WILSON-COOK TRI-TOME SELECT PLUS

K033203 · Wilson-Cook Medical, Inc. · KNS · Dec 19, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K033203
• Device Name: WILSON-COOK TRI-TOME SELECT PLUS
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Tri-Tome Select Plus is a triple-lumen sphincterotome used during endoscopic procedures. It allows for the simultaneous insertion of a .035" wire guide and the injection of contrast media through separate lumens. The device is operated by a physician in a clinical setting to facilitate ductal access and perform sphincterotomy. By providing a dedicated channel for wire guidance and contrast, it assists in navigating the biliary or pancreatic ductal systems, potentially improving procedural efficiency and patient outcomes during endoscopic interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristic comparisons.

Technological Characteristics

Triple-lumen sphincterotome; accommodates .035" wire guide; allows simultaneous contrast media injection. Class II device (21 CFR 876.4300).

Indications for Use

Indicated for cannulation of the ductal system and for sphincterotomy in patients requiring endoscopic biliary or pancreatic duct access.

Regulatory Classification

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.

Predicate Devices

• Wilson-Cook Sphincterotome/Papillotome (k901443)
• Microvasive Autotome™ RX (k013153)

Submission Summary (Full Text)

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DEC 1 9 2003

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

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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.

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.

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.

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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.

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i

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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)

OR

**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