(11 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 natural rubber latex ligating bands. The ligating unit is attached to the handle by the activating cable sheath. The bands are 1.9 mm thick with a 5.1 mm outer diameter and a 2.0 mm inner diameter. Three endoscope adapters and a centering sleeve are provided to allow the ligating unit to fit securely on endoscopes ranging from 8.5 mm to 10.8 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. No adapter is required for 10.8 to 11.5 mm scopes. A scope gauge is included to determine the required adapter for the endoscope.
Here's an analysis of the provided text regarding the Bard® UltraView™ Multiple Band Ligator:
This document, K022434, describes a 510(k) premarket notification for a medical device. The 510(k) process is typically used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to establish strict acceptance criteria based on novel performance metrics. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one might expect for a new, groundbreaking technology with quantitative performance targets is not directly applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices through comparative performance data and other characteristics.
Therefore, many of the requested points below will reflect this aspect of substantial equivalence rather than a new device's performance against predefined quantitative benchmarks.
1. A table of acceptance criteria and the reported device performance
As mentioned, there aren't explicit quantitative "acceptance criteria" presented in the document in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various tests.
| Acceptance Criteria (Implied for Substantial Equivalence via Predicate Comparison) | Reported Device Performance (Summary from K022434) |
|---|---|
| Biocompatibility | Biocompatibility tests were completed that demonstrate the device is safe for its intended use and patient population. (Implied acceptance: device is biocompatible and safe.) |
| Functionality | Functionality testing demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: device performs its intended mechanical actions comparably to predicates.) |
| Tensile Strength (Bands) | Tensile testing demonstrated that the Bard® UltraView™ (likely its bands) is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: bands have comparable mechanical integrity to predicates, preventing premature breakage or failure.) |
| Endoscope Aspiration and Retention | Comparative endoscope aspiration and retention testing demonstrated that the Bard® UltraView™ is substantially equivalent to the Wilson-Cook® Ten Shot Multi-Band Ligator and the Bard® Steigmann-Goff™ Ligator. (Implied acceptance: device maintains secure fit on endoscope and allows for comparable aspiration/suction capabilities during use as predicates, crucial for proper ligation.) |
| Material Composition | The proposed Bard UltraView ligator is comprised of similar medical grade plastics, stainless steels and uses the same band material as the predicates. (Implied acceptance: materials are known and accepted for medical use in similar devices.) |
| Intended Use | Used for endoscopic ligation of esophageal varices, same as predicate devices. (Implied acceptance: device serves the same clinical purpose as existing devices.) |
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 sample sizes for any of the testing mentioned (biocompatibility, functionality, tensile, aspiration/retention). It simply states that these tests were completed.
The data provenance (country of origin, retrospective/prospective) is also not specified in this summary. These details would typically be found in more detailed test reports or study protocols, not usually in the 510(k) summary itself. The submitting company is Bard Endoscopic Technologies, C.R. Bard, Inc., based in the USA, but the contact person is from N.V. KEMA in The Netherlands, suggesting potential international collaboration or testing.
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 type of information is not relevant to this device's submission. The device is a mechanical ligator, not an AI or diagnostic imaging device that requires expert ground truth labeling of images or data. The "ground truth" for this device's performance would be the direct results of the physical and functional tests, compared against the performance of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not the primary focus here.
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 device is a surgical tool, not an imaging or diagnostic aid, and therefore MRMC studies are not relevant. Its effectiveness is based on its mechanical function and ability to perform ligation, not on improving human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical, human-operated medical device. There is no "algorithm only" performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like this, the "ground truth" or standard for comparison is embedded in the predicate devices themselves and the established understanding of their functional performance.
- Functionality: The "ground truth" for functionality is the successful and consistent operation of the predicate devices in performing ligation, aspiration, and band deployment. The new device is tested to perform these actions similarly.
- Tensile Strength: The "ground truth" is the established tensile strength properties of the bands used in the predicate devices, or industry standards for such materials in this application.
- Biocompatibility: The "ground truth" is adherence to established international standards for biocompatibility (e.g., ISO 10993 series) and no adverse biological reactions.
- Aspiration/Retention: The "ground truth" performance of aspiration and retention would be benchmarked against the known performance of the predicate devices on endoscopes.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have "training sets."
9. How the ground truth for the training set was established
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.