Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed 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 <3cm, bleeding ulcers and arteries <2mm, polyps<1.5cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

Device Description

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips. These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope. When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

AI/ML Overview

The provided document (K990687) is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and specifying the intended use, rather than detailing a study with specific acceptance criteria and performance metrics.

Therefore, many of the requested sections (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, specific ground truth types) are not available in this type of regulatory submission. This document does not describe a study to prove the device meets acceptance criteria in the way a clinical trial report would. Instead, it describes the device and its intended use, and asserts its substantial equivalence to a previously cleared device.

However, I can extract information related to the device's functional description and intended use, which inherently defines some performance expectations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense. The "performance" described is largely functional and mechanical, demonstrating how the device operates and what it is designed to achieve in clinical use. The "criteria" are inferred from the device's intended use and design description, and the "performance" is a description of its operational mechanics.

Acceptance Criteria (Inferred from Intended Use/Function)	Reported Device Performance (Description of Operation)
Clip Deployment Mechanism:	Clips are attached to a hook on the wire. Applying tension to the control wire "seats" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath is advanced to cover the coil and attached clip. The device is inserted through the endoscope channel.
Clip Retraction and Closure:	Tube sheath is retracted by moving the tube joint distally until an audible "click." When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe).
Clip Opening and Closing Dynamics:	Due to the clip's shape, it initially opens wider as it is pulled into the pipe. As it is pulled further, the clip pipe forces the clip arms to close on the target tissue and deploy.
Intended Use - Endoscopic Marking:	Designed for endoscopic clip placement within the GI tract for endoscopic marking.
Intended Use - Hemostasis (Upper GI Mucosal/Submucosal Defects):	Designed for hemostasis in the upper GI tract for mucosal/submucosal defects <3cm.
Intended Use - Hemostasis (Bleeding Ulcers and Arteries):	Designed for hemostasis for bleeding ulcers and arteries <2mm.
Intended Use - Hemostasis (Polyps):	Designed for hemostasis for polyps <1.5cm in diameter.
Intended Use - Anchoring (Jejunal Feeding Tubes):	Designed for anchoring to affix jejunal feeding tubes to the wall of the small bowel.
Exclusion of GI Tract Repair:	Not intended for the repair of GI tract lumenal perforations. (This is a negative criterion, indicating a limitation.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. This document does not detail a study involving a test set of data or subjects.
Data Provenance: Not applicable, as no external data set or study is described in this summary. The information pertains to the device's design and intended function.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth establishment for a test set is not described.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set or ground truth adjudication process is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. The document does not describe a comparative effectiveness study involving human readers with or without AI assistance. The device is a mechanical clipping device, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Standalone Study: No. This is a medical device, not an algorithm, so this concept is not applicable. The device is designed for human-in-the-loop operation by a clinician performing an endoscopic procedure.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable. The document is not about evaluating a diagnostic algorithm against a ground truth. Its purpose is to demonstrate substantial equivalence of a physical medical device. The "ground truth" here is implied by the clinical context in which such clipping devices are used, as established by medical practice and guidelines for endoscopic hemostasis and marking.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This concept applies to machine learning algorithms, not a physical medical device like an endoscopic clipper.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary (K990687) is a regulatory filing for an endoscopic clipping device, not a report of a study involving clinical data, AI algorithms, or a detailed breakdown of acceptance criteria and performance against those criteria. It describes the device's design, intended use, and asserts its substantial equivalence to a predicate device already on the market.

Summary

{0}------------------------------------------------

3/26/99

$\kappa$ 990687 pg, /gr

510(k) SUMMARY OLYMPUS HX-5/6-1 Endoscopic Clipping Device

A. Submitter's Name, Address, Phone and Fax Numbers

1. Manufacturer of the subject devices

Name & Address of manufacturer:	Olympus Optical Co., Ltd.22-2 Nishi-Shinjuku, 1-Chome,Shinjuku-ku, Tokyo 163-8610Japan
Registration No.:	8010047
Address, Phone and Fax Numbers:	2951 Ishikawa-Cho,
of R&D Department,	Hachioji-shi, Tokyo 192-8507
Endoscope Division	Japan
	TEL 0426-42-5101
	FAX 0426-46-2786

B. Name of Contact Person

Name: Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Regulatory Affairs Two Corporate Center Drive Melville, New York 11747-3157 TEL: (516)-844-5688 FAX: (516)-844-5416

C. Device Name, Common Name, Classification Name and Predicate Devices

Device Name:	Olympus HX-5/6-1 Endoscopic Clipping Device
	Standard Clips MD-59/850
	Long Clips MD-858
	Short Clips MD-859
	MAJ-459 Short Clip
Common Name:	Endoscopic Clipping Device
Classification Name:	Endoscope and accessories
Predicate Device:	Olympus HX-5/6-1 Endoscopic Clipping DeviceK963160

{1}------------------------------------------------

K 99 0687 pg 2gr

D. Description of the Device(s)

The HX-5/6-1 Endoscopic Clipping Device is available as a set consisting of the HX-5/6-1 Endoscopic Clipping Device main body and clips.

These clips are attached to the hook when the wire is advanced out of the distal end of the device. Applying tension to the control wire will "seat" a step on the clip onto the distal end of the stainless steel coil. The FEP tube sheath may then be advanced to cover the distal end of the coil and the attached clip. The device may then be inserted through the instrument channel of the appropriate endoscope.

When the device has been advanced to the area of interest, the tube sheath is retracted by moving the tube joint distally until an audible "click" is heard. When the control section slider is pulled proximally, the control wire is tensioned, and the clip is pulled into the clip body (pipe). Due to the shape of the clip itself, when the clip is pulled into the clip pipe, it will initially open wider. As it is pulled in even further, the clip pipe will force the clip arms to close on the target tissue and deploy.

E. Intended Use of the Device(s)

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2015

Olympus America, Inc. Laura Storms-Tyler Director, Regulatory Affairs Two Corporate Center Drive Melville, NY 11747-3157

Re: K990687

Trade/Device Name: Olympus HX-5/6-1 Endoscope Clipping Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE Itr): February 25, 1999 Received (Date on orig SE Itr): March 1, 1999

Dear Laura Storms-Tyler,

This letter corrects our substantially equivalent letter of March 26, 1999.

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

{3}------------------------------------------------

Page 2 -

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Safety/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,

Joyce M. Whang -S

for 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

{4}------------------------------------------------

15 990687 510(k) Number(if known): __

Device Name: Olympus HX-5/6-1 Endoscopic Clipping Device Indications for Use:

Olympus HX-5/6-1 Endoscopic Clip Fixing Device has been designed 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 <3cm, bleeding ulcers and arteries <2mm, polyps <1.5cm in diameter, ' and anchoring to affix jejunal feeding tubes to the wall of the small bowel. This device is not intended for the repair of GI tract lumenal perforations.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

Division of	ctive, Abdominal, ENT, and Radiological Devices
-------------	-------------------------------------------------

510(k) Number	K990687
---------------	---------

Prescription Use		OR	Over-The-Counter Use
------------------	-------------	----	----------------------

(Per 21 CFR 801.109)

(Optoinal Format 1-2-96)

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.