K Number

Device Name

ENDOSCOPIC MULTI-FIRE CLIP APPLIER

Manufacturer

INSCOPE, LLC.

Date Cleared

2002-02-07

(76 days)

Product Code

PKL

Regulation Number

876.4400

Intended Use

The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. The device is not intended for repair of gastrointestinal tract lumenal perforations.

Device Description

The InScope Endoscopic Multi-Fire Clip Applier is designed for gastrointestinal endoscopic clipping for marking and hemostasis. It consists of a control handle, an insertion tube, jaws at the distal end for gripping the tissue, and up to 5 clips that can be attached to the tissue individually with each actuation of the device handle. The device is provided sterile and is for one time use only.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K963160

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical function and does not mention any AI/ML components or capabilities.

Therapeutic

Yes

The device is intended for hemostasis, a medical procedure used to stop bleeding, indicating a therapeutic purpose.

Diagnostic

The device is intended for therapeutic interventions such as hemostasis, marking within the GI tract, and anchoring, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as a control handle, insertion tube, jaws, and clips, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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.
Device Function: The description clearly states the device is an "Endoscopic Multi-fire Clip Applier" used with an endoscope to place clips directly within the gastrointestinal tract for purposes like marking, hemostasis, and anchoring.
No Sample Analysis: The device does not involve the collection or analysis of samples taken from the body. It is a tool used inside the body during an endoscopic procedure.

Therefore, the device's function and intended use fall outside the scope of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Regulation Number and Section

§ 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.

Summary

FEB 0 7 2002

K013889
Page 1 of 3

Summary of Safety and Effectiveness for the InScope Endoscopic Multi-Fire Clip Applier

submitted by

InScope, LLC 8210 NW 27th Street Miami. Fl 33122 Phone: (305) 716-7000 Facsimile: (305) 716-7020

Identification of a Legally Marketed Predicate Device

The InScope Endoscopic Multi-Fire Clip Applier is substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device manufactured and marketed by the Olympus Optical Company, Ltd pursuant to 510(k) K963160.