K Number
K161463
Device Name
SureClip(TM) Repositionable Hemostasis Clip
Date Cleared
2017-01-06

(225 days)

Product Code
Regulation Number
876.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: (1) endoscopic marking, (2) hemostasis for (a) mucosal / sub-mucosal defects < 3cm, (b) bleeding ulcers, (c) polyps < 1.5cm in diameter, (d) diverticula in the colon, (3) as a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
Device Description
The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.
More Information

Not Found

No
The summary describes a mechanical hemostasis clip and delivery system with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.

No
The device is described as an endoscopic clipping device used for mechanical purposes like marking, hemostasis, and closing perforations, rather than providing therapy through biological, chemical, or physical means to treat a disease or condition.

No

The device description and intended use indicate that the SureClip(TM) Repositionable Hemostasis Clip is used for therapeutic purposes (hemostasis, closure of perforations) and endoscopic marking, not for diagnosing conditions or diseases.

No

The device description explicitly states it consists of "two main components, delivery system and clip assembly," which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
  • Device Description and Intended Use: The SureClip™ Repositionable Hemostasis Clip is a device used within the gastrointestinal tract for physical actions like marking, hemostasis (stopping bleeding), and closing perforations. It is a therapeutic and procedural device, not a diagnostic test performed on a sample.

The description clearly indicates a device used for direct intervention within the body, which is the opposite of an in vitro diagnostic.

N/A

Intended Use / Indications for Use

The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

(1) endoscopic marking,

(2) hemostasis for
(a) mucosal / sub-mucosal defects

§ 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.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

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

January 6, 2017

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality Director No. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K161463

Trade/Device Name: SureClip(TM) Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: November 21, 2016 Received: November 28, 2016

Dear Becky Li:

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 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.

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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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161463

Device Name

SureClip(TM) Repositionable Hemostasis Clip

Indications for Use (Describe)

The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

(1) endoscopic marking,

(2) hemostasis for

(a) mucosal / sub-mucosal defects Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Image /page/3/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font. To the right of the letters is the text "MICRO-TECH" in a sans-serif font. Below the text "MICRO-TECH" is some text in a different language.

510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K161463

1. Date of Preparation: 2017-01-05

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone,

Nanjing, Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Becky Li

Position: Quality Director

Tel: +86-25-58646378

Fax: +86-25-58744269

Email: In@micro-tech.com.cn

3. Identification of Proposed Device

Trade Name: SureClip™ Repositionable Hemostasis Clip Common Name: Hemostasis Clipping Device

Regulatory Information

Classification Name: Hemostatic Metal Clip for the GI Tract Classification: 2 Product Code: PKL Regulation Number: 876.4400 Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue, three-dimensional "MT" on the left, followed by the words "MICRO-TECH" in blue on the right. Below "MICRO-TECH" are two Chinese characters.

Intended Use Statement:

This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.

4. Identification of Predicate Device

510(k) Number: K152001

Product Name: Sterile Repositionable Hemostasis Clipping Device

5. Indications for Use

The SureClip™ Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

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