties, etc.).
The data provenance is from China, as the submitter, Beijing ZKSK Technology Co., Ltd., is located in Beijing, China, and the designated submission correspondent is in Shanghai, China. The testing described is prospective in nature, as it involves testing new units of the device against predefined requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the document describes bench testing for a mechanical device, not an AI/imaging device where expert ground truth establishment for a test set would be relevant. The "ground truth" for these tests comes from engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not the type of testing described here. The testing involves objective measurements and compliance with engineering specifications.
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, an MRMC comparative effectiveness study was not done. This device is a mechanical multi-band ligator and not an AI-assisted diagnostic tool or an imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not done. This is a mechanical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the bench tests described is based on:
- Engineering specifications and design requirements: For functional and mechanical performance, appearance, and physical properties.
- International standards: Such as ASTM F 1980-16 for shelf life and ISO 10993 for biocompatibility.
- Company's technical requirements: For specific mechanical properties of the loop.
8. The sample size for the training set
This is not applicable. The document describes a medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.