(25 days)
Not Found
No
The device description focuses on mechanical components and actions for clip deployment, with no mention of AI/ML terms, image processing, or data-driven functionalities.
Yes.
The device is used for hemostasis in the upper GI tract for mucosal/submucosal defects, bleeding ulcers, and polyps. It is also used for anchoring to affix jejunal feeding tubes. These are therapeutic interventions.
No
The device is designed for endoscopic clip placement for therapeutic purposes such as hemostasis and anchoring, and marking, not for diagnosing medical conditions.
No
The device description clearly details physical components (main body, clips, wire, tube sheath, coil, pipe) and mechanical actions (advancing, applying tension, retracting, pulling). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the Olympus HX-5/6-1 Endoscopic Clip Fixing Device is used for endoscopic clip placement within the gastrointestinal (GI) tract. It is a surgical/interventional device used directly on tissue inside the body.
- Intended Use: The intended uses listed (endoscopic marking, hemostasis, anchoring feeding tubes) are all procedures performed directly on the patient's internal tissues.
Therefore, this device falls under the category of a surgical or interventional medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects
§ 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
3/26/99
t
$\kappa$ 990687 pg, /gr
510(k) SUMMARY OLYMPUS HX-5/6-1 Endoscopic Clipping Device
A. Submitter's Name, Address, Phone and Fax Numbers
1. Manufacturer of the subject devices
| Name & Address of manufacturer: | Olympus Optical Co., Ltd.
22-2 Nishi-Shinjuku, 1-Chome,
Shinjuku-ku, Tokyo 163-8610
Japan |
|---------------------------------|----------------------------------------------------------------------------------------------------|
| Registration No.: | 8010047 |
| Address, Phone and Fax Numbers: | 2951 Ishikawa-Cho, |
| of R&D Department, | Hachioji-shi, Tokyo 192-8507 |
| Endoscope Division | Japan |
| | TEL 0426-42-5101 |
| | FAX 0426-46-2786 |
B. Name of Contact Person
Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Regulatory Affairs Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516)-844-5688 FAX: (516)-844-5416
C. Device Name, Common Name, Classification Name and Predicate Devices
| Device Name: | Olympus HX-5/6-1 Endoscopic Clipping Device |
|---|---|
| Standard Clips MD-59/850 | |
| Long Clips MD-858 | |
| Short Clips MD-859 | |
| MAJ-459 Short Clip | |
| Common Name: | Endoscopic Clipping Device |
| Classification Name: | Endoscope and accessories |
| Predicate Device: | Olympus HX-5/6-1 Endoscopic Clipping Device |
| K963160 |
1
K 99 0687 pg 2gr
D. Description of the Device(s)
The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips.
These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope.
When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.
E. Intended Use of the Device(s)
Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects Trade/Device Name: Olympus HX-5/6-1 Endoscope Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE Itr): February 25, 1999 Received (Date on orig SE Itr): March 1, 1999
Dear Laura Storms-Tyler,
This letter corrects our substantially equivalent letter of March 26, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
15 990687 510(k) Number(if known): __
Device Name: Olympus HX-5/6-1 Endoscopic Clipping Device Indications for Use:
Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis in the upper GI tract for mucosal/submucosal defects | OR | Over-The-Counter Use |
|------------------|-------------|----|----------------------|
|------------------|-------------|----|----------------------|
(Per 21 CFR 801.109)
(Optoinal Format 1-2-96)