Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Device Description

Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.

The Endoscopic Injection Needle is available in three needle sizes (20 gauges 22 gauge and 25 gauge), five needle lengths (4mm,5mm,8mm and 10mm),five working length(1200mm,1600mm, 1950mm,2000mm, 2300mm). There are 5 series (SN18-05 series, SN18-07 series, SN18-09 series, SN19-05 series and SN19-07 series) total ninety (90) specification injection needles.

The Endoscopic Injection Needle is sterile, single-use device. It is expected to be used in conjunction with an endoscope to perform endoscopic injections into tissue in the GI tract during an endoscopic procedure.

The Endoscopic Injection Needle is designed to pass through the endoscope's forceps to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1600mm, 1950mm,2000mm, 2300mm, and the minimum working clamp channel is φ 2.8 mm.

AI/ML Overview

The provided text describes the Endoscopic Injection Needle (K213239) and its acceptance criteria, along with a summary of the testing performed to demonstrate its safety and effectiveness.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful completion of the tests listed. The "Reported Device Performance" column indicates that the device met these criteria through successful testing.

Test Item	Acceptance Criteria (Implied)	Reported Device Performance
Integrity Checks
Appearance	Integrity, cleanliness, and hygiene	Confirmed to be integrity and cleanliness and hygiene
Dimension	Complied with company's requirements	Complied with company's requirements
Leakage	No gas leakage	No gas leakage
Needle Protection	Needle shall not be exposed when pulling rod back	Needle not exposed when pulling rod back
Material/Mechanical Properties
Resistance to Corrosion	No corrosive marks in immersed part of the needle	No corrosive marks found
Stiffness	Needle tube is not easy to deform	Confirmed not easy to deform
Resistance to Breakage	Needle tube is not broken during use	Confirmed not broken during use
Penetrating Force	Needle tip is sharp (implies sufficient sharpness)	Confirmed needle tip is sharp
Connection Strength	All joints are rigid connect	Confirmed all joints are rigid connect
Luer Lock Connectors	Meets the requirement of ISO 80369-7	Meets ISO 80369-7
Functional Testing
Basic Functional Testing	Successfully inserted and withdrawn into/out of endoscope; stylet passes syringe successfully	Successfully inserted and withdrawn, stylet passes through
Chemical/Sterilization Properties
Chemical Properties	pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet related requirements	Met related requirements
Sterility	Device shall be sterile (SAL: 10-6)	Sterile (by ethylene oxide, SAL: 10-6)
EO Residue	≤10 μg/g	≤10 μg/g
Pyrogen	No pyrogen	No pyrogen
Biocompatibility	Conform with ISO10993-1, -4, -5, -10, -11 (Hemolysis, cytotoxicity, sensitization, intracutaneously irritation, acute systemic toxicity, material medicated pyrogenicity)	Verified with ISO 10993 (non-toxic and biocompatible)
Shelf Life	Maintain sterility and performance for 2 years	2-year shelf life established

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state the sample size used for each specific bench test item. It generally refers to "bench testing" being performed.
Data Provenance: The data is from "Summary of non-clinical and performance testing- Bench testing" carried out by Beijing ZKSK Technology Co., Ltd. The tests were performed according to recognized consensus standards and the company's technical requirements. This is retrospective testing performed by the manufacturer on its own device prototypes/production samples. The country of origin for the testing is implied to be China, where the manufacturer is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a physical medical instrument, not an AI/software device that relies on expert interpretation for ground truth in its performance evaluation as described in the context of AI/ML devices. The "ground truth" for the bench tests is based on objective measurements and adherence to engineering and biological standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring human adjudication for performance evaluation. Adjudication methods are typically relevant for subjective expert assessments or when there are disagreements in interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an Endoscopic Injection Needle, a physical instrument, and its evaluation focuses on bench testing and mechanical/biocompatibility performance, not on AI-assisted human reading.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Not applicable. This is not an algorithm or AI device; it's a physical medical instrument. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on objective measurements, adherence to recognized consensus standards (e.g., ISO 7864, ISO 9626, ISO 10993 series, ISO 11607-1, ISO 80369-7), and the manufacturer's internal design requirements and specifications. For biocompatibility, the ground truth is established by the biological responses observed against the criteria in ISO 10993.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The device's safety and effectiveness are established through physical and biological testing as described above.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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June 2, 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: K213239

Trade/Device Name: Endoscopic Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: FBK Dated: April 25, 2022 Received: April 29, 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-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 Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213239

Device Name Endoscopic Injection Needle

Indications for Use (Describe)

Single use injection needle is to be used in conjunction with an endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K213239

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 Economic Development Zone, Tongzhou District,Beijing 101105, China Tel: +86 -13811778090 Contact: Ma Li

Designated Submission Correspondent

Contact: Mr. Boyle Wang Name: Shanghai Truthful Information Technology Co., Ltd. Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

Date of Preparation: Apr.22, 2022

2.0 Device Information

Trade name: Endoscopic Injection Needle Common name: Endoscopic Injection Needle, Gastroenterology-Urology Classification name: Endoscope and accessories Production code: FBK Regulation number: 21 CFR 876.1500 Classification: Class II Gastroenterology/Urology Panel:

3.0 Predicate Device Information

Manufacturer: Anrei Medical (Hangzhou) Co., Ltd. Trade/Device Name: Single Use Injection Needle 510(k) number: K210917

4.0 Device Description

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Endoscopic Injection Needle consists of Handle, Rod, Needle, Needle holder, Sheath, Catheter, Adapter, Sheath holder, Sheath protection pipe, Tube cap.

5.0 Indication for Use Statement

Single use injection needle is to be used in conjunction with an endoscope to perform endoscopic injections, such as for the treatment of esophageal and gastric varies and for submucosal dye marking in the GI tract.

6.0 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 7864, ISO 9626,ISO 10993-7, ISO 10993-1, ISO 11607-1,and Technical Requirements of "Endoscopic Injection Needle" provided by 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 Endoscopic Injection Needle 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 Endoscopic Injection Needle has successfully been tested for hemolysis, 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. Endoscopic Injection Needle

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is non-toxic and biocompatible.

7.3 Performance testing - Bench: The performance of Endoscopic Injection Needle 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 and hygiene.
Dimension	To confirm that the dimensions of the subject device complied with the company's requirements.
Leakage	There shall be no gas leakage.
Needle protection	Needle shall not be exposed when pulling rod back.
Resistance to corrosion	No corrosive marks should be found in the immersed part of the needle.
Stiffness	To confirm the needle tube is not easy to deform
Resistance to breakage	To confirm the needle tube is not broken during use
Penetrating force	Make sure the needle tip is sharp
Connection strength	To confirm all joints of the subject device is rigid connect.
Basic functional testing	To confirm the device can be successfully inserted and withdrawn into and out of an endoscope, and the stylet can pass through the syringe successfully.
Luer lock connectors	To confirm the performance of the luer lock connectors of the device meets the requirement of ISO 80369-7
Chemical properties	To confirm that pH, Total content of heavy metals, Potassium permanganate reductive substance, Evaporative residues and Ultraviolet Absorbance meet the related requirements.
Sterility	This device is sterilized by ethylene oxide. The device shall be sterile.
EO residue	EO residue shall be ≤10 $ μ $ g/g.
Pyrogen	Shall be no pyrogen

Table 1: Performance testing summary - Bench
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7.0 Summary of Clinical Testing

No clinical study is included in this submission.

8.0 Technological Characteristic Comparison Table

ltem	Subject Device	Predicate Device
510(k) No.	K213239	K210917
Product Name	Endoscopic Injection Needle	Single Use Injection Needle

Table 2- Comparison of Technology Characteristics

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Product Code	FBK	FBK
Regulation No.	21 CFR 876.1500	21 CFR 876.1500
Class	II	II
Indication for Use	Single use injection needle is to beused in conjunction with anendoscope to perform endoscopicinjections, such as for thetreatment of esophagealandgastric varies and for submucosaldye marking in the GI tract.	Single use injection needle is to beused in conjunction with anendoscope to perform endoscopicinjections, such as for thetreatment of esophagealandgastric varies and for submucosaldye marking in the GI tract.
Configuration	Endoscopic InjectionNeedleconsists of Handle, Rod, Needle,Needle holder, Sheath, Catheter,Adapter, Sheath holder, Sheathprotection pipe, Tube cap.	Needle, Connecting Tube, InnerTube, Sheath, Protect Tube, MetalTube, handle, Luer Connector
Minimal requiredworking channel	2.8mm	2.8mm
Outer Sheathdiameter	1.8mm,2.4mm	2.4mm
Needle size	20G, 22G, 25G	21G, 23G, 25G
WorkingLength	1200mm,1600mm,1950mm,2000mm, 2300mm	1800mm, 2000mm, 2300mm
Needle Length	4mm, 5mm,6mm,8mm,10mm	4mm, 6mm
Patient ContactMaterial	Sheath: PTEFCatheter:SN18 series:Polypropylene(PP)/SN19 series: Nylon (PA)Needle/ Needle holder: StainlesssteelRod:Acrylonitrile/butadiene/styrenecopolymer (ABS)	Not publicly Available
Sterile	Ethylene Oxide, SAL: 10-6	Ethylene Oxide, SAL: 10-6
Shelf Life	2 years	3 years
Single Use	Single Use	Single Use
Biocompatibility	Conform with ISO10993-1(ISO10993-4,ISO10993-5,ISO10993-10, ISO10993-11)	Conform with ISO 10993standards

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

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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 outer sheath diameter of the subject device is different with that of the predicate device, but it does not affect the device compatibility with the endoscope of the minimum working cannel size of 2.8 mm.

The Needle size, working length and Needle Length of the subject device are larger than those of the predicate device, bench performance and Comparison testing including Stiffness testing, breakage testing, Penetration testing and Connection strength testing on the subject device and the predicate device shown the difference does not affect the device's safety and effectiveness, the subject device is substantially equivalent to the predicate device.

9.0 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 K210917 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.