OLYMPUS HX-20 SERIES LIGATING DEVICE by OLYMPUS CORP OF AMERICA

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.

AI/ML Overview

The provided text is a 510(k) summary for the Olympus HX-20-1 Endoscopic Ligator, a medical device. This document does not describe a study to prove the device meets acceptance criteria or contain performance data in the context of an AI/algorithm-driven device.

The 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (Olympus HX-20-1 Endoscopic Ligator, #K964667). Substantial equivalence is determined based on intended use, device description, and technological characteristics. The significant point in this submission is the modification of the instruction manual with emergency treatments and warnings, not changes to the device's fundamental function or a new performance study.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The document is for a medical device (endoscopic ligator), not an AI or algorithmic medical device, and the submission is about a minor modification and substantial equivalence, not a performance study.

Summary

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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-TylerOlympus America, Inc.Regulatory Affairs2 Corporate Center DriveMelville, NY 11747-3157(516) 844-5688

November 24, 1998 Summary Preparation Date:

Statement of Intended Use:

Device Description:

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
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.(b)
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.