K Number
K213223
Device Name
Multi-Band Ligator
Date Cleared
2022-06-06

(250 days)

Product Code
Regulation Number
876.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Used to endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on mechanical function and bench testing, with no mention of AI/ML terms or data-driven performance metrics.

Yes
The device is used to ligate (tie off) esophageal varices or hemorrhoids, which directly treats or modifies a physiological function of the body to alleviate a disease or condition.

No

This device is designed for therapeutic ligation of esophageal varices or hemorrhoids, not for diagnosing medical conditions.

No

The device description clearly outlines multiple physical components (control handle, loading catheter, irrigation adapter, barrel, trigger cord, loop) and describes a mechanical process of deployment. This is a hardware-based medical device.

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

Here's why:

  • Intended Use: The intended use is to "endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids." This is a therapeutic procedure performed directly on the patient's body.
  • Device Description: The description details a mechanical device used for physically applying bands to tissue. It does not involve analyzing biological samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
  • Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device performs a physical intervention (ligation) and does not fit that definition.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FHN, MND

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

esophageal varices at or above the gastroesophageal junction or internal hemorrhoids.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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 Items:

  • Appearance: To confirm that subject device is integrity and cleanliness and hygiene.
  • Functional performance: To confirm that the functions of the subject device complied 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 the related requirements.
  • Mechanical performance of the Loop: To confirm Hardness, Tensile strength, Tensile elongation and Tensile deformation meet the company's technical requirements.
  • Tensile strength: To conform the Tensile strength of the Trigger cord.
  • Physical properties of Irrigation adapter: To conform connection firmness, Inner surface and Luer connector
  • Leakage of the barrel: To check the tightness of the barrel, it shall have no leakage

No clinical study is included in this submission.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K974018

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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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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Page 2

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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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.

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

ModelsLoop No.Components
BL18-4A4 bands
BL18-5A5 bandsControl handle (rotation handle, shaft and joint),
BL18-6A6 bandsloading catheter, irragation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets), loop.
BL18-7A7 bands
BL18-8A8 bands
BL18-9A9 bands
BL18-4M4 bandsLoading catheter, irrigation adapter (irrigation pipe and base), barrel, trigger cord (cord and pellets), loop.
BL18-5M5 bands
BL18-6M6 bands
BL18-7M7 bands
BL18-8M8 bands
BL18-9M9 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

5

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 ItemDescription
AppearanceTo confirm that subject device is integrity and cleanliness
and hygiene.
Functional performanceTo confirm that the functions of the subject device
complied with the Indication for Use.
Chemical propertiesTo confirm that pH, Total content of heavy metals,
Potassium permanganate reductive substance,
Evaporative residues and Ultraviolet Absorbance meet the
related requirements.
Mechanical performance of
the LoopTo confirm Hardness, Tensile strength, Tensile elongation
and Tensile deformation meet the company's technical
requirements.
Tensile strengthTo conform the Tensile strength of the Trigger cord.
Physical properties of
Irrigation adapterTo conform connection firmness, Inner surface and Luer
connector
Leakage of the barrelTo check the tightness of the barrel, it shall have no
leakage
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

ItemSubject DevicePredicate Device
510(k) No.K213223K974018
Product CodeFHN, MNDFHN, MND
Regulation No.21 CFR 876.440021 CFR 876.4400

Table 2- Comparison of Technology Characteristics

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III
Class
Indication for UseUsed 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.
Components1) Non-patient Contacting
  1. Loading Catheter;
  2. Irrigation Adapter;
  3. Barrel with preloaded loops
  4. Trigger Cord
  5. Multi-Band Ligator handle | 1) Non-patient Contacting
  6. Loading Catheter;
  7. Irrigation Adapter;
  8. Barrel with 10 Ligation Bands
  9. Trigger Cord
  10. Deployment Handle |
    | Patient
    Contacting
    Materials | Irrigation Adapter: Polyurethane
    Barrel: Polycarbonate (PC), silicone rubber
    Trigger Cord: Polypropylen (PE)
    Loop: Natural rubber | Friction Fit Adapter:Polyurethane
    Barrel:Polycarbonate
    Trigger Cord: Vectran
    Bands: 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 |
    | Performance
    Comparison
    testing | 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.