HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

K963160 · Olympus America, Inc. · PKL · Jun 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963160
• Device Name: HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
• Applicant: Olympus America, Inc.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus HX-5/6-1 Endoscopic Clipping Device is intended 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 <3 cm, bleeding ulcers and arteries <2 mm, polyps <1.5 cm 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 Story

Endoscopic clipping device used by physicians in clinical settings to place clips within the GI tract. Device facilitates endoscopic marking, hemostasis for specific mucosal/submucosal defects, bleeding ulcers, and polyps, and anchoring of jejunal feeding tubes. Operates via manual endoscopic delivery. Output is the physical placement of a clip to provide mechanical closure or marking. Benefits include localized hemostasis and secure tube placement. Device is not for lumenal perforation repair.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics compared to predicate devices.

Technological Characteristics

Endoscopic clipping device; manual mechanical actuation; designed for use with endoscopes. No software or electronic components.

Indications for Use

Indicated for patients requiring endoscopic clip placement in the GI tract for marking, hemostasis (upper GI mucosal/submucosal defects <3 cm, bleeding ulcers/arteries <2 mm, polyps <1.5 cm), or anchoring jejunal feeding tubes. Contraindicated for repair of GI tract lumenal perforations.

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

• Olympus HX-2 Clipping Device
• Olympus HX-3 Clipping Device
• Olympus HX-4 Clipping Device

Submission Summary (Full Text)

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JUN 27 1997
K 963160
141

# 510(k) Summary
## For The
### Olympus HX-5/6-1 Endoscopic Clipping Device

**Device Name:** Olympus HX-5/6-1 Endoscopic Clipping Device

**Common/Usual Name:** Endoscopic Clipping Device

**Classification Name:** Endoscopes and Accessories
21 CFR 876.1500

**Predicate Devices:** Olympus HX-2, HX-3, and HX-4 Clipping Devices

**Contact Person:** Subhash R. Patel
Olympus America, Inc.
Endoscope Division
2 Corporate Center Drive
Melville, NY 11747-3157
[phone]

**Summary Preparation Date:** March 26, 1997

**Statement of Intended Use:** The Olympus HX-5/6-1 Endoscopic Clipping Device is intended 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 &lt;3 cm, bleeding ulcers and arteries &lt;2 mm, polyps &lt;1.5 cm 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 Olympus HX-5/6-1 Endoscopic Clipping Device is specifically designed for endoscopic clipping for marking, hemostasis, and temporary anchoring within the GI tract. The Olympus HX-5/6-1 Endoscopic Clipping Device is based on the design of predicate clipping devices and is substantially equivalent in design, method of operation, and safety to these predicate devices.

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U.S. DEPARTMENT OF HEALTH &amp; HUMAN SERVICES

Public Health Service

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

March 25, 2015

Olympus America, Inc.
Subhash R. Patel
Regulatory Affairs Manager
Two Corporate Center Drive
Melville, NY 11747-3157

Re: K963160
Trade/Device Name: HX-5/6-1 Endoscopic Clipping Device
Regulation Number: 21 CFR§ 876.4400
Regulation Name: Hemorrhoidal ligator
Regulatory Class: II
Product Code: PKL
Dated (Date on orig SE ltr): April 24, 1997
Received (Date on orig SE ltr): May 2, 1997

Dear Subhash R. Patel,

This letter corrects our substantially equivalent letter of June 27, 1997.

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 (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 [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/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 [phone] or [phone] 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

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K963160

Subject Device Name: Olympus HX-5/6-1 Endoscopic Clipping Device

Indications for Use:
The subject 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 &lt;3 cm, bleeding ulcers and arteries &lt;2 mm, polyps &lt;1.5 cm 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

Prescription Use ☑ (per 21CFR 801.109)
OR
510(k) Number K963160
Over-the-Counter Use
(Optional Format 1-2-96)