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Bard papillotomes are designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.

The Bard® ProForma™ and Apollo3™ Papillotomes are designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi. A papillotome is placed under direct vision of a side-viewing duodenoscope, with or without fluoroscopic aid. Both the double lumen and triple lumen designs will have a variety of precurved tip configurations and cutting wire lengths. The Bard papillotomes are compatible with a 0.035 inch O.D. guidewire. The Bard" ProForma™ and Apollo3™ Papillotomes have equivalent intended uses as the Wiltek papillotomes. The general design characteristics and functionality are also similar. They all have a one (1) piece system construction which includes a handle, either double or triple lumen shafts, various cutting wire lengths and construction with precurved tips in multiple lengths. Both the Wiltek and Bard devices may be advanced with or without using an .035 inch guidewire through the biopsy channel of a duodenoscope with optional use of fluoroscopy. A diathermic current is applied through the cutting wire to incise the Papilla of Vater or Sphincter of Oddi. A Touhy Borst may be attached to the guidewire lumen of the double lumen device to assist in placement and minimize contrast leakage. The major design difference between the Bard and Wiltek papillotomes is the ProForma™ and Apollo³™ will have an ergonomic handle made from ABS instead of the polycarbonate handle used in the Wiltek design. The precurved tips on the Bard papillotomes will be either beveled or tapered, where the Wiltek tips are only beveled. A full range of tip lengths, from 8mm to 20mm, are provided by both manufacturers.

This 510(k) premarket notification for the Bard® ProForma™ and Apollo3™ Papillotomes focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a de novo study with acceptance criteria and device performance metrics in the way a new, breakthrough device might.

Here's an analysis of the provided text based on your request, highlighting what is and isn't present:

Key Takeaway: The provided document is a 510(k) summary, which aims to prove a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and intended use, and that any differences do not raise new questions of safety or effectiveness. It does not involve clinical studies with acceptance criteria and measured performance in the same way a novel device might go through a clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. As a 510(k) submission for substantial equivalence, the focus is on comparing the new device's characteristics and intended use to a predicate device, rather than setting and meeting specific performance acceptance criteria from a clinical study. The document states:

"Any difference between the products raises no issue of safety or effectiveness based upon bow orientation, joint integrity, radiopacity, electrical and biocompatibility testing."

This implies that these technical characteristics were likely evaluated against internal or industry standards, or compared directly to the predicate, but specific acceptance criteria and detailed performance results from these tests are not publicly disclosed in this summary.

2. Sample Size for Test Set and Data Provenance:

This information is not provided as there is no specific "test set" or clinical study described in this 510(k) summary that would typically involve a sample size of patients/cases. The evaluation appears to be based on technical characteristics and design comparison.

3. Number of Experts and Qualifications for Ground Truth:

This information is not provided. Ground truth established by experts is typically associated with clinical studies involving interpretation or diagnosis, which is not the nature of this 510(k) submission.

4. Adjudication Method:

This information is not provided. Adjudication methods are relevant in clinical studies where multiple experts assess cases, which is not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study measures the impact of technology on human readers' performance, which is beyond the scope of a substantial equivalence submission for a device like a papillotome.

6. Standalone (Algorithm Only) Performance:

No, a standalone performance evaluation (algorithm only, without human-in-the-loop) was not done or described. This is not an AI or imaging diagnostic device where such a study would be relevant.

7. Type of Ground Truth Used:

Ground truth in the clinical study sense (e.g., pathology, outcomes data, expert consensus) is not applicable to this document as no clinical study for device performance is described. The "ground truth" for the 510(k) submission is the pre-existingpredicate device and its established safety and effectiveness.

8. Sample Size for Training Set:

This information is not provided. There is no "training set" in the context of an AI/machine learning model described in this document.

9. How Ground Truth for Training Set Was Established:

This information is not provided. As there's no training set for an AI/ML model, the establishment of its ground truth is not relevant here.

In Summary:

The provided K92551 document is solely a 510(k) Premarket Notification Summary for the Bard® ProForma™ and Apollo3™ Papillotomes. Its purpose is to demonstrate substantial equivalence to already marketed predicate devices (Wiltek Papillotomes). This process primarily involves:

• Identifying a predicate device: Wiltek Papillotome (K894861).
• Comparing intended use: Both Bard and Wiltek papillotomes are for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or Sphincter of Oddi.
• Comparing design characteristics and functionality: General design, one-piece system, handle, lumen types, cutting wire lengths, precurved tips.
• Highlighting differences and mitigating concerns: The differences (ergonomic handle material, beveled/tapered tips, inclusion of "cannulation" in intended use) are deemed minor and do not raise new issues of safety or effectiveness based on underlying technical testing (bow orientation, joint integrity, radiopacity, electrical, and biocompatibility testing – though specific results are not provided).

Therefore, the type of detailed clinical study data, acceptance criteria, and ground truth establishment you've requested are typically associated with novel devices undergoing de novo premarket approval or clinical trials, not with a 510(k) substantial equivalence submission for a manually-operated medical instrument like a papillotome.

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The Bard High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.

The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating. The High Flow papillotome luer fitting is PVC and the handle assembly material is ABS. The High Flow papillotome electrode assembly is similar in construction to the Bard Proforma except that the set screw is stainless steel versus nickel plated brass. The High Flow papillotome shaft is an 8 french O. D. that tapers to 5.5 french tip O. D.

The provided text is a 510(k) summary for a medical device (Bard® High Flow Papillotome) and describes a comparison to predicate devices, rather than a study with acceptance criteria and reported device performance in the way a clinical trial or AI validation study would.

Therefore, the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) is not applicable in the context of this document. This document focuses on demonstrating substantial equivalence to existing devices based on material comparisons, functional tests, and in-vitro performance, not on a new clinical study with specific acceptance criteria as you've described.

To address your request by interpreting the document as best as possible within its context:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) summary focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate devices. The "reported device performance" refers to how the new device compares to these predicates in specific technical aspects.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "Comparative movement testing," "Electrical testing," "Biocompatibility testing," "In Vitro flow testing," and "Bow force, bow orientation, radiopacity and joint integrity tests." These are likely benchtop or in-vitro tests, not clinical studies with human patient sample sizes. The number of samples/units tested is not provided.
• Data Provenance: The tests are in-vitro/benchtop. There is no indication of country of origin for "data" in the sense of patient data. These are laboratory tests. The document is for a device in the US market (510(k) summary).
• Retrospective/Prospective: Not applicable, as these are benchtop tests, not clinical studies involving patient data collected retrospectively or prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in the context of this document refers to established engineering or material science standards and physical measurements, not expert clinical interpretation. The tests mentioned (e.g., electrical, flow, biocompatibility) rely on objective measurements against established specifications or predicate device performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are used in clinical trials or studies where human expert interpretation is ambiguous and needs resolution. This document describes objective engineering tests.

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:

• Not applicable. This document describes a physical medical device (papillotome) for an interventional procedure, not an AI-powered diagnostic tool for human readers. No MRMC study was performed or is relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" here is based on engineering specifications, material science standards (e.g., biocompatibility guidance), and the measured performance of predicate devices in a laboratory setting. For instance, electrical testing uses "the requirements of the ANSI/AMMI HF18-1993 standard" as its reference. Flow testing uses the "Microvasive® Ultratome XL sphincterotome" as its comparative benchmark.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. (See #8)

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