WILSON-COOK NEEDLE KNIFE PAPILLOTOME

K972674 · Wilson-Cook Medical, Inc. · KNS · Aug 15, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972674
• Device Name: WILSON-COOK NEEDLE KNIFE PAPILLOTOME
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is intended for single use only.

Device Story

Device is a single-lumen needle knife papillotome for endoscopic use; consists of 23-gauge needle, catheter, and handle. Operated by physician during endoscopic procedures. Device inserted through endoscope accessory channel to position needle near papillary orifice. Connected to external electrocautery unit; electrical current passes through cutting wire to distal needle tip to perform small incisions in papilla. Enables subsequent cannulation of biliary tree. Benefits patient by providing access to bile duct when conventional methods fail.

Clinical Evidence

No clinical data. Bench testing only; functional testing included visual, dimensional, and functional analysis per approved protocol. Biocompatibility established through history of use in similar devices.

Technological Characteristics

Single-lumen catheter; 23-gauge 304 stainless steel needle; polytetrafluoroethylene (PTFE) introducer; 3-ring handle; 5 French outer sheath; 1.5-inch radius curve distal tip; 200 cm length. Electrosurgical energy source. Sterile, single-use, EO-sterilized (AAMI Overkill Method, SAL 10^-6).

Indications for Use

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

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

• Endovations, Inc. .035" Pre-Cut Needle Knife (K934315)

Submission Summary (Full Text)

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K 9726 74 Pg 183

Page 9 of 11

### PREMARKET NOTIFICATION FOR THE WILSON-COOK NEEDLE RE: KNIFE PAPILLOTOME

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ್ಕೋ

AUG | 5 10077

# Submitted By:

Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

## Device Description:

The Wilson-Cook Needle Knife Papillotome consists of a single lumen tubing, 23 gauge needle, and a papillotome handle. This device is designed for insertion through the accessory channel of an endoscope. The catheter is advanced through the accessory channel positioning the needle knife near the papillary orifice. The device is connected to an electrocautery unit via an active cord. The current from the electrocautery unit is passed through the cutting wire to the distal end of the papillotome thus allowing the needle knife to make small incisions in the papilla. Once the appropriate incision has been made the needle knife may be retracted allowing cannulation of the biliary tree.

| Trade Name: | Wilson-Cook Needle Knife Papillotome |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Needle Knife Papillotome |
| Classification Name: | Device, Electrosurgical, Cutting and Coagulation & Accessories; 79 GEI |
| Classification: | FDA has classified similar devices as Class II, per 21 CFR § 878.4400. This device falls within the purview of the Gastroenterology and Urology Devices Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. |
| Sterility: | Validated EO cycle, following the AAMI Overkill Method to SAL 10 ^-6 . |
| Intended Use: | The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. |
| Predicate Device: | |

Predicate Device:

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K 9 726 74

Page 10 of 11

## PREMARKET NOTIFICATION FOR THE WILSON-COOK NEEDLE RE: KNIFE PAPILLOTOME

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) J.

| DEVICE<br>CHARACTERISTIC | WILSON-COOK<br>NEEDLE KNIFE<br>PAPILLOTOME<br>[Subject of 510(K)] | ENDOVATIONS, INC.<br>.035" PRE-CUT<br>NEEDLE KNIFE<br>(K934315) |
|----------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Intended Use | Accessing the common bile<br>duct when standard<br>cannulation methods have<br>been exhausted. | Accessing the common bile<br>duct when standard<br>cannulation methods have<br>been exhausted. |
| Introducer Catheter/Sheath | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Handle Style | 3-Ring | 3-Ring |
| Needle | 304 Stainless Steel | 304 Stainless Steel |
| Needle Gauge | 23 GA | 23 GA |
| Needle Extension | 4 mm | 4 mm |
| Outer Sheath | 5 French | .035" |
| Distal Tip | $1\frac{1}{2}$ " Radius Curve | $1\frac{1}{2}$ " Radius Curve |
| Length | 200 cm | 210 cm |
| Number of Lumens | 1 | 2 |
| Sterility | Sterile, disposable | Sterile, disposable |

Testing:

Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices.

Functional testing conducted per approved protocol. Samples were subjected to visual, dimensional, and functional analysis. All samples were deemed acceptable, in that test specifications were met.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract, curved shapes that resemble human figures or flowing lines. The overall design is simple and conveys a sense of government authority and public service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 1997

Ms. Linda Hensley Regulatory Affairs Specialist Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, North Carolina 27105 Re: K972674

Wilson-Cook Needle Knife Papillotome Dated: July 11, 1997 ...... . . Received: July 16, 1997 Regulatory Class: II 21 CFR §876.4300/Product Code: 78 KNS

Dear Ms. Hensley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for use stated in the enclosure) to 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). You may, therefore, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/edrhidsmain.html".

Sincerely yours.

W. D'Liau Yzu
William D'Lieu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

15972674 510(k) Number (if known):

Device Name: Wilson-Cook Needle Knife Papillotome

Indications For Use: The Wilson-Cook Needle Knife Papillotome is used for accessing the common bile duct when standard cannulation methods have been exhausted. This device is supplied sterile and is 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)

Peter R. Sather

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K172274

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)