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.

AI/ML Overview

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.

Summary

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K92551

Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989

SEP 1 0 1998

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VI 510(k) SUMMARY FOR THE BARD® ProForma™ and Apollo3™ PAPILLOTOMES

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (I)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.

A. General Information

Name and address of submitter: -Bard Interventional Products Division, C.R. Bard. Inc. 129 Concord Road, Building 3 Billerica, MA 01821
Contact: Marion Gordon R.A.C. Senior Regulatory Affairs Coordinator Telephone (978) 262-4867 Fax (978) 262-4878
Date of Summary: -July 21, 1998

Name of Device:
Trade Name:	Bard® ProForma™ and Apollo3™ Papillotomes
Common/Usual Name:	Papillotome
Classification Name:	Endoscopic electrosurgical unit and accessories

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Predicate Device: Wiltek Papillotome Wiltek Medical, Inc.
.. Description and Intended Use of Device:

B. Summary of Similarities and Differences

The Bard® ProForma™ and Apollo3™ Papillotomes are substantially equivalent to the following legally marketed papillotomes manufactured by Wiltek Medical, Inc. (K894861) and commercialized under the trade names of:

Accuratome3 *, Accuratome" , and Double Lumen * Papillotome .

Similarities

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

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contrast leakage.

Differences

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.

Additionally, Wiltek does not include the term 'cannulation' in their intended use. However, this is a common practice among billary endoscopists and a term found in the labeling accompanying other competitive papillotomes, such as the Wilson Cook papillotome supplied in Appendix C.

Although there may be minor differences in the manufacture and packaging of the Bard papillotomes, they are considered substantially equivalent to the Wiltek papillotomes. Any difference between the products raises no issue of safety or effectiveness based upon bow orientation, joint integrity, radiopacity, electrical and biocompatibility testing.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Mr. Marion Gordon Regulatory Affairs Coordinator C. R. Bard, Inc. 129 Concord Road, Bldg. 3 P.O. Box 7031 Billerica, MA 01821-7031

Re: K982557

Bard® ProForma™ and Apollo³™ Pre-Curved Papillotomes Dated: July 21, 1998 Received: July 22, 1998 Regulatory Class: II 21 CFR 876.4300/Procode: 78 KNS

Dear Mr. Gordon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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. 510(k) Number (if known): _________________________________________________________________________________________________________________________________________________ Bard® ProForma™ and Apollo3™ Papillotomes_____________________________________________________________________________________________________________________________________ Device Name: Indications For Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vand C. Szyrm

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).