SPEEDBAND MULTIPLE BAND LIGATOR

K964079 · Boston Scientific Corp · FHN · Feb 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964079
• Device Name: SPEEDBAND MULTIPLE BAND LIGATOR
• Applicant: Boston Scientific Corp
• Product Code: FHN · Gastroenterology, Urology
• Decision Date: Feb 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.

Device Story

Speedband Multiple Band Ligator; endoscopic device for ligation of anorectal hemorrhoids and esophageal varicies. Comprises ligating handle and ligating unit. Used by physicians during endoscopic procedures. Device facilitates mechanical ligation of target tissue. Substantially equivalent to predicate ligators; design and materials similar to existing market devices.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. No clinical data presented.

Technological Characteristics

Device consists of ligating handle and ligating unit. Materials are biocompatible. Mechanical ligation principle. No software or electronic components.

Indications for Use

Indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies 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

• Speedband™ Multiple Band Ligator (K964079)
• Wilson Cook Six Shooter

Submission Summary (Full Text)

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FEB 13 1997
K964079
P102
SECTION 7
510(K) SUMMARY

# FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification “...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person.” Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

- COMMON/USUAL NAMES: Hemorrhoidal Ligator, Esophageal Variceal Ligator
- TRADE/PROPRIETARY NAME: Speedband™ Multiple Band Ligator
- CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II
- CONTACT PERSON: Lisa M. Quaglia, Senior Regulatory Affairs Specialist

## INDICATIONS FOR USE

The Speedband Multiple Band Ligator is indicated for endoscopic ligation of anorectal hemorrhoids and esophageal varicies.

## DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Modified Speedband™ is substantially equivalent to the currently-marketed Speedband™ and the Wilson Cook Six Shooter. These devices share similar materials, manufacturing process, and intended use. The major components of the Modified Speedband™ are the ligating handle and the ligating unit.

## PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Modified Speedband™ to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Speedband™ with satisfactory results.

## CONCLUSION

Boston Scientific Corporation believes that Modified Speedband™ is substantially equivalent to the currently-marketed Speedband™ as well as the Wilson Cook Six Shooter. The Modified Speedband™ is equivalent in its indications for use, while being very similar in design and

Premarket Notification, Modified Speedband™, November 1, 1996
Proprietary and Confidential Information of Boston Scientific Corporation

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K964079
p272

materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Speedband™ will meet the minimum requirements that are considered acceptable for its intended use.

Premarket Notification, Modified Speedband™, November 1, 1996
Proprietary and Confidential Information of Boston Scientific Corporation
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