OLYMPUS HX-20 SERIES LIGATING DEVICE

K984255 · Olympus Corp of America · MND · Jan 12, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984255
• Device Name: OLYMPUS HX-20 SERIES LIGATING DEVICE
• Applicant: Olympus Corp of America
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Jan 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Olympus HX-20-1 Endoscopic Ligator "EndoLoop" has been designed to be used with Olympus endoscopes in delivering a MAJ-254 Ligation Loop(Standard) or MAJ-340 Ligation Loop (Small) 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; prevents or controls post-polypectomy bleeding. Operated by physicians during endoscopic procedures. Modification involves updated instruction manual with emergency treatment information and warnings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical endoscopic accessory; used with Olympus endoscopes; delivers ligation loops (MAJ-254/MAJ-340). No electronic, software, or energy-based components.

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

• Olympus HX-20-1 Endoscopic Ligator (K964667)

Submission Summary (Full Text)

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K 98 4255

JAN 1 2 1999

## 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: | Olympus HX-20-1 Endoscopic Ligator, #K964667 |
| Contact Person: | Laura Storms-Tyler<br>Olympus America, Inc.<br>Regulatory Affairs<br>2 Corporate Center Drive<br>Melville, NY 11747-3157<br>[phone] |

November 24, 1998 Summary Preparation Date:

## Statement of Intended Use:

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

## Device Description:

The Olympus HX-20-1 Endoscopic Ligator is intended to deliver a MAJ-254 Ligation Loop (Standard) or MAJ-340 Ligation Loop (Small ) to prevent or control bleeding following polypectomy of pedunculated polyps. The Olympus HX-20-1 Endoscopic Ligator "EndoLoop" is substantially equivalent in intended use to the Olympus HX-20-1 which has been cleared premarket notification with #K964661. The modification on this submission differs from previously cleared 510(k) HX-20-1 in the instruction manual with emergency treatments and warnings.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, facing to the right.

JAN 1 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laura Storms-Tyler Director, Regulatory Affairs Olympus America Inc. 2 Corporate Center Drive Melville, NY 11747-3157

Re: K984255 HX-20-1 Endoscopic Ligator Dated: November 24, 1998 Received: November 30, 1998 Regulatory Class: II 21 CFR 876.4400/Procode: 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 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, 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 yiltro 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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510(k) Number (if known); K 98 42 5 5 5

OLYMPUS HX-20-1 LIGATING DEVICE Device Name:

Indications for Use:

Olympus HX-20-1 Ligating device 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number
K984255