Multi-band ligator inculding control handle (rotation handle, shaft and joint), loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets) and loop.The barrel preloaded with 4~9 loops. This device is designed for attachment to the end of an endoscope for ligating esophageal varices or hemorrhoids. Once assembled and attached the endoscope is advanced to the desired banding site and individual bands are deployed via manipulation of the deployment handle and trigger cord. The multi-band feature allows for serial ligations, which reduces the need to remove the endoscope for reloading. This device is supplied non-sterile and is intended for single use only.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Multi-Band Ligator." It outlines the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence to legally marketed devices.

Here's an analysis of the acceptance criteria and the study information as requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format for each test. Instead, it describes the purpose or goal of each test and then generally states that the device "meets the related requirements" or "complied with the Indication for Use."

Acceptance Criteria (Implied from Description)	Reported Device Performance
Device integrity, cleanliness, and hygiene (Appearance)	Confirmed as integrity, cleanliness, and hygiene.
Device functions comply with Indication for Use (Functional performance)	Confirmed to comply with the Indication for Use.
pH, Total heavy metals, Potassium permanganate reductive substance, Evaporative residues, Ultraviolet Absorbance meet related requirements (Chemical properties)	Confirmed to meet related requirements.
Loop Hardness, Tensile strength, Tensile elongation, Tensile deformation meet technical requirements (Mechanical performance of the Loop)	Confirmed to meet the company's technical requirements.
Trigger cord Tensile strength (Tensile strength)	Confirmed.
Irrigation adapter connection firmness, Inner surface, and Luer connector (Physical properties of Irrigation adapter)	Conformed.
Barrel tightness; no leakage (Leakage of the barrel)	Confirmed no leakage.
Shelf life of 2 years	Successfully tested according to ASTM F 1980-16 for 2 years.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneously irritation per ISO 10993)	Test results verify biocompatibility criteria fulfilled.
Functional performance compared to predicate device	Performance comparison testing conducted; subject device found to have substantially equivalent functional performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the bench tests (e.g., how many units were tested for appearance, functional performance, chemical properties, etc.).

The data provenance is from China, as the submitter, Beijing ZKSK Technology Co., Ltd., is located in Beijing, China, and the designated submission correspondent is in Shanghai, China. The testing described is prospective in nature, as it involves testing new units of the device against predefined requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes bench testing for a mechanical device, not an AI/imaging device where expert ground truth establishment for a test set would be relevant. The "ground truth" for these tests comes from engineering specifications and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not the type of testing described here. The testing involves objective measurements and compliance with engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This device is a mechanical multi-band ligator and not an AI-assisted diagnostic tool or an imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm-only) performance study was not done. This is a mechanical medical device, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests described is based on:

Engineering specifications and design requirements: For functional and mechanical performance, appearance, and physical properties.
International standards: Such as ASTM F 1980-16 for shelf life and ISO 10993 for biocompatibility.
Company's technical requirements: For specific mechanical properties of the loop.

8. The sample size for the training set

This is not applicable. The document describes a medical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 6, 2022

Beijing ZKSK Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 CHINA

Re: K213223

Trade/Device Name: Multi-Band Ligator Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: FHN, MND Dated: September 20, 2021 Received: September 29, 2021

Dear Boyle 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 (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-regulatory-information/postmarketing-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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/device-advicecomprehensive-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,

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

510(k) Number (if known) K213223

Device Name Multi-Band Ligator

Indications for Use (Describe)

Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

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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510(k) Summary K213223

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

1.0 Submitter's Information

Name: Beijing ZKSK Technology Co., Ltd

Address: Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzhou District,Beijing 101105, China Tel: +86 -13811778090

Contact: Ma Li

Designated Submission Correspondent

Contact: Mr. Boyle Wang Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

Date of Preparation: Apr.26, 2022

2.0 Device Information

Trade name: Multi-Band Ligator Common name: Band Ligator Classification name: Hemorrhoidal ligator.

Production code: FHN, MND Regulation number: 21 CFR 876.4400 Classification: Class II Panel: Gastroenterology/Urology 3.0 Predicate Device Information

WILSON-COOK MEDICAL, INC. Manufacturer: Trade/Device Name: WILSON-COOK 10 SHOT MULTI-BAND LIGATOR 510(k) number: K974018

4.0 Device Description

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Models difference of the subject device depends on loops number and components, see Table 1.

Models	Loop No.	Components
BL18-4A	4 bands
BL18-5A	5 bands	Control handle (rotation handle, shaft and joint),
BL18-6A	6 bands	loading catheter, irragation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets), loop.
BL18-7A	7 bands
BL18-8A	8 bands
BL18-9A	9 bands
BL18-4M	4 bands	Loading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets), loop.
BL18-5M	5 bands
BL18-6M	6 bands
BL18-7M	7 bands
BL18-8M	8 bands
BL18-9M	9 bands

Table 1 Multi-Band Ligator Models

5.0 Indication for Use Statement

Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.

6.0 Summary of Non-Clinical Testing

Summary of non-clinical and performance testing- Bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The subject device has been subjected to compliance testing according

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to Technical Requirements of Multi-Band Ligator. Results from testing performed confirms that the design requirement specification and user needs have been met. The subject device is confirmed to be safe and effective for the intended use.

7.1 Shelf life of Multi-Band Ligator is have successfully been tested according to ASTM F 1980-16. The label shelf life is 2 years.

7.2 Biocompatibility testing of Multi-Band Ligator has successfully been tested for cytotoxicity, sensitization and intracutaneously irritation. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Multi-Band Ligator is biocompatible.

7.3 Performance testing – Bench: The performance of Multi-Band Ligator have been verified. Tests as described in table 1 have been completed.

Test Item	Description
Appearance	To confirm that subject device is integrity and cleanlinessand hygiene.
Functional performance	To confirm that the functions of the subject devicecomplied with the Indication for Use.
Chemical properties	To confirm that pH, Total content of heavy metals,Potassium permanganate reductive substance,Evaporative residues and Ultraviolet Absorbance meet therelated requirements.
Mechanical performance ofthe Loop	To confirm Hardness, Tensile strength, Tensile elongationand Tensile deformation meet the company's technicalrequirements.
Tensile strength	To conform the Tensile strength of the Trigger cord.
Physical properties ofIrrigation adapter	To conform connection firmness, Inner surface and Luerconnector
Leakage of the barrel	To check the tightness of the barrel, it shall have noleakage

Table 1: Performance testing summary - Bench

7.0 _Summary of Clinical Testing

No clinical study is included in this submission.

8.0 Technological Characteristic Comparison Table

Item	Subject Device	Predicate Device
510(k) No.	K213223	K974018
Product Code	FHN, MND	FHN, MND
Regulation No.	21 CFR 876.4400	21 CFR 876.4400

Table 2- Comparison of Technology Characteristics

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	I	II
Class
Indication for Use	Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.	Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Components	1) Non-patient Contacting2) Loading Catheter;3) Irrigation Adapter;4) Barrel with preloaded loops5) Trigger Cord6) Multi-Band Ligator handle	1) Non-patient Contacting2) Loading Catheter;3) Irrigation Adapter;4) Barrel with 10 Ligation Bands5) Trigger Cord6) Deployment Handle
PatientContactingMaterials	Irrigation Adapter: PolyurethaneBarrel: Polycarbonate (PC), silicone rubberTrigger Cord: Polypropylen (PE)Loop: Natural rubber	Friction Fit Adapter:PolyurethaneBarrel:PolycarbonateTrigger Cord: VectranBands: Latex Rubber
Method of Use	Friction Fit adapter and barrel with ligation loops mounted to the distal tip of the endoscope. Band release from the barrel accomplished by trigger cord and Multi-Band Ligator handle.	Friction Fit adapter and barrel with ligation bands mounted to the distal tip of the endoscope. Band release from the barrel accomplished by trigger cord and deployment handle.
Loops(Bands)	Multiple loops (4~9 )can perform serial ligations without removal of the endoscope for reloading of bands	Multiple bands (10 )can perform serial ligations without removal of the endoscope for reloading of bands
Sterile	Non-sterile	Non-sterile
Shelf Life	2 years	3 years
Single Use	Single Use	Single Use
PerformanceComparisontesting	The test was conducted to the predicate device and current device to compare their functional performance.
Biocompatibility	Conform with ISO10993-1 (ISO10993-5, ISO10993-10,)	Conform with ISO 10993 standards

The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device. The comparison between the subject and predicate devices is based on the following:

• Same intended use

Same indications for use
Similar material types that meet ISO 10993 biocompatibility requirements

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· Same fundamental technology/principal of operation/user interface

The quantity of the loop of the subject device is 4,5,6,7,8,9 pcs, which is different with those of predicate device which is 10 pcs. But this difference will not raise any risk in safety and effectiveness.

Performance comparison testing was conducted to the predicate device and current device to compare their physical performance.It can be found the subject device incorporates substantially equivalent device materials, design, configuration, fundamental technology, sterilization process and intended use as those featured in the predicate device.

9.0 Conclusion

The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device in K974018 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

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.