(143 days)
Not Found
No
The summary describes a mechanical clipping device and its intended uses, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is used for hemostasis, closure of GI tract luminal perforations, and endoscopic marking, which are all therapeutic interventions within the gastrointestinal tract.
No
The device is described as a "Sterile Repositionable Hemostasis Clipping Device" intended for endoscopic clip placement for purposes like marking, hemostasis, and closure of perforations. Its function is to perform therapeutic actions within the gastrointestinal tract, not to diagnose conditions.
No
The device description explicitly states it consists of "two main components, delivery system and clip assembly," which are physical hardware components.
No, 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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sterile Repositionable Hemostasis Clipping Device is a surgical/interventional device. It is used within the gastrointestinal tract to physically manipulate tissue for purposes like marking, stopping bleeding, and closing perforations. It does not analyze samples taken from the body.
The description clearly indicates a device used for direct intervention within the body, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Sterile Repositionable Hemostasis Clipping Device 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Micro-Tech (Nanjing) CO., Ltd. Becky Li Manager of Quality Department No. 10 Gaoke Third Road Nanjing, 210032 China
Re: K152001
Trade/Device Name: Sterile Repositionable Hemostasis Clipping Device Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: November 10, 2015 Received: November 12, 2015
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 vours.
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Benjamin R. Fisher, Ph.D. for 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
510(k) Number (if known) K152001
Device Name
Sterile Repositionable Hemostasis Clipping Device
Indications for Use (Describe)
The Sterile Repositionable Hemostasis Clipping Device 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 Department of Health and Human Services Food and Drug 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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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: K152001
1. Date of Preparation: 12/08/2015
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: Manager of Quality Department
Tel: +86-25-58646378
Fax: +86-25-58744269
Email: In@micro-tech.com.cn
3. Identification of Proposed Device
Trade Name: Sterile Repositionable Hemostasis Clipping Device
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
Intended Use Statement:
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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: K122660
Product Name: Resolution™ Hemomstasis Clipping Device
5. Indications for Use
The Sterile Repositionable Hemostasis Clipping Device 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