Single Use MultiClip Device

K180325 · Micro-Tech (Nanjing) Co., Ltd. · PKL · Jun 1, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180325
• Device Name: Single Use MultiClip Device
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single Use MultiClip Device 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

Device Story

Single-use endoscopic clipping device; consists of delivery system and clip assembly (3 or 5 clips). Used by physicians in clinical settings for GI tract procedures. Device delivers clips to target site for marking, hemostasis, or perforation closure. Clips are released continuously via delivery system. Provides mechanical closure of tissue defects; aids in bleeding control and marking. Benefits include minimally invasive management of GI lesions and perforations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via mechanical testing (clamping strength, tensile strength, rotation, deployment, repositioning) and biocompatibility/sterilization validation per ISO 10993 and ISO 11135 standards.

Technological Characteristics

Sterile, single-use endoscopic delivery system with 3 or 5 clip assembly. Compatible with 2.8mm working channels. Materials evaluated per ISO 10993-1. Sterilization via Ethylene Oxide (ISO 11135). MR compatibility assessed per ASTM F2052, F2119, and F2182. Packaging validated per ASTM F88, F1929, F1886, and F1980.

Indications for Use

Indicated for patients requiring endoscopic clip placement in the GI tract for marking, hemostasis of mucosal/submucosal defects <3cm, bleeding ulcers, polyps <1.5cm, colonic diverticula, or closure of GI 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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June 1, 2018

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

Re: K180325

Trade/Device Name: Single Use MultiClip Device Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: April 19, 2018 Received: April 23, 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 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 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.

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.

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,

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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)

K180325

Device Name

Single Use MultiClip Device

Indications for Use (Describe)

The Single Use MultiClip Device 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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## Tab 7

## 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: _K180325_

# 1. Date of Preparation: 2018-05-30

## 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: [e-mail]

## 3. Identification of Proposed Device

Trade Name: Single Use MultiClip Device

Common Name: Hemostasis Clipping Device

#### Regulatory Information

Classification Name: Hemorrhoidal ligator

Classification: 2

Product Code: PKL

Regulation Number: 876.4400

Review Panel: Gastroenterology/Urology

#### Intended Use Statement:

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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 Single Use MultiClip Device 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 Single Use MultiClip Device 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 has 3 or 5 clips, the 3 or 5 clips could be continuous released by the delivery system.

## 7. Comparison of Technological Characteristics

The Single Use MultiClip Device incorporates substantially equivalent device

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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>Single Use MultiClip Device | 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 | 10mm | Similar |
| Smallest working<br>channel | 2.8mm | Same |
| Working Length | 1250mm, 1650mm, 1950mm, 2350mm | Similar |
| Indications for Use | The Single Use MultiClip Device is<br>indicated for endoscopic clip placement<br>within the gastrointestinal tract for the<br>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<br>GI tract luminal perforations <20mm that can<br>be treated conservatively | Same |
| Single Use | Yes | Same |
| Packaging | Single-use EO sterilized rigid tray with a<br>sealable cover | Similar |
| Shelf Life | Two years | Similar |

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#### 8. Performance Data

The proposed device the Single Use MultiClip Device meets the requirements of AAMI ANSI ISO 10993-1 :2009/(R)2013 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process", 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", and ISO 10993-7 Second Edition 2008-10-15 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals",

ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials.

ASTM F1929 - 15, Standard Test Method For Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration,

AAMI ANSI ST72:2011/(R)2016 bacterial endotoxins - test methods, routine monitoring, and alternatives to batch testing,

ASTM F1886/F1886M - 09 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection,

ASTM F1980 - 16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices,

ISO 11737-1 Second edition 2006-04-01, sterilization of medical devices -

microbiological methods - part 1: determination of a population of microorganisms on products [including: technical corrigendum 1 (2007)] .

USP 40-NF35:2017, <71> Sterility tests,

ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on medical devices in the magnetic resonance environment. (Materials) ,

ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants , and

ASTM F2182 - 11a Standard Test Method for Measurement of Radio Frequency

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Image /page/7/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the company name "MICRO-TECH" in a smaller, sans-serif font. Below the company name are two Chinese characters.

Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging.

The following bench tests were performed on the Single Use MultiClip Device

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

The proposed device has 3 or 5 clips, the 3 or 5 clips could be continuous released by the delivery system, the model with 5 clips as the worst case to do the bench tests, each clip in the 5 clips has done the related bench tests, and conduct the substantially equivalent analysis to the predicate device The testing performed demonstrated that the proposed device and predicate device are substantially 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 Single Use MultiClip Device 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).