Search Results

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:

1. AI/ML Device Type: Not an AI/ML powered device. It is a physical medical instrument.

2. 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

3. 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.

4. 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.

5. Adjudication Method: Not applicable.

6. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No. The device is a physical instrument, not an AI assistance tool for human readers.

7. Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.

8. 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.

9. Sample Size for the Training Set: Not applicable. There is no AI model or training set.

10. 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.

Ask a specific question about this device

Ask a specific question about this device

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.

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.

Ask a specific question about this device