(344 days)
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 polypectompy of pedunculated polyps.
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.
This is a 510(k) premarket notification for a medical device (Olympus HX-20-1 Endoscopic Ligator), not a submission for an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, and AI/ML specific metrics (like algorithm performance, training/test sets, human-in-the-loop, etc.) is not applicable to this document.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use and device description, as required for traditional 510(k) submissions. There's no mention of any AI or software-based components in the device or its evaluation.
{0}------------------------------------------------
K 964661
510(k) SUMMARY OLYMPUS HX-20-1 ENDOSCOPIC LIGATOR
OCT 30 1997
| Device Name: | Olympus HX-20-1 Endoscopic Ligator |
|---|---|
| Common/Usual Name: | HX-20-1 Endoscopic Ligator |
| Classification Name: | Endoscope and Accessories21 CFR 876.1500 |
| Predicate Device: | Endoscopic Ligators by C.R. Bard, Wilson-Cook, andMicrovasive |
| Contact Person: | Laura Storms-TylerOlympus America, Inc.Endoscope Division2 Corporate Center DriveMelville, NY 11747-3157(516) 844-5688 |
| 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 MAI-254 Standard Ligation Loop or MAJ-340 Small Ligation Loop 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 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.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 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 ass stated in the enelosure) to devices marketed in interstate commerce international 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, 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 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 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 predication 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 (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/dsmamain.html".
Sincerely yours
W.Liau Yu
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
{2}------------------------------------------------
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.
Bober R. Sathing/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use_
§ 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.