Single Use Hemoclip

K172762 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · PKL · Mar 20, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K172762
• Device Name: Single Use Hemoclip
• Applicant: Zhejiang Chuangxiang Medical Technology Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Mar 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Single Use Hemoclip 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 (4) the age of the intended population for the device is for patients who are 18 and older.

Device Story

Single Use Hemoclip is a sterile, single-use endoscopic device consisting of a delivery system and a clip assembly. Used by physicians in clinical settings to perform endoscopic marking, hemostasis of GI defects, or closure of small luminal perforations. The device is inserted through an endoscope; the operator deploys the clip to the target site. The clip is repositionable up to 8 times before final release, allowing for precise placement. The output is the physical placement of the clip, which provides mechanical closure or marking. This aids in managing bleeding or defects, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

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

Technological Characteristics

Sterile, single-use endoscopic clipping device. Components: delivery system and clip assembly. Materials: unspecified. Dimensions: 9mm-15mm open width; 2.8mm minimal working channel; 1650mm-2700mm working length. Sterilization: Ethylene Oxide (EO). Connectivity: None. Software: None.

Indications for Use

Indicated for patients 18+ requiring endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, polyps <1.5cm, colonic diverticula), 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

• Sterile Repositionable Hemostasis Clipping Device (K152001)
• SureClipTM Repositionable Hemostasis Clip (K161463)

Submission Summary (Full Text)

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March 20, 2018

Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long Quality Supervisor 301B, No.22, XinYan Road Hanzhou. Zhejiang 311100 China

Re: K172762

Trade/Device Name: Single Use Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: February 5, 2018 Received: February 5, 2018

Dear Lucius Long:

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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined. The background has a faint watermark.

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) K172762

Device Name Single Use Hemoclip

Indications for Use (Describe)

The Single Use Hemoclip 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

(4) the age of the intended population for the device is for patients who are 18 and older.

X 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 contains a logo for a company called MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in green and blue to the right of the shape. Above the text "MEDNOVA" are some blue Chinese characters.

## Section 4 510(k) Summary( 21CFR 807.92)

## 1. Submitter's information

Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Address: 301B, No.22, XinYan Road Yuhang Economic And Technological Development Zone Hangzhou Zhejiang China

Contact person: Lucius.Long Telephone: [phone]-8187 Fax: [phone]

### 2. Device

Name of the device: Single Use Hemoclip Classification name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL

### 3. Predicate device

510(k) Number: K152001, Product Name: Sterile Repositionable Hemostasis Clipping Device

510(k) Number: K161463 Product Name: SureClipTM Repositionable Hemostasis Clip 4. Device description

The proposed device Single Use Hemoclip 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.

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Image /page/4/Picture/1 description: The image shows the logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, followed by the company name in blue and green. The text "MEDNOVA" is in green, and the other text is in blue.

## 5.Indication for use

The Single Use Hemoclip 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

(4) the age of the intended population for the device is for patients who are 18 and older.

6. Summary of comparison of technological characteristics with the predicate device

The Single Use Hemoclip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Micro-Tech predicate devices.

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Image /page/5/Picture/1 description: The image contains a logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in blue and green below it. To the right of the hexagon shape, there are three Chinese characters in blue.

| Comparison to Predicate Devices: | | | | |
|----------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------|
| Item | Proposed device | Predicate device | Additional predicate device | Comparison to<br>Predicate<br>Devices |
| Device name | Single use hemoclip | Sterile repositionable<br>hemostasis clipping device | SureClipTM Repositionable<br>Hemostasis Clip | Similiar |
| 510(k) number | K172762 | K152001 | K161463 | Different 510(k)<br>number |
| Manufacturer | Zhejiang Chuangxiang medical<br>technology Co., Ltd. | Micro-Tech(Nanjing) Co., Ltd. | Micro-Tech(Nanjing) Co., Ltd. | Different<br>manufacturer |
| Product Code | PKL | PKL | PKL | Same |
| Regulation No. | 876.4400 | 876.4400 | 876.4400 | Same |
| Class | 2 | 2 | 2 | Same |
| Supplied Sterile | Yes | Yes | Yes | Same |
| Configuration | Delivery system and clip assembly | Delivery system and clip<br>assembly | Delivery system and clip<br>assembly | Same |
| Open width | 9mm, 12mm,13mm,15mm | 11mm | 8mm, 11mm and 16mm | similar |
| Minimal working<br>channel | 2.8mm | 2.8mm | 2.8mm | Same |
| Working Length | 1650mm, 1950mm, 2300mm,<br>2700mm | 1650mm,1950mm,2350mm,<br>2700mm | 1650mm, 1950mm ,2350mm,<br>2700mm | similar |
| Indications for<br>Use | The single use hemoclip is indicated<br>for endoscopic clip | The Sterile Repositionable<br>Hemostasis Clipping | The SureClipTMRepositionable<br>Hemostasis | similar<br>The indications for |
| | placement within the | Device is indicated for | Clip is indicated for endoscopic | use of proposed |
| | gastrointestinal tract for | endoscopic clip | clip | device is narrow than |
| | the purpose of: | placement within the | placement within the | predicate device, the |
| | (1) endoscopic marking, | gastrointestinal tract for | gastrointestinal tract for | age of the intended |
| | (2) hemostasis for | the purpose of: | the purpose of: | population for the |
| | (a) mucosal / sub-mucosal defects < | (1) endoscopic marking, | (1) endoscopic marking, | proposed device is |
| | 3cm, | (2) hemostasis for | (2) hemostasis for | patients who are 18 |
| | (b) bleeding ulcers, | (a) mucosal / sub-mucosal | (a) mucosal / sub-mucosal | and older. |
| | (c) polyps < 1.5cm in diameter, | defects < 3cm, | defects < 3cm, | |
| | (d) diverticula in the colon, | (b) bleeding ulcers, | (b) bleeding ulcers, | |
| | (3) as a supplementary method, | (c) polyps < 1.5cm in diameter, | (c) polyps < 1.5cm in diameter, | |
| | closure of GI tract luminal | (d) diverticula in the colon, | (d) diverticula in the colon, | |
| | perforations <20mm that can be | (3) as a supplementary method, | (3) as a supplementary method, | |
| | treated conservatively | closure of GI tract luminal | closure of GI tract luminal | |
| | (4)the age of the intended | perforations <20mm that can be | perforations <20mm that can be | |
| | population for the device is for | treated conservatively | treated conservatively | |
| | patients who are 18 and older. | | | |
| | | | | Similar |
| Repositionability | | | | Proposed device can |
| | | | | reopened and |
| | Clip reopened and repositioned up | Clip reopened and repositioned | Clip reopened and repositioned | repositioned up to 8 |
| | to 8 times | up to 5 times | up to 5 times | times, predicate |
| | | | | device can reopened |
| | | | | and repositioned up |
| | | | | to 5 times. Both are<br>within their claimed<br>performance<br>characteristics . |
| Single Use | Yes | 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 | Single-use EO sterilized pouch<br>with one device per pouch | Same |
| Shelf Life | Three years | Three years | Three years | Same |

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Image /page/6/Picture/1 description: The image contains a logo with a blue and green color scheme. On the left side of the logo is a geometric shape with a gradient from green to blue. To the right of the shape is the text "MEDNOVA" in blue, with the "MED" portion in a darker shade of blue and the "NOVA" portion in a lighter shade of blue. Above the text "MEDNOVA" is Chinese characters in blue.

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Image /page/7/Picture/1 description: The image contains a logo with a green and blue color scheme. On the left side of the logo, there is a geometric shape that resembles a shield or emblem, with a gradient from green to blue. To the right of the emblem, there is text in blue that appears to be Chinese characters, followed by the word "MEDNOVA" in green and blue. The overall design is modern and professional, suggesting a company or organization with a focus on innovation and technology.

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Image /page/8/Picture/1 description: The image contains a logo with a hexagon shape on the left side that transitions from green to blue. To the right of the logo, there is text in blue that appears to be Chinese characters. Below the Chinese characters, the word "MEDNOVA" is written, with "MED" in blue and "NOVA" in green.

## 7. Performance data

The proposed device the Single Use Hemoclip 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 the Single Use Hemoclip:

| Appearance |
|---------------------------|
| Dimensional verification |
| Clamping Strength Testing |
| Release Force Testing |

Open and Close Mechanical Integrity of Clip Assembly Tensile Strength Testing Rotation Testing

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

8. Clinical Test Conclusion

No clinical study is included in this submission.

### 9. Conclusions

Based on the indications for use, technological characteristics, and safety and performance testing, Single Use Hemoclip 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) and SureClipTM Repositionable Hemostasis Clip (K161463).