K Number

Device Name

Disposable Hemostatic Clips

Manufacturer

Ningbo Xinwell Medical Technology Co., Ltd

Date Cleared

2024-06-07

(260 days)

Product Code

PKL REG

Regulation Number

876.4400

Intended Use

The Disposable Hemostatic Clips is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult populations only via a straight or side viewing flexible endoscope 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. E) Arteries < 2 mm. F) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection. 3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively 4) Anchoring to affix jejunal feeding tubes to the wall of the small bowel

Device Description

The proposed device is consisted of a clip section. The delivery section. The delivery section include: slide bar, slip ring, protective sleeve, rotation head, coated spring tube, slip ring holder, traction assembly, connecting tube, decoupled piece, decoupled shrapnel, rotation sleeve. And the clip section include: clip, sliding block, shaft and rocker arm. The clip is made of stainless steel. The clip can be opened and closed more than five times prior to deployment, aiding in repositioning of the lesion site. The proposed device is available in single ring and three ring models, and each case is divided into rotatable and non-rotatable clip. The effective length of the proposed device includes 1250mm, 1650mm, 2350mm and the opening width is 9mm, 11mm. 13mm and 16mm. The proposed devices are provided in sterile and single use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202333

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a disposable hemostatic clip and its delivery system. There is no mention of any software, algorithms, data processing, or learning capabilities that would indicate the use of AI or ML.

Therapeutic

Yes.

The device is indicated for various therapeutic purposes within the gastrointestinal tract, including hemostasis for bleeding, closure of perforations, and anchoring feeding tubes. These are direct medical interventions aimed at treating conditions.

Diagnostic

No.

The device is designed for therapeutic purposes such as hemostasis, closure of perforations, and anchoring, not for diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines numerous physical components made of materials like stainless steel, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body (Gastrointestinal tract) for mechanical purposes like marking, hemostasis, closure of perforations, and anchoring. IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
Device Description: The description details a mechanical device with clips, delivery systems, and various components designed for physical manipulation within the GI tract. This is consistent with a surgical or endoscopic device, not an IVD.
Performance Studies: The performance studies focus on mechanical properties, biocompatibility, sterility, and compatibility with endoscopes. These are typical tests for medical devices used internally, not for IVDs which would involve analytical performance characteristics related to detecting or measuring substances in biological samples.

Therefore, the Disposable Hemostatic Clips is a medical device used for therapeutic and procedural purposes within the body, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Performance testing included: Appearance, Rotation performance, Release force, Clamping strength, Relocation, Tensile strength, Dimension, Mechanical integrity of clip assembly, Scope compatibility/usability, Endoscope damage, Torque, Clip approach, Three ring handle strength. All tests were passed.

Biocompatibility evaluation for the clip component included: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Sub-acute Systemic Toxicity, Genotoxicity, Pyrogenicity, Implantation Test.
Biocompatibility evaluation for the delivery component included: Cytotoxicity, Irritation, Skin Sensitization, Acute Systemic Toxicity, Pyrogenicity.
The biocompatibility evaluation was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1.

Sterilization process validation: using Ethylene Oxide (EO) in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below 2.15 EU/device in accordance with USP .

Shelf-life testing: Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3 year shelf-life.
Package integrity tests included: after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-22 on final, packaged, and sterile device.
Sterile Barrier Packaging performed on the proposed device: Seal Strength ASTM F88/F88-15, Dye penetration ASTM F1929-15, Visual Inspection ASTM F1886/F1886M-16.
Shelf-life of 3-years is validated using FDA recognized standard ASTM F1980 -16.

No clinical study is included in this submission.

Key Metrics

Not Found

Predicate Device(s)

K202333

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
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.(b)
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.

Summary

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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2024

Ningbo Xinwell Medical Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K232969

Trade/Device Name: Disposable Hemostatic Clips Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dated: September 21, 2023 Received: May 9, 2024

Dear Diana Hong:

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).

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 OS 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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Indications for Use

Submission Number (if known)

K232969

Device Name

Disposable Hemostatic Clips

Indications for Use (Describe)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K232969

1. Date of Preparation: 06/03/2024
1. Sponsor Identification

Ningbo Xinwell Medical Technology Co., Ltd. No.188 Binjiang Road, Cixi High-tech Industrial Development Zone, Cixi City, Zhejiang,P.R. China

Establishment Registration Number: 3013526170

Contact Person: Lei Xi Position: RA manager Tel: +86-021-34693382 Email: xilei@xinhaigroup.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: Disposable Hemostatic Clips Common Name: Hemostasis Clipping Device

Regulatory Information Classification Name: Hemorrhoidal Ligator;

Classification: II, Product Code: PKL, Regulation Number: 21CFR 876.4400 Review Panel: Gastroenterology/Urology,

Indications for Use:

1. Endoscopic marking;
1. Hemostasis for:
A) Mucosal/sub-mucosal defects ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP Bacterial Endotoxins Test
A ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems

Performance testing

The following bench tests were performed on the Disposable Hemostatic Clips:

. Appearance
Rotation performance •
Release force
. Clamping strength
. Relocation
. Tensile strength
. Dimension
. Mechanical integrity of clip assembly
Scope compatibility/usability
. Endoscope damage
. Torque
Clip approach .
Three ring handle strength

Above all tests were passed and demonstrated the result can meet the product requirements.

Biocompatibility testing

The biocompatibility evaluation for the proposed device was conducted in accordance with FDA Guidance, Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020. The following tests were conducted for the clip component of Disposable Hemostatic Clips:

. Cytotoxicity
Irritation .
Skin Sensitization .
Acute Systemic Toxicity
. Sub-acute Systemic Toxicity
. Genotoxicity
. Pyrogenicity
Implantation Test

The following tests were conducted for the delivery component of Disposable Hemostatic Clips:

. Cytotoxicity
Irritation ●
. Skin Sensitization
. Acute Systemic Toxicity
. Pyrogenicity

Sterility, Shipping, and Shelf -life

The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 106. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 2.15 EU/device in accordance with USP . Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 3 year shelf-life.

. Package integrity test - after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-22 on final, packaged, and sterile device.
Sterile Barrier Packaging performed on the proposed device: .
- Seal Strength ASTM F88/F88-15 o
- Dye penetration ASTM F1929-15 O
- Visual Inspection ASTM F1886/F1886M-16 O
. Shelf-life of 3-years is validated using FDA recognized standard ASTM F1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

Clinical Test Conclusion 8.

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

Table 1. General Comparison
Item	Proposed Device	Predicate Device	Remark
Product Code	PKL	PKL	Same
Regulation Number	21CFR 876.4400	21CFR 876.4400	Same
Indications for Use	The Disposable
Hemostatic Clips is indicated
for Endoscopic clip placement
within the Gastrointestinal tract
in adult populations only via a
straight or side viewing flexible
endoscope for the purpose of :

Endoscopic marking;
Hemostasis for:
A) Mucosal/sub-mucosal
defects