Wilson-Cook's Tri-Tome Select Plus Sphincterotome is intended for cannulation of the ductal system and for sphincterotomy.
Used for cannulation of the ductal system and for sphincterotomy.

Device Description

The proposed Tri-Tome Select Plus Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating a .035" wire guide while allowing simultaneous injection of contrast media through separate lumens.

AI/ML Overview

The provided document is a 510(k) summary for the Wilson-Cook Tri-Tome Select Plus Sphincterotome. It declares the device to be substantially equivalent to predicate devices based on performance characteristics and biocompatibility. However, it does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.

Here's what can be extracted and what is not available from the provided text:

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

This information is not provided in the document. The document states:

"We believe the proposed device to be substantially equivalent to the named predicates in terms of performance characteristics tested and biocompatibility."

This suggests that performance testing was conducted, but the specific acceptance criteria, numerical performance metrics, and a comparison table are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The document does not mention sample sizes for any testing, nor does it describe the nature or origin of the data.

3. 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):

This information is not provided. The assessment appears to be based on the device's physical characteristics and its intended use compared to predicate devices, rather than an expert-driven evaluation with a "ground truth" as might be seen for diagnostic AI.

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

This information is not provided.

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:

This is not applicable as the device is not an AI diagnostic tool that assists human readers. It is a medical instrument (sphincterotome). Therefore, an MRMC study is not relevant here.

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

This is not applicable as the device is not an algorithm or AI.

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

This information is not provided and is not directly relevant for this type of device submission. The "ground truth" in this context would likely be engineering specifications, material properties, and functional tests demonstrating safety and technical performance, which are not detailed in this summary.

8. The sample size for the training set:

This is not applicable as the device is not an AI system that requires a training set.

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

This is not applicable as the device is not an AI system that requires a training set.

In summary: The provided document is a 510(k) summary for a medical device (a sphincterotome) focused on establishing substantial equivalence to existing predicate devices. It does not contain the detailed performance study information, acceptance criteria, sample sizes, expert ground truth, or AI-specific study details that your request outlines. This type of information is typically found in more extensive technical reports or test protocols, which are not part of this summary document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains a handwritten string of characters. The string starts with a capital letter 'K', followed by the number '6', then '33', '2', '0', and finally '3'. The characters are written in a simple, slightly irregular style, typical of handwriting.

DEC 1 9 2003

ATTACHMENT D: 510(k) Summary of Safety and Effectiveness

SPONSOR:

CONTACT/SUBMITTER:

DATE OF SUBMISSION:

DEVICE:

Trade Name: Common Name: Classification:

PREDICATE DEVICES:

INTENDED USE:

DEVICE DESCRIPTION:

COMPARISON OF CHARACTERISITICS:

PERFORMANCE DATA:

Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105

Marge Walls-Walker Requlatory Affairs Specialist [336] -744-0157 Ex.290

September 30, 2003

Tri-Tome Select Plus

Tri-Tome Select Plus Sphincterotome Unit. Electrosurgical, Endoscopic w/w/o Accessories, Class II 21 CFR § 876.4300

Wilson-Cook Sphincterotome/Papillotome (K901443) Microvasive Autotome™ RX (K013153)

Wilson-Cook's Tri-Tome Select Plus Sphincterotome is intended for cannulation of the ductal system and for sphincterotomy.

We believe the proposed device to be substantially equivalent to currently marketed triple-lumen transendoscopic sphincterotomes.

We believe the proposed device to be substantially equivalent to the named predicates in terms of performance characteristics tested and biocompatibility.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three curved lines that could be interpreted as wings or flowing fabric.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105

Re: K033203

Trade/Device Name: Wilson-Cook Tri-Tome Select Plus Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Codc: 78 KNS Dated: September 30, 2003 Received: October 2, 2003

Dear Ms. Walls-Walker:

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 (PMA), it may be subject to 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.

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.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and your your e FDA finding of substantial equivalence of your device to a legally prematicated predicated 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 11 you done office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Other or other warket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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

{3}------------------------------------------------

510(k) Number (if known): K_________________________________________________________________________________________________________________________________________________

Device Name: Wilson-Cook Tri-Tome Select Plus Sphicterotome

Indications for Use:

Used for cannulation of the ductal system and for sphincterotomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only
(Per 21 CFR § 801.109

David R. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devig

510(k) Number.

Over-the-Counter_____

States of States

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).