(116 days)
No
The summary describes a mechanical tissue closure device and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is intended for clinical use in the gastrointestinal tract for purposes such as endoscopic marking, hemostasis, and closure of luminal perforations, which are therapeutic interventions.
No
Explanation: The device is intended for therapeutic interventions such as tissue compression, hemostasis, and closure of perforations in the gastrointestinal tract, rather than 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, further indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The Disposable Dual Action Tissue Closure Device is a surgical tool used inside the body during flexible endoscopy procedures. It is used for mechanical actions like compressing, manipulating, and closing tissue.
- Intended Use: The intended use clearly describes its application within the gastrointestinal tract for procedures like marking, hemostasis, and closing perforations. These are all in vivo (within the living body) procedures.
The device description and intended use clearly indicate that this is a therapeutic and procedural device used directly on tissue within the body, not a device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
The Disposable Dual Action Tissue Closure Device 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 Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
-
Endoscopic marking:
-
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 19, 2024
Micro-Tech (Nanjing) Co., Ltd. Sally He Regional RA Manager No.10 Gaoke Third Road Nanjing National Hi-Tech, Industrial Development Zone Nanjing, Jiangsu 210032 China
Re: K233772
Trade/Device Name: Disposable Dual Action Tissue Closure Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: January 19, 2024 Received: January 19, 2024
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 (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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Shanil P. Haugen -S
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
510(k) Number (if known) K233772
Device Name
Disposable Dual Action Tissue Closure Device
Indications for Use (Describe)
The Disposable Dual Action Tissue Closure Device 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 Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
-
Endoscopic marking:
-
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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Image /page/4/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.
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: K233772
1. Date of Preparation: 2024-03-14
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: Regional RA Manager
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 Closure Device
Common Name: Hemostasis Clip
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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K233772 Page 2 of 7
510(k) summary
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Identification of Predicate Device 4.
510(k) Number: K212748
Product Name: Disposable Dual Action Tissue Clip
Manufacturer: Micro-Tech (Nanjing) Co., Ltd.
5. Indications for Use
The Disposable Dual Action Tissue Closure Device 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 Closure Device is indicated for clip placement within the gastrointestinal tract for the purpose of:
- Endoscopic marking,
- Hemostasis for
- O Mucosal/sub-mucosal defects