(84 days)
The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) is intended to be used for patients requiring transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
The bow string papillotome is one of the most commonly used E.R.C.P. (Endoscopic Retrograde Colangio-Pancreatography) devices and has been established in the industry for several years. It has evolved into several variations on one general theme, facilitating entrance into the biliary tree. It performs this by housing a stainless steel mono-filament or stranded wire that is to be the active wire when monopolar, surgical power is introduced into the device handle connection. A sheath runs the length of the wire and allows only that portion of the wire that is needed to cut be exposed and insulates the remainder from the patient. The bow geometry and wire tension aid in cutting the tissue at the precise location. The wire is attached to a handle, that when manipulated, allows the operator to apply tension forming a " bow" at the distal end.
The Ballard Medical Products® Faciletome™ Bow String Papillotome is placed under direct vision of a duodenscope, with or without fluoroscopic aid. The single lumen, double lumen and triple lumen designs have a variety of cutting wire lengths as well as a variety of precurved tip configurations in the precurved model type.
The provided text is a 510(k) Premarket Notification Summary Statement for the Ballard Medical Products® Faciletome™ Bow String Papillotome. It describes the device, its intended use, and its substantial equivalence to a predicate 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 present a table of acceptance criteria with reported device performance in the format of specific quantitative metrics for a clinical study. Instead, it lists non-clinical (in vitro) tests performed to demonstrate substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Non-Clinical Data) |
|---|---|
| Electrical safety: High Frequency Leakage Current | Test performed |
| Electrical safety: Capacitive Coupling between device and guidewire | Test performed |
| Electrical signal integrity: Verification of Frequency and Voltage | Test performed (800V p-p @ 1MHz) |
| Electrical safety: Dielectric Withstand Test | Test performed |
The conclusion states that based on indications for use, technological characteristics, and performance testing, the device is "safe and effective for its intended use" and "substantially equivalent" to the predicate device. This implies that the device met the acceptance criteria for these non-clinical tests.
2. Sample size used for the test set and the data provenance
The document refers to "in vitro tests" and does not describe a clinical test set involving human patients or data with specific provenance (e.g., country of origin). The testing was non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed were non-clinical (in vitro) and would not involve experts establishing ground truth in the context of clinical outcomes.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and non-clinical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (papillotome), not an AI algorithm. Its performance is inherent to its physical and electrical properties, and its use involves human application.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" was established by objective physical and electrical measurements against predefined engineering specifications or industry standards for similar devices. There was no clinical ground truth (e.g., pathology, outcomes data) used in this submission summarized in the provided text.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI or machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As noted above, there is no training set mentioned for this medical device.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).