SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228

K990864 · Boston Scientific Corp · MND · Jun 11, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990864
• Device Name: SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
• Applicant: Boston Scientific Corp
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation/injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.

Device Story

Multiple band ligator; consists of distal cylinder for endoscope and handle unit with trip wire. Elastic bands loaded on cylinder; handle features plastic spool rotating clockwise to fire bands. Operation: spool rotation triggers trip wire; audible 'click' confirms band deployment. Used in clinical settings by physicians during endoscopic procedures. Device facilitates mechanical ligation of varices or hemorrhoids; aids in therapeutic intervention for gastrointestinal conditions.

Clinical Evidence

Bench testing only. Laboratory testing performed to verify safety and performance characteristics. Biocompatibility assessment conducted on patient- and fluid-contact materials with satisfactory results.

Technological Characteristics

Components: Ligating unit (distal cylinder) and handle unit (plastic spool, trip wire, scope fastener, irrigation valve). Energy source: Manual mechanical operation. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring treatment of esophageal varices via combination ligation/injection therapy or band ligation treatment of anorectal 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

• Superview

Submission Summary (Full Text)

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K990864

# SECTION 10 510(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.

| > DATE: | March 15, 1999 | | |
|---------------------------------------------------|----------------------------------------------------------------------------------|--------|------------|
| > COMMON/USUAL NAMES: | Hemorrhoidal Ligator, Esophageal Variceal Ligator | | |
| > TRADE/PROPRIETARY NAME: | Speedband Superview Multiple Band Ligator | | |
| > CLASSIFICATION NAME &<br>DEVICE CLASSIFICATION: | Class II | | |
| | Name | Number | 21 CFR Ref |
| | Ligator, Homorrhoidal | 78 FHN | 876.4400 |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU)<br>Gastro-Renal (GRDB) | | |
| > OWNER/OPERATOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 | | |
| > CONTACT PERSON: | Abby Lipman, Senior Regulatory Affairs Specialist | | |

# DESCRIPTION OF DEVICE

The Microvasive Modified Superview is a Multiple Band Ligator composed of two major components.

#### 1. The Ligating Unit

The main component of the ligating unit is a cylinder which fits at the distal end of the endoscope. Elastic bands are stretched around the distal portion of the cylinder.

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<990864

#### 2. Handle Unit with Trip Wire and Scope Fastener

The main component of the Handle Unit is a plastic spool which turns only in the clockwise direction. A trip wire is attached to the plastic spool. When the plastic spool is rotated, the handle will make a distinct "click" sound, and one band will be fired automatically. The Handle Unit also incorporates a scope fastener to secure the handle onto the endoscope. An irrigation valve is located on the side of the Handle Unit.

## INDICATIONS FOR USE

The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation/injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.

# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Modified Superview is substantially equivalent to the currently-marketed Superview. The major components of the Modified Superview are the Ligating Unit and the Handle. A thorough comparison of the descriptive characteristics between the Modified Superview and the currently-marketed Superview show equivalence.

#### PERFORMANCE CHARACTERISTICS

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

## CONCLUSION

Boston Scientific Corporation believes that Modified Superview is substantially equivalent to the currently-marketed Superview. A comparison of the descriptive characteristics of these products demonstrate the Modified Superview is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has performed laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Superview will meet the minimum requirements that are considered acceptable for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 1999

Ms. Abby Lipman Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick. Massachusetts 01760

Re: K990864

Speedband Modified Superview Multiple Band Ligator Regulatory Class: II 21 CFR §876.4400 Product Codes: 78 KHN/78 MND Dated: March 15, 1999 Received: March 16, 1999

Dear Ms. Lipman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, vou are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) vou must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Ms. Abby Lipman

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 the Electronic Product 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 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro 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 entitled, "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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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# SECTION 1 INDICATIONS FOR USE

To Be Determined 510(k) Number:

Modified Superview Device Name:

Indication for Use:

The Modified Superview is indicated for use in treatment of esophageal varicies utilizing combination ligation /injection therapy. The Modified Superview is indicated for band ligation treatment of anorectal hemorrhoids.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K990864

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)