(81 days)
Not Found
No
The device description and performance studies focus on mechanical clip application and tissue approximation, with no mention of AI or ML technologies.
Yes
The device is used to place clips in the GI tract for purposes such as hemostasis (stopping bleeding), anchoring, and closure of perforations, which are all therapeutic interventions.
No
The device is described as an "InScope Multi-Clip Applier" used to place clips in the GI tract for purposes such as endoscopic marking, hemostasis, anchoring feeding tubes, and closure of perforations. These are interventional or therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a sterile, single patient use, disposable instrument with physical components like a flexible portion, jaws, a handle, and a firing mechanism that deploys titanium clips. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The InScope Multi-Clip Applier is a surgical instrument used inside the body (in vivo) during an endoscopic procedure. It directly interacts with and modifies tissue within the gastrointestinal tract.
- Intended Use: The intended uses listed (endoscopic marking, hemostasis, anchoring feeding tubes, closure of perforations) are all therapeutic or procedural actions performed directly on the patient's internal tissues. They do not involve testing samples taken from the body.
Therefore, the InScope Multi-Clip Applier falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking, .
- Hemostasis for: ●
- o Mucosal and 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
OCT 7 - 2005
InScope™ Multi-Clip Applier 510(k) Summary of Safety and Effectiveness
Company
INSCOPE A Division of Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Kimberly Shoemaker, RAC Manager, Regulatory Affairs
Date Prepared:
July 15, 2005
Name of Device
Trade Name: InScope™ Multi-Clip Applier Classification Name: Clip Applier/Endoscopic Clipping Device
Predicate Devices:
Trade Name: Syntheon, LLC: Endoscopic Multi-Fire Clip Applier Olympus Optical Co., Ltd .: Rotatable Clip Fixing Device HX-5/6-1
Device Description
The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.
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Indications for Use
The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:
- Endoscopic marking, .
- Hemostasis for: ●
- o Mucosal and submucosal defects