Hemoclip

K172727 · Hangzhou AGS MedTech Co., Ltd. · PKL · Apr 16, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172727
• Device Name: Hemoclip
• Applicant: Hangzhou AGS MedTech Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Apr 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for - Mucosal/sub-mucosal defects <3cm - Bleeding ulcers - Arteries<2mm - Polyps<1.5cm 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 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

Device Story

Sterile, single-use endoscopic clipping device; consists of delivery system (handle, catheter) and clip. Delivery system constructed of stainless steel and polyester; allows distal rotation. Clip comprises stainless steel capsule, clip arms, Cobalt Chrome yoke, and styrene tension breaker. Operated by physician via endoscope working channel; jaws open/close up to five times for repositioning before final deployment. Used for GI tract marking, hemostasis, feeding tube anchoring, and perforation closure. Provides mechanical tissue approximation to manage bleeding or defects; benefits patient by facilitating minimally invasive endoscopic repair.

Clinical Evidence

No clinical data. Bench testing only. Tests included: open/close functionality, clip releasing force, clamping strength, tensile strength, separation force, rotation property, corrosion, appearance, and size. All tests passed. Biocompatibility and sterilization validated per ISO 10993 and ISO 11135-1.

Technological Characteristics

Materials: Stainless steel (SUS631), Cobalt Chrome, polyester, styrene. Principle: Mechanical endoscopic clip delivery. Form factor: 1650mm, 1950mm, 2300mm working lengths; 2.6mm outer tube diameter. Sterilization: Ethylene Oxide (EO). No software or electronic components.

Indications for Use

Indicated for patients requiring endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), prophylactic bleeding reduction, anchoring jejunal feeding tubes, 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™ Hemostasis Clipping Device (K122660)
• SureClip(TM) Repositionable Hemostasis Clip (K161463)

Submission Summary (Full Text)

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April 16, 2018

Hangzhou AGS MedTech CO., Ltd % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd., 211/6F Shanghai, 201100 China

Re: K172727 Trade/Device Name: Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: March 5, 2018 Received: March 8, 2018

Dear Ethan Liu:

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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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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# Indications for Use

510(k) Number (if known)

K172727

Device Name Hemoclip

Indications for Use (Describe)

The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

- 1. Endoscopic marking
- 2. Hemostasis for
- · Mucosal/sub-mucosal defects <3cm
- · Bleeding ulcers
- · Arteries<2mm
- Polyps<1.5cm 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
- 4. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

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

| Y Prescription Use (Part 21 CFR 801 Subpart D)

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

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K172727 Page 1 of 4

#### 510(k)Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

### 5.1 Submitter

| Submitted by: | Hangzhou AGS MedTech CO., Ltd.<br>Building 6, Kangxin Road No.597, Qianjiang Economic<br>Development Area, Hangzhou, Zhejiang, 311106, China |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | Active; Awaiting Assignment Of Registration Number |
| Owner/Operator Number: | 10052959 |
| Contact Person: | Ethan Liu<br>Phone:[phone]<br>Fax: [phone]<br>Email:[e-mail] |
| Date Prepared: | Jan 18, 2017 |

#### 5.2 Proposed Device

| Trade Name: | Hemoclip |
|---------------------------|----------------------------------------|
| Common Name: | Endoscope Clipping Device |
| Classification: | Class II |
| Regulation Number | 876.4400 |
| Classification Name: | Hemorrhoidal ligator |
| Product Code Description: | Hemostatic Metal Clip For The Gi Tract |
| Product Code: | PKL |

## 5.3 Predicate Device

K122660 - Resolution™ Hemostasis Clipping Device(Primary) K161463- SureClip(TM) Repositionable Hemostasis Clip(Secondary)

## 5.4 Device Description

The Hemoclip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2300mm working lengths.

The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories

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Section 5 510(k) Summary Hemoclip

included with this device.

## 5.5 Indication for Use:

The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

- Endoscopic marking 1.
- Hemostasis for 2.
- Mucosal/sub-mucosal defects <3cm
- Bleeding ulcers ●
- . Arteries<2mm
- Polyps<1.5cm in diameter ●
- Diverticula in the colon ●
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel 3.
- As a supplementary method, closure for GI tract luminal perforations<20mm that can be 4. treated conservatively.

## 5.6 Comparison of Technology Characteristics

The Hemoclip has substantially equivalent device material, design, configuration, packaging fundamental technology, manufacturing process, sterilization process and intended use as those featured in the predicate device Resolution™ Hemostasis Clipping Device, Boston Scientific Corporation, K122660. And the Hemoclip has similar characteristics in Clip Opening Width, Working Length, and Rotation with SureClip™ Repositionable Hemostasis Clip, Micro-Tech(Nanjing) Co., Ltd, K161463.

Below is a table describing the differences and similarities of the Hemoclip in comparison to the Resolution™ Hemostasis Clipping Device and the SureClip™ Repositionable Hemostasis Clip.

| Device &<br>Predicate<br>Devices | K172727 | K122660 | K161463 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The hemoclip is indicated for<br>use endoscopic clip placement<br>within the gastrointestinal tract<br>for the purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for;<br>- mucosal/sub-mucosal defects<br><3 cm<br>- bleeding ulcers<br>- arteries < 2cm<br>- polyps <1.5cm in diameter<br>- diverticula in the colon<br>3. Anchoring to affix jejunal<br>feeding tubes to the wall of the<br>small bowel<br>4. As a supplemental closure<br>method of luminal perforations<br><20mm that can be treated<br>conservatively. | The resolution(tm)<br>hemostasis clipping device<br>is indicated for use<br>endoscopic clip placement<br>within the gastrointestinal<br>tract for the purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for;<br>- mucosal/sub-mucosal<br>defects <3 cm<br>- bleeding ulcers<br>- arteries < 2cm<br>- polyps <1.5cm in<br>diameter<br>- diverticula in the colon<br>3. Anchoring to affix<br>jejunal feeding tubes to the<br>wall of the small bowel<br>4. As a supplemental<br>method of luminol | The SureClip(TM)<br>Repositionable Hemostasis<br>Clip is indicated for<br>endoscopic clip placement<br>within the gastrointestinal<br>tract 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<br>diameter,<br>(d) diverticula in the colon,<br>(3) as a supplementary<br>method, closure of GI tract<br>luminal perforations <20mm<br>that can be treated<br>conservatively |

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Section 5 510(k) Summary

| | | perforations <20mm that<br>can be treated<br>conservatively | Hemocli |
|---------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Principle of<br>Operation | Endoscopic accessory used to<br>deliver metal clips to the GI<br>tract. | Endoscopic accessory used<br>to deliver metal clips to the<br>GI tract. | Endoscopic accessory used<br>to deliver metal clips to the<br>GI tract. |
| Repositionable<br>Clip? | Yes and No (depending on<br>model) | Yes | Yes |
| Minimum<br>Endoscopic<br>Working<br>Channel | 2.8 mm | 2.8 mm | 2.8 mm |
| Working Length | 1650 mm, 1950 mm, 2350<br>mm | 1550 mm and 2350 mm | 1650mm, 1950mm,<br>2350mm,<br>2700mm |
| Outer Tube<br>Diameter | 2.6 mm | 2.6 mm | 2.6 mm |
| Clip Opening<br>Width | 9 mm, 11 mm, 13 mm | 11 mm | 8mm, 11mm, 16mm |
| Sterilization<br>method | EO | EO | EO |
| Clip Materials | Stainless Steel (SUS631) | 304 Stainless Steel | SUS 631, SUS316, and<br>SUS304 (Stainless steels) |

# 5.7 Applicable Guidance Document

NA

## 5.8 Performance Data

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "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 Hemoclip: Open and Close, Clip releasing force, Clamping strength, Tensile Strength, Seperation Force, Rotation property, Corrosion, Appearance, Size. The results of all testing were passing.

#### 5.9 Clinical Test

No Clinical test is included in this submission.

#### 5.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has

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Section 5 510(k) Summary Hemoclip

demonstrated that proposed device Hemoclip is substantially equivalent to Boston Scientific Corporation's currently marketed Resolution™ Hemostasis Clipping Device, K122660 and SureClip(TM) Repositionable Hemostasis Clip, Micro-Tech(Nanjing) Co., Ltd, K161463.