(150 days)
No
The 510(k) summary describes a mechanical hemostasis clip and delivery system. There is no mention of AI, ML, image processing, or any software component that would suggest the use of these technologies. The performance studies focus on mechanical properties and compatibility.
Yes.
The device is used for hemostasis, closure of perforations, and anchoring, which are all therapeutic interventions designed to treat medical conditions within the GI tract.
No
The device is a hemostasis clip used for therapeutic purposes like stopping bleeding, closing perforations, and endoscopic marking, not for diagnosing conditions.
No
The device description explicitly states it consists of "two main components, delivery system and clip assembly," which are physical hardware components. The performance studies also focus on mechanical and material properties of the device.
Based on the provided information, the Lockado™ Repositionable Hemostasis Clip is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Lockado™ clip is a medical device used within the body during an endoscopic procedure.
- The intended use and device description clearly state its purpose is for endoscopic clip placement within the gastrointestinal tract for mechanical actions like marking, hemostasis, closure, and anchoring. These are all therapeutic or procedural actions performed directly on the patient's tissues, not diagnostic tests performed on samples outside the body.
- There is no mention of analyzing biological samples or providing diagnostic information based on the analysis of such samples.
Therefore, the Lockado™ Repositionable Hemostasis Clip is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Lockado™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations 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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January 14, 2021
Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer No.10 Gaoke Third Road Nanjing, Jiangsu 210032 CHINA
Re: K202333
Trade/Device Name: Lockado™ Repositionable Hemostasis Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: November 26, 2020 Received: November 30, 2020
Dear Sally He:
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. Although this letter refers to your product as a device, please be aware 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. You must comply with all the Act's
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality 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)
K202333
Device Name
LockadoTM Repositionable Hemostasis Clip
Indications for Use (Describe)
The Lockado™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope 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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K202333 Page 1 of 6
Image /page/3/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional design. The "M" is on the left and the "T" is on the right, with the "M" appearing slightly in front of the "T". A registered trademark symbol is located in the upper right corner of the logo. The logo has a modern and corporate feel.
Section 5 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: K202333
1. Date of Preparation: 2020-09-17
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: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Lockado™ Repositionable Hemostasis Clip
Common Name: Hemostasis Clip
Regulatory Information
Classification Name: Hemorrhoidal ligator
Classification: II
Product Code: PKL
Regulation Number: 876.4400
Review Panel: Gastroenterology/Urology
4. Identification of Reference device
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Image /page/4/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are blocky and appear to be connected, with the "M" slightly overlapping the "T". A registered trademark symbol (®) is visible in the upper right corner of the logo. The logo has a clean and modern look.
Reference Device
510(k) Number: K182556 Product Name: SureClip™ Repositionable Hemostasis Clip Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
5. Identification of Predicate Device
Predicate Device
510(k) Number: K151802
Product Name: Resolution 360™ Clip
Manufacturer: Boston Scientific Corporation
6. Indications for Use
The Lockado™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations 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;
-
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 >
-
Mechanical Integrity of the Clip Assembly
-
MR Conditional Safety
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Two-year aging test will be performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014+A1:2018 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
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Image /page/8/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol is located in the upper right corner of the logo.
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16,2016.
10. Animal Study
No animal study is included in this submission.
11. Clinical Study
No clinical study is included in this submission.
12. Substantially Equivalent (SE) Conclusion
The nonclinical tests demonstrate that the device Lockado™ Repositionable Hemostasis Clip is as safe, as effective, and performs as well as or better than the legally marketed device.
Based on the indications for use, technological characteristics, and safety and performance testing, the Lockado™ 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).