Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.

Device Description

The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare. The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.

Non-rotating snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm. Working lengths 1800mm and 2300mm.
Rotatable snares: available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. Opening widths 10mm, 15mm, 20mm.25mm. 30mm. 35mm. Working lengths 1800mm and 2300mm.

The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid. The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.

Non-rotating snares: available in the opening widths 10mm, 15mm. Working lengths 1800mm and 2300mm.
Rotatable snares: available 10mm, 15mm. Working lengths 1800mm and 2300mm.

AI/ML Overview

The provided text is a 510(k) summary for a Disposable Polypectomy Snare and Hybrid Snare. This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data, rather than presenting a study to prove a device meets specific clinical acceptance criteria for a new AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable or not provided in this type of submission.

Here's an explanation based on the provided text:

No clinical study was conducted or included in this submission. The device is being cleared based on substantial equivalence to a legally marketed predicate device, primarily through bench testing and comparison of technical specifications.
The summary explicitly states: "No Clinical Study is included in this submission." (Section 5.8)

However, I can extract the "Non-clinical Performance Data" which serves as the basis for demonstrating safety and effectiveness for this type of medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance (Non-clinical)

Based on the "Non-clinical Performance Data" section (5.7), the acceptance criteria are generally adherence to recognized international standards and satisfactory results from specific bench tests.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" (10993-1)	Comply with ISO 10993-1
Sterilization	Compliance with 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"	EO Sterilization; SAL:10-6 (Same as predicate)
Ethylene Oxide Residuals	Compliance with ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"	Comply with ISO 10993-1 (Implied compliance with 10993-7 given general 10993 compliance)
Physical Properties / Bench Testing	Satisfactory performance for "Appearance" and "Physical properties" tests (implied acceptance)	The results of all testing were passing.
Shelf Life	3 years	3 years (Same as predicate)
Material/Design equivalence to predicate	Differences do not raise questions of safety and effectiveness	Differences listed and deemed "Substantially equivalent" or "Similar"

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for the bench tests. Typically, regulatory submissions for physical devices include testing on a representative number of units to ensure consistency and performance across the product line.
Data Provenance: The tests were performed on the Disposable Polypectomy Snare and Disposable Polypectomy Hybrid Snare (the proposed device). The provenance of the raw data (e.g., country of origin, retrospective/prospective) is not detailed in this summary. These are typically controlled laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission relies on objective physical and chemical testing standards (ISO standards, bench tests) rather than expert-derived ground truth.

4. Adjudication method for the test set

Not applicable. This submission relies on objective physical and chemical testing standards.

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

Not applicable. This device is a physical medical instrument (polypectomy snare), not an AI or diagnostic device that involves human readers.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For biocompatibility and sterilization, the "ground truth" is defined by adherence to internationally recognized ISO standards.
For physical properties, the "ground truth" is adherence to pre-defined specifications and satisfactory performance in bench tests.

8. The sample size for the training set

Not applicable. No machine learning or AI component, thus no training set.

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

Not applicable. No machine learning or AI component, thus no training set or its associated ground truth establishment.

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). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. The right side of the logo features the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

June 27, 2022

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

K220790 Re:

Trade/Device Name: Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: May 17, 2022 Received: May 23, 2022

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.

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

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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-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 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 (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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220790

Device Name

Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare

Indications for Use (Describe)

Disposable Polynectomy Snare, Disposable Polypectomy Hybrid Snare is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract. Disposable Polypectomy Snare shall be used with monopolar diathermic energy. Disposable Polypectomy Hybrid Snare shall be used with or without monopolar diathermic energy.

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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 contains a logo for "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is in a stylized, bold, blue font with a yellow accent on the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY" in a smaller, sans-serif font, also in blue. The logo appears to be for a company specializing in endoscopy equipment.

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,
	Yangzhou 225106 Jiangsu, China
ContactPerson:	Ethan LiuRA Specialist
	Shanghai Thinkwell Consulting Co., Ltd
	Address: Room 211/6F, Xinling Road, Minhang Districtt,
	Shanghai, China.
	Phone: 0086-15216699240
	Email: xtdeepwater@126.com
DatePrepared:	May 17, 2022

5.2 Device

Device Name:	Disposable Polypectomy Snare,Disposable Polypectomy Hybrid Snare
Classification Name:	Endoscopic electrosurgical unit and accessories
Regulatory Class:	II
Regulation Number:	21 CFR 876.4300
Product Code:	FDI

5.3 Predicate Device

Device Name:	Polypectomy SnareK172729
Manufacturer:	Hangzhou AGS MedTech CO., Ltd.
Classification Name:	Endoscopic electrosurgical unit and accessories
Regulatory Class:	II
Regulation Number:	21 CFR 876.4300
Product Code:	FDI

5.4 Device Description

Disposable Polypectomy Snare

The Disposable Polypectomy Snare is available in two different types with rotating snare and non-rotating snare.

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Image /page/4/Picture/0 description: The image shows the logo for ARTLEY. The logo is in blue and yellow. The text "UNIQUE ENDOSCOPY" is below the main logo.

The cutting wire diameter of the snares is 0.4mm. The catheter diameters are 1.8mm and 2.4mm the depending on the version. The snares are available in different forms, lengths and openings depending on the type.

- Non-rotating snares

The non-rotating snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The snares are available in the opening widths 10mm, 15mm, 20mm, 25mm,30mm, 35mm.The snares are available in the working lengths 1800mm and 2300mm.

- Rotatable snares

The rotary snare is available in six different loop shape: Oval, Hexagon, Lune, Combination, Multiple and Composite. The opening widths are 10mm, 15mm, 20mm.25mm. 30mm. 35mm. depending on the version. The snares are available in the working lengths 1800mm and 2300mm.

Disposable Polypectomy Hybrid Snare

The Disposable Polypectomy Hybrid Snare is available in two different types with rotating snare and non-rotating snare. Only one available loop shape is Hybrid.

The cutting wire diameter of the snares is 0.4mm. The catheter diameters is 2.4mm. The snares are available in different forms, lengths and openings depending on the type.

Non-rotating snares
The non-rotating snare is available in the opening widths 10mm, 15mm,depending on the version.The snares are available in the working lengths 1800mm and 2300mm.
Rotatable snares
The rotary snares are available 10mm, 15mm, depending on the version. The snares are available in the working lengths 1800mm and 2300mm.

5.5 Indication for Use:

5.6 Comparison of Technological Characteristics

The Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare 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 Polypectomy Snare, K172729. The

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Image /page/5/Picture/0 description: The image shows the logo for ARTLEY UNIQUE ENDOSCOPY. The logo is in blue, except for the "Y" in ARTLEY, which is in yellow. The word "UNIQUE" is stacked on top of the word "ENDOSCOPY".

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	DisposablePolypectomy Snare,DisposablePolypectomy HybridSnare(Proposed Device)	Polypectomy Snare,K172729	Discussion
Indication forUse	Disposable PolypectomySnare, DisposablePolypectomy HybridSnare is usedendoscopically in theremoval of diminutivepolyps, sessile polyps,pedunculated polyps andtissue from within the GItract. DisposablePolypectomy Snare shallbe used with monopolardiathermic energy.Disposable PolypectomyHybrid Snare shall beused with or withoutmonopolar diathermicenergy.	Polypectomy Snare isused endoscopicallyin the removaland/or cauterizationof diminutive polyps,sessile polyps,pedunculated polypsand tissue from withinthe GI tract.	Substantiallyequivalent
Product Code	FDI	FDI	Same
Energy Use	Monopolar RadioFrequency Current	Monopolar RadioFrequency Current	Same
Loop Shape	DisposablePolypectomySnare:Oval, Hexagon,Lune, Combination,Multiple and CompositeDisposablePolypectomy HybridSnare:Hybrid	Hexagonal, Polygon ,Oval, Round, DuckBill	Substantiallyequivalent
Loop Width	DisposablePolypectomySnare:10mm, 15mm,20mm,25mm, 30mm,35mm	Hexagonal: 10mm,15mm, 25mm, 32mmPolygon:10mm,15mm, 25mm, 32mmOval:10mm, 15mm,	Similar
Item	DisposablePolypectomy Snare,DisposablePolypectomy HybridSnare(Proposed Device)	Polypectomy Snare,K172729	Discussion
	DisposablePolypectomy HybridSnare:10mm, 15mm	25mm, 32mmRound: 10mm,15mm, 25mm, 32mmDuck Bill: 10mm,15mm, 25mm, 32mm
Out tubediameter	DisposablePolypectomySnare:1.8mm, 2.4mmDisposablePolypectomy HybridSnare:2.4mm	1.8mm, 2.4mm	Same
WorkingLength	1800mm, 2300mm	1800mm, 2300mm	Same
Sterilization	EO Sterilization;SAL:10-6	EO Sterilization;SAL:10-6	Same
Single Use	Yes	Yes	Same
Shelf Life	3 years	3 years	Same
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1	Same

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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 streak on the right side of the "Y". Below "ARTLEY" is the phrase "UNIQUE ENDOSCOPY" in a smaller, blue font. The logo appears to be for a medical device company.

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 Polypectomy Snare, Disposable Polypectomy Hybrid Snare: Appearance, Physical properties. 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

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Image /page/7/Picture/0 description: The image shows the "ARTLEY UNIQUE ENDOSCOPY" logo. The word "ARTLEY" is in large, bold, blue font. Below that, the words "UNIQUE ENDOSCOPY" are in a smaller, blue font. There is a yellow line above the "EY" in "ARTLEY".

Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare is substantially equivalent to Hangzhou AGS MedTech CO., Ltd's currently marketed Polypectomy Snare, K172729.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).