(202 days)
The RapidFire Multiple Band Ligator is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
The Bard RapidFire Multiple Band Ligator is a device used for endoscopic ligation. It is attached to the endoscope prior to introduction into the esophagus or rectum. The firing system includes a spool with crank-trip wire filament. It contains either five or eight ligating bands per ligating unit.
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a modern regulatory submission would. Instead, this is a 510(k) summary from 1997, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria through a specific study design.
Here's why and what information can be extracted if we interpret "acceptance criteria" and "study" in the context of this 1997 510(k) process:
- Acceptance Criteria: In a 510(k) from this era, "acceptance criteria" for performance were often implicitly met by demonstrating that the new device was "substantially equivalent" to a legally marketed predicate device. This meant showing similar indications for use, fundamental technology, materials, and performance characteristics. The "performance" being evaluated was primarily its equivalence to already approved devices.
- Study Proving Acceptance: The "study" in this context is the comparison itself, highlighting similarities and differences, and relying on the established safety and effectiveness of the predicate devices. There isn't a standalone clinical trial or performance study with defined endpoints and statistical analysis described.
Given these limitations, here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for a modern device submission is absent:
Acceptance Criteria and Study to Prove Device Meets Criteria
No explicit acceptance criteria or a dedicated study with defined endpoints, sample sizes, and ground truth establishment, as would be expected in a modern performance study, are described in this 510(k) summary.
The document's purpose is to establish substantial equivalence to predicate devices. The "performance" discussed relates to design, materials, and functionality being "nearly identical" or "equivalent" to already approved devices.
If we interpret the comparison to predicate devices as the "study" and the demonstration of "equivalence" in design, materials, and intended use as meeting "acceptance criteria," then the following can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Similar Indications for Use | "The indications for use of the RapidFire™ Multiple Band Ligator are equivalent to both the Microvasive® Speedband™ Ligator and the Stiegmann-Goff™ Endoscopic Ligator." |
| Similar General Design | "The general design... of the RapidFire Multiple Band Ligator is equivalent to the Microvasive Speedband Ligator." |
| Similar Materials | "The materials used in the RapidFire Multiple Band Ligator and the Microvasive Speedband Ligator units are nearly identical and are all commonly used in the medical device industry..." |
| Similar Functionality | "The... functionality of the RapidFire Multiple Band Ligator is equivalent to the Microvasive Speedband Ligator." |
| Similar Firing System | "The firing system of the RapidFire Ligator and the Microvasive Speedband Ligator include a spool with crank-trip wire filament." |
| Similar Dimensions (Assemblies & Bands) | "The dimensions of the RapidFire Multiple Band Ligator assemblies and bands are nearly identical to the Microvasive Speedband Ligator..." |
| Biocompatibility | "biocompatibility testing will be completed to confirm that the different vendor materials used in the RapidFire Multiple Band Ligator are safe for limited and prolonged contact with mucosa and tissue." (Commitment to complete, not performance reported yet). |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not applicable. No test set (e.g., patient cases, specific measurements) for a performance study is described. The "sample" implicitly consists of the design specifications and components of the RapidFire Ligator being compared against those of the predicate devices.
- Data Provenance: Not applicable. No "data" in the sense of clinical or performance data is presented. The provenance is the design and manufacturing specifications of the Bard RapidFire Ligator and the two predicate devices (Microvasive® Speedband™ Multiple Band Ligator and Bard Stiegmann-Goff™ Endoscopic Ligator).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) summary. The "ground truth" for substantial equivalence is primarily based on the regulatory history and established performance of the predicate devices.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set or adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned or implied. The document focuses on device design and function comparison, not on improvements in human reader performance with or without AI assistance, as AI was not a component of this device.
6. Standalone (Algorithm Only) Performance Study
- No standalone performance study for an algorithm is described. This device is a physical medical instrument, not an AI or software algorithm.
7. Type of Ground Truth Used
- Inferred/Implicit Ground Truth: The "ground truth" relied upon is the established safety, effectiveness, and regulatory clearance of the predicate devices (Microvasive® Speedband™ Multiple Band Ligator and Bard Stiegmann-Goff™ Endoscopic Ligator). The substantial equivalence claim is built upon the premise that these predicates are safe and effective for their intended use.
8. Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above.
In summary: The provided 510(k) summary is typical for a device from 1997 seeking substantial equivalence. It highlights design and functional similarities to predicate devices as the basis for regulatory clearance, rather than presenting a detailed performance study against explicit acceptance criteria. Many of your questions are geared towards more modern regulatory submissions, especially those involving AI/ML components or complex clinical trials, which are not relevant to this historical document about a mechanical ligator.
§ 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.