Disposable Hemostatic Clips

K232450 · Zhejiang Soudon Medical Technology Co., Ltd. · PKL · Jan 26, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K232450
• Device Name: Disposable Hemostatic Clips
• Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jan 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Disposable Hemostatic Clips 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 3.Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4.As a supplementary method, closure for Gl tract luminal perforations<20mm that can be treated conservatively.

Device Story

Disposable Hemostatic Clips; endoscopic accessory for delivery of stainless steel clips to GI tract. Device consists of pre-loaded clip and delivery system; single-patient use. Clip features superelasticity; allows opening/closing up to five times for repositioning at lesion site before final deployment. Available in various opening widths (9-16mm) and working lengths (1650-2300mm). Operated by physician via endoscope working channel (min 2.8mm). Used for hemostasis, marking, anchoring, and perforation closure. Benefits include precise tissue approximation and bleeding control. Sterile, EO-sterilized.

Clinical Evidence

No clinical data. Bench testing only: appearance, dimensional verification, separating force, clamping force, opening/closing force, rotational performance, post-detachment state, and passability.

Technological Characteristics

Stainless steel clips; superelastic. EO sterilization (ISO 11135-1, ISO 10993-7). Biocompatible (ISO 10993-1). Delivery system: spring tube, 2.5mm outer diameter. Compatible with 2.8mm endoscope channels. Manual mechanical actuation.

Indications for Use

Indicated for endoscopic clip placement in GI tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), anchoring jejunal feeding tubes, and 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

• Hemoclip (K172727)

Reference Devices

• Single Use Rotatable and Repositionable Hemoclip (K201771)

Submission Summary (Full Text)

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January 26, 2024

Zhejiang Soudon Medical Technology Co.,Ltd % Nick Wang RA Specialist Shanghai Vanhe Consulting Co., Ltd 2F, Building No.1, 3938 Hugingping Road, Oingpu District Shanghai. 201703 China

Re: K232450

Trade/Device Name: Disposable Hemostatic Clips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: August 11, 2023 Received: August 14, 2023

#### Dear Nick Wang:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sivakami Venkatachalam -S

for

Shanil P. Haugen. Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

Submission Number (if known)

K232450

Device Name

Disposable Hemostatic Clips

Indications for Use (Describe)

Disposable Hemostatic Clips 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
3.Anchoring to affix jejunal feeding tubes to the wall of the small bowel
4.As a supplementary method, closure for Gl 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/0 description: The image is a logo for Soudon Medical. The logo is blue and features a stylized design with the words "soudon medical" written in a sans-serif font below the design. The design itself appears to be a stylized representation of a medical device or symbol, with a flame-like element at the top.

# 510(k) Summary

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

# 1. Submitter

| Submitted by: | Zhejiang Soudon Medical Technology Co.,Ltd<br>Address:Room 302-1, Building 4, No.1 Nangonghe Road,<br>Donghu Street, Linping District, Hangzhou 311100 Zhejiang,<br>China |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Nick Wang<br>RA Specialist<br>Shanghai Vanhe Consulting Co., Ltd<br>Address: 2F, Building No.1, 3938 Huqingping Road, Qingpu<br>District, Shanghai, China.<br>Phone: [phone]<br>Email: [e-mail] |
| Date<br>Prepared: | Jan 24, 2024 |

### Device

| Device Name: | Disposable Hemostatic Clips |
|----------------------|-----------------------------|
| Classification Name: | Hemorrhoidal Ligator |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |

# Predicate Device

| Device Name: | Hemoclip, K172727 |
|----------------------|-------------------------------|
| Manufacturer: | Hangzhou AGS MedTech CO., Ltd |
| Classification Name: | Hemorrhoidal Ligator |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |

### Reference device

| Device Name: | Single Use Rotatable and Repositionable Hemoclip,<br>K201771 |
|---------------|--------------------------------------------------------------|
| Manufacturer: | Anrei Medical (Hangzhou) Co., Ltd |

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Image /page/4/Picture/1 description: The image is a logo for Soudon Medical. The logo is blue and features a stylized design with the words "soudon medical" written in lowercase letters below the design. The design consists of two horizontal bars with a shape above them that resembles flames.

| Classification Name: | Hemorrhoidal Ligator |
|----------------------|----------------------|
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |

# 2. Device Description

The Disposable Hemostatic Clips consist of one pre-loaded clip and delivery system for single patient use only. It is provided in sterile.

The clip is made of stainless steel with good superelasticity performance. The clip is pre-loaded in end of the Spring tube part through its deformation and it is deployed from the delivery system during use.The clip is 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.

The device is available in four clip opening widths, which are 9mm, 11mm, 13mm and 16mm, and the device effective length is available in 1650mm, 1950mm and 2300mm.

### 3. Indication for Use:

The Disposable Hemostatic Clips 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 ●
- 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.

# 4. Comparison of Technological Characteristics

The Disposable Hemostatic Clips has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS MedTech CO., Ltd 's Hemoclip. K172727. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

| Item | Disposable Hemostatic<br>Clips(Proposed Device) | Hemoclip<br>K172727 | Discussion |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication<br>for Use | The Disposable Hemostatic<br>Clips is indicated for | The hemoclip is indicated<br>for endoscopic clip | Same |
| Item | Disposable Hemostatic<br>Clips(Proposed Device) | Hemoclip<br>K172727 | Discussion |
| | endoscopic clip placement<br>within the gastrointestinal<br>tract for the purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for:<br>Mucosal/sub-mucos<br>al defects <3cm Bleeding ulcers Arteries<2mm Polyps < 1.5cm in<br>diameter Diverticula in the<br>colon 3. Anchoring to affix<br>jejunal feeding tubes to<br>the wall of the small<br>bowel<br>4. As a supplementary<br>method, closure for GI<br>tract luminal<br>perforations<20mm that<br>can be treated<br>conservatively. | placement within the<br>gastrointestinal tract for the<br>purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for:<br>Mucosal/sub-mucos<br>al defects <3cm Bleeding ulcers Arteries<2mm Polyps < 1.5cm in<br>diameter Diverticula in the<br>colon 3. Anchoring to affix<br>jejunal feeding tubes to<br>the wall of the small<br>bowel<br>4. As a supplementary<br>method, closure for GI<br>tract luminal<br>perforations<20mm that<br>can be treated<br>conservatively. | |
| Principle of<br>Operation | 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. | Same |
| Minimum<br>Endoscopic<br>Working<br>Channel | 2.8mm | 2.8mm | Same |
| Working<br>Length | 1650mm, 1950mm and<br>2300mm | 1650mm, 1950mm, 2350mm | Similar |
| Clip<br>Opening<br>Width | 9mm,11mm, 13mm, 16mm | 9mm,11mm, 13mm | Similar |
| Outer Tube<br>Diameter | 2.5mm | 2.6mm | Similar |
| SAL | $10^{-6}$ | $10^{-6}$ | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |

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Image /page/5/Picture/1 description: The image shows a logo for Soudan Medical. The logo is primarily blue and features a stylized design with the words "soudan medical" written in a sans-serif font at the bottom. Above the text, there is a geometric shape resembling a stylized building or structure, with a symbol that looks like a stylized bird or wave on top of it.

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Image /page/6/Picture/0 description: The image shows a logo for Soudon Medical. The logo is primarily blue and features a stylized design. The design includes a symbol that resembles a flame or a stylized bird above two pillars or blocks. Below the pillars, the text "soudon medical" is written in a small, sans-serif font.

### 5. Non-clinical 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 Disposable Hemostatic Clips: Appearance, Dimensional verification test, Separating force test. Clamping force test, Opening and closing force test, Rotational performance test, State of the clamping part after detachment test, and Passability of the clamping part after leaving the conveying part test. The results of all testing were passing.

### 6. Clinical Test Data

No Clinical Study is included in this submission.

### 7. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Zhejiang Soudon Medical Technology Co.,Ltd has demonstrated that proposed device Disposable Hemostatic Clips is substantially equivalent to Hangzhou AGS MedTech CO., Ltd 's currently marketed Hemoclip, K172727.