Who is the manufacturer of Disposable Polyp Snare?

Jiangsu Vedkang Medical Science and Technology Co., Ltd. filed the 510(k) submission for Disposable Polyp Snare (K220089).

What is the FDA product code for Disposable Polyp Snare?

FDI. It is classified under 21 CFR 876.4300 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Disposable Polyp Snare?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Disposable Polyp Snare?

Single Use Electrosurgical Snare SD-400 (K172734).

Who can help prepare an FDA 510(k) submission like Disposable Polyp Snare?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Disposable Polyp Snare

K220089 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · FDI · Sep 22, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K220089
Device Name	Disposable Polyp Snare
Applicant	Jiangsu Vedkang Medical Science and Technology Co., Ltd.
Product Code	FDI · Gastroenterology, Urology
Decision Date	Sep 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4300
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

Disposable endoscopic accessory for tissue resection; consists of handle, tube, and loop. Operated by physician in healthcare facility/hospital. Loop inserted through endoscope working channel; extended/retracted via handle to capture target tissue. Resection performed with or without high-frequency electrosurgical current. Device facilitates removal of polyps or redundant tissue; benefits patient by enabling minimally invasive tissue excision.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included size, strength, maneuverability, rotation, and cold/hot cutting ability. Biocompatibility testing (cytotoxicity, sensitization, irritation, toxicity, pyrogen) per ISO 10993-1. Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-2-2. Shelf-life validated per ASTM F1980-16.

Technological Characteristics

Loop: stainless steel; Tube sheath: PTFE; Handle: ABS; Protective sleeve: PU. Manual actuation via handle. Energy: high-frequency electrosurgical current. Dimensions: 1.8-2.3mm O.D., 1200-3000mm length. Sterile (ETO, SAL 10^-6). Single-use. Complies with AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-2-2.

Indications for Use

Indicated for cutting polyps or redundant tissues in the digestive tract in patients other than infants and young children. Can be used with or without high-frequency current.

Regulatory Classification

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.

Predicate Devices

Single Use Electrosurgical Snare SD-400 (K172734)

Related Devices

K172734 — Single Use Electrosurgical Snare SD-400 · Olympus Medical Systems Corp. · Dec 7, 2017
K220846 — CORE-SNARE · Incore Co., Ltd. · Nov 21, 2022
K251692 — Advanced Tissue Resection Device · Micro-Tech (Nanjing) Co., Ltd. · Feb 21, 2026
K123223 — EC SINGLE USE, POLYPECTOMY SNARE · Endochoice, Inc. · Jan 10, 2013
K213222 — Disposable Polypectomy Snare · Beijing Zksk Technology Co., Ltd. · Jun 6, 2022

Submission Summary (Full Text)

{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) 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. 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 Economic Development 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 Times Square, 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 and accessories | | | Manual gastroenterology-urology surgical instrument 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. 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. ### 6. Intended Use/ Indications for Use 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. | Comparison item | Subject Device: Disposable Polyp Snare (K220089) | Predicate Device: Single Use Electrosurgical Snare SD- 400(K172734) | Comments | |---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product Code | FDI, FGX | FDI, FGX | Same | | Regulation Number | 21 CFR § 876.4300 21 CFR § 876.4730 | 21 CFR § 876.4300 21 CFR § 876.4730 | Same | | Classificatio n | Class II | Class II | Same | | Comparison item | Subject Device: Disposable Polyp Snare (K220089) | Predicate Device: Single Use Electrosurgical Snare SD- 400(K172734) | Comments | | Type of use | Prescription Use | Prescription Use | Same | | Intended use & Indication s for Use | 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. | These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the Gl tract. | Same | | Applicable user | The subject device is intended for use in people other than infants and young children. | The device is intended for use in people other than infants and young children. | Same | | Environment of 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 | | Sterilization method and SAL | ETO sterile SAL=10-6 | ETO sterile SAL=10-6 | Same | | Energy source | With or without High- frequency current | With or without High- frequency current | Same | | Materials | Loop: stainless steel Tube sheath: Polytetrafluoroethylene (PTFE) Handle: ABS Protective sleeve: Polyurethane (PU) | Loop: stainless steel Tube: fluorocarbon polymer Handle: ABS | Similar | | Patient - contact potential (Duration and type of contact) | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours) | Surface-contacting device in contact with mucosal membranes. The contact duration is limited exposure (i.e. contact is up to 24 hours) | Same | | Configuratio n | 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, 40 mm, 45 mm, 50 mm | 10 mm, 15 mm | Different | | Working Length | 1200 mm,1600 mm, 1800 mm, 2300 mm, 2400 mm, 3000 mm | 2300 mm | Different | | Comparison item | Subject Device: Disposable Polyp Snare (K220089) | Predicate Device: Single Use Electrosurgical Snare SD- 400(K172734) | Comments | | Tube sheath O.D. | 1.8 mm, 2.3 mm | Unknown | Different | | Minimal working channel | 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.