(265 days)
The Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Spincter of Oddi. The device is supplied sterile and intended for single use only.
The Sphincterotome described in this submission is a sterile, single use device compatible with the working channel of endoscope. The device consists of a long plastic tube with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation.
For non-exchangeable models, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 2.8mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For normal exchangeable models, there is a small hole on the sheath which is about 200mm far away from the distal end, it is used to insert the guide wire rapidly, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For C-type exchangeable models, there is an open channel on the sheath to rapid exchange the guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the recommended guide wire OD is 0.63mm (0.025inch) or 0.89mm (0.035inch);
For 50910, 50913, 50916 and 50917 series, there's preloaded guide wire, the sphincterotome is compatible with endoscopes with a working channel diameter not less than 3.7mm, and the OD of preloaded guide wire is detailed in the device's label.
The provided text describes a 510(k) premarket notification for a medical device called "Sphincterotome." This submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data and does not include a study with explicit acceptance criteria and device performance results in the format requested.
Here's an analysis of what is available and what is missing, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria and corresponding reported device performance values. Instead, it states broadly that "The Sphincterotome meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."
The comparison tables (Table 5.6-1 and Table 5.6-2) highlight similarities and differences between the proposed device and predicate devices for various characteristics but do not present acceptance criteria or quantitative performance data. For example, under "Performance," it lists several performance aspects like "Injection performance, Compatibility with traction guide wire, Compatibility with endoscope, Ray detectability, Visibility under endoscopy, Electric performance, Operation flexibility, Connected firmly, Rotation performance, Force to Bow, Orientation of Cutting Wire and Visualization of Cutting Wire, Ink Validation; Cutting rate; Energy dose analyses;" and states "Unknown" for predicate device K013153 and provides a similar list for predicate K201121. For the proposed device, it states that "Bench test has been conducted to demonstrate substantial equivalence," but the specific results of these tests against predefined acceptance criteria are not presented in the provided text.
2. Sample Size for Test Set and Data Provenance
Not applicable. The document explicitly states: "No Clinical test is included in this submission." The performance data mentioned are non-clinical bench tests. The sample size for these bench tests is not provided, and the data provenance, beyond being "non-clinical," is not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device submission relies on non-clinical bench testing to demonstrate substantial equivalence, not on human expert assessments of medical images or diagnoses. Therefore, there is no mention of experts establishing ground truth.
4. Adjudication Method for Test Set
Not applicable. As no clinical test involving human readers and ground truth establishment was conducted, no adjudication method is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. The document states "No Clinical test is included in this submission." An MRMC study would be a type of clinical study involving human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (Sphincterotome), not an AI algorithm. Its performance is assessed through bench testing, not an algorithm-only study.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence for this device would be established through engineering specifications, recognized medical device standards (e.g., IEC 60601, ISO 10993, ISO 11135), and results from non-clinical bench tests. These tests confirm that the device performs as intended and is comparable to predicate devices in terms of mechanical, electrical, and biological safety and performance. No pathology, outcomes data, or expert consensus (in the typical sense of diagnostic accuracy studies) were used as ground truth for this submission.
8. Sample Size for Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established
Not applicable. As above, this is a physical medical device, not an AI model.
Summary of what is missing/not applicable based on the provided text:
- Specific, quantifiable acceptance criteria and device performance results in a table.
- Sample sizes for the "test set" (as this was non-clinical bench testing, not a clinical test set).
- Data provenance for any performance testing.
- Information on experts for ground truth or adjudication methods.
- Any multi-reader multi-case or standalone AI performance studies.
- Information on training sets or how their ground truth was established.
The document is a 510(k) summary focused on demonstrating substantial equivalence to previously cleared devices through comparison of technical characteristics and compliance with recognized standards via non-clinical testing. It explicitly states that no clinical tests were included.
§ 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).