(88 days)
No
The description focuses on a mechanical clipping device and its delivery system, with no mention of AI or ML capabilities.
Yes
The device is used for hemostasis, which is a therapeutic intervention to stop bleeding. It also aids in the closure of GI tract luminal perforations, thereby treating a medical condition.
No
The device is indicated for therapeutic purposes like hemostasis and closure of luminal perforations, as well as endoscopic marking. None of its stated uses involve diagnosing a condition.
No
The device description clearly states it consists of two main components, a 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 Function: The SureClip Repositionable Hemostasis Clip is a medical device used inside the body (in vivo) during an endoscopic procedure. Its purpose is to physically interact with tissue for marking, hemostasis, and closure of perforations.
- Lack of Sample Analysis: The device does not analyze any biological samples to provide diagnostic information. It is a therapeutic and procedural device.
Therefore, the SureClip Repositionable Hemostasis Clip falls under the category of a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2018
Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China
Re: K182556
Trade/Device Name: SureClip Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 13, 2018 Received: September 17, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel G. Walter Jr -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182556
Device Name
SureClip Repositionable Hemostasis Clip
Indications for Use (Describe)
The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of :
(1) Endoscopic marking;
(2) Hemostasis for
(a) Mucosal / sub-mucosal defects Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The 'M' is larger and positioned slightly behind the 'T', creating a sense of depth. To the right of the logo, there is some text, but it is too blurry to read.
510K Summary
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: K182556
1. Date of Preparation: 2018-12-05
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 and Regulatory Affairs Director
Tel: +86-25-58646378
Fax: +86-25-58744269
Email: Beckyli mt@outlook.com
3. Identification of Proposed Device
Trade Name: SureClip™ Repositionable Hemostasis Clip
Common Name: Hemostasis Clipping Device
Regulatory Information
Classification Name: Hemorrhoidal Ligator Classification: II Product Code: PKL Requlation Number: 876.4400 Review Panel: Gastroenterology/Urology
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Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH (Nanjing) Co., Ltd. The logo consists of the company name in English, followed by the company name in Chinese characters. The English name is in a blue sans-serif font, and the Chinese name is in a similar font and color. There is a blue graphic to the left of the company name.
510K Summary
4. Identification of Predicate Device
Predicate Device
510(k) Number: K151802
Product Name: Resolution 360™ Clip
Manufacturer: Boston Scientific Corporation
Reference Device
510(k) Number: K152001
Product Name: Sterile Repositionable Hemostasis Clipping Device
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
5. Indications for Use
The SureClip™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of :
- (1) Endoscopic marking;
- (2) Hemostasis for
- (a) Mucosal / sub-mucosal defects Dimension;
- Release Force; >
-
Clamping Strength;
-
Mechanical integrity Of Clip Assembly;
-
Tensile Strength;
- Clip Assembly Repeated Open/Close; >
-
Clip Open And Close Force
-
Rotation;
-
Scope Compatibility/Usability;
-
Endoscope Damage;
-
Torque;
-
Biopsy Valve Compatibility;
-
Clip Approach;
-
Coil to Handle Tensile
The testing performed demonstrated that the proposed device and predicate device are equivalent.
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the SureClip™ Repositionable Hemostasis Clip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Resolution 360™ Clip (K151802).