HX-20/21-1 ENDOSCOPIC LIGATOR

K964661 · Olympus America, Inc. · MND · Oct 30, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964661
• Device Name: HX-20/21-1 ENDOSCOPIC LIGATOR
• Applicant: Olympus America, Inc.
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Oct 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop designed to prevent or control bleeding following polypectomy of pedunculated polyps.

Device Story

Endoscopic accessory used with Olympus endoscopes; delivers ligation loops (MAJ-254 or MAJ-340) to pedunculated polyps post-polypectomy. Operates via through-the-scope technique to prevent or control bleeding. Used by clinicians in endoscopic procedures. Provides mechanical ligation to secure polyp stalks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endoscopic accessory; through-the-scope delivery system for ligation loops; compatible with Olympus endoscopes; mechanical operation.

Indications for Use

Indicated for use with Olympus endoscopes to deliver MAJ-254 Standard or MAJ-340 Small Ligation Loops to prevent or control bleeding following polypectomy of pedunculated polyps.

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

• Endoscopic Ligators by C.R. Bard
• Endoscopic Ligators by Wilson-Cook
• Endoscopic Ligators by Microvasive

Submission Summary (Full Text)

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To: Mary J. Cornelius
Page 2 of 4 Thursday, October 23, 1997 4:07:15 PM
K 964661
OCT 30 1997

# 510(k) SUMMARY
## OLYMPUS HX-20-1 ENDOSCOPIC LIGATOR

**Device Name:** Olympus HX-20-1 Endoscopic Ligator

**Common/Usual Name:** HX-20-1 Endoscopic Ligator

**Classification Name:** Endoscope and Accessories
21 CFR 876.1500

**Predicate Device:** Endoscopic Ligators by C.R. Bard, Wilson-Cook, and Microvasive

**Contact Person:** Laura Storms-Tyler
Olympus America, Inc.
Endoscope Division
2 Corporate Center Drive
Melville, NY 11747-3157
[phone]

**Summary Preparation Date:** October 22, 1997

### Statement of Intended Use:

Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop designed to prevent or control bleeding following polypectomy of pedunculated polyps.

### Device Description:

The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus “EndoLoop” is substantially equivalent in intended use to endoscopic ligators marketed by Bard, Microvasive, and Wilson-Cook. The subject ligating device differs from these devices in that it operates via through-the-scope techniques.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
OCT 30 1997

Ms. Laura Storms-Tyler
Director, Regulatory Affairs
Endoscopic Division
Olympus America, Inc.
Two Corporate Center Drive
Melville, New York 11747-3157

Re: K964661
HX-20/21-1 Endoscopic Ligator
Dated: September 3, 1997
Received: September 4, 1997
Regulatory class: II
21 CFR §876.4400/Product code: 78 FHN and MND

Dear Ms. Storms-Tyler:

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

Sincerely yours,


Lillian Yin, Ph.D.
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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To: Mary J. Cornelius
Page 4 of 4 Thursday, October 23, 1997 4:08:36 PM

# Indications for Use Statement

510(k) Number (if known): Not assigned yet K 964661

Device Name: Olympus HX-20-1 Endoscopic Ligator

Indications for Use:

The Olympus HX-20-1 Endoscopic Ligator has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop, designed to prevent or control bleeding following polypectomy of pedunculated polyps.

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K 964661

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use