OMNI SPHINCTEROTOME

K052051 · Wilson-Cook Medical, Inc. · KNS · Aug 5, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K052051
• Device Name: OMNI SPHINCTEROTOME
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used for cannulation of the ductal system and sphincterotomy.

Device Story

OMNI™ Sphincterotome is a triple-lumen transendoscopic device used for ductal system cannulation and sphincterotomy. It accommodates wire guides ranging from .018" to .035" in diameter while allowing simultaneous injection of contrast media through separate lumens. The device incorporates DomeTip™ technology and a breakthrough catheter feature. It is intended for use by clinicians in endoscopic procedures. The device functions as an accessory to an electrosurgical unit to perform sphincterotomy, aiding in biliary or pancreatic duct access and therapeutic intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and biocompatibility assessment.

Technological Characteristics

Triple-lumen transendoscopic sphincterotome; accommodates .018" to .035" wire guides; features DomeTip™ technology and breakthrough catheter design; electrosurgical accessory; Class II device per 21 CFR 876.4300.

Indications for Use

Indicated for patients requiring cannulation of the ductal system and sphincterotomy.

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 Triple Tome Select Plus Sphincterotome (K033203)

Submission Summary (Full Text)

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Ko 5205/

## AUG 5 - 2005

## ATTACHMENT F: 510(k) Summary

SPONSOR: Wilson-Cook Medical 4900 Bethania Station Road Winston-Salem, NC 27105 Marge Walls-Walker CONTACT/SUBMITTER: Regulatory Affairs Manager [800] 245-4707 Ex.6290 DATE OF SUBMISSION: July 28, 2005 DEVICE: OMNI™ Sphincterotome OMNI™ Sphincterotome Trade Name: Common Name: Sphincterotome Unit, Electrosurgical, Endoscopic w/w/o Classification: Accessories, Class II 21 CFR § 876.4300 Wilson-Cook Triple Tome Select Plus PREDICATE DEVICES: Sphincterotome (k033203) Wilson-Cook's OMNI™Sphincterotome is INTENDED USE: intended for cannulation of the ductal system and sphincterotomy. The proposed OMNI™ Sphincterotome is a triple-lumen sphincterotome. It is capable of accommodating wire guides from .018" to .035" DEVICE DESCRIPTION: in diameter while allowing simultaneous injection of contrast media through separate lumens. We believe the proposed device to be COMPARISON OF CHARACTERISITICS: substantially equivalent to currently marketed triple-lumen transendoscopic sphincterotomes with respect to Intended Use and Method of Operation. The subject sphincterotome also incorporates DomeTip™ technology and a breakthrough catheter feature.

PERFORMANCE DATA:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

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

Re: K052051

Trade/Device Name: Wilson-Cook OMNI™ Sphincterotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: July 28, 2005 Received: July 29, 2005

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 (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.

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms loter will and in your your finding of substantial equivalence of your device to a legally promatics motively on " 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 ir you don't if you of Compliance at one of the following numbers, based or 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" (21 CFR Allot process nother general information on your responsibilities under the Act from the 001:37): " Col may overnin varies, International and Consumer Assistance at its toll-free number [phone] or [phone] 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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Kus 2051

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Wilson-Cook OMNI™ Sphicterotome

Indications for Use:

Used for cannulation of the ductal system and sphincterotomy.

.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Leggrom

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

Prescription Use Only_ (Per 21 CFR § 801.109

OR

Over-the-Counter_