Who is the manufacturer of Disposable Dual Action Tissue Closure Device?

Mirco-Tech (Nanjing) Co., Ltd. filed the 510(k) submission for Disposable Dual Action Tissue Closure Device (K233772).

What is the FDA product code for Disposable Dual Action Tissue Closure Device?

PKL. It is classified under 21 CFR 876.4400 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Disposable Dual Action Tissue Closure Device?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Disposable Dual Action Tissue Closure Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Dual Action Tissue Closure Device

K233772 · Mirco-Tech (Nanjing) Co., Ltd. · PKL · Mar 19, 2024 · Gastroenterology, Urology

Device Facts

Record ID	K233772
Device Name	Disposable Dual Action Tissue Closure Device
Applicant	Mirco-Tech (Nanjing) Co., Ltd.
Product Code	PKL · Gastroenterology, Urology
Decision Date	Mar 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4400
Device Class	Class 2
Attributes	Therapeutic

Intended 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: 1. Endoscopic marking: 2. Hemostasis for: a.Mucosal/sub-mucosal defects < 5 cm, b.Bleeding ulcers, c.Polyps < 1.5 cm in diameter, d.Diverticula in the colon, e. Arteries < 2 mm, 3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

Device Story

Sterile, single-use endoscopic clipping device; consists of delivery system and clip assembly. Operated by physician during flexible endoscopy. Principle of operation: steel wire pulled through operating handle to drive opening/closing of metallic clip to compress/manipulate GI tissue. Used for endoscopic marking, hemostasis, and closure of small perforations. Benefits patient by providing mechanical tissue closure/hemostasis. Device is manually operated; no software or algorithm involved.

Clinical Evidence

No clinical study included. Bench testing performed for mechanical integrity, dimensions, and usability. Shelf-life validated via accelerated aging (ASTM F1980-16). Clinical literature used to support expanded indication for hemostasis of mucosal/sub-mucosal defects up to 5 cm.

Technological Characteristics

Metallic clip with clasping mechanism; EO sterilized (SAL 10^-6); shelf life 3 years. Materials conform to ISO 10993-1. MR compatibility evaluated per ASTM F2503, F2052, F2119, F2182, F2213. Dimensions: 15 mm open width; working lengths 1650, 1950, 2350 mm; compatible with 3.2 mm endoscope working channel.

Indications for Use

Indicated for adult patients undergoing flexible endoscopy for clip placement in the GI tract for endoscopic marking, hemostasis (mucosal/sub-mucosal defects < 5 cm, bleeding ulcers, polyps < 1.5 cm, colonic diverticula, arteries < 2 mm), and closure of GI luminal perforations < 20 mm.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Disposable Dual Action Tissue Clip (K212748)

Related Devices

K212748 — Disposable Dual Action Tissue Clip · Micro-Tech (Nanjing) Co., Ltd. · Jan 20, 2022
K250229 — Dual Action Tissue Closure Device · Micro-Tech (Nanjing) Co., Ltd. · Sep 8, 2025
K180325 — Single Use MultiClip Device · Micro-Tech (Nanjing) Co., Ltd. · Jun 1, 2018
K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) · Olympus Medical Systems Corp. · Jun 3, 2024
K152001 — Sterile Repositionable Hemostasis Clipping Device · Micro-Tech (Nanjing) Co., Ltd. · Dec 10, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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). {2}------------------------------------------------ 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 {3}------------------------------------------------ ## 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: 1. Endoscopic marking: 2. Hemostasis for: a.Mucosal/sub-mucosal defects < 5 cm, b.Bleeding ulcers, c.Polyps < 1.5 cm in diameter, d.Diverticula in the colon, e. Arteries < 2 mm, 3. As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {4}------------------------------------------------ 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 {5}------------------------------------------------ K233772 Page 2 of 7 510(k) summary Image /page/5/Picture/2 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 angled slightly to the right, giving the logo a sense of depth. A registered trademark symbol is located in the upper right corner of the logo. #### 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 < 5 cm, - O Bleeding ulcers. - O Polyps < 1.5 cm in diameter, - O Diverticula in the colon, - O Arteries < 2 mm, - As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively. #### 6. Device Description The proposed device Disposable Dual Action Tissue Closure Device is a sterile, single-use endoscopic clipping device, intended to be used in flexible endoscopy for the compression, manipulation of tissue in the gastrointestinal tract. It consists of two main components, delivery system and clip assembly. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 106 and placed in a sterility maintenance package to ensure a shelf life of 3 years. #### 7. Comparison of Technological Characteristics The Disposable Dual Action Tissue Closure Device incorporates substantially equivalent device's {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol is located in the upper right corner of the logo. The logo has a modern and corporate appearance. materials, design, configuration, packaging fundamental technology, manufacturing processes including sterilization process as those featured in the predicate device Disposable Dual Action Tissue Clip | cleared under K212748. | | |------------------------|--| |------------------------|--| | | Proposed Device | Predicate Device | | |-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | ITEM | Disposable Dual Action Tissue Closure Device | Disposable Dual Action Tissue Clip (K212748) | Remark | | Product Code | PKL | PKL | Same | | Regulation No. | 876.4400 | 876.4400 | Same | | Class | 2 | 2 | Same | | 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 ○Mucosal/sub-mucosal defects < 5 cm, ○Bleeding ulcers, ○Polyps < 1.5 cm in diameter, ○Diverticula in the colon, ○Arteries < 2 mm, • As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively. | 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 ○Mucosal/sub-mucosal defects < 3 cm, ○Bleeding ulcers, ○Polyps < 1.5 cm in diameter, ○Diverticula in the colon, ○Arteries < 2 mm, • As a supplementary method, closure of GI tract luminal perforations < 20 mm that can be treated conservatively. | One indication is changed | | Configuration | 2 delivery units of the delivery system and 2 separate clips of the clip assembly | 2 delivery units of the delivery system and 2 separate clips of the clip assembly | Same | | Principles of Operation | Pull the steel wire through the operating handle to drive the opening and closing of the clip to clamp the tissue. It is a metallic | Pull the steel wire through the operating handle to drive the opening and closing of the clip to clamp the tissue. It is a metallic | Same | | | 510(k) summary | | | | | Proposed Device | Predicate Device | | | ITEM | Disposable Dual Action Tissue Closure Device device with a clasping mechanism. | Disposable Dual Action Tissue Clip (K212748) device with a clasping mechanism. | Remark | | Open width (mm) | 15 | 15 | Same | | Working Length (mm) | 1650,1950,2350 | 1650,1950,2350 | Same | | Minimal working channel of endoscopy (mm) | 3.2 | 3.2 | Same | | Supplied in Sterile | Yes | Yes | Same | | Single Use | Yes | Yes | Same | | Packaging | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Same | | Shelf Life | Three years | One year | Different | | Biocompatibility | Conform to ISO 10993-1 | Conform to ISO 10993-1 | Same | | Sterilization | EO Sterilized, SAL:10-6 | EO Sterilized, SAL:10-6 | Same | | Labeling | Conform to 21 CFR part 801 | Conform to 21 CFR part 801 | Same | | MRI information | Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 | Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 | Same | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional font. The letters are predominantly blue, with the "M" appearing to the left and slightly behind the "T", creating a sense of depth. A registered trademark symbol is visible in the upper right corner of the logo. #### 8. Performance Data The performances of Disposable Dual Action Tissue Closure Device are as follows: - Dimension - . Clip Assembly Repeated Open/Close; - Scope Compatibility/Usability; - Endoscope Damage; - Biopsy Valve compatibility; {8}------------------------------------------------ K233772 Page 5 of 7 #### 510(k) summary Image /page/8/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, with the "M" on the left and the "T" on the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. - Clip approach; O - Clip Open and Close Force ● - Release Force; - Tensile Strength: - Clamping Strength; - Coil to handle Tensile. - Mechanical Integrity of Clip Assembly Compared with the predicate device Disposable Dual Action Tissue Clip cleared under K212748, the proposed devices have the same design, dimension, configuration, material, principles of operation, control mechanism as the predicate device, the performances and performance specification are also the same as the predicate device, no change. The performance of proposed device is substantially equivalent to the predicate devices Disposable Dual Action Tissue Clip (K212748). The bench performance testing that was previously conducted on the predicate device and not reconducted on the proposed device. 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. Compared with the predicate device, the shelf life was changed to three years. Three-years accelerated aging tests were performed using the same test method and acceptance criteria as predicate device to demonstrate the 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". Compared with the predicate device, the sterilization method is not changed. The sterilization testing that was previously conducted on the predicate device and not re-conducted on the proposed device. Compared with the predicate device, the material of proposed device is not changed, therefore, the biocompatibility of proposed device is also the same. The tests that were submitted for the predicate {9}------------------------------------------------ #### 510(k) summary Image /page/9/Picture/2 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, creating a sense of depth and solidity. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. device are as followed: - Cytotoxicity a) - b) Sensitization - Intracutaneous Reactivity c) - d) Acute Systemic Toxicity - Material Mediated Pyrogenicity e) - f) Chemical Characterization The biocompatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device. MR compatibility was evaluated in accordance with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 and FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment issued on May 20, 2021. Compared with the predicate device, the material and MR environment of proposed device are not changed. The MR compatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device. For the indication change, clinical literature was used to support changing the IFU to include hemostasis for mucosal/sub-mucosal defects up to 5 cm. For the shelf life change, shelf-life testing was conducted to support a longer shelf-life of 3 years. #### 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, safety and performance testing, {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol is located in the upper right corner of the logo. The logo appears to be for a company or organization with the initials "MT". 510(k) summary Disposable Dual Action Tissue Closure Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Disposable Dual Action Tissue Clip cleared under K212748.