WILSON-COOK PANCREATIC WEDGE STENT

K990130 · Wilson-Cook Medical, Inc. · FGE · Feb 12, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990130
• Device Name: WILSON-COOK PANCREATIC WEDGE STENT
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to drain obstructed pancreatic ducts

Device Story

The Wilson-Cook Pancreatic Wedge Stent is a sterile, disposable catheter designed to drain obstructed pancreatic ducts. The device is inserted into the pancreatic duct to maintain patency. It features a polycarbonate-based polyurethane stent body with tapered ends for retention, differing from the pigtail configuration of the predicate. The system includes a pushing catheter and guiding catheter, and is compatible with .035" wire guides. It is intended for use by clinicians in a medical setting. The device facilitates drainage, thereby relieving obstruction and potentially improving patient outcomes related to pancreatic duct blockage.

Clinical Evidence

No clinical data. Substantial equivalence is supported by design verification, dimensional and functional testing, and biocompatibility assessments based on historical use of similar materials.

Technological Characteristics

Stent material: Polycarbonate-based polyurethane. Introducer components: Polytetrafluoroethylene. Dimensions: 6, 8, 10 French sizes; 4-24 cm lengths. Compatibility: .035" wire guide. Sterilization: Ethylene Oxide (EO) per AAMI Standard 11135 (SAL 10^6).

Indications for Use

Indicated for patients requiring drainage of obstructed pancreatic ducts.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Wilson-Cook Pancreatic Stent (K900923)

Reference Devices

• Wilson-Cook Pancreatic Stent (K911023)

Submission Summary (Full Text)

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2/12/99

990130
pg 1 of 2

- SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK PANCREATIC RE: STENT
## 510(k) Summary of Safety & Effectiveness J.

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

Device Description: The Modified Wilson-Cook Pancreatic Stent is a sterile,

disposable device, used to drain obstructed pancreatic ducts.

Trade Name: Wilson-Cook Pancreatic Wedge Stent

Pancreatic Stent Common/Usual Name:

Classification Name/Code: Catheter, Biliary, GU/78 FGE

FDA has classified similar devices as Class II as per 21 CFR § Classification: 876.5010. This device falls within the purview of the theGastroenterology and Urology Devices Panel.

Establishment Registration Number: 1037905

- Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 106.
- No performance standards applicable to Biliary Catheters Performance Standards: have been established by the Food and Drug Administration.
- Used to drain obstructed pancreatic ducts. Intended Use:

Predicate Devices:

| Predicate Device | Manufacturer | Document Control Number |
|---------------------------------|--------------------------|-------------------------|
| Wilson-Cook Pancreatic<br>Stent | Wilson-Cook Medical Inc. | K900923 |

Substantial Equivalence:

The Modified Wilson-Cook Pancreatic Stent is substantially equivalent to the referenced predicate devices in that it is similar with respect to technological characteristics and intended use.

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K990130

SPECIAL 510 (K) : DEVICE MODIFICATION FOR THE WILSON-COOK PANCREATIC RE: STENT

## pg 2 of ..

## 510(k) Summary of Safety & Effectiveness (continued) J.

| | Beadthene Wilson-Cook<br>Pancreatic Stent<br>(K911023) | Modified Wilson-Cook<br>Pancreatic Stent (Subject of<br>"Special" 510(k)) |
|--------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Intended Use | Drain obstructed pancreatic<br>ducts. | Drain obstructed pancreatic<br>ducts. |
| Stent | Polyethylene | Polycarbonate based<br>Polyurethane |
| Introducer<br>Components | Polyethylene | Polytetrafluoroethylene |
| Sterility | Sterile, Disposable | Sterile, Disposable |
| Wire Guide | Accepts .035" wire guide | Accepts .035" wire guide |

| Stent Configuration | Pigtail ends for retention | Tapered ends for retention |
|--------------------------|--------------------------------------------------------|---------------------------------------------------------------------------|
| Dimensions | Stent French Sizes: 5,7,9, 10<br>Stent Length: 1-15 cm | Stent French Sizes: 6, 8, 10<br>Stent Length: 4-24 cm |
| Introducer<br>Components | Pushing Catheter<br>Wire Guide | Pushing Catheter<br>Guiding Catheter<br>Wire Guide (Available separately) |

Biocompatibility: Reasonable assurance of biocompatibility for the patient contacting materials has been established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results.

## Design Control/Risk Analysis/Design Verification:

Design Control, risk analysis and design verification activities for the subject of this 510(k) have been conducted in accordance with all applicable internal procedures. The design control process employed is inclusive of the elements as stipulated by 21CFR § 820.30, as applicable to the project. The risk analysis performed identified the risks relative to the performance requirements, as specified by our internal procedure for Risk Analysis. The failure mode, effect of failure, severity, potential cause, rate of occurrence, design control element/production controls to eliminate, the potential to detect and our recommended actions were also documented. During Design Verification, dimensional and functional testing to ensure the performance and design integrity of this product line was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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FEB 1 2 1999

Ms. Paula Joyce QA/RA Manager Wilson Cook® Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990130 Wilson-Cook® Pancreatic Wedge Stent Dated: January 13, 1999 Received: January 14, 1999 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE

Dear Ms. Joyce:

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 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Special Controls) or dass 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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/cdrh/dsma/dsmamain.html".

Sincerely yours,

ﺮ ﺍ

Capt. Daniel G. Schultz, M.D. Acting 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_

510(k) Number (if known):__K990130 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:_Wilson-Cook Pancreatic Wedge Stent

Indications For Use:

Used to drain obstructed pancreatic ducts

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use V<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use__<br>(Optional Format 1-2-96) |
|---------------------------------------------|--------------------------------------------------------|
|---------------------------------------------|--------------------------------------------------------|

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

| 510(k) Number | K990130 |
|---------------|---------|
|---------------|---------|