BARD HIGH FLOW PAPILLOTOME by BARD INTERVENTIONAL PRODUCTS DIV.

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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Bard® High Flow Papillotome)
Movement through side viewing endoscope & guidewire movement: Equivalent to Bard ProForma Papillotome and Microvasive Sphincterotomes.	Comparative movement testing: Demonstrated substantial equivalence to predicate devices.
Electrical safety: Meets national/international standards for electrosurgical accessories (e.g., ANSI/AMMI HF18-1993).	Electrical testing: Confirmed the High Flow papillotome meets the requirements of the ANSI/AMMI HF18-1993 standard.
Biocompatibility: Materials are safe for contacting mucosa and tissue, similar to commonly used materials in medical devices (implicitly, predicate devices).	Biocompatibility testing: Confirmed the materials used for the proposed High Flow papillotome are safe for contacting mucosa and tissue. (Note: materials are described as "commonly used" in the industry, implying safety by common usage, and further confirmed by testing).
Flow rate: Equivalent to Microvasive® Ultratome XL sphincterotome.	In Vitro flow testing: Confirmed the device is substantially equivalent to the Microvasive® Ultratome XL sphincterotome.
Mechanical integrity/functionality: Adequate bow force, bow orientation, radiopacity, and joint integrity (implicitly, similar to predicate devices).	Additional tests: Bow force, bow orientation, radiopacity, and joint integrity tests were completed to confirm device safety and effectiveness. (No specific numerical results or direct comparison to predicates are given for these, but "confirmed" implies they met expectations for safety and effectiveness).

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)

Summary

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Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989

BARRID

510(k) SUMMARY FOR THE BARDOHIGH FLOW PAPILLOTOME 6.0

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

6.1 General Information
- -Name and address of submitter:

Bard Interventional Products Division, C.R. Bard, Inc. 129 Concord Road Billerica, MA 01821-7031

Contact: a
Beth A. Rochette Regulatory Affairs Manager Phone: (508) 663-8989 Fax: (508) 670-9827
Date of Summary: -
August 12, 1996
Name of Device: -
Trade Name: Common/Usual Name: Classification Name:

Bard® High Flow Papillotome Papillotome Endoscopic Electrosurgical Accessory

Predicate Device(s):

Bard ProForma Papillotome and the Microvasive® (Boston Scientific Corp.) Fluorotome™/Ultratome™/Ultratome XL Sphincterotomes

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Description and Intended Use of Device:

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.

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6.2 Summary of Similarities and Differences

The High Flow papillotome is substantially equivalent to the currently marketed Bard® Proforma Papillotome (#K894861) manufactured by Wiltek Medical, Inc. and the Microvasive® (Boston Scientific Corporation) Sphincterotomes, which received concurrence through #K930022.

The indications for use of the High Flow papillotome are equivalent to both the Bard Proforma papillotome and the Microvasive sphincterotomes. The general design and functionality of the High Flow papillotome are similar to these currently marketed devices. All three of the papillotomes are advanced with or without a guidewire through the biopsy channel of a side viewing endoscope under endoscopic and/or fluoroscopic visualization and a diathermic current is applied to the cutting wire to incise the Papilla of Vater and/or the Sphincter of Oddi. The major differences between the papillotomes are:

1. The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating, while both the Bard Proforma papillotome and the Microvasive sphincterotomes use PTFE. Comparative movement testing through a side viewing endoscope and guidewire movement testing has demonstrated substantial equivalence.
1. The High Flow papillotome uses a different plastic material for both the luer fitting and the handle assembly. The High Flow papillotome luer fitting is PVC and the handle assembly material is ABS; the Bard Proforma papillotome uses polycarbonate for both of these components.
1. 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. Electrical testing has confirmed the High Flow papillotome meets the requirements of the ANSI/AMMI HF18-1993 standard.
The High Flow papillotome shaft is an 8 french O. D. that tapers to 4. a 5.5 french tip O. D. The currently marketed papillotomes are labeled as either a 5 Fr., 7.5 Fr. or a 7 Fr. that tapers to a 5.5 Fr. O.D.

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Although some of the materials used for the High Flow papillotome are different from the Bard Proforma and Microvasive sphincterotomes they are commonly used materials in the medical device industry. Biocompatibility testing has confirmed the materials used for the proposed High Flow papillotome are safe for contacting mucosa and tissue.

The larger O. D. of the High Flow papillotome shaft provides a slightly larger guide lumen for accessory devices and contrast medium injection. In Vitro flow testing has confirmed the device is substantially equivalent to the Microvasive® Ultratome XL sphincterotome.

In addition, bow force, bow orientation, radiopacity and joint integrity tests were completed to confirm device safety and effectiveness. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Regulation Number and Section

§ 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).