MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR

K020526 · Don Wilson/Wilson-Cook Medical, Inc. · FHN · Mar 19, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020526
• Device Name: MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
• Applicant: Don Wilson/Wilson-Cook Medical, Inc.
• Product Code: FHN · Gastroenterology, Urology
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to ligate internal hemorrhoids.

Device Story

The Wilson-Cook Modified Multiple Band Ligator is a single-use, non-sterile device designed for the ligation of internal hemorrhoids. It features a modified handle to facilitate single-handed operation when used in conjunction with an anoscope. The device comes preloaded with the barrel attached to the tip of the handle. Operation involves the use of a trigger cord to deploy bands for ligation. The device is intended for use by clinicians in a clinical setting. By enabling the ligation of internal hemorrhoids, the device assists in the management of this condition. The barrel, bands, and trigger cord materials are identical to those used in the predicate device, with the trigger cord length adjusted to accommodate the modified handle design.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design verification, including dimensional and functional testing, and risk analysis conducted in accordance with 21 CFR 820.30.

Technological Characteristics

Manual ligation device consisting of a handle, trigger cord, and barrel. Designed for single-handed operation with an anoscope. Materials are identical to the predicate device. Non-sterile, single-use. No electronic components or software.

Indications for Use

Indicated for the ligation of internal hemorrhoids in patients requiring such treatment.

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 Multiple Band Ligator (K944220/A)

Submission Summary (Full Text)

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MAR 1 9 2002

510 (K) SUMMARY (Based on 21 CFR Part 807.92)

Submitted By: Wilson-Cook Medical Inc. 4900 Bethania Station Road & 5951 Grassy Creek Boulevard Winston-Salem, NC 27105

### Device Description:

The Wilson-Cook Modified Multiple Band Ligator is used to ligate internal hemorrhoids. This device is supplied non-sterile and intended for single use only.

| Trade Name: | Wilson-Cook Multiple Band Ligator |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Multiple Band Ligator |
| Classification Name/Code: | Ligator, Hemorrhoidal, GU, 78 FHN |
| Classification: | FDA has classified similar devices as<br>Class II, as per 21 CFR § 876.4400. This<br>device falls within the purview of the<br>Gastroenterology and Urology Device<br>Panel. |
| Performance Standards: | To the best of our knowledge, performance<br>standards for this device do not exist. |
| Intended Use: | Used to ligate internal hemorrhoids. |

#### Predicate Device:

| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL NUMBER |
|--------------------------------------|------------------------|-------------------------|
| Wilson-Cook Multiple<br>Band Ligator | Wilson-Cook<br>Medical | K944220/A |

#### Substantial Equivalence:

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

| DEVICE<br>CHARACTERISTIC | Wilson-Cook Modified<br>Multiple Band Ligator<br>[Subject of Special<br>510(k)] | Wilson-Cook<br>Multiple Band Ligator<br>(K944220/A) |
|--------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Used to ligate internal<br>hemorrhoids. | Used to ligate<br>esophageal varices at or<br>above the<br>gastroesophageal<br>junction and to ligate<br>internal hemorrhoids. |
| Sterility | Non-sterile, Disposable | Non-sterile, Disposable |

the predicate Wilson-Cook Multiple Band The modification of Ligator (K944220/A) consists of a change to the handle in order accommodate single-hand operation through an anoscope. to In addition, the modified device comes preloaded with the barrel attached to the tip of the handle. The predicate device is designed for attachment to the end of an endoscope, while the

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### 510 (K) SUMMARY (continued)

modified Multiple Band Ligator is used in conjunction with an anoscope .

The barrel and bands of the modified device are identical to the burrer and bands Wilson-Cook Multiple Band Ligator in the chose of the production and the specifications of each. The trigger cord is comprised of the same materials, however the Crigger Cord ID ockparis slightly shorter in length for the vectrail string aacd in brights) - ar need to fit the length of modified devices, as a se the modified device comes production and an chaobeope. Doading catheter and irrigation adapter are not needed.

It is also important to note that both the predicate and the modified device share the same intended use, share similar methods of operation, and are comprised of the same raw materials.

#### Biocompatibility:

assurance of biocompatibility for for the patient -Reasonable keasonable as been established through a history of contacting mater patient-contacting medical devices and, as applicable, biocompatibility test results.

## Design Control/Risk Analysis/Design Verification:

Design Control, Risk Analysis, Design Verification activities for the subject of this special 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 21 CFR Part 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 performance roquis. 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 were conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 9 2002

Ms. Margaret J. Posner Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105 Re: K020526

Trade/Device Name: Wilson-Cook Multiple Band Ligator (Device Modification) Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 FHN Dated: February 13, 2002 Received: February 19, 2002

Dear Ms. Posner:

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.

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. 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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you ding of substantial equivalence of your device to a legally marketed nontheation. The I Dr Intelliges if cation 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), please If you doshe specific ac-ripliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on of folor to premained the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ KOZLES26

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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Used to ligate internal hemorrhoids.

(Please do not Write Below This Line – Continue on Another Page, if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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

| 510(k) Number | K020526 |
|---------------|---------|
|---------------|---------|