(83 days)
The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only.
The Disposable 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. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304. Type A, Type B and Type C are included in this submission. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.
This looks like a 510(k) premarket notification for a medical device. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for novel acceptance criteria.
Based on the provided text, the "acceptance criteria" for the Disposable Sphincterotome are primarily established by its similarity to the predicate device (Hangzhou AGS MedTech Co., Ltd.'s Sphincterotome, K201121) and compliance with relevant consensus standards.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in the way one might see for a novel AI algorithm or a device with new performance claims. Instead, the performance is demonstrated by showing the proposed device is substantially equivalent to the predicate device and meets established safety and performance standards.
| Acceptance Criteria Category (Implied) | Reported Device Performance (vs. Predicate/Standards) |
|---|---|
| Indications for Use | Same as predicate: "The Disposable Sphincterotome is indicated for use in the cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device is supplied sterile and intended for single use only." |
| Product Code | Same as predicate: KNS |
| Regulation Number | Same as predicate: 878.4300 |
| Regulatory Class | Same as predicate: Class II |
| Sterility | Same as predicate: Supplied sterile, EO sterilized to achieve SAL of 10-6. |
| Principles of Operation | Same as predicate: Uses thermal effect from high-frequency current for incision, Monopolar Radio Frequency Current from an electrosurgical generator. |
| Injection Capability | Same as predicate: Can inject Contrast Medium (for models with injection). |
| Packaging | Same as predicate: Single-use EO sterilized pouch with one device per pouch. |
| Biocompatibility | Conform to ISO 10993-1 (Same as predicate). |
| Sterilization Residuals | Conform to ISO 10993-7. |
| Physical Properties | Passing results for Appearance and Physical properties bench tests. |
| Wire Guide Diameter | Proposed: 0.89mm; Predicate: 0.63mm, 0.89mm. Similar; the proposed device's diameter is within the range of the predicate, and this difference is explicitly stated not to raise safety/effectiveness concerns. |
| Minimum Accessory Channel | Proposed: 2.4mm; Predicate: 2.8mm. Similar; the proposed device has a smaller requirement, which is unlikely to raise safety/effectiveness concerns related to the endoscopic channel. |
| Working Length | Proposed: 2000mm; Predicate: 1800mm. Similar; a longer length may offer more reach but doesn't fundamentally change the device's function or safety as long as it handles appropriately. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document describes bench testing for physical properties ("Appearance, Physical properties") and compliance with standards (e.g., sterilization, biocompatibility). It does not specify the exact number of units tested for these bench tests.
- Data Provenance: The tests are non-clinical (bench tests) conducted by the manufacturer, Zhejiang Soudon Medical Technology Co.,Ltd. The country of origin of the device is China. The data is prospective in the sense that the manufacturer performed these tests specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as this submission relies on engineering and manufacturing standards verification as opposed to clinical expert assessment of a diagnostic outcome. For bench testing, ground truth is typically defined by engineering specifications and standard test methods.
4. Adjudication method for the test set:
- This is not applicable as the document describes bench testing against predefined engineering specifications and compliance with international standards, rather than expert-adjudicated clinical outcomes.
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:
- No, an MRMC study was not done. This device is a Disposable Sphincterotome, which is an electrosurgical accessory used by a clinician, not an AI-assisted diagnostic tool for "human readers." Therefore, this type of study is irrelevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is an electrosurgical medical device, not an algorithm or software requiring standalone performance testing in that context.
7. The type of ground truth used:
- For the non-clinical performance data, the ground truth is based on:
- Engineering specifications and design requirements for "Appearance" and "Physical properties."
- International Consensus Standards such as ISO 10993-1 (Biocompatibility), ISO 11135-1 (EO Sterilization), and ISO 10993-7 (Ethylene Oxide Sterilization Residuals).
- Substantial Equivalence to the legally marketed predicate device (K201121) in terms of indications for use, technological characteristics, and safety/performance profiles.
8. The sample size for the training set:
- This is not applicable. This submission is for a physical medical device, not an AI algorithm, and 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 for the same reason as point 8.
§ 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).