Who is the manufacturer of Disposable hemoclip?

Beijing Zksk Technology Co., Ltd. filed the 510(k) submission for Disposable hemoclip (K213217).

What is the FDA product code for Disposable hemoclip?

PKL. It is classified under 21 CFR 876.4400 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Disposable hemoclip?

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

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

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 hemoclip

Q: What are the predicate devices for Disposable hemoclip?

Single Use Rotatable and Repositionable Hemoclip Device (K201771).

K213217 · Beijing Zksk Technology Co., Ltd. · PKL · Nov 14, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K213217
Device Name	Disposable hemoclip
Applicant	Beijing Zksk Technology Co., Ltd.
Product Code	PKL · Gastroenterology, Urology
Decision Date	Nov 14, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter. Diverticula in the colon, 3 ) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Device Story

Disposable, single-use endoscopic clipping device; used for GI tract hemostasis, marking, and perforation closure. Consists of delivery system and HC series clip; clip pre-installed at front of chuck releaser. Physician operates device through endoscope; finds bleeding site; uses thumb ring to release chuck; clip clamps tissue. Jaws open/close up to 5 times for repositioning before final deployment. Device provides mechanical closure of tissue; aids in stopping bleeding or sealing perforations; benefits patient by enabling minimally invasive endoscopic treatment of GI lesions.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993 series), sterility (USP <71>), packaging integrity (ASTM standards), and mechanical performance (clamping force, rotation, repositionability, and release strength).

Technological Characteristics

Materials: SUS304 (clip), PE (outer tube). Energy: Mechanical. Form factor: Endoscopic delivery system with rotatable clip. Sterilization: Ethylene Oxide (EO). Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring endoscopic marking, hemostasis of GI defects (mucosal/sub-mucosal <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), or closure of GI luminal perforations <20mm treatable conservatively.

Regulatory Classification

Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

Single Use Rotatable and Repositionable Hemoclip Device (K201771)

Related Devices

K180325 — Single Use MultiClip Device · Micro-Tech (Nanjing) Co., Ltd. · Jun 1, 2018
K152001 — Sterile Repositionable Hemostasis Clipping Device · Micro-Tech (Nanjing) Co., Ltd. · Dec 10, 2015
K201771 — Single Use Rotatable and Repositionable Hemoclip · Anrei Medical (Hangzhou) Co., Ltd. · Oct 19, 2020
K212669 — Single Use Hemoclip · Zhejiang Chuangxiang Medical Technology Co., Ltd. · May 27, 2022
K222146 — Disposable Endoscopic Hemoclip · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Mar 28, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ 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 name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. November 14, 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: K213217 > Trade/Device Name: Disposable hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: October 9, 2022 Received: October 11, 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 {1}------------------------------------------------ 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-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 -S 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K213217 Device Name Disposable Hemoclip Indications for Use (Describe) Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter. Diverticula in the colon, 3 ) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively. | 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.qov "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 K213217 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 Company name: Beijing ZKSK Technology Co., Ltd. Address: Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzhou District, Beijing 101105, China Phone Number: 86-13811778090 Fax number: 86-010-63777521 Date of Preparation: Oct.09, 2022 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn #### 2.0 Device information Trade name: Disposable Hemoclip Common name: Hemorrhoidal ligator Classification name: Hemorrhoidal ligator Model(s): HC-10-16526P, HC-10-19526P, HC-10-23026P, HC-11-16526P, HC-11-19526P, HC-11-230/26P, HC-14-165/26P, HC-14-195/26P, HC-14-230/26P, HC-16-165/26P, HC-16-16-230/26P, HC-10-10-165/26, HC-10-195/26, HC-10-230/26, HC-11-165/26, HC-11-195/26, HC-11-14-165/26, HC-14-165/26, HC-14-195/26, HC-14-230/26, HC-16-165/26, HC-16-195/26, HC-16-230/26. Model difference: There are 30 models of Disposable Hemoclip. The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. #### 3.0 Classification Production code: PKL Regulation number: 21CFR 876.4400 Classification: Class II Panel: Gastroenterology/Urology {4}------------------------------------------------ #### 4.0 Predicate device information Manufacturer: Anrei Medical (Hangzhou) Co., Ltd Single Use Rotatable and Repositionable Hemoclip Device: 510(k) number: K201771 #### 5.0 Intended Use/Indication for Use Statement Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking. 2) Hemostasis for: Mucosal/sub-mucosal defects <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter, Diverticula in the colon, 3 > As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively. #### 6.0 Device description The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding. The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site. There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same. #### 7.0Technological Characteristic Comparison Table {5}------------------------------------------------ | | Table 3 - General Comparison | | | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--| | Item | Proposed device | Predicated device | Remark | | | Product Code | PKL | PKL | Identical | | | Regulation No. | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical | | | Class | II | II | Identical | | | Product name | Disposable Hemoclip | Single Use Rotatable and Repositionable Hemoclip | Similar | | | 510(k) No. | K213217 | K201771 | Different | | | Models | HC-10-165/26P, HC-10- 195/26P, HC-10-230/26P, HC- 11-165/26P, HC-11-195/26P, HC-11-230/26P, HC-14- 165/26P, HC-14-195/26P, HC- 14-230/26P, HC-16-165/26P, HC-16-195/26P, HC-16- 230/26P ,HC-10-165/26, HC-10- 195/26, HC-10-230/26, HC-11- 165/26, HC-11-195/26, HC-11- 230/26, HC-14-165/26, HC-14- 195/26, HC-14-230/26, HC-16- 165/26, HC-16-195/26, HC-16- 230/26 | Not publicly available | Different | | | Intended Use/Indications for Use | Disposable hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1 ) Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter, Diverticula in the colon, 3 ) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively. | Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1 ) Endoscopic marking 2 ) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter, Diverticula in the colon, 3) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively | Identical | | | Configuration | Delivery system and HC series | Delivery system and jaw | * Gap 1 | | | Material | SUS304 | SUS304 | Identical | | | Sterility | Sterile | sterile | Identical | | | Sterilization method | EO | EO | Identical | | | Shelf life | 3 years | 3 years | Identical | | | Single Use | Yes | Yes | Identical | | | Rotation function | rotatable | rotatable | Identical | | | Open width | 8mm, 10mm, 12mm, 14mm and 16mm | 9mm, 11mm, 13mm and 16mm | * Gap 2 | | | Working length | 1650mm, 1950mm, 2300mm | 1650mm, 1950mm, 2300mm | * Gap 3 | | | Minimal working channel | 2.8mm | 2.8mm | Identical | | | Release the performance | The clip of the tissue clamp shall be able to open and close smoothly, and the slider shall be pushed and pulled to successfully complete the clamping action. After the clip assembly is disengaged from the device, the remaining part can be manually removed from the analog endoscope tube. The force to remove the clip from the endoscope tube is not more than 5N. | Not publicly available | * Gap 6 | | | Clamping force | After the tissue clamp is used to clamp the isolated pig stomach tissue, 100g weight is applied to the clamp seat, and it shall not be separated for 1min. | Not publicly available | * Gap 7 | | | Get out of the strength | greater than 20N | Not publicly available | * Gap 8 | | | Relocatable | The clamp shall be able to open normally and separate from the tissue. It shall be able to withstand repeated operation for 5 times. | Not publicly available | * Gap 9 | | | Clip assembly mechanical integrity | Visually observe that the clip assembly should fall off as a whole, and the connecting parts between clip assemblies should not fall off or become loose. | Not publicly available | *Gap 10 | | | Clamping release force | The force separating the clamp assembly from the outer tube after biting and locking shall be greater than 20N. | Not publicly available | *Gap 11 | | | Open and close of hemoclip | Push the slider towards the far end, and the clip should be able to open. Pull the slider towards the near end, and the clip shall be closed. This method should be able to withstand repeated operation for 5 times | Not publicly available | * Gap12 | | | In vitro Cytotoxicity | Under the condition of the test, no potential cytotoxicity | Under the condition of the test, no potential cytotoxicity | Identical | | | Intradermal reactivity | Under the condition of the test, no potential intracutaneous reactions | / | * Gap4 | | | Skin Sensitization | Under the condition of the test, no potential sensitization | Under the condition of the test, no potential sensitization | Identical | | | Irritation | | No irritation | * Gap 5 | | | Acute Systemic Toxicity | No acute toxicity | No acute toxicity | Identical | | | Material-mediated Pyrogens | No pyrogen | No pyrogen | Identical | | | Sub-acute Systemic Toxicity | No sub-acute toxicity | No sub-acute toxicity | Identical | | #### Tahle 3 - General Comparison {6}------------------------------------------------ {7}------------------------------------------------ * Gap analysis: Gap 1: The configuration of the proposed device is Delivery system and HC series,the configuration of the predicate device is Delivery system and jaw, this is just a different description of the text, from the following structural diagram can be seen that HC series is jaw, this difference does not create additional risks to the device. | Item | Proposed device | Predicated device | |---------------|------------------------|--------------------------| | Configuration | Image: Proposed device | Image: Predicated device | Gap 2-3: the two devices have some little deviation in product performance, but the difference in the performance test result does not raise additional questions for safety and effectiveness. Gap 4-5, the two devices have some little deviation in the irritation ,this difference does not create additional biocompatibility risks to the device. * Gap 6-11; performance test was performed on both the proposed device and predicate device and the test result demonstrated that there was no signification difference between them. ### 8.0 Non-Clinical Test Conclusion The proposed device was tested and conformed to the related recognized standards 2-258 ISO 10993-1:2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing 2-245 ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. 2-174 ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. {8}------------------------------------------------ #### K213217 ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11:Tests for systemic toxicity ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene Oxide Sterilization Residuals. USP31-NF26 <71> sterility test ASTM F 1980-16 Standard quidelines for accelerated aging of sterile barrier systems for medical devices ASTM FI 886/FI886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration. ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials ASTM D3078-02(2013) Standard Test Method for Determination of Flexible Packaging Leakage by Bubble Generation DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized ASTM D4169-16 Standard practice for performance testing of shipping containers and systems(DC-13,Level II) Dimension test was performed on the proposed device and the test result demonstrated that the device could meet its design specification requirement. Performance test was performed on the proposed device and predicate device and the test result demonstrated that there was no significant difference between them, the test include following items | Items | Test Methodology | Acceptance Criteria | Results | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Release the performance | Prepare a piece of 10cm*10cm isolated pig stomach tissue, insert the tissue clamp into the simulated clamp channel with a diameter ≥ 2.8mm, after the clamp assembly extends out of the clamp channel, align the clamp with the tissue, move the slider to the proximal end, until there is resistance on the handle, gradually close the tissue clamp, and then clamp the tissue and lift it away from the desktop. (Note: after feeling resistance, do not continue to move the slider to the near end. If you hear a click, the clip will not reopen). | The clip of the tissue clamp shall be able to open and close smoothly, and the slider shall be pushed and pulled to successfully complete the clamping action. After the clip assembly is disengaged from the device, the remaining part can be manually removed from the analog endoscope tube. The force to remove the clip from the endoscope tube is not more than 5N. | Meet the requirements | | | | | | | | Continue to move the slider towards the near end until the second resistance is reached, where a second click is felt or heard. Continue to move the slider towards the proximal end until the thumb ring is reached. After the clip assembly is released and disengaged, use the manual tension machine to hook the proximal finger ring of the handle, and pull the outer tube of the tissue clip and the adapter out of the simulated clamp channel. | | | | Clamping force | Fix the ex-vivo pig stomach tissue on a vise or other device and keep it still. Push the slide block of the conveying device to make the clip tissue clamp the tissue, and pull the slide block towards the near end until the clip is closed and the clip assembly is disengaged. Thread the silk thread through the small hole at the rear end of the clamp base, hang a 100g weight on the silk thread, and rotate the soft tissue clamp assembly to open and close repeatedly after 1min. The soft tissue clamp assembly shall not be separated from the tissue. | After the tissue clamp is used to clamp the isolated pig stomach tissue, 100g weight is applied to the clamp seat, and it shall not be separated for 1min. | Meet the requirements | | Get out of the strength | The isolated porcine gastric tissue was fixed on the lower side fixture of the electronic universal testing machine and kept moveable. The slider of the delivery device was pushed so that the clip clamped the porcine gastric tissue, and the slider was pulled hard proximally until the clip closed. The position of the slider was kept constant and the clip was always in a closed state. The side of the outer catheter of the tissue clip near the clip assembly was fixed on the upper fixture of the electronic universal testing machine, and the electronic | The force required to remove a deployed clip from the tissue model should be between 0.9N and 2.5N. | Meet the requirements | | | | | | | | universal testing machine was started to measure. | | | | Surface roughness | Use sample block comparison to compare with the measured surface according to the visual and tactile senses, and judge that the measured surface roughness is equivalent to that value. | The surface roughness parameter Ra of clamps shall not be greater than 0.5µm | Meet the requirements | | Hardness | Carry out the Vickers hardness test, the indenter is in contact with the surface of the sample, and the test force is applied perpendicular to the test surface. The test force holding time is 10-15s | The hardness of the clip shall be ≥260HV0.2. | Meet the requirements | | Corrosion resistance | The test piece is immersed (the immersion height should not be less than 30mm) and boil for at least 30 minutes in a glass beaker filled with boiling water (4.1); cool it in the test water for at least 1 hour, then take the test piece out of the test water, expose it to the air for 2 hours, and then dry it. Wipe the surface of the test piece vigorously with the cloth | Corrosion resistance of metal caps and clamps shall not be lower than class b requirements of class b of boiling water test method. | Meet the requirements | | Rotation performance | Bend the outer tube for a circle with a diameter of 20cm, hold the positioning cap, and then rotate the handle. Visually observe that the clip assembly should rotate smoothly without jamming. As shown in the following figure: Image: Illustration of rotation performance test | Visually observe that the clip assembly should follow the handle to rotate 360 ° left and right, and the rotation should be smooth without jamming. | Meet the requirements | | Repositionability | Prepare a 10cm*10cm piece of isolated pig stomach tissue, align the clip with the tissue, move the slider to the proximal end, until you feel resistance on the handle, and gradually close the tissue clip, then clamp the tissue and lift it away from the desktop. (Note: after feeling resistance, do not continue to move the slider to the near end. If you hear a click, the clip cannot be reopened.) after the operation | The clamp shall be able to open normally and separate from the tissue. It shall be able to withstand repeated operation for 5 times. | Meet the requirements | | | | | | | | is completed, move the slider to the far end and repeat the above operation for 4 times. | | | | Hemoclip assembly mechanical integrity | Prepare a piece of 10cm*10cm isolated pig stomach tissue, insert the tissue clamp into the simulated clamp channel with a diameter $\geq$ 2.8mm. After the clamp assembly extends out of the clamp channel, align the clamp with the tissue, move the slider to the proximal end, until there is resistance on the handle, and gradually close the tissue clamp, clamp the tissue and lift it away from the table. (Note: after feeling resistance, do not continue to move the slider to the near end. If you hear a click, the clip will not reopen). Continue to move the slider towards the near end until the second resistance is felt or heard here. Continue to move the slider toward the near end until you reach the thumb ring. | Visually observe that the clip assembly should fall off as a whole, and the connecting parts between clip assemblies should not fall off or become loose. | Meet the requirements | | Clamping release force | As shown in the figure below, fix the handle on one end of the force measuring machine, fix the sliding block on the other end of the force measuring machine, start the force measuring machine in the direction shown in the figure below, and the stretching speed is 200mm/min. As a result, the force separating the clamp assembly from the outer tube after biting and locking shall be greater than 20N Image: [Diagram of force measuring machine] | The force separating the clamp assembly from the outer tube after biting and locking shall be greater than 20N. | Meet the requirements | | Open and Close of hemoclip | Gently push the slider toward the far end to open the clip. Pull the slider towards the near end to close the clip. | Push the slider towards the far end, and the clip should be able to open. Pull the slider towards the near end, and the clip shall be closed. This method should be able to withstand repeated operation for 5 times. | Meet the requirements | | | | | | | Reducing substances | Preparation of test solution Take the sample, press 0.2g sample Add 1ml of water and extract for 72 hours at 37°C±1°C. Separate the sample from the liquid, cool to room temperature, and use it as the test solution. Take the same volume of water and place it in a glass container, and prepare a blank control solution in the same way Take 10mL of calibrated potassium permanganate solution and sodium thiosulfate solution and dilute to 0.002 mol/L. Add 10 mL of the test solution to a 250 mL iodine flask, add 1 mL of dilute sulfuric acid and 10 mL of 0.002 mol/L potassium permanganate standard solution, boil for 3 minutes, cool rapidly, add 0.1 g of potassium iodide, close it, and shake well. Immediately titrate with the same concentration of…