WILSON-COOK 10 SHOT MULTI-BAND LIGATOR

K974018 · Wilson-Cook Medical, Inc. · FHN · Jan 20, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974018
• Device Name: WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
• Applicant: Wilson-Cook Medical, Inc.
• Product Code: FHN · Gastroenterology, Urology
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to endoscopically ligate esophageal varices at or above the gastroesophagel junction or to ligate internal hemorrhoids.

Device Story

Endoscopic accessory for ligation of esophageal varices or internal hemorrhoids. Device consists of friction fit adapter for endoscope distal tip, barrel preloaded with ten ligation bands, trigger cord, deployment handle, irrigation adapter, and loading catheter. Operated by physician during endoscopy. Physician attaches device to endoscope, advances to target site, and manipulates handle/cord to deploy bands serially. Multi-band design allows ten ligations without removing endoscope for reloading. Single-use, non-sterile device. Benefits include reduced procedure time and trauma by eliminating need for repeated endoscope withdrawal/reinsertion.

Clinical Evidence

No clinical data. Biocompatibility established via history of use in similar devices and functional testing. Results comparable to predicate device.

Technological Characteristics

Materials: Polyurethane (adapter), Polycarbonate (barrel), Vectran (trigger cord), Latex Rubber (bands). Mechanical deployment via trigger cord and handle. Single-use. Non-sterile. No electronic or software components.

Indications for Use

Indicated for patients requiring endoscopic ligation of esophageal varices at or above the gastroesophageal junction or internal hemorrhoids.

Regulatory Classification

Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device 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 Six Shot Multi-Band Ligator (K944220/A)

Submission Summary (Full Text)

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## PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR

#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 。
中国中

JAN 20 1998

# Submitted By:

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

# Device Description:

The Wilson-Cook 10 Shot Multi-Band Ligator consists of a friction fit adapter for attachment to the distal tip of an endoscope, a barrel preloaded with ten (10) ligation bands, a trigger cord and handle for band deployment, an irrigation adapter and a loading catheter. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

| Trade Name: | Wilson-Cook Ten Shot Multi-Band Ligator |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Band Ligator |
| Classification Name/Code: | Ligator, Hemorrhodial, 78 FHN<br>Ligator, Esophageal 78 MND |
| Classification: | FDA has classified similar devices as Class II, as per 21<br>CFR § 876.4400. This device falls within the purview of<br>the Gastroenterology and Urology Device Panel. |
| Performance Standards: | To the best of our knowledge, performance standards for<br>this device do not exist. |
| Intended Use: | Used to endoscopically ligate esophageal varices at or above the<br>gastroesophagel junction or to ligate internal hemorrhoids. |

# Predicate Device:

| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL<br>NUMBER |
|--------------------------------------------|--------------------------|----------------------------|
| Wilson-Cook Six Shot<br>Multi-Band Ligator | Wilson-Cook Medical Inc. | K944220/A |

## Substantial Equivalence:

The Wilson-Cook 10 Shot Multi-Band Ligator is substantially equivalent to the referenced predicate device with respect to design, materials of construction and intended use.

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**PREMARKET NOTIFICATION**

## PREMARKET NOTIFICATION FOR THE WILSON-COOK 10 SHOT RE: MULTI-BAND LIGATOR

### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) 。
上一篇:

| DEVICE<br>CHARACTERISTIC | Wilson-Cook<br>10 Shot Multi-Band Ligator<br>[Subject of 510(K)] | Wilson-Cook<br>Multi-Band Ligator<br>(K944220/A) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to endoscopically ligate<br>esophageal varices at or above<br>the gastroesopahgeal junction<br>or to ligate internal<br>hemorrhoids. | Used to endoscopically ligate<br>esophageal varices at or above<br>the gastroesopahgeal junction<br>or to ligate internal<br>hemorrhoids. |
| Components | 1) Non-Patient Contacting<br>Loading Catheter<br>2) Irrigation Adapter<br>3) Barrel with 10 Ligation<br>Bands<br>4) Trigger Cord<br>5) Deployment Handle | 1) Non-Patient Contacting<br>Loading Catheter<br>2) Irrigation Adapter<br>3) Barrel with 6 Ligation<br>Bands<br>4) Trigger Cord<br>5) Deployment Handle |
| Patient Contacting Materials | Friction Fit Adapter:<br>Polyurethane<br>Barrel: Polycarbonate<br>Trigger Cord: Vectran<br>Bands: Latex Rubber | Friction Fit Adapter:<br>Polyurethane<br>Barrel: Polycarbonate<br>Trigger Cord: Vectran<br>Bands: Latex Rubber |
| Method of Use | Friction Fit adapter and barrel<br>with ligation bands mounted to<br>the distal tip of the endoscope.<br>Band release from the barrel<br>accomplished by trigger cord<br>and deployment handle. | Friction Fit adapter and barrel<br>with ligation bands mounted to<br>the distal tip of the endoscope.<br>Band release from the barrel<br>accomplished by trigger cord<br>and deployment handle. |
| Bands | Multiple bands can perform<br>serial ligations without<br>removal of the endoscope for<br>reloading of bands. | Multiple bands can perform<br>serial ligations without<br>removal of the endoscope for<br>reloading of bands. |

Testing:

Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices and as applicable biocompatibility test results. This product line has been subjected to functional testing as appropriate for this modification. All results were comparable to results obtained for the predicate device hence establishing the safety and effectiveness for this product line extension.

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Image /page/2/Picture/0 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

Ms. Paula Joyce Regulatory Affairs Manager Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-Salem, NC 27105

Re: K974018

Wilson-Cook 10 Shot Multi-band Ligator Dated: October 17, 1997 Received: October 22, 1997 Regulatory Class: II 21 CFR 876.4400/Procode: 78 FHN, 78 MND

Dear Ms. Joyce:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications 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, 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 misbranion.

If your device is classified (see above) into either class II (Special Controls) or 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 (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 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 marked 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 yitro 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 of titled, "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/dsmamain.html".

Sincerely yours,

W. Liao Yu

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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K974018

Page 14 of 14

510(k) Number (if known): INITIAL 510(k) SUBMISSION UNKNOWN

WILSON-COOK TEN SHOT MULTI-BAND LIGATOR Device Name:

Indications For Use:

Used to endoscopically ligate esophageal varices at or above the gastroesophagea1 junction or to ligate internal hemorrhoids.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Riker D. Sitting/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices K97 4018 510(k) Number _

Prescription Use I (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)