SureClip Repositionable Hemostasis Clip

K182556 · Micro-Tech (Nanjing) Co., Ltd. · PKL · Dec 14, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K182556
• Device Name: SureClip Repositionable Hemostasis Clip
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Dec 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients 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.

Device Story

SureClip Repositionable Hemostasis Clip is a sterile, single-use endoscopic device; consists of delivery system and clip assembly. Used by physicians during endoscopic procedures via straight or side-viewing flexible endoscopes. Device allows for clip placement to mark tissue, achieve hemostasis in bleeding sites or defects, and close small GI perforations. Repositionable design allows clinician to open/close clip multiple times before final deployment. Output is physical mechanical closure of tissue. Benefits include effective bleeding control and defect closure, reducing need for more invasive interventions.

Clinical Evidence

No clinical data. Bench testing only: dimension, release force, clamping strength, mechanical integrity, tensile strength, clip open/close cycles, rotation, scope compatibility, endoscope damage, torque, biopsy valve compatibility, clip approach, and coil-to-handle tensile strength.

Technological Characteristics

Single-use, sterile, ethylene oxide (EO) sterilized. Comprises delivery system and clip assembly. Available in 8mm, 11mm, 16mm open widths; 1650mm and 2350mm working lengths. Compatible with 2.8mm minimum working channel endoscopes. Mechanical actuation principle. Complies with ISO 10993-1 (biocompatibility), ISO 11135 (EO sterilization), and ISO 10993-7 (EO residuals).

Indications for Use

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

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

• Sterile Repositionable Hemostasis Clipping Device (K152001)

Submission Summary (Full Text)

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2018

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K182556

> Trade/Device Name: SureClip Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 13, 2018 Received: September 17, 2018

Dear Becky Li:

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 mav, 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 avare 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Daniel G. Walter Jr -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation 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)

### K182556

#### Device Name

SureClip Repositionable Hemostasis Clip

Indications for Use (Describe)

The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients 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.

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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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: K182556

# 1. Date of Preparation: 2018-12-05

# 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: Becky Li

Position: Quality and Regulatory Affairs Director

Tel: [phone]

Fax: [phone]

Email: Beckyli [e-mail]

# 3. Identification of Proposed Device

Trade Name: SureClip™ Repositionable Hemostasis Clip

Common Name: Hemostasis Clipping Device

# Regulatory Information

Classification Name: Hemorrhoidal Ligator Classification: II Product Code: PKL Requlation Number: 876.4400 Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH (Nanjing) Co., Ltd. The logo consists of the company name in English, followed by the company name in Chinese characters. The English name is in a blue sans-serif font, and the Chinese name is in a similar font and color. There is a blue graphic to the left of the company name.

510K Summary

#### 4. Identification of Predicate Device

#### Predicate Device

510(k) Number: K151802

Product Name: Resolution 360™ Clip

Manufacturer: Boston Scientific Corporation

### Reference Device

510(k) Number: K152001

Product Name: Sterile Repositionable Hemostasis Clipping Device

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

#### 5. Indications for Use

The SureClip™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients 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.

#### 6. Device Description

The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile,

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Image /page/5/Picture/1 description: The image shows a blue and white logo with the letters "MT" stacked on top of each other. The letters are in a bold, sans-serif font and have a 3D effect. The "M" is on top and the "T" is on the bottom. The logo is simple and modern.

510K Summary

single-use 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. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

# 7. Comparison of Technological Characteristics

The SureClip™ 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.

### Comparison to predicate Devices:

| Item | Proposed Device<br>SureClip™ Repositionable<br>Hemostasis Clip | Predicate Device<br>Resolution 360™ Clip | Substantial<br>Equivalence |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product Code | PKL | PKL | Same |
| Regulation No. | 876.4400 | 876.4400 | Same |
| Class | II | II | Same |
| Supplied in<br>Sterile | Yes | Yes | Same |
| Configuration | Delivery system and clip<br>assembly | Delivery system and clip assembly | Same |
| Open width | 8mm, 11mm and 16mm | 11mm | Similar |
| Minimal<br>working<br>channel | 2.8mm | 2.8mm | Same |
| Working<br>Length | 1650mm, 2350mm | 2350mm | Similar |
| Indications for<br>Use | The SureClip™ Repositionable<br>Hemostasis Clip is indicated<br>for Endoscopic clip placement<br>within the Gastrointestinal tract<br>in adult patients only via a<br>straight or side viewing flexible | The Resolution 360™ Clip is indicated for<br>clip placement within the gastrointestinal<br>(GI) tract for the purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for<br>● Mucosal/sub-mucosal defects < 3 | Similar |

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Image /page/6/Picture/1 description: The image shows a blue logo with the letters 'M' and 'T' stacked on top of each other. The letters are in a bold, sans-serif font and have a 3D effect, with the left and top sides of the letters appearing to be slightly raised. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

| Item | Proposed Device<br>SureClip™ Repositionable<br>Hemostasis Clip | 510K Summary<br>Predicate Device<br>Resolution 360™ Clip | Substantial<br>Equivalence |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | endoscope for the purpose of :<br>(1) Endoscopic marking;<br>(2) Hemostasis for<br>(a) mucosal / sub-mucosal<br>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<br>reduce the risk of delayed<br>bleeding post lesion resection;<br>(3) As a supplementary<br>method, closure of GI tract<br>luminal perforations <20mm<br>that can be treated<br>conservatively. | cm<br>● Bleeding ulcers<br>● Arteries < 2 mm`<br>● Polyps < 1.5 cm in diameter<br>● Diverticula in the colon<br>● Prophylactic clipping to reduce the<br>risk of delayed bleeding post<br>lesion resection<br>3. Anchoring to affix jejunal feeding tubes<br>to the wall of the small bowel; and<br>Anchoring to affix fully covered<br>esophageal self-expanding metal<br>stents to the wall of the esophagus<br>4. As a supplemental closure method of<br>luminal perforations < 20 mm that can<br>be treated conservatively | |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized<br>pouch with one device per<br>pouch | Single-use EO sterilized pouch with one<br>device per pouch | Same |
| Shelf Life | Three years | Three years | Same |

# 8. Performance Data

The proposed device the SureClip™ Repositionable Hemostasis Clip meets the

requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1:

Evaluation and Testing Within A Risk Management Process", ISO 11135

"Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for

Development, Validation, and Routine Control of Sterilization processes for

Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part

7: ethylene oxide sterilization residuals",

The following bench tests were performed on the SureClip™ Repositionable

### Hemostasis Clip

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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 'M' is formed by two angled lines that meet at the top, and the 'T' is a simple vertical line. The logo has a blocky, geometric appearance, and the blue color is consistent throughout the design.

- > Dimension;
- Release Force; >
- > Clamping Strength;
- > Mechanical integrity Of Clip Assembly;
- > 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

The testing performed demonstrated that the proposed device and predicate device are equivalent.

### 9. Clinical Test Conclusion

No clinical study is included in this submission.

#### 10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the SureClip™ 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).