(80 days)
The UltratomeRX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive UltratomeRX can also be used to cannulate and inject contrast medium.
The Microvasive UltratomeRX is a triple lumen sphincterotome. The UltratomeRX is capable of accepting a .035" guidewire in one open channel while simultaneously injecting or cutting in another lumen. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents and cutting. No stylet is necessary for scope passage.
This document describes a 510(k) premarket notification for the Boston Scientific Microvasive UltratomeRX, a sphincterotome. The submission focuses on demonstrating substantial equivalence to a predicate device, the Boston Scientific Ultratome XL.
Acceptance Criteria and Study for UltratomeRX
The provided text does not contain explicit acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) or a "study that proves the device meets the acceptance criteria" in the sense of a clinical trial or a performance study with defined endpoints and statistical analysis for clinical outcomes.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device based on:
- Descriptive and Technological Characteristics Comparison: The manufacturer states that the UltratomeRX is "very similar in design and materials" to the predicate device, Ultratome XL, and that a "thorough comparison of the descriptive characteristics" shows equivalence.
- Performance Characteristics (Laboratory Testing): "Laboratory testing regarding characteristics was performed on the UltratomeRX to verify its safety and performance."
- Biocompatibility Assessment: "A biocompatibility assessment was performed on the patient- and fluidcontact materials of the UltratomeRX with satisfactory results."
The acceptance criteria here are implicitly:
- The UltratomeRX must have descriptive and technological characteristics that are substantially equivalent to the predicate device.
- The UltratomeRX must demonstrate safe and acceptable performance in laboratory settings.
- The materials of the UltratomeRX must be biocompatible.
The "study that proves the device meets the acceptance criteria" is the comparison to the predicate device, laboratory testing, and biocompatibility assessment mentioned above.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Stated Method/Performance |
|---|---|
| Substantial Equivalence (Design & Materials) | "Boston Scientific Corporation believes that the UltratomeRX is substantially equivalent to the currently-marketed Boston Scientific Ultratome XL. The major components... are the catheter shaft, cutting wire, handle, guidewire introducer, and outer sheath. A thorough comparison of the descriptive characteristics between the UltratomeRX and the predicate device shows equivalence." The UltratomeRX is "equivalent in its indications for use, while being very similar in design and materials." |
| Safety and Performance (Functional) | "Laboratory testing regarding characteristics was performed on the UltratomeRX to verify its safety and performance." (No specific metrics or results from this lab testing are provided in the summary). |
| Biocompatibility | "A biocompatibility assessment was performed on the patient- and fluidcontact materials of the UltratomeRX with satisfactory results." |
Additional Information Requests (Based on the provided text, most of these are not applicable or not disclosed):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not disclosed. This submission is for a medical device (sphincterotome), not an AI/software device that typically uses "test sets" of data as in machine learning. The "testing" mentioned is laboratory-based and biocompatibility.
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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 / Not disclosed. This type of expert review to establish "ground truth" is not applicable to the type of device and testing described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not disclosed.
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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. This is not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this type of device, "ground truth" would be established by engineering specifications, material standards, and perhaps in vivo models for performance, rather than clinical "expert consensus" or "pathology" in the diagnostic sense.
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The sample size for the training set:
- Not applicable / Not disclosed. As this is not an AI/machine learning device, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable / Not disclosed. No training set.
§ 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).