The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

Device Description

The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.

AI/ML Overview

The provided text is a 510(k) summary for the ConMed Axcess Papillotome, which describes a medical device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested elements for a study on acceptance criteria and device performance cannot be extracted directly from this document.

However, I can extract information related to what was provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Electrical Safety	The Axcess Papillotome meets electrical safety standards.
In-vitro Performance	In-vitro testing was conducted which demonstrated that the device meets its performance specifications.

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

Not explicitly stated. The document mentions "in-vitro testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

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

Not applicable/Not stated. This information is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

4. Adjudication method for the test set

Not applicable/Not stated. This detail is usually found in studies involving human readers or expert consensus on interpretations.

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

No. This is a medical device clearance document, not a clinical study involving AI or MRMC.

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

Not applicable. The device described is a physical medical instrument (papillotome), not an algorithm or AI system.

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

For electrical safety, the ground truth would be compliance with established electrical safety standards.
For in-vitro performance, the ground truth would be pre-defined performance specifications for the device's mechanical and functional characteristics.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

Not applicable. As above, no training set is relevant to this device's clearance.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes performance testing which included:

Electrical safety standards compliance.
In-vitro testing to demonstrate the device meets its performance specifications.

The exact details of these tests (e.g., specific protocols, number of samples tested, specific "performance specifications") are not elaborated in this 510(k) summary but would have been part of the more extensive 510(k) submission to the FDA. The basis for clearance is substantial equivalence to predicate devices (Bard Apollo Papillotome K982557 and Boston Scientific Corporation Autotome K013153), rather than extensive clinical efficacy trials typically associated with AI or novel therapeutic devices. The document explicitly states: "The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications." and "The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate."

Summary

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K080946

ONMED

MAY 20 2008

Axcess Papillotome 510K Summary of Safety and Effectiveness January 14, 2008

1. Sponsor Name Sponsor/Manufacturer ConMed Endoscopic Technologies 129 Concord Rd Billerica, MA 01821 Telephone: 978 964 4251 Contact Individual: Beth Zis
  rina CDPH DMC

MAY - 5 2008

000 2002

2. Device Name

Proprietary Name: ConMed Axcess Papillotome Common/Usual Name: Papillotome

3. Identification of Predicate or Legally Marketed Device The Axcess Papillotome is substantially equivalent to the following devices:

Bard Apollo Papillotome cleared under K982557 .
Boston Scientific Corporation Autotome cleared under K013153 .

4. Device Description

1. Intended Use The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.
Comparison of Technological Characteristics 6. The Axcess Papillotome and the predicates have similar design characteristics. They both have construction which consists of a handle, triple lumen shaft, a

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2800446

ConMed Endoscopic Technologies Axcess Papillotome Premarket Notification

cutting wire, and a precurved radiopaque tip. The device lengths and wire diameters are comparable. The materials of construction are different but the materials used are widely used in medical devices and tested to be biocompatible. The Axcess Papillotome is multidirectional whereas the Apollo Papillotome is not, however the BSC Autotome is a multidirectional Papillotome.

1. Performance Testing
  The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications.
1. Statement of Equivalency
  The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate. The principal of operation of both devices are exactly the same. Since the Axcess Papillotome has the same intended use and technological characteristics as the predicate device, the Axcess Papillotome does not raise any new safety and efficacy concerns when compared to the similar legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 20 2008

ConMed Endoscopic Technologies, Inc. % Mr. Daniel W. Lehtonen Intertek Testing Services NA, Inc. 2307 E. Aurora Road., Unit B7 TWINSBURG OH 44087

Re: K080946

Trade/Device Name: ConMed Axcess Papillotome Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: May 2, 2008 Received: May 5, 2008

Dear Mr. Lehtonen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. In the center of the seal are the letters "FDA" in a stylized font. Below the letters, the word "Centennial" is written in cursive. The seal is surrounded by a border with stars and other decorative elements.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Amall Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ConMed Endoscopic Technologies Axcess Papillotome Premarket Notification

Indications for Use

510(k) Number (if known): K

Device Name: Axcess Papillotome

Indications For Use:

The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nogu M. Khan

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K080946

Page 1 of 1

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).