Disposable Polyp Snare
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 |
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.
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)
Submission Summary (Full Text)
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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.
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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-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
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# 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)
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# 510(k) Summary
Date of Summary prepare: December 30, 2021
# 1. Submission Sponsor
| Applicant Name | Jiangsu Vedkang Medical Science &<br>Technology Co., Ltd. |
|----------------|---------------------------------------------------------------------------------------------------|
| Address | No.52, Guoxiang Road, Wujin Economic<br>Development Zone, Changzhou 213149,<br>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<br>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 |
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| | 21 CFR § 876.4730 |
|------------------|------------------------------------------------------------------------|
| Regulation class | 2 |
| Regulation name | Endoscopic electrosurgical unit and<br>accessories |
| | Manual gastroenterology-urology surgical<br>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<br>item | Subject Device: Disposable<br>Polyp Snare (K220089) | Predicate Device: Single Use<br>Electrosurgical Snare SD-<br>400(K172734) | Comments |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product<br>Code | FDI, FGX | FDI, FGX | Same |
| Regulation<br>Number | 21 CFR § 876.4300<br>21 CFR § 876.4730 | 21 CFR § 876.4300<br>21 CFR § 876.4730 | Same |
| Classificatio<br>n | Class II | Class II | Same |
| Comparison<br>item | Subject Device: Disposable<br>Polyp Snare (K220089) | Predicate Device: Single Use<br>Electrosurgical Snare SD-<br>400(K172734) | Comments |
| Type of use | Prescription Use | Prescription Use | Same |
| Intended<br>use &<br>Indication<br>s for Use | The Disposable Polyp Snare<br>is intended to be used in<br>combination with endoscope<br>for cutting polyps or other<br>redundant tissues in digestive<br>tract. The snare can be used<br>with or without high-frequency<br>current. | These instruments have been<br>designed to be used with an<br>Olympus endoscope for the<br>removal and/or cauterization<br>of diminutive polyps, sessile<br>polyps, pedunculated polyps<br>and tissue from within the Gl<br>tract. | Same |
| Applicable<br>user | The subject device is intended<br>for use in people other than<br>infants and young children. | The device is intended for use<br>in people other than infants<br>and young children. | Same |
| Environment<br>of use | Healthcare facility/hospital | Healthcare facility/hospital | Same |
| Single<br>/repeat use | Single use | Single use | Same |
| Sterile /non-<br>sterile | Marketed as a sterile device | Marketed as a sterile device | Same |
| Sterilization<br>method and<br>SAL | ETO sterile<br>SAL=10-6 | ETO sterile<br>SAL=10-6 | Same |
| Energy<br>source | With or without High-<br>frequency current | With or without High-<br>frequency current | Same |
| Materials | Loop: stainless steel<br>Tube sheath:<br>Polytetrafluoroethylene<br>(PTFE)<br>Handle: ABS<br>Protective sleeve:<br>Polyurethane (PU) | Loop: stainless steel<br>Tube: fluorocarbon polymer<br>Handle: ABS | Similar |
| Patient -<br>contact<br>potential<br>(Duration<br>and type of<br>contact) | Surface-contacting device in<br>contact with mucosal<br>membranes.<br>The contact duration is limited<br>exposure (i.e. contact is up to<br>24 hours) | Surface-contacting device in<br>contact with mucosal<br>membranes.<br>The contact duration is limited<br>exposure (i.e. contact is up to<br>24 hours) | Same |
| Configuratio<br>n | Oval, Crescent, Hexagonal,<br>Rhombus, Dual-width oval,<br>Polygonal | Hexagonal | Different |
| Loop Width | 6 mm, 10 mm, 15 mm, 20 mm,<br>25 mm, 30 mm, 35 mm, 40<br>mm, 45 mm, 50 mm | 10 mm, 15 mm | Different |
| Working<br>Length | 1200 mm,1600 mm, 1800 mm,<br>2300 mm, 2400 mm, 3000 mm | 2300 mm | Different |
| Comparison<br>item | Subject Device: Disposable<br>Polyp Snare (K220089) | Predicate Device: Single Use<br>Electrosurgical Snare SD-<br>400(K172734) | Comments |
| Tube sheath<br>O.D. | 1.8 mm, 2.3 mm | Unknown | Different |
| Minimal<br>working<br>channel | 2.0 mm, 2.8 mm | 2.8 mm | Different |
### 7. Technological characteristics comparison
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# 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
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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.
