AUTO-BAND LIGATOR

K081142 · Scandimed International · MND · May 16, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K081142
• Device Name: AUTO-BAND LIGATOR
• Applicant: Scandimed International
• Product Code: MND · Gastroenterology, Urology
• Decision Date: May 16, 2008
• 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 for endoscopic ligation of esophageal varices or hemorrhoids. System comprises a ligator wheel head, scope fixation arm, and band barrel connected by stainless steel thread. Device attaches to an endoscope via an adjustable snap fixation system. Features include automatic reverse movement to start position after release, one-step release mechanism, and single-band release capability. Available in 5, 7, or 10 band configurations. Used by clinicians in clinical settings to perform ligation; device facilitates mechanical tissue strangulation to treat varices or hemorrhoids. This submission specifically introduces latex-free rubber bands to replace previous latex versions.

Clinical Evidence

Bench testing only. Performance testing demonstrated safety and effectiveness of the device with the new latex-free material.

Technological Characteristics

Mechanical ligator; stainless steel thread; latex-free rubber bands; adjustable snap fixation system for endoscope mounting; 5, 7, or 10 band configurations; single-use.

Indications for Use

Indicated for patients requiring ligation 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)

Submission Summary (Full Text)

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# 510(K) SUMMARY

#### 1. SUBMITTER:

MAY 1 6 2008

Scandimed International DK 2600 Glostrup Denmark Establishment Registration Number: 3003376126 Official contact: Mr. Salah Chami, CEO Telephone: [phone] Date Prepared: April 16, 2008

#### 2. DEVICE:

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

#### 3. PREDICATE DEVICE:

This Special 510(k) Premarket Notification is being submitted for a material change from latex ligation bands to latex free ligation bands. The predicate device used to determine substantial equivalence for this device was the Scandimed International Auto-Band Ligator (#K031236).

#### 4. DEVICE DESCRIPTION:

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 change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands.

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Image /page/1/Picture/0 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The string "K081142" is written on the top line, and the string "2+2" is written on the bottom line. The text is written in a bold, dark font, and the letters and numbers are clearly legible.

ﺔ ﺳﻬ

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 Free Rubber Bands ●
- Available in 5, 7 or 10 band configurations .

#### INTENDED USE: ડ.

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

#### 6. INDICATIONS FOR USE:

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

#### 7. COMPARISON OF CHARACTERISTICS:

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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 6 2008

SCANDIMED International c/o Mr. Stephen M. Page MedReg Associates, Inc. 29 Frigate Street JAMESTOWN RI 02835

Re: K081142

Trade/Device Name: Auto-Band Ligator Regulation Number: 21 CFR \$876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: MND Dated: April 16, 2008 Received: April 22, 2008

### 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). 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 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 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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Page 1 of 1

510(k) Number (if known): 1

Device Name: Auto-Band Ligator

Indications for Use:

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

For single use only.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

(Posted July 1, 1998)

Aonu M. Whay

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices Kog1142 510(k) Number

(Optional Format 3-10-98)