Single Use Hemoclips

K234124 · Promisemed Hangzhou Meditech Co., Ltd. · PKL · Jul 12, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K234124
• Device Name: Single Use Hemoclips
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

Device Story

Single-use sterile endoscopic hemoclip; consists of delivery system and metal clip assembly. Used in GI tract for hemostasis, marking, tube anchoring, and perforation closure. Operated by physician via endoscope (minimum 2.8mm channel). Features 360-degree rotation, repositioning capability, and multiple opening widths (9mm, 12mm, 15mm). Device facilitates tissue approximation to stop bleeding or close defects. Benefits include reduced risk of bleeding and minimally invasive defect management.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including appearance, clip releasing force, open/close functionality, clamping strength, tensile strength, separation force, rotation, endoscope compatibility, removability, mechanical integrity, EO residuals, sterility, package integrity, and biocompatibility.

Technological Characteristics

Materials: X7CrNiAl17-7 (SUS 631), X10CrNiS18-9 (SUS303), X7CrNi18-9 (SUS304). Mechanical actuation via delivery system. Dimensions: 9mm, 12mm, 15mm opening widths; 1650mm-2700mm working lengths. Sterilization: Ethylene Oxide (SAL 10^-6). Biocompatibility: ISO 10993-1:2018 compliant.

Indications for Use

Indicated for endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), anchoring jejunal feeding tubes, and closure of GI tract 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 (K211787)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

July 12, 2024

Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory affairs manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China

Re: K234124

Trade/Device Name: Single Use Hemoclips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: December 28, 2023 Received: June 12, 2024

Dear Zearou Yang:

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

Enclosure

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## Indications for Use

Submission Number (if known)

### K234124

Device Name

Single Use Hemoclips

## Indications for Use (Describe)

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 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 shows the logo for "Promisemed". The word "Promisemed" is written in a stylized font, with the "P" in green and the rest of the letters in blue. Above the "P" is a green circle connected to two blue circles by lines, resembling a molecular structure. To the right of the word is the registered trademark symbol.

Hangzhou City, 311121 Zhejiang, P. R. China.

## 510(k) Summary

Date prepared: 2024-07-12

K234124

| 1. Manufacturer[21 CFR 807.92 (a) (1)] | |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China. |
| Contact Person | Zearou Yang |
| Phone | [phone] |
| Fax | [phone] |
| Email | [e-mail] |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Single Use Hemoclips |
| Common Name | Single Use Hemoclips |
| Classification Name | Hemorrhoidal ligator |
| Regulation Number | 876.4400 |
| Class | Class II |
| Product Code | PKL |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Hemoclip |
| 510(k) Number | K211787 |
| Product Code | PKL |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |
| The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the | |

introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO).

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# R)

Hangzhou City, 311121 Zhejiang, P. R. China.

The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

### Indication for use [21 CFR 807.92 (a) (5)] 5.

The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix ieiunal feeding tubes to the wall of the small bowel. Closure of GI tract lumenal perforations less than 20mm that can be treated conservatively.

### Indications for Use Comparison [21 CFR 807.92 (a) (5)] 6.

The subject device and predicate device indications for use statements are similar. See Section 7 below.

### 7. Comparison of Technological Characteristic [21 CFR 807.92 (g) (6)]

Compared with the predicate device, the subject device is identical in mechanism of action, materials, dimension, sterilization method and biocompatibility. The subject device has the same performance specifications except for working length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent. At a high level, the subject and predicate devices are based on the following same technological elements:

| Specification | Subject Device | Predicate Device(K211787) | Discussion of<br>difference |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Single Use Hemoclips | Hemoclip | |
| Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Hangzhou AGS MedTech<br>Co., Ltd. | |
| Device Class | Class II | Class II | No difference |
| Product Code | PKL | PKL | No difference |
| Regulation number | 21 CFR 876.4400 | 21 CFR 876.4400 | No difference |
| Prescription/over-<br>the-counter use | Prescription | Prescription | No difference |
| Indications for Use | The device is used for<br>endoscopic clip placement<br>within the gastrointestinal(GI)<br>tract for the purpose of<br>endoscopic marking,<br>hemostasis for<br>mucosal/submucosal defects<br>less than 3cm, bleeding ulcers,<br>arteries less than 2mm, polyps<br>less than 1.5cm in diameter<br>and diverticula in the colon.<br>Anchoring to affix jejunal<br>feeding tubes to the wall of | The Hemoclip 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>• Mucosal / sub-mucosal<br>defects < 3cm,<br>• Bleeding ulcers,<br>• Arteries < 2 mm,<br>• Polyps < 1.5cm in<br>diameter,<br>• Diverticula in the colon,<br>• Prophylactic clipping to<br>reduce the risk of | Similar |
| | | Promisemed Hangzhou Meditech Co., Ltd. | K234124<br>Page 3 of 4 |
| | | No. 1388 Cangxing Street, Cangqian Community, Yuhang District,<br>Hangzhou City, 311121 Zhejiang, P. R. China. | |
| | the small bowel. Closure of GI<br>tract lumenal perforations less<br>than 20mm that can be<br>treated conservatively. | delayed bleeding post<br>lesion resection;<br>3. Anchoring to affix jejunal<br>feeding tubes to the wall<br>of the small bowel.<br>4. As a supplementary<br>method, closure of GI<br>tract luminal<br>perforations <20mm that<br>can be treated<br>conservatively. | |
| Single Use | Yes | Yes | No difference |
| Material (direct/indirect contact body) | | | |
| Clip and pressure<br>tube | X7CrNiAl17-7 (SUS 631),<br>X10CrNiS18-9 (SUS303) | Stainless steel (SUS631,<br>SUS304) | The use of SUS303<br>does not introduce<br>any new concerns<br>for safety or efficacy<br>which has been<br>confirmed<br>performance and<br>biocompatibility<br>testing. |
| Springe tube | X7CrNi18-9 (SUS304) | X7CrNi18-9 (SUS304) | No difference |
| Components | | | |
| Configuration | Delivery system and clip part | Delivery system and clip part | No difference |
| Performance | | | |
| Open width | 9mm, 12mm, 15mm | 9mm, 11mm, 13mm, 16mm<br>and 18mm | Open width of<br>subject device is<br>not beyond the<br>predicate device<br>scope and does<br>not introduce any<br>new concerns for<br>safety or efficacy<br>which has been<br>confirmed<br>performance<br>testing. |
| Minimal working<br>channel | 2.8mm | 2.8mm | No difference |
| Working length | 1650mm, 1950 mm, 2300 mm,<br>2700mm. | 1650mm, 1950mm, 2300mm | Working length of<br>subject device is<br>longer the<br>predicate device<br>scope and does not<br>introduce any new<br>concerns for safety<br>or efficacy which<br>has been confirmed<br>performance<br>testing. |
| Removability<br>performance | Yes | Yes | No difference |
| Sterility (SAL of 10-6) | Yes | Yes | No difference |
| Sterilization<br>method | Ethylene Oxide | Ethylene Oxide | No difference |
| Shelf life | 3 years | 3 years | No difference |
| Biocompatibility | ISO 10993-3:2014,<br>ISO 10993-5:2009,<br>ISO 10993-6:2016,<br>ISO 10993-10:2021,<br>ISO 10993-11:2017,<br>ISO 10993-23:2021,<br>USP <151>, 2017 | ISO 10993-3:2014,<br>ISO 10993-5:2009,<br>ISO 10993-6:2016,<br>ISO 10993-10:2010,<br>ISO 10993-11:2017 | The biocompatibility<br>testing for subject<br>device has been<br>tested in accordance<br>with the ISO 10993-<br>1: 2018, and results<br>are qualified. |

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Image /page/6/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. There is a graphic above the word "Promise" that is also in green and blue. There is a registered trademark symbol to the right of the word "med".

No. 1388 Cangxing Street, Canggian Community, Yuhang District, Hanazhou City 311121 Zheiiana P R China

Promisemed Hangzhou Meditech Co., Ltd.

### Nonclinical test [21 CFR 807.92 (b) (1)] 8.

The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:

- A Appearance;
- A Clip Releasing Force
- A Open and Close;
- > Clamping Strength;
- A Tensile Strength;
- > Separation Force;
- A Rotation property;
- > Matching with Endoscope;
- > Removability Performance;
- A Hemoclip assembly mechanical integrity;
- A EO residual;
- > Sterility;
- A Package performance (Appearance, Sealing strength, Dye penetration);
- > Biocompatibility was tested by the third GLP laboratory following ISO 10993-1:2018,

#### 9. Clinical test [21 CFR 807.92 (b) (2)]

No clinical test is included in this submission.

## 10. Conclusion [21 CFR 807.92 (b) (3)]

Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.