Zimmon Needle Knife Papillotome

K171993 · Wilson-Cook Medical Inc./Cook Endoscopy · KNS · Aug 17, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K171993
• Device Name: Zimmon Needle Knife Papillotome
• Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Aug 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted.

Device Story

Zimmon Needle Knife Papillotome is a sterile, single-use endoscopic accessory. Device consists of a long, thin plastic cannula containing an internal wire with an exposed distal tip. Operated by a physician during endoscopic procedures; device is inserted through the accessory channel of an endoscope. High-frequency electrosurgical current is passed through the wire to incise the roof of the papilla, exposing biliary or pancreatic orifices for selective cannulation. Output is a mechanical incision facilitated by electrosurgical energy. Benefits include enabling duct access in difficult cases where standard cannulation has been exhausted.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including sterilization, shelf life, and biocompatibility testing, demonstrating the device meets performance requirements.

Technological Characteristics

Sterile, single-use endoscopic accessory. Consists of a plastic cannula with an internal wire electrode. Operates via high-frequency electrosurgical current. Dimensions and materials are consistent with standard endoscopic electrosurgical accessories.

Indications for Use

Indicated for patients requiring access to the common bile duct when standard cannulation methods have failed.

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 Needle Knife Papillotome (K972674)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2017

Wilson-Cook Medical, Inc. / Cook Endoscopy Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K171993

Trade/Device Name: Zimmon Needle Knife Papillotome Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: June 30, 2017 Received: July 3, 2017

Dear Doris A. Hawks:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171993

#### Device Name Zimmon Needle Knife Papillotome

Indications for Use (Describe)

These devices are used for accessing the duct when standard methods of cannulation have been exhausted.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in smaller, bold letters.

COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

#### 510(k) Summary 009.

# Zimmon Needle Knife Papillotome

Traditional 510(k) Premarket Notification

June 30, 2017

# Applicant Information

| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|------------|------------------------------------------------------|
| | 4900 Bethania Station Road |
| | Winston-Salem, North Carolina 27105 |
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Phone: | [phone] ext. 396293 |
| Fax: | [phone] |

# Device Information

| Trade Name: | Zimmon Needle Knife Papillotome |
|----------------------|-------------------------------------------------|
| Common Names: | Papillotome, sphincterotome |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |

## Predicate Device

| Name: | Wilson-Cook Needle Knife Papillotome |
|----------------|--------------------------------------|
| 510(k) Number: | K972674 |
| Date: | Cleared August 15, 1997 |

## Device Description

The Zimmon Needle Knife Papillotome (subject device) is a sterile, single use device compatible with the accessory channel of endoscope. The device consists of a long, thin plastic tube (cannula) with a wire running the length of its interior. A small portion of that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the needle knife, exposing the biliary or pancreatic orifices for selective cannulation.

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VINSTON-SALEM, NC 27105 WWW.COOKMEDICAL.COM

# Intended Use

These devices are used for accessing the common bile duct when standard methods of cannulation have been exhausted.

# Comparison to Predicate Device

The subject device and predicate device have the same intended use and different technological characteristics. None of the differences in technological characteristics raise different questions of safety and effectiveness. Furthermore, performance data from acceptable scientific testing methods provide evidence that the subject device is substantially equivalent to the predicate device.

# Performance Data

Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Zimmon Needle Knife Papillotome meets the performance requirements to fulfill the intended use of the device.