Lockado Repositionable Hemostasis Clip

K202333 · Micro-Tech (Nanjing) Co., Ltd. · PKL · Jan 14, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K202333
• Device Name: Lockado Repositionable Hemostasis Clip
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jan 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 < 3cm, (b) Bleeding ulcers, (c) polyps < 1.5cm in diameter, (d) diverticula in the colon, (e) Arteries < 2 mm, (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. (3) as a supplementary method, closure of Gl tract luminal perforations 20mm that can be treated conservatively. (4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel;

Device Story

Sterile, single-use endoscopic clipping device; delivery system and clip assembly; used via straight or side-viewing flexible endoscope. Physician-operated in clinical settings. Device enables mechanical closure of tissue defects, hemostasis, marking, or tube anchoring. Repositionable design allows adjustment before final deployment. Output is physical tissue approximation; aids clinical decision-making by providing immediate mechanical intervention for bleeding or perforation. Benefits include reduced risk of delayed bleeding and minimally invasive closure of defects.

Clinical Evidence

Bench testing only. No clinical or animal studies were performed. Performance testing included dimension, release force, clamping strength, tensile strength, rotation, scope compatibility, and mechanical integrity. Biocompatibility testing followed ISO 10993-1; sterilization validated per ISO 11135:2014+A1:2018; MRI safety evaluated per ASTM F2503, F2052, F2119, F2182, and F2213.

Technological Characteristics

Single-use endoscopic clip assembly and delivery system. Compatible with endoscopes having a minimum 2.8mm working channel. Materials conform to ISO 10993-1. Sterilization via Ethylene Oxide (SAL 10^-6). MRI conditional per ASTM F2503, F2052, F2119, F2182, F2213. Available in multiple open widths (8mm, 11mm, 16mm, 22mm) and working lengths (1650mm, 1950mm, 2350mm, 2700mm).

Indications for Use

Indicated for adult patients requiring endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/submucosal defects <3cm, bleeding ulcers, polyps <1.5cm, colonic diverticula, arteries <2mm, prophylactic post-resection bleeding), closure of GI luminal perforations <20mm, or anchoring jejunal feeding tubes.

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

• Resolution 360™ Clip (K151802)

Reference Devices

• SureClip™ Repositionable Hemostasis Clip (K182556)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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 < 3cm,
- (b) Bleeding ulcers,
- (c) polyps < 1.5cm in diameter,
- (d) diverticula in the colon,
- (e) Arteries < 2 mm, `
- (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection.
- (3) as a supplementary method, closure of Gl tract luminal perforations 20mm that can be treated conservatively.
- (4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel;

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: [phone]

Fax: [phone]

Email: [e-mail]

## 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 < 3cm,
- (b) Bleeding ulcers,
- (c) Polyps < 1.5cm in diameter,
- (d) Diverticula in the colon,
- (e) Arteries < 2 mm,
- (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
- (3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.
- (4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

## 7. Device Description

The proposed device Lockado™ Repositionable Hemostasis Clip is a sterile, single-use

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Image /page/5/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 part of a single, solid shape. A registered trademark symbol (®) is located in the upper right corner of the logo.

Section 5 510K Summary

endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.

lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

# 8. Comparison of Technological Characteristics

The Lockado™ Repositionable Hemostasis Clip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device Resolution 360™ Clip under K151802.

| Item | Proposed Device<br>Lockado™ Repositionable<br>Hemostasis Clip | Predicate Device<br>Resolution 360™ Clip (K151802) | Remark |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | PKL | PKL | Same |
| Regulation No. | 876.4400 | 876.4400 | Same |
| Class | II | II | Same |
| Supplied in Sterile | Yes | Yes | Same |
| Configuration | Delivery system and clip assembly | Delivery system and clip assembly | Same |
| Open width | 8mm, 11mm and 16mm, 22mm | 11mm | Similar |
| Minimal working<br>channel of<br>endoscopy | 2.8mm | 2.8mm | Same |
| Working Length | 1650mm, 1950mm, 2350mm,<br>2700mm | 2350mm | Similar |
| Indications for Use | The Lockado™ Repositionable<br>Hemostasis Clip is indicated for<br>Endoscopic clip placement within the<br>Gastrointestinal tract in adult patients<br>only via a straight or side viewing<br>flexible endoscope for the purpose<br>of :<br>(1) Endoscopic marking: | The Resolution 360™ Clip is<br>indicated for clip placement within<br>the gastrointestinal (GI) tract for the<br>purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for<br>• Mucosal/sub-mucosal<br>defects < 3 cm | Similar |
| Item | Proposed Device<br>Lockado™ Repositionable<br>Hemostasis Clip | Predicate Device<br>Resolution 360™ Clip (K151802) | Remark |
| | (2) Hemostasis for<br>(a) mucosal / sub-mucosal defects < 3cm,<br>(b) bleeding ulcers,<br>(c) polyps < 1.5cm in diameter,<br>(d) diverticula in the colon,<br>(e) Arteries < 2 mm,<br>(f) Prophylactic clipping to reduce the<br>risk of delayed bleeding post lesion<br>resection;<br>(3) As a supplementary method,<br>closure of GI tract luminal<br>perforations <20mm that can be<br>treated conservatively.<br>(4) Anchoring to affix jejunal feeding<br>tubes to the wall of the small bowel. | Bleeding ulcers Arteries < 2 mm` Polys < 1.5 cm in diameter Diverticula in the colon Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus<br>4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively | |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized pouch with<br>one device per pouch | Single-use EO sterilized pouch<br>with one device per pouch | Same |
| Shelf Life | Two years | Three years | 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<br>F 2052, ASTM F2119, ASTM<br>F2182, ASTM F2213 | Comply with ASTM F 2503, ASTM<br>F 2052, ASTM F2119, ASTM<br>F2182, ASTM F2213 | Same |

# Comparison to predicate Devices:

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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" appearing to be in front of the "T". A registered trademark symbol (®) is located in the upper right corner of the logo. The logo has a clean and modern design.

Section 5 510K Summary

# 9. Performance Data

Performance testing was conducted to demonstrate the essential performance of the

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and connected, with the "M" appearing to be in front of the "T". A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo has a clean and modern appearance.

#### proposed device Lockado™ Repositionable Hemostasis Clip and confirmed that the

proposed device works as intended with the compatible devices.

The bench tests below were tested and evaluated as substantially equivalent to the predicate device.

- > 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).