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510(k) Data Aggregation
(247 days)
Sphincterotome / short-wire compatible, Sterile Sphincterotome
The Sphincterotome is intended to be used in the selective cannulation of the biliary ducts and the transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The device can also be used to inject contrast medium.
The proposed device has two types: Sphincterotome / short-wire compatible and Sterile Sphincterotome. Sterile commonly traditional Endoscopic Retrograde Sphincterotome used in Cholangiopancreatography (Hereinafter referred to ERCP) surgery need to be used with a long guidewire, while Sphincterotome / short-wire compatible with short-wire techniques to compatible with a short guidewire to achieve rapid exchange between ERCP devices.
The proposed device consists of Cutting Wire, Outer Tube and Handle Assembly. It is used with the High Frequency Generator (Hereinafter referred to HF Generator) and the endoscopic procedures. The HF Generator supplies high frequency energy through the Cutting Wire of the proposed device to cut the tissue at the appropriate power and voltage. The models with injection can inject contrast medium into the biliary ducts. The main materials of the proposed device include PTFE, ABS, SUS304.
The proposed device has 52 specifications, which mainly differ in cutting wire type, cutting wire length, preloaded guidewire length and with insulation tube or not.
The proposed device Sphincterotome 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 1 year.
This document describes the premarket notification (510(k)) for the Micro-Tech (Nanjing) Co., Ltd. Sphincterotome. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical studies or specific device performance acceptance criteria against which a study directly proves the device meets. Therefore, some of the requested information, particularly regarding specific acceptance criteria metrics, will not be directly available.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance values for clinical metrics. Instead, it lists various performance tests conducted to demonstrate essential performance and confirm that the proposed device works as intended and is substantially equivalent to the predicate device. The conclusion states that "the test results meet the requirement," implying that the device passed the internal acceptance criteria for each test.
Key Performance Tests Conducted (without specific numerical acceptance criteria or reported values in this document):
| Test Category | Description of Test (from document) | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Operational & Functional | Operation Testing | Device operates as intended. | Confirmed to operate as intended. |
| Endoscope Compatibility Testing | Compatible with specified endoscopes (e.g., working channel ≥3.2mm, ≥2.8mm). | Confirmed compatibility with specified endoscopes. (Document states "Compatible endoscopy working channel: ≥3.2mm, ≥2.8mm" for proposed device vs. "≥2.8mm" for predicate). | |
| Head Preflexed Testing | Device maintains structural integrity and function after preflexion. | Test results met requirements. | |
| Conductivity Testing | Electrical conductivity meets specifications for electrosurgical function. | Test results met requirements. | |
| Connection Strength Testing | Connections (e.g., handle to outer tube) are secure and maintain integrity. | Test results met requirements. | |
| Injection Luer Port Testing | Luer port for injection is functional and leak-free. | Test results met requirements. | |
| Infusion Patency Testing | Contrast medium can be infused freely through the device. | Test results met requirements. | |
| Energy Delivery and Cutting Testing | Device effectively delivers electrosurgical energy and performs cutting as intended. | The HF Generator supplies high frequency energy through the Cutting Wire of the proposed device to cut the tissue at the appropriate power and voltage. Test results met requirements. (Maximum rated accessory voltage: 1200Vp (2400Vp-p) for proposed vs. 750Vp (1500Vp-p) for predicate - difference noted but implied acceptable based on comparison with reference devices and performance testing). | |
| Cutting Rate Testing | Device cuts within acceptable timeframes and with appropriate efficiency. | Test results met requirements. | |
| Cannulation Performance Testing | Device enables successful cannulation. | Test results met requirements. | |
| Safety & Durability | Endoscopy Visualization Testing | Clear visualization through or around the device maintained during endoscopy. | Test results met requirements. |
| Shelf-life testing (Accelerated aging based on ASTM F1980-16; 1-year aging test) | Device maintains sterility and functional integrity for its claimed shelf-life. | Demonstrated 1-year shelf life. | |
| Sterilization validation (ISO 11135:2014) | Achieves Sterility Assurance Level (SAL) of 10^-6. | EO sterilized, SAL: 10^-6 achieved. | |
| Biocompatibility testing (ISO 10993) | Device materials are biocompatible and do not pose unacceptable biological risks. | Complies with ISO10993-1. | |
| Electromagnetic compatibility, electric safety, and thermal safety (IEC 60601-1, -1-2, -2-2, -2-18) | Device meets relevant electrical, electromagnetic, and thermal safety standards. | Conforms to IEC60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (number of devices) used for each of the performance tests listed. Since this is a submission based on physical and functional performance testing of the device itself rather than patient data, there is no information on data provenance in terms of country of origin or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The performance tests described are laboratory-based and do not involve human interpretation against a "ground truth" established by medical experts.
4. Adjudication method for the test set
This information is not applicable as the tests are objective performance measurements, not subjective evaluations requiring adjudication.
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
There was no MRMC comparative effectiveness study, as this device is not an AI-powered diagnostic or assistive tool. It is a medical instrument (sphincterotome).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical instrument, not an algorithm.
7. The type of ground truth used
This information is not applicable in the context of device performance testing for a physical instrument. The "ground truth" in this context would be engineering specifications and validated test methods for physical, electrical, and functional performance.
8. The sample size for the training set
This information is not applicable as this is not an AI/algorithm device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/algorithm device.
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