K Number

Device Name

SINGLE USE REPOSITIONABLE CLIP

Manufacturer

OLYMPUS MEDICAL SYSTEMS CORP.

Date Cleared

2013-04-29

(159 days)

Product Code

PKL

Regulation Number

876.4400

Intended Use

This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for (1) endoscopic marking (2) hemostasis for (a) mucosal/sub-mucosal defects < 3 cm, (b) bleeding ulcers, (c) arteries < 2 mm, (d) polyps < 1.5 cm in diameter, (e) diverticula in the colon, (3) anchoring to affix jejunal feeding tubes to the wall of the small bowel, (4) as a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

Device Description

The subject device is composed of two parts, the clip fixing device. The clip can be closed and re-opened. The clip is pre-loaded in the clip fixing device, connected with an operation wire. The clip will open when the slider of the clip fixing device is pushed, and close when it is pulled towards the operator. The clip could be closed and re-opened up to five times. When the slider is pulled further, the clip closes completely. The clip will be released when the slider is pushed.

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

K013066

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.

Therapeutic

Yes
The device is described as being used for medical purposes, specifically endoscopic clip placement for conditions like hemostasis, closure of perforations, and anchoring tubes, which are all therapeutic actions.

Diagnostic

The device is described as an endoscopic clip placement instrument used for therapeutic purposes such as hemostasis, marking within the GI tract, and closing perforations. It does not mention any diagnostic functions or capabilities.

SaMD (Software as a Medical Device)

The device description explicitly details physical components (clip fixing device, clip, operation wire, slider) and performance testing related to these physical components (tensile strength, opening width, rotation mechanism, biocompatibility, MRI testing). There is no mention of software as a component or its function.

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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
Device Function: The described device is an endoscopic clip placement instrument used within the gastrointestinal tract for procedures like hemostasis, marking, and closure of perforations. It is a surgical/interventional device, not a diagnostic one.
Intended Use: The intended uses listed are all related to therapeutic or procedural interventions within the body, not diagnostic testing of specimens.
Device Description: The description focuses on the mechanical aspects of the clip and delivery system for placement within the body.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.

Therefore, this device falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for

(1) endoscopic marking
(2) hemostasis for
- (a) mucosal/sub-mucosal defects

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

K123601 page 1 of 4

510(k) SUMMARY

APR 2 9 2013

Singe Use Repositionable Clip,

April 16, 2013

General Information 1

| | Applicant: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Establishment Registration No: 8010047 |
|--|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Official Correspondent: | Sheri L. Musgnung
Regulatory Affairs & Quality Assurance
Olympus America Inc.
3500 Corporate Parkway
PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-3147FAX: 484-896-7128
Email: sheri.musgnung@olympus.com |
| | Manufacturer: | Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0367
Establishment Registration No.: 9614641 |

Device Identification 2

| Device Name | HX-Y0003-L
HX-Y0003-U |
|-----------------------|----------------------------------------------------------|
| Device Trade Name: | Single Use Repositionable Clip |
| Common Name: | Endoscopic clipping device |
| Regulation Number: | 21CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Regulatory Class: | II |
| Product Code: | FHN (ligator, hemorrhoidal)
MND (ligator, esophageal) |
| Classification Panel: | Gastroenterology and Urology |

Predicate Device Information 8

| Device Name: | Endoscopic Clipping Device HX-5LR-1, HX-6UR-1
Standard Clip HX-600-135 |
|---------------|---------------------------------------------------------------------------|
| Common Name: | Endoscopic Clipping Device |
| Manufacturer: | Olympus Optical Co., Ltd. |

510(k) No. 대한 K013066

Device Description 4

This instrument is intended to be used with Olympus endoscope for endoscopic clip placement within the gastrointestinal (GI) tract. It is indicated to be used for

(1) endoscopic marking
(2) hemostasis for
- (a) mucosal/sub-mucosal defects