(317 days)
Not Found
Not Found
No
The summary describes a mechanical endoscopic clipping device and makes no mention of AI or ML capabilities.
Yes
The intended use explicitly states purposes like hemostasis for bleeding ulcers and arteries, and anchoring feeding tubes, which are therapeutic actions within the gastrointestinal tract.
No
The device is described as an "Endoscopic Clipping Device" intended for "clip placement" and "marking, hemostasis, and temporary anchoring within the GI tract." These are interventional and therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is an "Endoscopic Clipping Device," which is a physical, hardware-based medical device used within the GI tract. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the gastrointestinal tract for mechanical actions (marking, hemostasis, anchoring). This is a therapeutic and procedural use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description reinforces its use for "endoscopic clipping for marking, hemostasis, and temporary anchoring within the GI tract."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Olympus HX-5/6-1 Endoscopic Clipping Device is intended 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
JUN 27 1997
K 963160
ાના વિ
| Device Name: | Olympus HX-5/6-1 Endoscopic Clipping Device |
|---|---|
| Common/Usual Name: | Endoscopic Clipping Device |
| Classification Name: | Endoscopes and Accessories |
| 21 CFR 876.1500 | |
| Predicate Devices: | Olympus HX-2, HX-3, and HX-4 Clipping Devices |
| Contact Person: | Subhash R. Patel |
| Olympus America, Inc. | |
| Endoscope Division | |
| 2 Corporate Center Drive | |
| Melville, NY 11747-3157 | |
| (516) 844-5481 | |
| Summary Preparation Date: | March 26, 1997 |
| Statement of Intended Use: | The Olympus HX-5/6-1 Endoscopic Clipping Device is intended 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 |