(30 days)
The Bard® UltraView™ Multiple Band Ligator is used for endoscopic ligation of esophageal varices.
The Bard® UltraView™ Multiple Band Ligator is comprised of a ligating unit that fits over the distal end of an endoscope with seven premounted rubber latex ligating bands. The ligating unit is attached to the handle by the activating sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm diameter. Four endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 11.5 mm. The small adapter fits 8.5 to 9.3 mm scopes. The medium adapter fits 9.3 to 10.2 mm scopes. The large adapter fits 10.2 to 10.8 mm scopes. The X-large adapter fits 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope. The modified design differs from the predicate device in that the ligating tip has been modified to improve the sealing integrity of the lip seal during aspiration and to improve the smooth actuation of the Band Driver over the Band Carrier by the addition of 12 ribs to the Band Driver. The sheath attaches to the handle assembly, which can be held in the physician's hand or attached to the endoscope sheath outside of the patient. The bands are deployed by depressing the thumb paddle on the handle assembly causing the bands to be pushed/deployed off of the band carrier. The modified device mounts flush with the tip of the endoscope, as does the predicate device, to allow maximum visualization. The modified and current device tips extend beyond the distal tip of the endoscope allowing variceal tissue to be suctioned into the band carrier cylinder for ligation.
The provided text describes modifications to an existing medical device, the Bard® UltraView™ Multiple Band Ligator, and demonstrates its substantial equivalence to the predicate device. This is a 510(k) premarket notification, which typically focuses on demonstrating equivalence rather than establishing new performance criteria for a novel device.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense as might be seen for a new device's efficacy study. Instead, the performance data focuses on demonstrating that the modified device is substantially equivalent to the predicate device and remains safe and effective for its intended use.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: No adverse tissue reactions from patient-contacting components. | Cytotoxicity testing of the colored scope adaptors (the only newly patient-contacting components) showed no evidence of toxicity. All other material changes were to non-patient-contacting components. |
| Functionality: The device operates as intended for ligation. | Functionality testing demonstrated that the modified Bard® UltraView™ Multiple-Band Ligator is substantially equivalent to the current Bard® UltraView™ Multiple-Band Ligator. The modified design specifically aimed to "improve the sealing integrity of the lip seal during aspiration and to improve the smooth actuation of the Band Driver over the Band Carrier." The device mounts flush and allows variceal tissue to be suctioned for ligation, similar to the predicate. |
| Tensile Strength: The bands and components maintain integrity under expected forces. | Tensile testing demonstrated that the modified Bard® UltraView™ Multiple-Band Ligator is substantially equivalent to the current Bard® UltraView™ Multiple-Band Ligator. |
| Aspiration Performance: The device can effectively aspirate tissue for ligation. | Aspiration testing demonstrated that the modified Bard® UltraView™ Multiple-Band Ligator is substantially equivalent to the current Bard® UltraView™ Multiple-Band Ligator. |
| Safety and Effectiveness: The device is safe and effective for its intended use and patient population. | Based on the biocompatibility and engineering performance tests (functionality, tensile, aspiration), the manufacturer concluded that the device is safe for its intended use and patient population and is substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on sample sizes for the functionality, tensile, aspiration, or cytotoxicity tests. These are typically engineering and laboratory tests, not clinical studies with patient populations. The data provenance (country of origin, retrospective/prospective) is not specified, but these would be internal validation tests conducted by the manufacturer.
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 information is not applicable to the type of testing described. The "tests" mentioned are engineering performance tests (e.g., tensile strength, aspiration efficacy, functionality) and biocompatibility tests (cytotoxicity), not tests requiring expert interpretation of diagnostic outcomes or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts assess and come to a consensus on "ground truth" for medical images or clinical outcomes. The tests described are laboratory and engineering performance tests.
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This document describes a traditional medical device (a ligator) and its modification, not an AI-powered diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied in diagnostic or AI studies is not directly relevant here. The "truth" for the performance claims is based on:
- Biocompatibility Standards: For cytotoxicity, adherence to established standards for determining toxicity.
- Engineering Specifications: For functionality, tensile strength, and aspiration, performance is measured against internal engineering specifications and, by extension, the characteristics of the predicate device to demonstrate "substantial equivalence." The "ground truth" is whether the device performs as specified and as comparably to the predicate as required for safety and effectiveness.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The development process for this type of device involves engineering design, prototyping, and testing to meet functional requirements.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set."
In summary: This 510(k) submission details modifications to an existing physical medical device and relies on engineering and laboratory performance testing (biocompatibility, functionality, tensile, aspiration) to demonstrate substantial equivalence to its predicate device. It does not involve AI, clinical efficacy studies with human subjects, or the establishment of "ground truth" in the diagnostic sense. The "acceptance criteria" are implied by the need to show that the modified device remains safe and effective and performs at least as well as the predicate, which was confirmed through these specific tests.
§ 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.