(195 days)
The Disposable Sphincterotome is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. This device can also be used to cannulate and inject contrast medium.
The subject device Disposable Sphincterotome is a sterile, single-use endoscopic device, intended to be used with flexible endoscopes for intubation of the pancreaticobiliary system and for sphincterotome. The disposable sphincterotome consists of cutting wire, sheath, quide wire connector, injection connector, conductive column, finger ring, handle, and imaging ring. The subject device has 72 specifications. The differences among these models are the Cutting Length, Tip Length, Working Length and Type of guide wire lumen channel. The subject device is 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. The main materials used for construction of Disposable Sphincterotome include PTFE, ABS, SUS304.
The provided document is a 510(k) Summary for a Disposable Sphincterotome. This type of device is a medical instrument and not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML is not applicable.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Boston Scientific Corporation's Autotome™ RX). The "study" referenced in the document is a series of non-clinical, bench tests, and material conformity assessments rather than a clinical trial or AI/ML performance study.
Here's a breakdown based on the provided text, indicating why AI/ML specific questions are not relevant:
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AI/ML Device Type: Not an AI/ML powered device. It is a physical medical instrument.
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Acceptance Criteria and Reported Device Performance (as per the document):
Acceptance Criteria / Test Performed Reported Device Performance (Summary) Relevance to AI/ML Sterilization and Shelf Life Successfully tested per ISO 11135 and ASTM 1980; 3-year shelf life. Not Applicable Biocompatibility Successfully tested per ISO 10993 (cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity); non-toxic and biocompatible. Not Applicable Performance Testing (Bench) All tests verified (Appearance, Dimension, Operational Performance, Tensile Performance, Hydraulic Leak Resistance, Injection Connector performance, Conduction resistance, Contrast Agent Injection Function, Cutting Line Function, Radiopacity, Compatible endoscopes tests, Thermal effect test). Not Applicable Electromagnetic Compatibility & Electrical Safety Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-2. Not Applicable -
Sample Size for Test Set and Data Provenance:
- Sample Size: Not specified for individual bench tests, but generally refers to a set of devices tested in a lab setting.
- Data Provenance: The tests are "bench tests" performed by the manufacturer, Beijing ZKSK Technology Co., Ltd. Origin would be China (where the manufacturer is located). These are not patient data.
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: Not applicable. Ground truth for a physical medical device's performance in bench testing is established by engineering specifications and direct physical measurement/observation, not expert consensus on medical imaging or clinical interpretation.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No. The device is a physical instrument, not an AI assistance tool for human readers.
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Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.
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Type of Ground Truth Used: Engineering specifications, physical measurements, and conformity to international standards (e.g., ISO, IEC). This is about device function and safety, not diagnostic accuracy.
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Sample Size for the Training Set: Not applicable. There is no AI model or training set.
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How the Ground Truth for the Training Set Was Established: Not applicable.
In summary, the provided document describes a traditional medical device (Disposable Sphincterotome) submission to the FDA. The listed "studies" are bench tests and compliance assessments to demonstrate the device's physical and material properties, safety, and functionality, and to establish substantial equivalence to a predicate device. It does not involve any AI/ML components or associated performance testing.
§ 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).