(284 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 are a sterile, single use devices 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 the papilla is opened by passing high-frequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. For 50910 series, there's preloaded guide wire.
The provided document is a 510(k) summary for a medical device called "Sphincterotome" by Hangzhou AGS MedTech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study. As such, information regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, multi-reader multi-case studies, and detailed ground truth establishment is not explicitly present in the format typically seen for a de novo or PMA submission.
However, based on the provided text, the acceptance criteria are implicitly derived from the comparison of the proposed device's performance against its predicate devices, as well as adherence to relevant international standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are generally considered to be demonstrating substantial equivalence to the predicate devices through similar technological characteristics and comparable performance. The document states that the proposed device "meets all design specifications and medical device standards" and its "non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."
Specific performance aspects evaluated are implicitly the "acceptance criteria" based on comparison to the predicate.
| Acceptance Criteria (Implicitly based on Predicate Comparison & Standards) | Reported Device Performance (Summary) |
|---|---|
| Common Name, Intended Use, Technical Principles, Energy Use, Single Use, Shelf Life & Sterilization | All are stated as "Same" or "Similar" to the predicate devices, indicating equivalence. For sterilization, SAL of 10-6 is specified. |
| Device Dimensions (Sheath tube, Wire Guide Diameter, Minimum Accessory Channel, Working Length) | Reported as "Similar" to predicate devices. For example, sheath tube 2.4mm vs. 1.8-2.1mm; wire guide diameter 0.63mm, 0.89mm vs. 0.53mm, 0.58mm, 0.89mm; minimum accessory channel 2.8mm (same); working length 1800mm vs. 1960mm. The document indicates these differences do not raise safety/effectiveness questions. |
| Performance (Bench Testing categories listed) | Proposed device performance: (1) Injection performance; (2) Compatibility with traction guide wire; (3) Compatibility with Endoscope; (4) X-ray detectability; (5) Visibility under endoscopy; (6) Electric performance; (7) Operation flexibility; (8) Rotation performance; (9) Connected firmly; (10) Force to Bow; (11) Orientation of Cutting Wire and Visualization of Cutting Wire testing; (12) Ink Validation testing; (13) Fluoroscopic Visibility testing. |
The document states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." It also notes improved safety in some aspects (e.g., "proposed device is safer than our predicate device" for "Connected firmly" and "as safe and effective as our predicate device" for "Force to Bow," "Orientation of Cutting Wire," "Ink Validation," and "Fluoroscopic Visibility"). Predicate device performance: "No information" on detailed performance specifications is provided for the predicate regarding these bench tests, but the comparison indicates equivalence was demonstrated. |
| Biocompatibility | The proposed device uses different materials (Plastic PTFE, Stainless Steel 304) than the listed predicate materials (Plastic PTFE, Stainless Steel 304, PET; Silicone oil, PTFE, Polyurethane, Medical grade hydrophilic coating).
Biocompatibility tests (In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity) were performed according to ISO 10993 standards: ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017. The conclusion is "Biological risks are acceptable." |
| Adherence to Standards | The device meets IEC 60601 (electrosurgical safety), ISO 10993 (biocompatibility), and ISO 11135 (sterility). |
Study that proves the device meets the acceptance criteria:
The primary study mentioned to demonstrate that the device meets the acceptance criteria is a series of non-clinical performance bench tests comparing the proposed device to its predicate devices, as well as adherence to international standards.
- Non-clinical Performance Tests: The submission explicitly states: "We conducted all the performance testing on our proposed device in comparison with our chosen predicate. All the test results show that the proposed device is substantial equivalence with the predicate." Specific tests mentioned include:
- Injection performance
- Compatibility with traction guide wire
- Compatibility with Endoscope
- X-ray detectability
- Visibility under endoscopy
- Electric performance
- Operation flexibility
- Rotation performance
- Connected firmly
- Force to Bow
- Orientation of Cutting Wire and Visualization of Cutting Wire testing
- Ink Validation testing
- Fluoroscopic Visibility testing
- Biocompatibility Tests: A separate set of tests were conducted due to differences in materials. These include In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity, all performed according to ISO 10993 standards.
- Adherence to Standards: The device's compliance with IEC 60601, ISO 10993, and ISO 11135 is cited.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text for any of the individual bench tests. The term "bench tests" typically implies a limited number of samples to demonstrate adherence to specifications.
- Data Provenance: The tests were conducted by Hangzhou AGS MedTech Co., Ltd. in China. The nature of these tests (bench tests) is prospective in the sense that they were designed and performed for this submission.
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)
Not applicable. For a 510(k) submission based on non-clinical bench testing, expert consensus for ground truth is generally not required in the way it would be for a diagnostic AI device. The "ground truth" for these tests is adherence to engineering and performance specifications, and comparison to the predicate device's characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for studies involving human interpretation and clinical outcomes, not for the type of non-clinical bench testing described 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. The device is a physical medical instrument (Sphincterotome), not an AI software/device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is adherence to established technical specifications, engineering measurements, and comparison to the characteristics and performance of the legally marketed predicate devices. For biocompatibility, it's compliance with ISO 10993 standards.
8. The sample size for the training set
Not applicable. This device is not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not a machine learning model.
§ 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).