SureClip(TM) Repositionable Hemostasis Clip

K161463 · Micro-Tech (Nanjing) Co., Ltd. · PKL · Jan 6, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K161463
• Device Name: SureClip(TM) Repositionable Hemostasis Clip
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.

Device Story

SureClip is a sterile, single-use endoscopic hemostasis clipping device. It consists of a delivery system and a clip assembly. Used by physicians during endoscopic procedures within the gastrointestinal tract. The device is inserted through the working channel of an endoscope to the target site. The clip is deployed to provide mechanical hemostasis for bleeding or defects, or to mark a specific location. The repositionable feature allows the clinician to adjust the clip position before final release. The device aids in managing GI bleeding, polyps, and small perforations, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data. Bench testing only, including dimensional verification, mechanical integrity, clamping strength, tensile strength, release force, and rotation testing. Compliance with ISO 10993-1, ISO 11135, and ISO 10993-7 confirmed.

Technological Characteristics

Sterile, single-use endoscopic clipping device. Components: delivery system and clip assembly. Working lengths: 1650mm, 1950mm, 2350mm. Open widths: 8mm, 11mm, 16mm. Compatible with 2.8mm minimum working channel. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993-1, ISO 11135, ISO 10993-7.

Indications for Use

Indicated for endoscopic clip placement in the GI tract for: (1) endoscopic marking; (2) hemostasis for mucosal/sub-mucosal defects < 3cm, bleeding ulcers, polyps < 1.5cm, and colonic diverticula; (3) supplementary closure of GI tract luminal perforations < 20mm treatable conservatively.

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

• Sterile Repositionable Hemostasis Clipping Device (K152001)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 6, 2017

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

Re: K161463

Trade/Device Name: SureClip(TM) Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: November 21, 2016 Received: November 28, 2016

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 may, therefore, market the device, subject to the general controls provisions of the Act. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Benjamin R. Fisher -S

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) K161463

Device Name

SureClip(TM) Repositionable Hemostasis Clip

Indications for Use (Describe)

The SureClip(TM) Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract 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,

(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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font. To the right of the letters is the text "MICRO-TECH" in a sans-serif font. Below the text "MICRO-TECH" is some text in a different language.

# 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: K161463

# 1. Date of Preparation: 2017-01-05

## 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 Director

Tel: [phone]

Fax: [phone]

Email: [e-mail]

## 3. Identification of Proposed Device

Trade Name: SureClip™ Repositionable Hemostasis Clip Common Name: Hemostasis Clipping Device

## 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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Image /page/4/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue, three-dimensional "MT" on the left, followed by the words "MICRO-TECH" in blue on the right. Below "MICRO-TECH" are two Chinese characters.

#### Intended Use Statement:

This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract.

#### 4. Identification of Predicate Device

510(k) Number: K152001

Product Name: Sterile Repositionable Hemostasis Clipping Device

#### 5. Indications for Use

The SureClip™ Repositionable Hemostasis Clip is indicated for endoscopic clip placement within the gastrointestinal tract 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,
- (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,

single-use endoscopic clipping device, 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

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Image /page/5/Picture/1 description: The image contains the logo for Micro-Tech. The logo consists of a stylized blue "MT" monogram on the left, followed by the words "MICRO-TECH" in blue, with a line underneath. Below "MICRO-TECH" are two Chinese characters, also in blue.

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 Micro-Tech (Nanjing) CO., Ltd. predicate devices.

# Comparison to predicate Devices:

| Item | Proposed Device<br>SureClip™ Repositionable Hemostasis Clip | Comparison to<br>Predicate<br>Devices |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Product Code | PKL | Same |
| Regulation No. | 876.4400 | Same |
| Class | 2 | Same |
| Supplied Sterile | Yes | Same |
| Configuration | Delivery system and clip assembly | Same |
| Open width | 8mm, 11mm and 16mm | Similar |
| Minimal working<br>channel | 2.8mm | Same |
| Working Length | 1650mm, 1950mm and 2350mm | Same |
| Indications for Use | The SureClip™ Repositionable Hemostasis<br>Clip is indicated for endoscopic clip<br>placement within the gastrointestinal tract for<br>the purpose of:<br>(1) endoscopic marking,<br>(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>(3) as a supplementary method, closure of GI<br>tract luminal perforations <20mm that can be<br>treated conservatively | Same |
| Single Use | Yes | Same |
| Packaging | Single-use EO sterilized pouch with one<br>device per pouch | Same |
| Shelf Life | Three years | Same |

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Image /page/6/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the letters overlapping each other. To the right of the letters is the company name, "MICRO-TECH", in a simple sans-serif font. Below the company name are two Chinese characters.

#### 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,

| Dimensional verification | Mechanical Integrity of Clip Assembly |
|---------------------------|---------------------------------------|
| Clamping Strength Testing | Tensile Strength Testing |
| Release Force Testing | Rotation Testing |

The testing performed demonstrated that the proposed and predicate delivery systems are substantial 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 the Sterile Repositionable Hemostasis Clipping Device (K152001).