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 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.

AI/ML Overview

This document describes the premarket notification for the "Disposable Hemoclip" (K213217) and its substantial equivalence to a predicate device. The information details non-clinical tests conducted to demonstrate the device meets acceptance criteria.

Table of acceptance criteria and the reported device performance:

Item	Acceptance Criteria	Reported Device Performance
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.	Meet the requirements (Based on the description of steps to test smooth opening/closing, successful clamping action, and manual removal of the disassembled clip from the analog endoscope tube, implying successful demonstration against the acceptance criteria). Explicitly, the test involved inserting the clip into a simulated clamp channel, aligning with isolated pig stomach tissue, clamping, and then deploying, followed by removing the remaining part from the analog endoscope tube. No specific force value for removal was reported, but stated as "Meet the requirements", implying it was ≤5N.
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.	Meet the requirements (Based on the description of clamping isolated pig stomach tissue, applying a 100g weight and the clip assembly not separating for 1min).
Get out of the strength	The force required to remove a deployed clip from the tissue model should be between 0.9N and 2.5N.	Meet the requirements (Based on the description of fixing isolated porcine gastric tissue and the device, then measuring the force required to remove the clip from the tissue model with an electronic universal testing machine). No specific force value was reported, but stated as "Meet the requirements", implying it was within the 0.9N to 2.5N range.
Surface roughness	The surface roughness parameter Ra of clamps shall not be greater than 0.5µm.	Meet the requirements (Based on comparison with sample block). No specific Ra value reported, but stated as "Meet the requirements", implying it was ≤0.5µm.
Hardness	The hardness of the clip shall be ≥260HV0.2.	Meet the requirements (Based on the Vickers hardness test). No specific HV0.2 value reported, but stated as "Meet the requirements", implying it was ≥260HV0.2.
Corrosion resistance	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 (Based on immersion in boiling water and observation).
Rotation performance	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 (Based on rotating the handle with the outer tube bent, and visual observation).
Repositionability	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 (Based on repeated opening and closing with isolated pig stomach tissue for 5 times).
Hemoclip 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.	Meet the requirements (Based on clamping isolated pig stomach tissue and visual observation after deployment).
Clamping release force	The force separating the clamp assembly from the outer tube after biting and locking shall be greater than 20N.	Meet the requirements (Based on force measurement to separate the clamp assembly from the outer tube). No specific force value reported, but stated as "Meet the requirements", implying it was >20N.
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.	Meet the requirements (Based on pushing/pulling the slider to open/close and repeated operation for 5 times).
Reducing substances	The difference in consumption of 0.002mol/L potassium permanganate solution should be less than 2.0mL as compared to the same batch of blank control liquid at the same volume.	0.9ml (This value is less than 2.0mL, meeting the requirement).
Extractable metal content	The total extractable metal content in the test solution shall not exceed 5 µg/mL, and the cadmium content shall be less than 0.1 µg/mL.	Meet the requirements (Based on colorimetric tube comparison).
pH	The pH difference between the test solution and the same batch of blank solution shall not exceed 1.0.	0.7 (This value is not exceeding 1.0, meeting the requirement).
Evaporation residue	The total amount of dry residue should not exceed 5mg.	0.56mg (This value is not exceeding 5mg, meeting the requirement).
Ultraviolet absorbance	Within the wavelength range of 250nm to 320nm, the absorbance of the test solution shall not be greater than 0.1.	0.046 (This value is not greater than 0.1, meeting the requirement).
SAL (Sterility Assurance Level)	≤10-6	Aseptic growth (This implies sterility was achieved, meeting the SAL requirement. Test method cited: USP31-NF26 <71> sterility test).
EO residue	≤10µg/g	3.72 µg/g (This value is less than 10µg/g, meeting the requirement. Test method cited: ISO 10993-7:2008).
Shelf life	3 years	Meet the requirements (Test method cited: ASTM F 1980-16 for accelerated aging to support the reported shelf life).
In vitro Cytotoxicity	Under the condition of the test, no potential cytotoxicity.	Under the condition of the test, no potential cytotoxicity (Test method cited: ISO 10993-5 Third edition 2009-06-01).
Intradermal reactivity	Under the condition of the test, no potential intracutaneous reactions.	Under the condition of the test, no potential intracutaneous reactions (Test method cited: ISO 10993-10 Third Edition 2010-08-01).
Skin Sensitization	Under the condition of the test, no potential sensitization.	Under the condition of the test, no potential sensitization (Test method cited: ISO 10993-10 Third Edition 2010-08-01).
Acute Systemic Toxicity	Under the condition of the test, no acute toxicity.	Under the condition of the test, no acute toxicity (Test method cited: ISO 10993-11:2017).
Material-mediated Pyrogens	Under the condition of the test, no pyrogen.	Under the condition of the test, no pyrogen (Test method cited: ISO 10993-11:2017).
Sub-acute Systemic Toxicity	Under the condition of the test, no sub-acute toxicity.	Under the condition of the test, no sub-acute toxicity (Test method cited: ISO 10993-11:2017).

Sample size used for the test set and the data provenance:
- Sample size: The document does not explicitly state the numerical sample size for each performance test. It refers to "a piece of 10cm*10cm isolated pig stomach tissue" for certain tests (e.g., Release the performance, Clamping force, Repositionability, Hemoclip assembly mechanical integrity) and "sample block comparison" for surface roughness. For other tests like reducing substances, extractable metal content, pH, evaporation residue, and UV absorbance, it references using specific volumes of test solutions (e.g., "0.2g sample", "1ml of water", "10mL of the test solution", "25mL of the test solution", "50 mL of the test solution"). The biological tests (cytotoxicity, skin sensitization, acute systemic toxicity, pyrogens, sub-acute systemic toxicity) would have their own sample sizes as per the ISO standards cited, but these are not provided in this summary.
- Data provenance: The data is based on non-clinical testing conducted by the manufacturer, Beijing ZKSK Technology Co., Ltd., in China. The tissue model used in several tests is "isolated pig stomach tissue," indicating an ex-vivo or in-vitro animal tissue model. All results are from laboratory tests performed on the device itself or its materials, not human clinical trials. Thus, the data provenance is retrospective (tests already performed) and from the manufacturer's facility in China.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical device (hemoclip) and relies on objective, quantifiable performance and biocompatibility testing against established standards, not on expert-adjudicated ground truth like in diagnostic imaging with AI. The "ground truth" here is derived directly from the physical properties of the device and its interaction with test materials, measured according to recognized test methodologies and standards.
Adjudication method for the test set:
- Not applicable. As described above, the evaluation is based on objective measurements and adherence to specific numerical or qualitative criteria (e.g., "Meet the requirements", specific values for chemical tests, visual observation of functionality), not on human expert adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual endoscopic tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It is a physical medical device. The "standalone" performance testing refers to the device's inherent mechanical, material, and functional properties as evaluated in the non-clinical tests.
The type of ground truth used:
- The "ground truth" for the non-clinical tests is established by:
  - Standardized measurement methodologies: Testing performed according to recognized international and national standards (ISO, ASTM, USP).
  - Objective performance criteria: Specific quantitative thresholds (e.g., force values, concentration limits, roughness parameters) and qualitative observations (e.g., smooth rotation, no separation, no cytotoxicity) defined in the acceptance criteria.
  - Material properties and chemical analysis results: Direct measurements of material hardness, chemical residues, extractables, pH, and UV absorbance.
  - Functional demonstrations: Observing the device's ability to open, close, clamp, release, and rotate as intended with a tissue model (isolated pig stomach tissue).
The sample size for the training set:
- Not applicable. This submission concerns a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set was used.

Summary

{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:

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:

Endoscopic marking.
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

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 andRepositionable 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
IntendedUse/Indications forUse	Disposable hemoclip is indicatedfor clip placement within theGastrointestinal (GI) tract for thepurpose 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 luminalperforations < 20mm that can betreated conservatively.	Single Use Rotatable andRepositionable Hemoclip isindicated for clip placementwithin the Gastrointestinal (GI)tract for the purpose of:1 ) Endoscopic marking2 ) 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 luminalperforations < 20mm that canbe treated conservatively	Identical
Configuration	Delivery system and HC series	Delivery system and jaw	* Gap 1
Material	SUS304	SUS304	Identical
Sterility	Sterile	sterile	Identical
Sterilizationmethod	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, 14mmand 16mm	9mm, 11mm, 13mm and16mm	* Gap 2
Working length	1650mm, 1950mm, 2300mm	1650mm, 1950mm, 2300mm	* Gap 3
Minimal workingchannel	2.8mm	2.8mm	Identical
Release theperformance	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 thestrength	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 assemblymechanicalintegrity	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 releaseforce	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 ofhemoclip	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 vitroCytotoxicity	Under the condition of the test,no potential cytotoxicity	Under the condition of the test,no potential cytotoxicity	Identical
Intradermalreactivity	Under the condition of the test,no potential intracutaneousreactions	/	* 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 SystemicToxicity	No acute toxicity	No acute toxicity	Identical
Material-mediatedPyrogens	No pyrogen	No pyrogen	Identical
Sub-acuteSystemic 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 theperformance	Prepare a piece of 10cm*10cmisolated pig stomach tissue,insert the tissue clamp into thesimulated clamp channel witha diameter ≥ 2.8mm, after theclamp assembly extends out ofthe clamp channel, align theclamp with the tissue, movethe slider to the proximal end,until there is resistance on thehandle, gradually close thetissue clamp, and then clampthe tissue and lift it away fromthe desktop. (Note: afterfeeling resistance, do notcontinue to move the slider tothe near end. If you hear aclick, the clip will not reopen).	The clip of the tissue clampshall be able to open andclose smoothly, and theslider shall be pushed andpulled to successfullycomplete the clampingaction.After the clip assembly isdisengaged from thedevice, the remaining partcan be manually removedfrom the analog endoscopetube.The force to remove the clipfrom the endoscope tube isnot more than 5N.	Meet therequirements

	Continue to move the slidertowards the near end until thesecond resistance is reached,where a second click is felt orheard. Continue to move theslider towards the proximalend until the thumb ring isreached. After the clipassembly is released anddisengaged, use the manualtension machine to hook theproximal finger ring of thehandle, and pull the outer tubeof the tissue clip and theadapter out of the simulatedclamp channel.
Clamping force	Fix the ex-vivo pig stomachtissue on a vise or otherdevice and keep it still. Pushthe slide block of theconveying device to make theclip tissue clamp the tissue,and pull the slide blocktowards the near end until theclip is closed and the clipassembly is disengaged.Thread the silk thread throughthe small hole at the rear endof the clamp base, hang a100g weight on the silk thread,and rotate the soft tissueclamp assembly to open andclose repeatedly after 1min.The soft tissue clampassembly shall not beseparated from the tissue.	After the tissue clamp isused to clamp the isolatedpig stomach tissue, 100gweight is applied to theclamp seat, and it shall notbe separated for 1min.	Meet therequirements
Get out of thestrength	The isolated porcine gastrictissue was fixed on the lowerside fixture of the electronicuniversal testing machine andkept moveable. The slider ofthe delivery device waspushed so that the clipclamped the porcine gastrictissue, and the slider waspulled hard proximally until theclip closed. The position of theslider was kept constant andthe clip was always in a closedstate. The side of the outercatheter of the tissue clip nearthe clip assembly was fixed onthe upper fixture of theelectronic universal testingmachine, and the electronic	The force required toremove a deployed clipfrom the tissue modelshould be between 0.9Nand 2.5N.	Meet therequirements

	universal testing machine wasstarted to measure.
Surfaceroughness	Use sample block comparisonto compare with the measuredsurface according to the visualand tactile senses, and judgethat the measured surfaceroughness is equivalent to thatvalue.	The surface roughnessparameter Ra of clampsshall not be greater than0.5µm	Meet therequirements
Hardness	Carry out the Vickers hardnesstest, the indenter is in contactwith the surface of the sample,and the test force is appliedperpendicular to the testsurface. The test force holdingtime is 10-15s	The hardness of the clipshall be ≥260HV0.2.	Meet therequirements
Corrosionresistance	The test piece is immersed(the immersion height shouldnot be less than 30mm) andboil for at least 30 minutes in aglass beaker filled with boilingwater (4.1); cool it in the testwater for at least 1 hour, thentake the test piece out of thetest water, expose it to the airfor 2 hours, and then dry it.Wipe the surface of the testpiece vigorously with the cloth	Corrosion resistance ofmetal caps and clampsshall not be lower thanclass b requirements ofclass b of boiling water testmethod.	Meet therequirements
Rotationperformance	Bend the outer tube for a circlewith a diameter of 20cm, holdthe positioning cap, and thenrotate the handle. Visuallyobserve that the clip assemblyshould rotate smoothly withoutjamming. As shown in thefollowing figure:Image: Illustration of rotation performance test	Visually observe that theclip assembly should followthe handle to rotate 360 °left and right, and therotation should be smoothwithout jamming.	Meet therequirements
Repositionability	Prepare a 10cm*10cm piece ofisolated pig stomach tissue,align the clip with the tissue,move the slider to the proximalend, until you feel resistanceon the handle, and graduallyclose the tissue clip, thenclamp the tissue and lift itaway from the desktop. (Note:after feeling resistance, do notcontinue to move the slider tothe near end. If you hear aclick, the clip cannot bereopened.) after the operation	The clamp shall be able toopen normally and separatefrom the tissue. It shall beable to withstand repeatedoperation for 5 times.	Meet therequirements

	is completed, move the sliderto the far end and repeat theabove operation for 4 times.
Hemoclipassemblymechanicalintegrity	Prepare a piece of 10cm*10cmisolated pig stomach tissue,insert the tissue clamp into thesimulated clamp channel witha diameter $\geq$ 2.8mm. After theclamp assembly extends out ofthe clamp channel, align theclamp with the tissue, movethe slider to the proximal end,until there is resistance on thehandle, and gradually closethe tissue clamp, clamp thetissue and lift it away from thetable. (Note: after feelingresistance, do not continue tomove the slider to the nearend. If you hear a click, the clipwill not reopen). Continue tomove the slider towards thenear end until the secondresistance is felt or heard here.Continue to move the slidertoward the near end until youreach the thumb ring.	Visually observe that theclip assembly should fall offas a whole, and theconnecting parts betweenclip assemblies should notfall off or become loose.	Meet therequirements
Clampingrelease force	As shown in the figure below,fix the handle on one end ofthe force measuring machine,fix the sliding block on theother end of the forcemeasuring machine, start theforce measuring machine inthe direction shown in thefigure below, and thestretching speed is200mm/min. As a result, theforce separating the clampassembly from the outer tubeafter biting and locking shall begreater than 20NImage: [Diagram of force measuring machine]	The force separating theclamp assembly from theouter tube after biting andlocking shall be greater than20N.	Meet therequirements
Open and Closeof hemoclip	Gently push the slider towardthe far end to open the clip.Pull the slider towards the nearend to close the clip.	Push the slider towards thefar end, and the clip shouldbe able to open.Pull the slider towards thenear end, and the clip shallbe closed.This method should be ableto withstand repeatedoperation for 5 times.	Meet therequirements

Reducingsubstances	Preparation of test solutionTake the sample, press 0.2gsample Add 1ml of water andextract for 72 hours at37°C±1°C. Separate thesample from the liquid, cool toroom temperature, and use itas the test solution.Take the same volume ofwater and place it in a glasscontainer, and prepare a blankcontrol solution in the samewayTake 10mL of calibratedpotassium permanganatesolution and sodium thiosulfatesolution and dilute to 0.002mol/L. Add 10 mL of the testsolution to a 250 mL iodineflask, add 1 mL of dilutesulfuric acid and 10 mL of0.002 mol/L potassiumpermanganate standardsolution, boil for 3 minutes,cool rapidly, add 0.1 g ofpotassium iodide, close it, andshake well. Immediately titratewith the same concentration ofsodium thiosulfate standardsolution to light yellow, add0.25 mL of starch indicatorsolution, and continue to titratewith sodium thiosulfatestandard solution until it iscolorless. Titrate the blankcontrol solution in the sameway.	The difference inconsumption of 0.002mol/Lpotassium permanganatesolution should be less than2.0mL as compared to thesame batch of blank controlliquid at the same volume.	0.9ml
Extractable metalcontent	Accurately measure 25mL ofthe test solution in a 25mLNessler colorimetric tube, takeanother 25mL Nesslercolorimetric tube, add 25mLlead standard solution, andadd acetate buffer (pH3 .5)2mL, then add 2mL ofthioacetamide test solution,shake well, place for 2min,observe from above on a whitebackground, compare thecolor depth. If the test solutiondevelops color, a smallamount of dilute caramelsolution or other non-interfering colored solution canbe added to the standardcontrol solution to make it	The total extractable metalcontent in the test solutionshall not exceed 5 g/mL,and the cadmium contentshall be less than 0.1 g/mL	Meet therequirements

	consistent with the color of thetest solution. Then add 2 mL ofthioacetamide test solution tothe test solution and thestandard control solution,shake well, and place for 2minutes. Observe from aboveon a white background tocompare the shades of color.
PH	Take the test solution and theblank control solution, andmeasure the pH value with anacidity meter. The differencebetween the two is the testresult.	The PH difference betweenthe test solution and thesame batch of blanksolution shall not exceed1.0	0.7
Evaporationresidue	The evaporating dish is pre-dried to constant weight at105°C. Measure 50 mL of thetest solution into anevaporating dish, evaporate todryness on a water bath, anddry to constant weight in aconstant temperature oven at105°C. Determine the blankcontrol solution in the sameway.	The total amount of dryresidue should not exceed5mg	0.56mg
Ultravioletabsorbance	Take the test solution, use a1cm cuvette with the blankcontrol solution as a referencewithin 5h, and measure theabsorbance within thespecified wavelength range.	Within the wavelengthrange of 250nm to 320nm,the absorbance of the testsolution shall not be greaterthan 0.1.	0.046
SAL	USP31-NF26 <71> sterility tes	≤10-6	Aseptic growth
EO residue	ISO 10993-7:2008	≤10µg/g	3.72 µg/g
Shelf life	ASTM F 1980-16	3 years	Meet therequirements
In vitroCytotoxicity	ISO 10993-5 Third edition2009-06-01	Under the condition of thetest, no potential cytotoxicity	Under thecondition ofthe test, nopotentialcytotoxicity
Intradermalreactivity	ISO 10993-10 Third Edition2010-08-01,	Under the condition of thetest, no potentialintracutaneous reactions	Under thecondition ofthe test, nopotentialintracutaneousreactions
Skin Sensitization	ISO 10993-10 Third Edition2010-08-01,	Under the condition of thetest, no potentialsensitization	Under thecondition ofthe test, nopotentialsensitization
Acute Systemic	ISO 10993-11:2017	Under the condition of the	Under the
Toxicity		test, no acute toxicity	condition ofthe test, noacutetoxicity
Material-mediatedPyrogens	ISO 10993-11:2017	Under the condition of thetest, no pyrogen	Under thecondition ofthe test, nopyrogen
Sub-acuteSystemicToxicity	ISO 10993-11:2017	Under the condition of thetest, no sub-acute toxicity	Under thecondition ofthe test, nosub-acutetoxicity

{9}------------------------------------------------

{10}------------------------------------------------

{11}------------------------------------------------

{12}------------------------------------------------

{13}------------------------------------------------

{14}------------------------------------------------

9.0 Clinical Test Conclusion

No clinical study implemented for the Disposable Hemoclip.

10.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device , the Disposable Hemoclip is as safe, as effective, and performs as well as or better than the legally marketed predicate device K201771.

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
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.(b)
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.