Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords

K172665 · Wilson-Cook Medical Inc./Cook Endoscopy · KNS · May 24, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172665
• Device Name: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
• Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy. Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy. Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

Device Story

Sterile, single-use endoscopic sphincterotomes; long plastic cannula with internal wire; distal wire segment exposed. Used during ERCP; physician inserts device through endoscope accessory channel; high-frequency electrosurgical current applied via wire to cut papilla roof; enables access to biliary/pancreatic orifices. Active cords connect sphincterotomes to electrosurgical generators. Benefits: facilitates ductal cannulation and sphincterotomy; preloaded versions assist in bridging strictures. Used in clinical/hospital settings by gastroenterologists.

Clinical Evidence

Bench testing only. Includes biocompatibility (cytotoxicity, irritation, sensitization), electrical safety (IEC 60601-1, 60601-2-2, 60601-2-18), mechanical integrity (joint strength, force to bow), functional testing (visualization, fluoroscopic visibility, functional age), and sterilization/packaging validation.

Technological Characteristics

Materials: PTFE (catheter), 303/304 stainless steel (wire), Parylene C (coating). Design: Single/double/triple lumen, 4-7 Fr diameter, 196-200 cm length. Energy: Monopolar electrosurgical. Connectivity: Active cords connect to electrosurgical generators. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for patients requiring cannulation of the biliary or pancreatic ductal systems and sphincterotomy during ERCP procedures. Includes bridging of difficult strictures for preloaded devices. Active cords indicated for connecting electrosurgical accessories to generators.

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

• Zimmon® Papillotome (K901443)

Submission Summary (Full Text)

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May 24, 2018

Wilson-Cook Medical, Inc. / Cook Endoscopy Theresa De Prat Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105

#### Re: K172665

Trade/Device Name: Classic Cotton Cannulatome® CannulaTome II® Double Lumen Sphincterotome Cotton CannulaTome II® PC UTS® Ultra Taper Sphincterotome Tri-Tome pc® Triple Lumen Sphincterotome Howell D.A.S.H.® Sphincterotome with DomeTip® Billroth II Sphincterotome Soehendra® BII Sphincterotome Models ACU-1 and ACU-1-VL active cords Regulation Number: 21 CFR& 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: April 23, 2018 Received: April 24, 2018

Dear Theresa De Prat:

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.

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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); medical device 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Joyce M. Whang -S

for

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) K172665

#### Device Name

Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, and Models ACU-1 and ACU-1-VL active cords

#### Indications for Use (Describe)

Howell D.A.S.H.® Sphincterotome with Dome Tip® (Cook Reference Part Numbers DASH-21, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASH-ACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Tri-Tome po® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-30M), Cotton Cannulatome II® PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20M. UTS-25, UTS-30, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.

Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# K172665 Page 1 of 4

#### 510(k) Summary

#### Sphincterotomes and Active Cords

Traditional 510(k) Premarket Notification

April 23, 2018

### Applicant Information

| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|------------|---------------------------------------------------|
| | 4900 Bethania Station Road |
| | Winston-Salem, North Carolina 27105 |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist II |
| Phone: | [phone] ext. 396518 |
| Fax: | [phone] |

#### Device Information

| Trade Names: | Classic Cotton Cannulatome®<br>CannulaTome II® Double Lumen Sphincterotome<br>Cotton CannulaTome II® PC<br>UTS® Ultra Taper Sphincterotome<br>Tri-Tome pc® Triple Lumen Sphincterotome<br>Howell D.A.S.H.® Sphincterotome with DomeTip®<br>Billroth II Sphincterotome<br>Soehendra® BII Sphincterotome<br>Models ACU-1 and ACU-1-VL active cords |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names: | Papillotome, sphincterotome, active cord |
| Regulation 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: | Zimmon® Papillotome |
|----------------|-----------------------|
| 510(k) Number: | K901443 |
| Date: | Cleared June 18, 1990 |

#### Device Description

The sphincterotomes described in this submission are a sterile, single use devices 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

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that wire is exposed at its distal end. The roof of the papilla is opened by passing highfrequency current through the wire, exposing the biliary or pancreatic orifices for selective cannulation. The active cords are accessories to sphincterotomes so that a sphincterotome can be connected to an electrosurgical unit.

### Intended Use

Howell D.A.S.H.® Sphincterotome with DomeTip® (Cook Reference Part Numbers DASH-21, DASH-21-480, DASH-1, DASH-260, DASH-480, DASH-ACRO-25-450, DASH-35, DASH-ACRO-35-260, DASH-35-480, DASHACRO-35-450): This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP.

Tri-Tome pc® Triple Lumen Sphincterotome (Cook Reference Part Numbers TRI-20, TRI-20M, TRI-25, TRI-25M, TRI-25M-P, TRI-25M-SLT, TRI-30, TRI-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Classic Cotton® CannulaTome® (Cook Reference Part Numbers CCPT-25, CCPT-25-MONO, CCPT-25ME), CannulaTome II® Double Lumen Sphincterotome (Cook Reference Part Numbers CT-20, CT-20M, CT-30, CT-30M), Cotton Cannulatome II PreCurved Double Lumen Sphincterotome (Cook Reference Part Numbers CT-25, CT-25M, CT-25M-P UTS®), and Ultra Taper Sphincterotome (Cook Reference Part Numbers UTS-15, UTS-20, UTS-20M, UTS-25, UTS-25M, UTS-30, UTS-30M): This device is used for cannulation of the ductal system and for sphincterotomy.

Billroth II Sphincterotome (Cook Reference Part Numbers PTG-20-6-BII-NG) and Soehendra® BII Sphincterotome (Cook Reference Part Numbers PT-5.5-BII-SOEHENDRA): This device is used for the cannulation of the ductal system and for sphincterotomy.

Models ACU-1 and ACU-1-VL active cords: This device is used to connect Cook monopolar electrosurgical accessories to compatible electrosurgical generators.

### Comparison to Predicate Device

The subject device and predicate device have the same intended use and different technological characteristics.

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| Characteristic | Zimmon® Papillotome (K901443) | Cook Sphincterotomes and Active Cords (K172665) |
|------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used for endoscopic papillotomy/sphincterotomy. | This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP. |
| Sterile/Non-Sterile | Sterile, EO | Same |
| Disposable/Reusable | Disposable | Same |
| Cutting Wire Length | 15-30 mm | 15-30 mm |
| Cutting Wire Diameter | 0.012" (braided) | 0.012" (braided)<br>0.0075-0.010" (monofilament) |
| Handle configuration | Three Ring Handle | Same |
| Tip configuration | Straight or Tapered | Tapered or DomeTip |
| Wire Guide / Injection Port<br>Extension | No | Yes |
| Wire Control Port (WCP) with<br>Slide | No | Yes (on TriTome pc® Select) |
| Cutting Wire Material | 304 Stainless Steel | 303 stainless steel or 304 stainless steel; Parylene C added for "Protector" versions |
| Ink Marker Material | Gem Black | Black, Green, Blue, Silver,<br>Copper/Bronze, Gold |
| Packaging | PTEG Tray with Tyvek Lid | Tyvek and Mylar pouch |
| Catheter Design | Single lumen | Single, double or triple lumen |
| Catheter Design/Material | Polytetrafluoroethylene (PTFE) | Same |
| Catheter Length | 200 cm | 196 or 200 cm |
| Catheter Diameter | 5 Fr | 4-7 Fr |
| Wire Guide Compatibility | Not applicable | 0.021-0.035" |

# Substantial Equivalence Comparison

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, as follows, demonstrate that the subject device meets the performance requirements to fulfill the intended use of the device.

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- GLP Cytotoxicity 1X MEM ISO elution .
- GLP ISO Intracutaneous irritation - 2 extracts
- GLP ISO Guinea Pig Maximization, 2 extracts ●
- IEC 60601-1: 2006 + A12: 2014 (3.1 edition)- Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- . IEC 60601-2-2: 2017 (6.0 edition) - Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
- IEC 60601-2-18: 2009 (3.0 edition) Medical electrical equipment Part 2-18: . Particular requirements for the basic safety and essential performance of endoscopic equipment
- Ink visualization
- Visualization of Cutting Wire ●
- Orientation of Cutting Wire
- Fluoroscopic Visibility ●
- Drive Wire to Handle Joint Strength
- Brass Insert to Handle Joint Strength ●
- Active Cord to Pin Detachment ●
- Force to Bow .
- Functional Age Testing
- Sterile Barrier and Functional Testing After Shipping ●
- Active Cord: Wire to Universal Insert Solder Joint Strength
- Active Cord: Wire to Banana Plug Solder Joint Strength ●
- Active Cord: Wire to Valley Lab Plug Solder Joint Strength
- Active Cord: Functional Testing at Time Zero ●
- Active Cord: Functional Testing after Shipping ●
- Sterilization validation ●
- ETO residual testing
- Packaging visual inspection ●
- . Burst testing
- Dye leak testing ●