(23 days)
The TRUEtome™ Sphincterotome devices are indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome can also be used to cannulate and inject contrast medium.
TRUEtome™ Sphincterotome when connected to a monopolar current may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The TRUEtome™ Sphincterotome is a 200 cm, triple lumen sphincterotome that tapers from 7 Fr (2.3 mm) to 5.5 Fr (1.8 mm) with an atraumatic tip. The catheter is capable of accepting a 0.035 in (0.89 mm) Boston Scientific Guidewire and a 0.025 in (0.64 mm) Boston Scientific Guidewire, while injecting and/or cutting using other lumens. The sphincterotome may be placed with or without the aid of a guidewire. When connected to a monopolar current, the sphincterotome may be used to incise the Papilla of Vater and/or the Sphincter of Oddi. The sphincterotome is designed for use with endoscopes that have a working channel of 2.8 mm and larger.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TRUEtome™ Sphincterotome:
It's important to note that this document is a 510(k) summary, which is a premarket notification for a medical device. For devices seeking substantial equivalence to a predicate device, the regulatory focus is often on demonstrating that the new device is as safe and effective as the legally marketed predicate, rather than proving efficacy from scratch with extensive clinical trials. Therefore, the "study" described here is primarily a set of performance tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Specification | Reported Device Performance | Study Type |
|---|---|---|
| Cytotoxicity (Biocompatibility) | Met required specifications | In-vitro |
| Intracutaneous Reactivity (Irritation) (Biocompatibility) | Met required specifications | In-vitro |
| Sensitization (Biocompatibility) | Met required specifications | In-vitro |
| USP Physiochemical tests (Biocompatibility) | Met required specifications | In-vitro |
| EO residual testing | Met required specifications | In-vitro |
| Initial Tip Orientation | Met required specifications | In-vitro |
| Tip Bowing | Met required specifications | In-vitro |
| Tip Bow Holding | Met required specifications | In-vitro |
| Tip Rotation | Met required specifications | In-vitro |
| Guidewire Passage/Compatibility | Met required specifications | In-vitro |
| System Leakage | Met required specifications | In-vitro |
| Tip OD | Met required specifications | In-vitro |
| Luer to Extrusion Integrity | Met required specifications | In-vitro |
| Electrical safety (IEC 60601-1:1988 A1:1991 A2:1995) | Confirmed (met standard) | In-vitro |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each in-vitro test. It mentions that "all components, subassemblies, and/or full devices" were tested.
The data provenance is in-vitro (laboratory) testing. There is no mention of human subject data, animal data, or data from specific countries of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for these engineering and biocompatibility tests is based on established scientific principles, industry standards (e.g., AAMI/ANSI/ISO 10993-1, IEC 60601-1), and the manufacturer's internal specifications, not expert interpretation of complex clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" for these performance tests is based on objective measurements against predefined specifications, not on expert adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This 510(k) submission focuses on demonstrating substantial equivalence through non-clinical performance data (in-vitro testing) and comparison of technological characteristics to predicate devices. It does not involve human readers evaluating images or clinical outcomes that would necessitate an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This device is a medical instrument (sphincterotome), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not relevant here.
7. The Type of Ground Truth Used
The ground truth used for the performance tests is based on:
- Industry Standards: Such as AAMI/ANSVISO 10993-1, AAMI/ANSI/ISO 10993-7, and IEC 60601-1.
- Manufacturer's Required Specifications: Internal design and performance specifications for the device and its components.
- Engineering Principles: Applied to evaluate physical properties, electrical safety, and functional parameters.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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).