USW NEEDLEKNIFE PAPILLOTOME

K040981 · Wilson-Cook Medical, Inc. · KNS · May 7, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040981
• Device Name: USW NEEDLEKNIFE PAPILLOTOME
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Wilson-Cook's USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and intended for single use.

Device Story

Triple-lumen catheter; includes lumens for cutting wire, wire guide access, and contrast injection. Compatible with .035" wire guide. Features 24 GA stainless steel cutting wire for electrosurgical current transfer to facilitate cannulation. Handle includes electrocautery connection pin for external active cords. Used by physicians in endoscopic procedures to access common bile duct. Device provides mechanical access and electrosurgical cutting capability to assist when traditional cannulation fails.

Clinical Evidence

Bench testing only.

Technological Characteristics

Triple-lumen catheter; 24 GA stainless steel cutting wire; electrosurgical energy source; compatible with .035" wire guide; sterile, single-use.

Indications for Use

Indicated for accessing the common bile duct in patients where standard cannulation methods have been exhausted. Single use only.

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 Needleknife Papillotome (k972674)

Submission Summary (Full Text)

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K040981

MAY - 7 2004

## ATTACHMENT F: 510(k) Summary

| SPONSOR:<br>CONTACT/SUBMITTER: | Wilson-Cook Medical<br>4900 Bethania Station Road<br>Winston-Salem, NC 27105<br>Marge Walls-Walker<br>Requlatory Affairs Specialist<br>[336] -744-0157 Ex.290 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE OF SUBMISSION:<br>DEVICE: | April 14, 2004<br>USW Needleknife Papillotome |
| Trade Name:<br>Common Name:<br>Classification: | Wilson-Cook USW Needleknife Papillotome<br>Needleknife, Precut<br>Unit, Electrosurgical Endoscopic w,w/o<br>Accessories. 21 CFR § 876.4300, 78 KNS |
| PREDICATE DEVICES: | Wilson-Cook Needleknife Papillotome (k972674) |
| INTENDED USE: | Wilson-Cook's USW Needleknife Papillotome is<br>intended for accessing the common bile duct<br>when standard cannulation methods have been<br>exhausted. This device is supplied sterile and<br>intended for single use. |
| DEVICE DESCRIPTION: | The proposed USW Needleknife Papillotome is<br>a triple-lumen catheter, with one lumen<br>dedicated to the cutting wire, wire guide access<br>and contrast injection respectively. The wire<br>guide lumen is compatible with a .035" wire<br>quide. The 24 GA stainless steel cutting wire<br>allows for the transfer of electric current<br>enhance cannulation efforts when traditional<br>cannulation efforts have been exhausted. The<br>handle contains an electrocautery connection<br>pin, which is compatible with a variety of active<br>cords currently sold separately. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be<br>substantially equivalent to the named predicate<br>in terms of Intended Use, Indications for Use,<br>performance characteristics tested, materials of<br>construction, operation and biocompatibility. |
| PERFORMANCE DATA: | Non-Clinical Testing was performed on<br>characteristics of the USW Needleknife<br>Papillotome deemed necessary to verify safety<br>and performance. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2004

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

Re: K040981

Trade/Device Name: USW Needleknife Papillotome Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: 78 KNS Dated: April 14, 2004 Received: April 20, 2004

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 docs 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) r as lotter unfication. 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 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 by reference to premarket 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/cdrfv/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): K0409 8 (

## Device Name: Wilson-Cook USW Needleknife Papillotome

## Indications for Use:

The Wilson-Cook USW Needleknife Papillotome is intended for accessing the common bile duct when standard cannulation methods have been exhausted. The USW Needleknife Papillotome is supplied sterile and intended for single use only.

## (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

OR

David A. Aymer

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

Over-the-Counter_