MODIFICATION TO AUTO-BAND LIGATOR

K083556 · Scandimed International · MND · Feb 19, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083556
• Device Name: MODIFICATION TO AUTO-BAND LIGATOR
• Applicant: Scandimed International
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Feb 19, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

Device Story

Auto-Band Ligator is a mechanical device used by clinicians to perform ligation of esophageal varices or hemorrhoids. The device consists of a ligator wheel head mounted on a scope fixation arm, connected via a stainless steel thread to a band barrel. It features an adjustable snap fixation system for scope attachment, a precision one-step release mechanism, and an automatic reverse movement to the start position after each band release. The device is designed for single use. It allows for the sequential release of individual rubber ligation bands (available in 5, 6, 7, 8, or 10 band configurations). By applying bands to the target tissue, the device facilitates the ligation procedure, which can help manage varices or hemorrhoids.

Clinical Evidence

Bench testing only. Performance testing was conducted to demonstrate the safety and effectiveness of the device following the material formulation change and the expansion of the band configuration options.

Technological Characteristics

Mechanical ligation device. Components include a ligator wheel head, scope fixation arm, stainless steel thread, and band barrel. Features an adjustable snap fixation system and a one-step release mechanism. Bands are available in latex or latex-free rubber. Device is configured for single use. No electronic or software components.

Indications for Use

Indicated for banding of esophageal varices or hemorrhoids in the colon. For single use only.

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

• Scandimed International Auto-Band Ligator (K031236)
• Scandimed International Auto-Band Ligator (K081142)

Submission Summary (Full Text)

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.K083556

## 510(K) SUMMARY

FEB 1 9 2009

#### 1. SUBMITTER:

Scandimed International Korsdalsvej 125 DK-2610, Roedovre, Denmark Establishment Registration Number: 3003376126 Official contact: Mr. Salah Chami, CEO Telephone: [phone] Date Prepared: November 24, 2008

#### 2. DEVICE:

Auto-Band Ligator Tradename: Classification Name: Hemorrhoidal Ligator Class II Classification: 78 MND Product Code: Regulation Number: 876.4400 Classification Panel: Gastroenterology

#### PREDICATE DEVICE: 3.

This Special 510(k) Premarket Notification is being submitted for a material formulation change to the ligation bands and to expand the product line to include 6 and 8 band variations. The predicate device used to determine substantial equivalence for this device was the Scandimed International Auto-Band Ligator (#K031236 and #K081142).

#### DEVICE DESCRIPTION: 4.

The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel.

The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations.

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K083556

The Auto-Band Ligator incorporates the following product features:

- Automatic Reverse Movement to START position after each release
- Snap Fixation system ensures stable fixation on the scope
- Adjustable Snap Fixation System facilitates fixation on all brands of scopes
- Precision One-Step Release Mechanism of bands
- Only a single band can be released at a time
- Latex or Latex Free Rubber Bands
- Available in 5, 6, 7, 8 or 10 band configurations

#### INTENDED USE: 5.

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

#### INDICATIONS FOR USE: 6.

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.

#### COMPARISON OF CHARACTERISTICS: 7.

Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices.

#### PERFORMANCE DATA: 8.

The Auto-Band Ligator was subjected to relevant performance testing. The results of the performance testing demonstrated the safety and effectiveness of the device.

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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 & 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scandimed International c/o Mr. Stephen M. Page Regulatory Consultant MedReg Associates 29 Frigate Street JAMESTOWN RI 02835

...

FEB 1 9 2009

1000 Re: K083556

> Trade/Device Name: Auto-Band Ligator Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: MND Dated: January 16, 2009 Received: January 21, 2009

Dear Mr. Page:

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). Youmay, therefore, market the device, subject to the general controls previsions of the Act. The gouveral controls provisions of the Activelyde 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 such 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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

anine M. M. STT Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): #K083556

Device Name: Auto-Band Ligator

Indications for Use:

The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. : : الموالي الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الموقع الم . : 、 . . For single use only.

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lara Whalen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.

(Posted November 13, 2003)

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