(143 days)
No
The summary describes a mechanical tissue clip and its delivery system. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and material properties.
Yes
The device is described as assisting in hemostasis, which is a therapeutic action (stopping bleeding). It is also used for closure of perforations, which is a treatment.
No
The device is a therapeutic and interventional device used for tissue compression, hemostasis, and closure of perforations in the gastrointestinal tract, rather than for diagnosing conditions.
No
The device description clearly states it is a physical, sterile, single-use endoscopic clipping device with two main components: a delivery system and a clip assembly. It also details physical performance testing, sterilization, and biocompatibility, all indicative of a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "compression of tissue in the gastrointestinal tract" and lists various clinical applications like marking, hemostasis, and closure of perforations. These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The description details a mechanical device used for clipping tissue. It does not mention any components or processes related to testing samples of bodily fluids or tissues outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a surgical tool used directly on tissue within the body.
N/A
Intended Use / Indications for Use
The Disposable Dual Action Tissue Clip is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Clip is indicated for clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking,
- Hemostasis for
- 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
January 20, 2022
Micro-Tech (Nanjing) Co., Ltd. Cecilia Sun RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech Industrial Developement Zone Nanjing, Jiangsu Province 210032 CHINA
Re: K212748
Trade/Device Name: Disposable Dual Action Tissue Clip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL, Dated: December 3, 2021 Received: December 20, 2021
Dear Cecilia Sun:
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
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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) 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
for
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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Indications for Use
K212748
Device Name Disposable Dual Action Tissue Clip
Indications for Use (Describe)
The Disposable Dual Action Tissue Clip is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Clip is indicated for clip placement within the gastrointestinal tract for the purpose of:
Endoscopic marking,
Hemostasis for
·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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K212748 Page 1 of 6
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Section 5 510(k) Summary
510(k) 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: __________________________________________________________________________________________________________________________________________________
1. Date of Preparation: 2021-12-03
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: Cecilia Sun
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Disposable Dual Action Tissue Clip
Common Name: Hemostasis Clip
Regulatory Information
Classification Name: Hemostatic Metal Clip For The GI Tract
Classification: II
Product Code: PKL
Regulation Number: 876.4400
Review Panel: Gastroenterology/Urology
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K212748 Page 2 of 6
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Section 5 510(k) Summary
4. Identification of Predicate Device
Predicate Device
510(k) Number: K202333
Product Name: Lockado™ Repositionable Hemostasis Clip
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
5. Indications for Use
The Disposable Dual Action Tissue Clip is intended for use in flexible endoscopy for the compression of tissue in the gastrointestinal tract for adult patient only.
The Disposable Dual Action Tissue Clip is indicated for clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking,
- Hemostasis for
- O Mucosal/sub-mucosal defects Dimension;
- ア Release Force;
-
Clamping Strength;
-
Tensile Strength:
-
Clip Assembly Repeated Open/Close:
-
Clip Open And Close Force
-
Scope Compatibility/Usability;
-
Endoscope Damage;
-
Biopsy Valve Compatibility;
-
Clip Approach;
-
Coil to Handle Tensile
-
Mechanical integrity of Clip Assembly Test
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 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of
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Image /page/8/Picture/0 description: The image shows a logo with the letters 'MT' in a bold, sans-serif font. The letters are rendered in a deep blue color and have a three-dimensional effect, achieved through shading and perspective. A registered trademark symbol is visible in the upper right corner of the logo.
Section 5 510(k) Summary
International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
MR compatibility was evaluated in accordance with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 and FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," issued on May 20, 2021.
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Disposable Dual Action Tissue Clip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Lockado™ Repositionable Hemostasis Clip cleared under K202333.