HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

K013066 · Olympus America, Inc. · MND · Dec 11, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K013066
• Device Name: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
• Applicant: Olympus America, Inc.
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Dec 11, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Endoscopic marking and hemostasis for: (a) mucosal/sub-mucosal defects <3cm, (b) bleeding ulcers, (c) arteries <2mm, (d) polyps <1.5cm in diameter, (e) diverticula in the colon, and (f) other lesions and to close GI tract luminal perforations <20mm that can be treated conservatively.

Device Story

The Olympus HX-5/6-1 is an endoscopic clipping device used by physicians to perform hemostasis and tissue marking within the gastrointestinal tract. The device consists of a delivery system and a rotatable clip. The operator inserts the device through an endoscope; the clip is deployed at the target site to mechanically grasp and hold tissue together. This action facilitates the closure of mucosal/sub-mucosal defects, bleeding ulcers, or perforations, and marks specific areas for identification. The rotatable feature allows the physician to orient the clip precisely before deployment. By providing mechanical closure, the device assists in managing GI bleeding and defects, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, intended use, and technological similarities to legally marketed predicate devices.

Technological Characteristics

The device is a mechanical endoscopic clipping system. It features a rotatable clip mechanism for tissue grasping and closure. It is designed for use through an endoscope. The device is provided sterile.

Indications for Use

Indicated for endoscopic marking and hemostasis in patients with mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula, or GI tract luminal perforations <20mm treatable conservatively.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HX-5/6-1 Endoscopic Clipping Device (K963160)
• Olympus HX-5/6 Endoscopic Clipping Device (K990687)

Submission Summary (Full Text)

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

Olympus Optical Co., Ltd. % Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747-3157

.JUI 2 7 2015

Re: K013066

> Trade/Device Name: Rotatable Clip Fixing Devices HX-5/6-1 Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: FHN, MND Dated (Date on orig SE ltr): September 10, 2001 Received (Date on orig SE ltr): September 12, 2001

Dear Ms. Storms-Tyler,

This letter corrects our substantially equivalent letter of December 11, 2001

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

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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] 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/Safetv/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Benjamin R. Fisher -S

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

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| Prescription Use (Per 21 CFR 801.109) | |
|---------------------------------------|----|
| | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |

| | Money Brogdon |
|--|--------------------------------------|
| | (Division Sign-Om |
| | Division of Reproductive, Abdominal, |
| | and Radiological Devices |
| | 510(k) Number K013066 |

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K013066 pg. 1 of

DEC 1 1 2001

# 510(k) SUMMARY

## Rotatable Clip Fixing Device HX-5/6-1

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

#### 1. Manufacturer of the subject devices

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Bndoscope Division

Olympus Optical Co., Ltd. 2-3-1 Shinjyuku Monolis Nishishinjyuku Shinjuku-ku, Tokyo, Japan 8010047 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL [phone] FAX [phone]

#### B. Name of Contact Person

.Name: Address, Phone and Fax Numbers:

Ms. Laura Storms-Tyler Olympus America Inc. Director, Regulatory Affairs Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

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

Device Name : Olympus HX-5/6-1 Endoscopic Clipping Device Standard Clip HX-600-090 Standard Clip HX-600-135 Long Clip HX-600-090L Short Clip HX-600-0905 Short Clip MAI-458 Short Clip HX-600-135S

| Common Name | : Endoscopic Clipping Device |
|-----------------------|------------------------------------------------------------------------------------------------------|
| Classification Name | : Endoscope and accessories |
| Class | : Class II |
| Classification Number | : 21CFR 876.1500 |
| Predicate Device | : HX-5/6-1 Endoscopic Clipping Device #K963160<br>Olympus HX-5/6 Endoscopic Clipping Device #K990687 |

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