Disposable Polypectomy Snare

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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: K213222 Trade/Device Name: Disposable Polypectomy Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: April 22, 2022 Received: May 2, 2022 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. 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 {1}------------------------------------------------ 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-safety-reportingcombination-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 mediation-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) K213222 Device Name Disposable Polypectomy Snare Indications for Use (Describe) The Disposable Polypectorny Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 K213222 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<br>Economic Development Zone, Tongzhou District,Beijing 101105,<br>China | | Tel: | +86 -13811778090 | | Contact: | Ma Li | # Designated Submission Correspondent | Mr. Boyle Wang | |---------------------------------------------------------------| | Shanghai Truthful Information Technology Co., Ltd. | | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 | | China | | +86-21-50313932 | | Info@truthful.com.cn | | | Date Submitted: May.18, 2022 ## 2.0 Device Information | Trade name: | Disposable Polypectomy Snare | |----------------------|-------------------------------------------------| | Common name: | Polypectomy Snare | | Classification name: | Endoscopic electrosurgical unit and accessories | #### 3.0 Classification | Production code: | FDI | |--------------------|--------------------------| | Regulation number: | 21 CFR 876.4300 | | Classification: | Class II | | Panel: | Gastroenterology/Urology | ### 4.0 Predicate Device Information {4}------------------------------------------------ Manufacturer: Zhejiang Chuangxiang Medical Technology Co., LTD. Trade/Device Name: Disposable Polypectomy Snare K172758 510(k) number: #### 5.0 Device Description The Disposable Polypectomy Snare consists of an insertion part and a handle part. The insertion part includes cutting loop(a flexible wire cable), traction wire, and sheath; the handle part includes sheath sleeve, locking sleeve, rotating sleeve, electrode connector, slider and a handle. The cutting loop can be extended and retracted from the Snare's flexible outer sheath using a three ring handle. The cutting loop can also be rotated 360° using the rotating actuator on the handle. The inner diameter of the sheath is PTFE to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. The Disposable Polypectomy Snare is sterile for single use with no delayed hypersensitivity and no intracutaneous reactivity, have no animal or human origin substance. The cutting loop of disposable polypectomy snare has four shapes to be used in clinical practice: Ellipse type (E type), Hexagonal type (H type), Crescent type (C type), Round type (R type), and the loop can extend, retract from the snare's flexible outer sheath. The materials used for construction of Disposable Polypectomy Snare are typical for this type of medical device. Materials of Cutting Loop is stainless steel 06Cr19Ni10, the Sheath is made of PTEF, the Electrode Connector is made of stainless steel SUS304. The Handle, Slider, Rotating Sleeve and Locking Sleeve are made of ABS, the Sheath Sleeve is made of HDPE. ### 6.0 Indication for Use Statement The Disposable Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. # 7.0 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 to, by FDA, recognized consensus standards ISO 10993-7, ISO 10993-1, ISO 11607-1, and Technical Requirements of "Disposable Polypectomy Snare" provided by {5}------------------------------------------------ Beijing ZKSK Technology Co., Ltd. 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 Sterilization and shelf life of Disposable Polypectomy Snare is delivered sterile and have successfully been tested according to ISO 11607- 1. The label shelf life is 2 years. 7.2 Biocompatibility testing of Disposable Polypectomy Snare has successfully been tested for cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity and material medicated pyrogenicity. The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. Disposable Polypectomy Snare is non-toxic and biocompatible. 7.3 Performance testing – Bench: The performance of Disposable Polypectomy Snare has been verified. Tests as described in table 1 have been completed. | Test Item | Description | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appearance | To confirm that subject device is integrity and cleanliness<br>and hygiene. | | Dimension | To confirm that the dimensions of the subject device<br>complied with the company's requirements. | | Physical properties | To confirm the device functionality, tensile strength, cutting<br>wire strength, electrical resistance tests and<br>Compatible endoscopes tests. | | Conduction resistance | The resistance between the connector and the Cutting<br>Loop shall be $\leq 30\Omega$ . | | Corrosion resistance | should be no corrosive marks on the Cutting Loop. | | Chemical properties | To confirm that pH, Total content of heavy metals,<br>Potassium permanganate reductive substance,<br>Evaporative residues and Ultraviolet Absorbance meet the<br>related requirements. | | Sterility | This device is sterilized by ethylene oxide. The device<br>shall be sterile. | | EO residue | EO residue shall be $\leq 10 \mu g/g$ . | # Table 1: Performance testing summary - Bench 7.4 Electromagnetic Compatibility and Electrical Safety: Tests on Electromagnetic Compatibility and Electrical Safety were performed in accordance to requirements per IEC 60601-1:2005+A1:2012 ,IEC 60601-2-2:2017 and IEC 60601-1-2:2020. ### 8.0 _Summary of Clinical Testing No clinical study is included in this submission. {6}------------------------------------------------ # 9.0 Technological Characteristic Comparison Table | Item | Subject Device | Predicate Device | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) No. | K213222 | K172758 | | Product Code | FDI | FDI | | Regulation No. | 21 CFR 876.4300 | 21 CFR 876.4300 | | Class | II | II | | Intended Use | The Disposable Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. | The Polypectomy Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract. | | Configuration | Ellipse, Hexagonal, Crescent, Round | Oval, Hexagonal, Crescent, Round | | Minimal working channel | 2.8mm | 2.8mm | | Sheath OD. | 2.4mm,1.8mm | 2.4mm,1.8mm | | Working Length | 1600mm,1800mm,2400mm | 1600mm,1800mm,2400mm | | Loop width | 10mm 15mm 22mm 25mm 32mm | 10mm 15mm 22mm 25mm 32mm | | | | | | Materials of<br>Construction | Cutting Loop - Stainless Steel<br>06Cr19Ni10 (patient contacting)<br>Sheath – Teflon (PTEF) (patient<br>contacting)<br>Traction Wire- Nitinol( non-patient<br>contacting)<br>Sheath Sleeve- HDPE( non-patient<br>contacting)<br>Locking Sleeve- Acrylonitrile /<br>Butadiene / Styrene Copolymer<br>(ABS)(non-patient contacting)<br>Rotating Sleeve- Acrylonitrile /<br>Butadiene / Styrene Copolymer<br>(ABS)(non-patient contacting)<br>Wire Pusher- Stainless Steel<br>SUS304(non-patient contacting)<br>Electrode Connector-<br>H62(non-patient contacting)<br>Slider- Acrylonitrile / Butadiene /<br>Styrene Copolymer<br>(ABS)(non-patient contacting)<br>Handle- Acrylonitrile / Butadiene /<br>Styrene Copolymer<br>(ABS)(non-patient contacting) | Cutting loop made of stainless<br>steel, Sheath made of Teflon<br>(PTEF) | | Target<br>Population | Patients undergoing an<br>endoscopic mucosal resection<br>procedure | Patients undergoing an<br>endoscopic mucosal resection<br>procedure | | Sterile | Ethylene Oxide, SAL: 10-6 | Ethylene Oxide, SAL: 10-6 | | Shelf Life | 2 years | 3 years | | Single Use | Single Use | Single Use | | Performance<br>Comparison<br>testing | The test was conducted to the predicate device and current device to<br>compare their performance including device functionality, tensile<br>strength, cutting wire strength, electrical resistance tests and<br>Compatible endoscopes tests. | | | Biocompatibility | Conform with ISO10993-1<br>(ISO10993-5,<br>ISO10993-10,<br>ISO10993-11) | Conform with ISO 10993<br>standards | | Electromagnetic<br>Compatibility<br>and Electrical<br>Safety | Conform with IEC<br>60601-1:2005+A1:2012,IEC<br>60601-2-2:2017and<br>60601-1-2:2020 | Conform with AAMI/ANSI ES<br>60601-1:2005/(R)2012 and<br>AAMI/ANSI/IEC 60601-2-2:2009. | | | | | | Compatible<br>electrical<br>surgical<br>generators | ICC300 by ERBE Elektromedizin GmbH,<br>Valleylab Force FX-8C by Medtronic,<br>B.Braun Melsungen AG company produced GB300 high frequency<br>electric burner device. | Not publicly available | # Table 2- Comparison of Technology Characteristics {7}------------------------------------------------ {8}------------------------------------------------ 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 - · Same sterilization methods - Same fundamental technology/principal of operation/user interface The type of the cutting loop of the subject device is same with those of predicate device, just the expression is in different words, ellipse or oval, the description of same shape. The compatible electrical surgical generators of the predicate device are not publicly available. The function of the Cutting Loop of the proposed device and the predicate device remains the same in that it is attached to the generator to allow the flow of electrical energy to the cutting loop for the purpose of resecting tissue. The use of the different electrosurgical generator does not change the intended use or fundamental technology of the subject device. 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. #### 10.0 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 predicated device in K172758 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.