The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.

Device Description

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Disposable Polyp Snare) and does not contain information about software as a medical device (SaMD) or an AI/ML device. Therefore, it does not describe acceptance criteria, the study that proves a device meets those criteria, or the other specific details requested in the prompt related to AI/ML or SaMD performance.

The document pertains to a physical medical device and its substantial equivalence to a predicate device based on non-clinical performance testing. The "510(k) Summary," specifically section 8 "Summary of non-clinical testing," outlines the tests conducted to support its marketing claims and confirm safety and effectiveness.

Based on the provided text, I cannot provide the requested information for the following reasons:

Device Type: The device is a "Disposable Polyp Snare," which is a physical endoscopic accessory, not an AI/ML or software device.
Study Type: The document explicitly states "No clinical tests were performed" (Section 9). The "non-clinical testing" summarized in Section 8 refers to physical performance tests (e.g., strength, maneuverability, cutting ability), sterilization, shelf-life, biocompatibility, and electrical safety, not the performance of an AI algorithm.
Ground Truth/Experts/Sample Size (for AI): Since this is not an AI/ML device, there is no mention of training sets, test sets for AI performance, expert consensus for ground truth, or adjudication methods for AI performance evaluation.

In summary, the provided document does not contain the type of information needed to answer your detailed questions about acceptance criteria and study data for an AI/ML or SaMD product.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

September 22, 2022

Jiangsu Vedkang Medical Science and Technology Co.,Ltd. % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K220089

Trade/Device Name: Disposable Polyp Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: FDI, FGX Dated: August 18, 2022 Received: August 18, 2022

Dear Joyce 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 (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.

{1}------------------------------------------------

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-regulatoryinformation/postmarketing-safety-reporting-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-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220089

Device Name Disposable Polyp Snare

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Date of Summary prepare: December 30, 2021

1. Submission Sponsor

Applicant Name	Jiangsu Vedkang Medical Science &Technology Co., Ltd.
Address	No.52, Guoxiang Road, Wujin EconomicDevelopment Zone, Changzhou 213149,Jiangsu, P.R.China
Contact person	Tang Ting
Phone	+86 519 69877755

2. Submission correspondent

Name	Shenzhen Joyantech Consulting Co., Ltd
Address	1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen
Post Code	518000
Phone No.	+86-755-86069197
Contact Person	Joyce Yang
Email	joyce@cefda.com

3. Device Identification

Type of 510(k) submission: Traditional
	Trade Name: Disposable Polyp Snare
Classification name:	Endoscopic Electrosurgical
	Unit and Accessories
Review Panel:	Gastroenterology/Urology
Product Code:	FDI
	FGX
Device Class:	2
Regulation Number:	21 CFR § 876.4300
	21 CFR § 876.4730

4. Legally Marketed Predicate Device

Trade Name	Single Use Electrosurgical Snare SD-400
Regulation number	21 CFR § 876.4300

{4}------------------------------------------------

	21 CFR § 876.4730
Regulation class	2
Regulation name	Endoscopic electrosurgical unit andaccessories
	Manual gastroenterology-urology surgicalinstrument and accessories
510(k) Number	K172734
Product Code	FDI
	FGX
Manufacturer	Aomori Olympus Co., Ltd.

Device Description 5.

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

6. Intended Use/ Indications for Use

Comparisonitem	Subject Device: DisposablePolyp Snare (K220089)	Predicate Device: Single UseElectrosurgical Snare SD-400(K172734)	Comments
ProductCode	FDI, FGX	FDI, FGX	Same
RegulationNumber	21 CFR § 876.430021 CFR § 876.4730	21 CFR § 876.430021 CFR § 876.4730	Same
Classification	Class II	Class II	Same
Comparisonitem	Subject Device: DisposablePolyp Snare (K220089)	Predicate Device: Single UseElectrosurgical Snare SD-400(K172734)	Comments
Type of use	Prescription Use	Prescription Use	Same
Intendeduse &Indications for Use	The Disposable Polyp Snareis intended to be used incombination with endoscopefor cutting polyps or otherredundant tissues in digestivetract. The snare can be usedwith or without high-frequencycurrent.	These instruments have beendesigned to be used with anOlympus endoscope for theremoval and/or cauterizationof diminutive polyps, sessilepolyps, pedunculated polypsand tissue from within the Gltract.	Same
Applicableuser	The subject device is intendedfor use in people other thaninfants and young children.	The device is intended for usein people other than infantsand young children.	Same
Environmentof use	Healthcare facility/hospital	Healthcare facility/hospital	Same
Single/repeat use	Single use	Single use	Same
Sterile /non-sterile	Marketed as a sterile device	Marketed as a sterile device	Same
Sterilizationmethod andSAL	ETO sterileSAL=10-6	ETO sterileSAL=10-6	Same
Energysource	With or without High-frequency current	With or without High-frequency current	Same
Materials	Loop: stainless steelTube sheath:Polytetrafluoroethylene(PTFE)Handle: ABSProtective sleeve:Polyurethane (PU)	Loop: stainless steelTube: fluorocarbon polymerHandle: ABS	Similar
Patient -contactpotential(Durationand type ofcontact)	Surface-contacting device incontact with mucosalmembranes.The contact duration is limitedexposure (i.e. contact is up to24 hours)	Surface-contacting device incontact with mucosalmembranes.The contact duration is limitedexposure (i.e. contact is up to24 hours)	Same
Configuration	Oval, Crescent, Hexagonal,Rhombus, Dual-width oval,Polygonal	Hexagonal	Different
Loop Width	6 mm, 10 mm, 15 mm, 20 mm,25 mm, 30 mm, 35 mm, 40mm, 45 mm, 50 mm	10 mm, 15 mm	Different
WorkingLength	1200 mm,1600 mm, 1800 mm,2300 mm, 2400 mm, 3000 mm	2300 mm	Different
Comparisonitem	Subject Device: DisposablePolyp Snare (K220089)	Predicate Device: Single UseElectrosurgical Snare SD-400(K172734)	Comments
Tube sheathO.D.	1.8 mm, 2.3 mm	Unknown	Different
Minimalworkingchannel	2.0 mm, 2.8 mm	2.8 mm	Different

7. Technological characteristics comparison

{5}------------------------------------------------

{6}------------------------------------------------

8. Summary of non-clinical testing

Performance testing was conducted on the following items to support the marketing claims and to confirm that the safety and effectiveness of the Disposable Polyp Snare is at least equivalent to the predicate device.

Size
Strength
Maneuverability
Rotation degree of snare loop
Cold cutting ability
Hot cutting ability

The EO residual and ECH residual were measured after sterilization of the device to meet the criteria defined in ISO 11135 Second edition 2014 and ISO 10993-7:2008.

The shelf-life for three years had been validated in accelerated testing according to ASTM F1980-16 and the requirements on packaging for terminally sterilized medical device per ISO 11607-1:2006 are also met. The testing successfully demonstrated essential performance is achieved before and after the shelf life test.

The biocompatibility evaluations were conducted in accordance with the 2020 FDA Guidance document Use of International Standard ISO-10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The cytotoxicity, sensitization, intracutaneous irritation, system toxicity and pyrogen tests were performed to demonstrate the biocompatibility of the device.

Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012

{7}------------------------------------------------

and IEC 60601-1-2 Edition 3: 2007-03, and in particular we also conducted tests on high frequency surgical equipment and accessories for endoscopes per IEC 60601-2-18:Edition 3.0 2009-08 and AAMI/ANSI/IEC 60601-2-2:2009.

9. Brief discussion of clinical tests

No clinical tests were performed.

10. Conclusions

The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Polyp Snares are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K172734.

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).