(43 days)
Not Found
No
The summary describes a mechanical device for delivering ligation loops and makes no mention of AI or ML.
Yes
The device is used to prevent or control bleeding, which is a therapeutic action.
No
The device is an endoscopic ligator designed to prevent or control bleeding, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is an "Endoscopic Ligator" and is intended to "deliver a MAJ-254 Ligation Loop (Standard) or MAJ-340 Ligation Loop (Small)". This indicates a physical device used in conjunction with an endoscope and ligation loops, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver a ligation loop to prevent or control bleeding following polypectomy. This is a therapeutic procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description reinforces its function as a delivery tool for a ligation loop used during a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information.
Therefore, the Olympus HX-20-1 Endoscopic Ligator "EndoLoop" is a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
78 FHN, 78 MND
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| Olympus America, Inc. | |
| Regulatory Affairs | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5688 |
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.
1
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
2
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