Disposable Hemoclip

K230004 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · PKL · Jul 31, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K230004
• Device Name: Disposable Hemoclip
• Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jul 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable 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 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

Disposable Hemoclip; endoscopic accessory for GI tract. Consists of pre-loaded stainless steel clip and delivery system (handle and catheter). Operated by physician during endoscopy; inserted through endoscope working channel (min 2.8mm). Clip allows multiple opening/closing cycles for repositioning at lesion site before final deployment. Rotatable distal end aids placement. Used for marking, hemostasis, anchoring feeding tubes, or closing small perforations. Benefits patient by providing mechanical closure of defects or bleeding sites, potentially avoiding more invasive procedures.

Clinical Evidence

No clinical data. Bench testing only. Tests included appearance, size, hardness, surface roughness, open/close performance, rotation, releasing force, clipping force, peeling force, connection firmness, dimensional verification, and MR safety. All tests passed.

Technological Characteristics

Stainless steel clip; delivery system with handle and catheter. EO sterilization (SAL 10^-6). Compatible with 2.8mm minimum working channel. Rotatable distal end. Dimensions: working lengths 1600-2700mm; clip opening widths 9-16mm; outer tube diameter 2.5mm. Complies with ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization).

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), 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

• Hemoclip (K172727)

Submission Summary (Full Text)

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July 31, 2023

Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Speciialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 China

Re: K230004 Trade/Device Name: Disposable Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: June 29, 2023 Received: June 30, 2023

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. 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 located 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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

# Shanil P. Haugen -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K230004

Device Name Disposable Hemoclip

The Disposable 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
- 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)

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

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

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# 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.

## 5.1 Submitter

| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|--------------------|------------------------------------------------------------------------------------------|
| | Address:Beizhou Road, Lidian Town, Guangling District,<br>Yangzhou 225106 Jiangsu, China |
| Contact<br>Person: | Ethan Liu<br>RA Specialist |
| | Shanghai Thinkwell Consulting Co., Ltd |
| | Address: Room 211/6F, Xinling Road, Minhang Districtt,<br>Shanghai, China. |
| | Phone: [phone] |
| | Email: [e-mail] |
| Date<br>Prepared: | June 26, 2023 |

## 5.2 Device

| Device Name: | Disposable Hemoclip |
|----------------------|----------------------------------------|
| Classification Name: | Hemostatic Metal Clip For The Gi Tract |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Product Code: | PKL |

#### 5.3 Predicate Device

| Device Name: | Hemoclip<br>K172727 |
|----------------------|----------------------------------------|
| Manufacturer: | Hangzhou AGS MedTech Co., Ltd. |
| Classification Name: | Hemostatic Metal Clip For The Gi Tract |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.4400 |
| Regulation Name: | Hemorrhoidal ligator |
| Product Code: | PKL |

## 5.4 Device Description

The Disposable Hemoclip consists of one pre-loaded clip and delivery system for single patient use only. Disposable Hemoclip is provided in sterile.

The clip is made of stainless steel with good superelasticity performance. The clip is

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Image /page/4/Picture/0 description: The image shows the brand logo for "ARTLEY UNIQUE 4 ENDOSCOPY". The word "ARTLEY" is in a stylized, bold, blue font, with a yellow streak extending from the top right of the "Y". Below "ARTLEY" is the phrase "UNIQUE 4 ENDOSCOPY", also in blue, but in a smaller, less bold font. The logo appears to be for a company that specializes in endoscopy equipment.

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 many 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.

The delivery system consists of a handle and delivery catheter. The delivery system will allow for the device to rotate at the distal end.

#### 5.5 Indication for Use:

The Disposable 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 ●
- 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.

#### 5.6 Comparison of Technological Characteristics

The Disposable Hemoclip 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<br>Hemoclip(Proposed Device) | Hemoclip<br>K172727 | Discussio<br>n |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Indication<br>for Use | The Disposable Hemoclip is<br>indicated for endoscopic clip<br>placement within the<br>gastrointestinal tract for the<br>purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for: | The hemoclip is indicated<br>for endoscopic clip<br>placement within the<br>gastrointestinal tract for the<br>purpose of:<br>1. Endoscopic marking<br>2. Hemostasis for: | Same |
| | • Mucosal/sub-mucos<br>al defects <3cm<br>• Bleeding ulcers<br>• Arteries<2mm<br>• Polyps < 1.5cm in | • Mucosal/sub-mucos<br>al defects <3cm<br>• Bleeding ulcers<br>• Arteries<2mm<br>• Polyps < 1.5cm in | |
| Item | Disposable<br>Hemoclip(Proposed Device) | Hemoclip<br>K172727 | Discussio<br>n |
| | diameter<br>● Diverticula in the colon<br>3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel<br>4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively. | diameter<br>● Diverticula in the colon<br>3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel<br>4. As a supplementary method, closure for GI tract luminal perforations <20mm that can be treated conservatively. | |
| Principle of<br>Operation | Endoscopic accessory used to deliver metal clips to the GI tract. | Endoscopic accessory used to deliver metal clips to the GI tract. | Same |
| Minimum<br>Endoscopic<br>Working<br>Channel | 2.8mm | 2.8mm | Same |
| Working<br>Length | 1600mm, 1800mm, 2300mm, 2700mm | 1650mm, 1950mm, 2350mm | Similar |
| Clip<br>Opening<br>Width | 9mm,12mm, 16mm | 9mm,11mm, 13mm | Similar |
| Outer Tube<br>Diameter | 2.5mm | 2.6mm | Similar |
| SAL | 10-6 | 10-6 | Same |
| Sterilizatio<br>n Method | EO Sterilization | EO Sterilization | Same |

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#### 5.7 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 Hemoclip: Appearance, Size,

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Image /page/6/Picture/0 description: The image shows the logo for "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is in large, bold, blue font, with a yellow accent on the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY", in a smaller, blue font. The logo appears to be for a medical device company specializing in endoscopes.

Hardness, Surface Roughness, Open and close performance, Rotation performance, Releasing force, Clipping force, Peeling force, Connection firmness, Dimensional Verification and MR Safety Testing. The results of all testing were passing.

#### 5.8 Clinical Test Data

No Clinical Study is included in this submission.

#### 5.9 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Hemoclip is substantially equivalent to predicate device Hangzhou AGS MedTech Co., Ltd.'s currently marketed Hemoclip K172727 in terms of safety and effectiveness.