(90 days)
The HX-5/6-1 Clip Fixing Devices are intended to be used with an Olympus endoscope for the purpose of:
(1) endoscopic marking,
(2) 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,
(3) as a method for endoscopic closure of
(a) mucosal/sub-mucosal defects <3cm,
(b) polyps <1.5cm in diameter,
(c) diverticula in the colon,
(d) fistulas <20mm that can be treated conservatively.
Not Found
The provided text is a 510(k) summary for the Olympus HX-5/6-1 Endoscopic Clipping Device. While it describes the device's intended use and provides a comparison to predicate devices, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance studies.
Therefore, I cannot extract the requested information from the given text.
The document discusses:
- Device Name: Rotatable Clip Fixing Devices HX-5/6-1
- Manufacturer: Olympus Optical Co., Ltd.
- Regulation Number: 21 CFR 876.4400 (Hemorrhoidal Ligator, Class II)
- Intended Use: Endoscopic marking, hemostasis (for mucosal/sub-mucosal defects, bleeding ulcers, arteries <2mm, polyps <1.5cm, diverticula in the colon), and as an aid to clip closure of GI tract perforations <20mm that can be treated conservatively.
- Predicate Devices: HX-5/6-1 Endoscopic Clipping Device #K963160 and Olympus HX-5/6 Endoscopic Clipping Device #K990687.
The document is primarily a regulatory filing (510(k) summary) demonstrating substantial equivalence to previously marketed devices rather than a detailed report of performance testing against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
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
{1}------------------------------------------------
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 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 (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/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 (800) 638-2041 or (301) 796-7100 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
{2}------------------------------------------------
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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 |
{3}------------------------------------------------
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 (426)-42-5177 FAX (426)-46-5613
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: (631) 844-5688 FAX: (631) 844-5416
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 #K963160Olympus HX-5/6 Endoscopic Clipping Device #K990687 |
{4}------------------------------------------------
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§ 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.