(116 days)
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 < 5 cm,
b.Bleeding ulcers,
c.Polyps < 1.5 cm in diameter,
d.Diverticula in the colon,
e. Arteries < 2 mm,
- As a supplementary method. closure of GI tract luminal perforations < 20 mm that can be treated conservatively.
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.
This document outlines the acceptance criteria and supporting studies for the Micro-Tech (Nanjing) Co., Ltd. Disposable Dual Action Tissue Closure Device (K233772).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device as substantially equivalent to a predicate device (K212748) except for one indication and shelf-life, and therefore, directly stated acceptance criteria are not explicitly presented as separate quantitative values for each performance test. Instead, the document relies on demonstrating that the proposed device performs the same or better than the predicate device for all shared characteristics, and that the changes in indications and shelf-life are supported by additional testing or literature.
Below is a table summarizing the performance data presented, emphasizing the comparison to the predicate device.
| Test Item / Characteristic | Acceptance Criteria (Implied by Predicate Equivalence or Specific Testing) | Reported Device Performance (Proposed Device K233772) |
|---|---|---|
| Form Factor / Dimensions | Same as predicate (K212748) | Same as predicate (K212748), including: - Open width (15 mm) - Working Length (1650, 1950, 2350 mm) - Minimal working channel of endoscopy (3.2 mm) |
| Material / Configuration | Same as predicate (K212748) | Same as predicate (K212748) |
| Principles of Operation | Same as predicate (K212748) | Same as predicate (K212748) |
| Endoscopic Marking Indication | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Bleeding Ulcers | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Polyps (< 1.5 cm) | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Diverticula in the Colon | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Arteries (< 2 mm) | Same as predicate (K212748) | Same as predicate (K212748) |
| GI Tract Luminal Perforation Closure (< 20 mm) | Same as predicate (K212748) | Same as predicate (K212748) |
| Hemostasis for Mucosal/Sub-mucosal Defects | < 5 cm (Expanded from predicate's < 3 cm) | Supported by clinical literature to include up to 5 cm. |
| Device Performance (Mechanical, Functional) | Same performance specifications as predicate (K212748) | - Dimension: Same as predicate - Clip Assembly Repeated Open/Close: Same performance as predicate. - Scope Compatibility/Usability: Same performance as predicate. - Endoscope Damage: Same performance as predicate. - Biopsy Valve compatibility: Same performance as predicate. - Clip approach: Same performance as predicate. - Clip Open and Close Force: Same performance as predicate. - Release Force: Same performance as predicate. - Tensile Strength: Same performance as predicate. - Clamping Strength: Same performance as predicate. - Coil to handle Tensile: Same performance as predicate. - Mechanical Integrity of Clip Assembly: Same performance as predicate. |
| Shelf Life | 3 years (Increased from predicate's 1 year) | 3-years accelerated aging tests performed using the same test method and acceptance criteria as predicate device. |
| Sterilization (Method, SAL) | EO Sterilized, SAL: 10^-6 (Same as predicate) | EO Sterilized, SAL: 10^-6 (Same as predicate) |
| Biocompatibility | Conform to ISO 10993-1 (Same as predicate) | Conform to ISO 10993-1. Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Chemical Characterization) are the same as predicate. |
| MRI Compatibility | Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 (Same as predicate) | Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213 (Same as predicate). |
2. Sample Size Used for the Test Set and Data Provenance
- Mechanical and Functional Performance Tests (Dimension, Open/Close, Compatibility, Forces, Strength, etc.): The document states that "The bench performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." This implies that the sample sizes for these tests were those used for the K212748 predicate device. The specific sample sizes for these tests are not provided in this summary. The data provenance would be from the original studies for K212748, likely prospective bench testing. The country of origin of this data is not specified, but given the manufacturer's location (China), it's highly probable the testing was conducted there or by affiliated labs.
- Shelf-life Testing: "Three-years accelerated aging tests were performed." The sample size for these accelerated aging tests is not specified. This would be prospective testing. The country of origin is not specified.
- Sterilization Validation: "The sterilization testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
- Biocompatibility Testing: "The biocompatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
- MRI Compatibility Testing: "The MR compatibility performance testing that was previously conducted on the predicate device and not re-conducted on the proposed device." The sample size for this is not provided but would refer to the tests for K212748.
- Indication Change (Mucosal/sub-mucosal defects < 5 cm): "clinical literature was used to support changing the IFU." This suggests the test set for this particular change relied on retrospective data from published clinical studies, not new testing by the manufacturer. The specific sample sizes and provenance of these literature studies are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- For all mechanical, functional, and material tests (including shelf-life, sterilization, biocompatibility, MRI compatibility), the "ground truth" is established by adherence to engineering specifications, regulatory standards (e.g., ISO, ASTM), and comparison to the predicate device's established performance. There is no mention of external human experts establishing ground truth for these technical tests in the sense of clinical interpretation.
- For the indication change regarding mucosal/sub-mucosal defects, the "ground truth" was established by clinical literature. The document does not specify the number of experts in these literature studies or their qualifications, as it references existing publications rather than new expert review panels for this submission.
4. Adjudication Method for the Test Set
- For the technical and performance testing (mechanical, functional, material, shelf-life, sterilization, MRI compatibility), no specific adjudication method is mentioned. Adherence to established test protocols and comparison to predicate device performance would be the primary method.
- For supporting the indication change with clinical literature, no adjudication method is described for the selection or interpretation of the literature. It's implicitly assumed that the referenced literature itself has undergone peer review and scientific scrutiny.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No animal study is included in this submission. No clinical study is included in this submission."
Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance, as this device is a physical medical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical tissue closure device and does not involve an algorithm or human-in-the-loop performance in the sense of AI-driven medical imaging or diagnostics. The performance described is purely mechanical and functional.
7. The Type of Ground Truth Used
The ground truth used depends on the aspect being evaluated:
- Mechanical, Functional, Material, Sterilization, MRI Compatibility Performance: Established through objective physical measurements against specifications and regulatory standards (e.g., ISO 11135, ISO 10993-1, ASTM standards) and direct comparison to the predicate device's previously established performance.
- Shelf-life: Established through accelerated aging test data (ASTM F1980-16).
- Expanded Indication (Mucosal/Sub-mucosal defects < 5 cm): Established through clinical literature.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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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 < 5 cm,
b.Bleeding ulcers,
c.Polyps < 1.5 cm in diameter,
d.Diverticula in the colon,
e. Arteries < 2 mm,
- 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)
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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
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
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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 TissueClosure Device | Disposable Dual Action TissueClip (K212748) | Remark |
| Product Code | PKL | PKL | Same |
| Regulation No. | 876.4400 | 876.4400 | Same |
| Class | 2 | 2 | Same |
| Indications for Use | The Disposable Dual ActionTissue Closure Device is intendedfor use in flexible endoscopy forthe compression of tissue in thegastrointestinal tract for adultpatient only.The Disposable Dual ActionTissue Closure Device is indicatedfor clip placement within thegastrointestinal tract for thepurpose 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 luminalperforations < 20 mm that can betreated conservatively. | The Disposable Dual Action TissueClosure Device is intended for usein flexible endoscopy for thecompression of tissue in thegastrointestinal tract for adultpatient only.The Disposable Dual Action TissueClosure Device is indicated for clipplacement within thegastrointestinal tract for thepurpose 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 luminalperforations < 20 mm that can betreated conservatively. | Oneindicationis changed |
| Configuration | 2 delivery units of the deliverysystem and 2 separate clips of theclip assembly | 2 delivery units of the deliverysystem and 2 separate clips of theclip assembly | Same |
| Principles ofOperation | Pull the steel wire through theoperating handle to drive theopening and closing of the clip toclamp the tissue. It is a metallic | Pull the steel wire through theoperating handle to drive theopening and closing of the clip toclamp the tissue. It is a metallic | Same |
| 510(k) summary | |||
| Proposed Device | Predicate Device | ||
| ITEM | Disposable Dual Action TissueClosure Devicedevice with a clasping mechanism. | Disposable Dual Action TissueClip (K212748)device with a clasping mechanism. | Remark |
| Open width (mm) | 15 | 15 | Same |
| Working Length(mm) | 1650,1950,2350 | 1650,1950,2350 | Same |
| Minimal workingchannel ofendoscopy (mm) | 3.2 | 3.2 | Same |
| Supplied in Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized pouchwith one device per pouch | Single-use EO sterilized pouchwith 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 |
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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;
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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
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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,
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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.
§ 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.