(90 days)
Not Found
No
The provided 510(k) summary describes a mechanical clipping device used with an endoscope for various endoscopic procedures. There is no mention of any software, image processing, AI, or ML capabilities in the intended use, device description (though not found), or any other section. The predicate devices are also mechanical clipping devices.
Yes
The device is intended for endoscopic marking, hemostasis, and endoscopic closure of various defects, which are all therapeutic interventions.
No
The device's intended uses are for endoscopic marking, hemostasis, and endoscopic closure of defects, polyps, diverticula, and fistulas. These are all therapeutic and interventional procedures, not diagnostic ones.
No
The device is described as "Clip Fixing Devices" and is intended to be used with an endoscope. The predicate devices are also described as "Endoscopic Clipping Device". This strongly suggests a physical, hardware-based device used for clipping, not a software-only product.
Based on the provided information, the HX-5/6-1 Clip Fixing Devices are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed within the body using an endoscope (endoscopic marking, hemostasis, endoscopic closure). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The lack of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," "Intended User / Care Setting," and details about training/test sets further supports that this is not an IVD. These sections are often relevant for devices that analyze biological samples or medical images.
The device is an endoscopic accessory used for therapeutic and marking procedures performed directly on tissues within the body.
N/A
Intended Use / Indications for Use
The Rotatable Clip Fixing Devices HX-5/6-1 are intended to be used with an endoscope for:
- endoscopic marking
- hemostasis for
a. mucosal/sub-mucosal 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus Optical Co., Ltd. % Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747-3157
.JUI 2 7 2015
Re: K013066
Trade/Device Name: Rotatable Clip Fixing Devices HX-5/6-1 Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: FHN, MND Dated (Date on orig SE ltr): September 10, 2001 Received (Date on orig SE ltr): September 12, 2001
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent letter of December 11, 2001
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Safetv/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.
Benjamin R. Fisher -S
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
2
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Regulable Clip Fixing Devices RE-5/6-1
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