The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.The Disposable Injection Needles are consist of needle tube, inner tube, outer tube, protective sleeve, booster tube, handle, limitation ring, buckle and conical connector. The needle tube and booster tube are made of 06Cr19Ni10. The inner tube are made of PP.The handle, limitation ring, buckle and connector are made of ABS. The diameter of the outer tube is available in two specifications, respectively are 1.8mm and 2.3mm. There are five specifications for the working length of the outer tube, respectively are 1200mm,1800mm,2000mm and 2300mm. There are three specifications for outer diameters of needle tube, respectively are 21G, 23G and 25G. Five specifications for lengths of needle tube, respectively are 4mm, 5mm, 7mm and 8mm.

The device is sterilized by ethylene oxide. The shelf life is 3 years.

The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Disposable Injection Needles), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than complex performance criteria for AI/ML devices. Therefore, many of the requested categories for AI/ML device performance are not applicable to this submission.

Based on the provided document, here's an analysis of the acceptance criteria and supporting studies:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" in the way one might expect for a digital health or AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with established medical device standards and demonstrating performance comparable to the predicate device. The Reported Device Performance is stated as meeting the requirements of these standards.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit in Document)	Reported Device Performance
Biocompatibility	No cytotoxicity (ISO 10993-5:2009)	No cytotoxicity
	No intracutaneous reactivity (ISO 10993-23:2021)	No intracutaneous reactivity
	No skin sensitization (ISO 10993-10:2021)	No skin sensitization
	No systemic toxicity (ISO 10993-11:2017)	No systemic toxicity
	No Pyrogen (no specific standard cited, but general requirement)	No Pyrogen
	No Hemolysis (ASTM F756-17)	No Hemolysis
	Assessment of circulating blood-contacting materials on Partial Thromboplastin Time (PTT) (ASTM F2382-18)	Test performed (results imply acceptance)
	Platelet Leukocyte Count (ASTM F2888-19)	Test performed (results imply acceptance)
Performance Bench Testing	Tensile strength (ISO 20695:2020)	Test performed (results imply acceptance)
	Fracture force (ISO 20695:2020)	Test performed (results imply acceptance)
	Stainless steel needle tubing requirements (ISO 9626:2016)	Test performed (results imply acceptance)
	Resistance against autoclaving, corrosion, thermal exposure (ISO 13402:1995)	Test performed (results imply acceptance)
	Small-bore connectors for liquids and gases (ISO 80369-7:2021)	Test performed (results imply acceptance)
	Sterile hypodermic needles requirements (ISO 7864:2016)	Test performed (results imply acceptance)
	Patency	Performance tested
	Injection residue	Performance tested
	Needle retraction suitability	Performance tested
Sterilization	EO Sterilized	EO Sterilized
	SAL (Sterility Assurance Level)	10^-6
	Endotoxin Limit	20 EU per device

The document concludes that "The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914)." This general statement serves as the overall reported device performance and proof that it meets the implicit acceptance criteria of substantial equivalence.

The following information is not applicable to this traditional medical device submission, as it pertains to AI/ML device evaluations:

Sample size used for the test set and the data provenance: Not applicable. The tests are physical and chemical bench tests on the device materials and functional aspects, not AI performance on data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device often involves expert annotation. For this physical device, "ground truth" is measured by adherence to established engineering and biocompatibility standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML ground truth. For this device, the "ground truth" is adherence to performance specifications outlined in the referenced ISO and ASTM standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 12, 2024

Ningbo Xinwell Medical Technology Co., Ltd Lei Xi Registration Manager No.188 Binjiang Road, Cixi High-tech Industrial Development Zone Cixi, Zhejiang 315301 China

Re: K232200

Trade/Device Name: Disposable Injection Needles Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FBK Dated: March 12, 2024 Received: March 12, 2024

Dear Lei Xi:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sivakami Venkatachalam -S

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232200

Device Name

Disposable Injection Needles

Indications for Use (Describe)

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection 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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1. SUBMITTER

Ningbo Xinwell Medical Technology Co., LTD

No.188 Binjiang Road, Cixi High-tech industrial Development Zone, Cixi City, 315301 Zhejiang,P.R.China

Contact Person: Lei Xi

Title: RA manager

Tel: +86574-63026388

Email: xilei@xinhaigroup.com

Summary Prepared: 2024-04-04

2. DEVICE

Name of device: Disposable Injection Needles Regulation Number: 21 CFR 876.1500 Classification name: Endoscope and accessories Common name:Endoscopic injection needle Regulatory Class: Class II Product Code: FBK

3. PREDICATE DEVICE

The predicate device is Injection Needle(K213914).

4. DEVICE DESCRIPTION

The device is sterilized by ethylene oxide. The shelf life is 3 years.

The inner, middle and transportation packaging ways respectively are sealed pouch, box and carton.The corresponding product quantities is 1 pc per bag, 10 pcs per box and 5 boxes per carton.

PRINCIPLE OF OPERATION

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The Disposable Injection Needles achieve its intended use by combining them with the flexible channel of the endoscope. Firstly, the Disposable Injection Needles passed through the endoscopic channel to the channel port, and the lesion was determined through the endoscopic visual field. After the lesion was determined, the needle tube of the Disposable Injection Needles was extended out of the outer tube by pushing the conical connector at the end of the handle, and then inserted into the target tissue. And the Luer interface at the end of the handle is connected to the syringe for fluid injection; After the injection is completed, pull the conical connector at the handle to retrieve the needle tube into the outer tube, and then withdraw the Disposable Injection Needles from the endoscopic channel.

1. Available model

Specification and Model	Model Code	Outer tube diameter (mm)	Working length (mm)	Outer diameter of needle tube (G)	Length of needle tube (mm)
XY-ZSZ-C-18×1200×21×4	C	1.8	1200	21	4
XY-ZSZ-C-18×1200×21×5	C	1.8	1200	21	5
XY-ZSZ-C-18×1200×21×6	C	1.8	1200	21	6
XY-ZSZ-C-18×1200×21×7	C	1.8	1200	21	7
XY-ZSZ-C-18×1200×21×8	C	1.8	1200	21	8
XY-ZSZ-C-18×1200×23×4	C	1.8	1200	23	4
XY-ZSZ-C-18×1200×23×5	C	1.8	1200	23	5
XY-ZSZ-C-18×1200×23×6	C	1.8	1200	23	6
XY-ZSZ-C-18×1200×23×7	C	1.8	1200	23	7
XY-ZSZ-C-18×1200×23×8	C	1.8	1200	23	8
XY-ZSZ-C-18×1200×25×4	C	1.8	1200	25	4
XY-ZSZ-C-18×1200×25×5	C	1.8	1200	25	5
XY-ZSZ-C-18×1200×25×6	C	1.8	1200	25	6
XY-ZSZ-C-18×1200×25×7	C	1.8	1200	25	7
XY-ZSZ-C-18×1200×25×8	C	1.8	1200	25	8
XY-ZSZ-C-18×1600×21×4	C	1.8	1600	21	4
XY-ZSZ-C-18×1600×21×5	C	1.8	1600	21	5
XY-ZSZ-C-18×1600×21×6	C	1.8	1600	21	6
XY-ZSZ-C-18×1600×21×7	C	1.8	1600	21	7
XY-ZSZ-C-18×1600×21×8	C	1.8	1600	21	8
XY-ZSZ-C-18×1600×23×4	C	1.8	1600	23	4
XY-ZSZ-C-18×1600×23×5	C	1.8	1600	23	5
XY-ZSZ-C-18×1600×23×6	C	1.8	1600	23	6
XY-ZSZ-C-18×1600×23×7	C	1.8	1600	23	7
XY-ZSZ-C-18×1600×23×8	C	1.8	1600	23	8
XY-ZSZ-C-18×1600×25×4	C	1.8	1600	25	4
XY-ZSZ-C-18×1600×25×5	C	1.8	1600	25	5
XY-ZSZ-C-18×1600×25×6	C	1.8	1600	25	6
XY-ZSZ-C-18×1600×25×7	C	1.8	1600	25	7
XY-ZSZ-C-18×1600×25×8	C	1.8	1600	25	8
XY-ZSZ-C-18×1800×21×4	C	1.8	1800	21	4
XY-ZSZ-C-18×1800×21×5	C	1.8	1800	21	5
XY-ZSZ-C-18×1800×21×6	C	1.8	1800	21	6
XY-ZSZ-C-18×1800×21×7	C	1.8	1800	21	7
XY-ZSZ-C-18×1800×21×8	C	1.8	1800	21	8
XY-ZSZ-C-18×1800×23×4	C	1.8	1800	23	4
XY-ZSZ-C-18×1800×23×5	C	1.8	1800	23	5
XY-ZSZ-C-18×1800×23×6	C	1.8	1800	23	6
XY-ZSZ-C-18×1800×23×7	C	1.8	1800	23	7
XY-ZSZ-C-18×1800×23×8	C	1.8	1800	23	8
XY-ZSZ-C-18×1800×25×4	C	1.8	1800	25	4
XY-ZSZ-C-18×1800×25×5	C	1.8	1800	25	5
XY-ZSZ-C-18×1800×25×6	C	1.8	1800	25	6
XY-ZSZ-C-18×1800×25×7	C	1.8	1800	25	7
XY-ZSZ-C-18×1800×25×8	C	1.8	1800	25	8
XY-ZSZ-C-18×2000×21×4	C	1.8	2000	21	4
XY-ZSZ-C-18×2000×21×5	C	1.8	2000	21	5
XY-ZSZ-C-18×2000×21×6	C	1.8	2000	21	6
XY-ZSZ-C-18×2000×21×7	C	1.8	2000	21	7
XY-ZSZ-C-18×2000×21×8	C	1.8	2000	21	8
XY-ZSZ-C-18×2000×23×4	C	1.8	2000	23	4
XY-ZSZ-C-18×2000×23×5	C	1.8	2000	23	5
XY-ZSZ-C-18×2000×23×6	C	1.8	2000	23	6
XY-ZSZ-C-18×2000×23×7	C	1.8	2000	23	7
XY-ZSZ-C-18×2000×23×8	C	1.8	2000	23	8
XY-ZSZ-C-18×2000×25×4	C	1.8	2000	25	4
XY-ZSZ-C-18×2000×25×5	C	1.8	2000	25	5
XY-ZSZ-C-18×2000×25×6	C	1.8	2000	25	6
XY-ZSZ-C-18×2000×25×7	C	1.8	2000	25	7
XY-ZSZ-C-18×2000×25×8	C	1.8	2000	25	8
XY-ZSZ-C-18×2300×21×4	C	1.8	2300	21	4
XY-ZSZ-C-18×2300×21×5	C	1.8	2300	21	5
XY-ZSZ-C-18×2300×21×6	C	1.8	2300	21	6
XY-ZSZ-C-18×2300×21×7	C	1.8	2300	21	7
XY-ZSZ-C-18×2300×21×8	C	1.8	2300	21	8
XY-ZSZ-C-18×2300×23×4	C	1.8	2300	23	4
XY-ZSZ-C-18×2300×23×5	C	1.8	2300	23	5
XY-ZSZ-C-18×2300×23×6	C	1.8	2300	23	6
XY-ZSZ-C-18×2300×23×7	C	1.8	2300	23	7
XY-ZSZ-C-18×2300×23×8	C	1.8	2300	23	8
XY-ZSZ-C-18×2300×25×4	C	1.8	2300	25	4
XY-ZSZ-C-18×2300×25×5	C	1.8	2300	25	5
XY-ZSZ-C-18×2300×25×6	C	1.8	2300	25	6
XY-ZSZ-C-18×2300×25×7	C	1.8	2300	25	7
XY-ZSZ-C-18×2300×25×8	C	1.8	2300	25	8
XY-ZSZ-C-23×1200×21×4	C	2.3	1200	21	4
XY-ZSZ-C-23×1200×21×5	C	2.3	1200	21	5
XY-ZSZ-C-23×1200×21×6	C	2.3	1200	21	6
XY-ZSZ-C-23×1200×21×7	C	2.3	1200	21	7
XY-ZSZ-C-23×1200×21×8	C	2.3	1200	21	8
XY-ZSZ-C-23×1200×23×4	C	2.3	1200	23	4
XY-ZSZ-C-23×1200×23×5	C	2.3	1200	23	5
XY-ZSZ-C-23×1200×23×6	C	2.3	1200	23	6
XY-ZSZ-C-23×1200×23×7	C	2.3	1200	23	7
XY-ZSZ-C-23×1200×23×8	C	2.3	1200	23	8
XY-ZSZ-C-23×1200×25×4	C	2.3	1200	25	4
XY-ZSZ-C-23×1200×25×5	C	2.3	1200	25	5
XY-ZSZ-C-23×1200×25×6	C	2.3	1200	25	6
XY-ZSZ-C-23×1200×25×7	C	2.3	1200	25	7
XY-ZSZ-C-23×1200×25×8	C	2.3	1200	25	8
XY-ZSZ-C-23×1600×21×4	C	2.3	1600	21	4
XY-ZSZ-C-23×1600×21×5	C	2.3	1600	21	5
XY-ZSZ-C-23×1600×21×6	C	2.3	1600	21	6
XY-ZSZ-C-23×1600×21×7	C	2.3	1600	21	7
XY-ZSZ-C-23×1600×21×8	C	2.3	1600	21	8
XY-ZSZ-C-23×1600×23×4	C	2.3	1600	23	4
XY-ZSZ-C-23×1600×23×5	C	2.3	1600	23	5
XY-ZSZ-C-23×1600×23×6	C	2.3	1600	23	6
XY-ZSZ-C-23×1600×23×7	C	2.3	1600	23	7
XY-ZSZ-C-23×1600×23×8	C	2.3	1600	23	8
XY-ZSZ-C-23×1600×25×4	C	2.3	1600	25	4
XY-ZSZ-C-23×1600×25×5	C	2.3	1600	25	5
XY-ZSZ-C-23×1600×25×6	C	2.3	1600	25	6
XY-ZSZ-C-23×1600×25×7	C	2.3	1600	25	7
XY-ZSZ-C-23×1600×25×8	C	2.3	1600	25	8
XY-ZSZ-C-23×1800×21×4	C	2.3	1800	21	4
XY-ZSZ-C-23×1800×21×5	C	2.3	1800	21	5
XY-ZSZ-C-23×1800×21×6	C	2.3	1800	21	6
XY-ZSZ-C-23×1800×21×7	C	2.3	1800	21	7
XY-ZSZ-C-23×1800×21×8	C	2.3	1800	21	8
XY-ZSZ-C-23×1800×23×4	C	2.3	1800	23	4
XY-ZSZ-C-23×1800×23×5	C	2.3	1800	23	5
XY-ZSZ-C-23×1800×23×6	C	2.3	1800	23	6
XY-ZSZ-C-23×1800×23×7	C	2.3	1800	23	7
XY-ZSZ-C-23×1800×23×8	C	2.3	1800	23	8
XY-ZSZ-C-23×1800×25×4	C	2.3	1800	25	4
XY-ZSZ-C-23×1800×25×5	C	2.3	1800	25	5
XY-ZSZ-C-23×1800×25×6	C	2.3	1800	25	6
XY-ZSZ-C-23×1800×25×7	C	2.3	1800	25	7
XY-ZSZ-C-23×1800×25×8	C	2.3	1800	25	8
XY-ZSZ-C-23×2000×21×4	C	2.3	2000	21	4
XY-ZSZ-C-23×2000×21×5	C	2.3	2000	21	5
XY-ZSZ-C-23×2000×21×6	C	2.3	2000	21	6
XY-ZSZ-C-23×2000×21×7	C	2.3	2000	21	7
XY-ZSZ-C-23×2000×21×8	C	2.3	2000	21	8
XY-ZSZ-C-23×2000×23×4	C	2.3	2000	23	4
XY-ZSZ-C-23×2000×23×5	C	2.3	2000	23	5
XY-ZSZ-C-23×2000×23×6	C	2.3	2000	23	6
XY-ZSZ-C-23×2000×23×7	C	2.3	2000	23	7
XY-ZSZ-C-23×2000×23×8	C	2.3	2000	23	8
XY-ZSZ-C-23×2000×25×4	C	2.3	2000	25	4
XY-ZSZ-C-23×2000×25×5	C	2.3	2000	25	5
XY-ZSZ-C-23×2000×25×6	C	2.3	2000	25	6
XY-ZSZ-C-23×2000×25×7	C	2.3	2000	25	7
XY-ZSZ-C-23×2000×25×8	C	2.3	2000	25	8
XY-ZSZ-C-23×2300×21×4	C	2.3	2300	21	4

XY-ZSZ-C-23×2300×21×5	C	2.3	2300	21	5
XY-ZSZ-C-23×2300×21×6	C	2.3	2300	21	6
XY-ZSZ-C-23×2300×21×7	C	2.3	2300	21	7
XY-ZSZ-C-23×2300×21×8	C	2.3	2300	21	8
XY-ZSZ-C-23×2300×23×4	C	2.3	2300	23	4
XY-ZSZ-C-23×2300×23×5	C	2.3	2300	23	5
XY-ZSZ-C-23×2300×23×6	C	2.3	2300	23	6
XY-ZSZ-C-23×2300×23×7	C	2.3	2300	23	7
XY-ZSZ-C-23×2300×23×8	C	2.3	2300	23	8
XY-ZSZ-C-23×2300×25×4	C	2.3	2300	25	4
XY-ZSZ-C-23×2300×25×5	C	2.3	2300	25	5
XY-ZSZ-C-23×2300×25×6	C	2.3	2300	25	6
XY-ZSZ-C-23×2300×25×7	C	2.3	2300	25	7
XY-ZSZ-C-23×2300×25×8	C	2.3	2300	25	8

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7. Indication for use

The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

1. Comparison of technological characteristics with the predicate device
  The Disposable Injection Needles are compared with the predicate device Injection Needles(K213914).The results are shown below in the Technological Characteristics Comparison Table:

ITEM	Proposed Device	Predicate DeviceK213914	Remark
Product	Disposable InjectionNeedles	Injection Needle	/
Product Code	FBK	FBK	Same
Regulation Number	21 CFR 876.1500	21 CFR 876.1500	Same
Class	Class II	Class II	Same
Indication for Use	The device is intendedto be used with anendoscope to performendoscopic vascular orsubmucosal injection inthe GI tract.	The device is intendedto be used with anendoscope to performendoscopic vascular orsubmucosal injection inthe GI tract.	Same

Configuration	Needle tube, Inner tube,Outer tube, Protectivesleeve, Handle,Limitation ring, Buckle,Conical connector,Booster tube.	needle, connector tube,guiding head, innertube, outer tube,protective sleeve, fronthandle, injectionhandle, front handlecover, boosting tube.	Difference
Environment of use	Hospital	Hospital	Same
Intended users	The device must beused by trained doctorsor technicians.	The device must beused by trained doctorsor technicians.	Same
Single Use	Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFRpart 801	Complied with 21 CFRpart 801	Same
Specifications
Working Length	1200mm,1600mm,1800mm,2000mm2300mm	1200mm, 1800mm,2300mm, 3000mm	Difference
Minimum workingchannel	2.0mm, 2.8mm	2.0mm, 2.8mm	Same
Needle Size	21G, 23G, 25G	19G, 20G, 21G, 22G,23G, 25G	Difference
Needle Length	4mm, 5mm, 6mm,7mm,	3mm, 4mm, 5mm,6mm, 8mm	Difference
Patientcontactmaterial	Needle tube :Stainlesssteel (06Cr19Ni10)Inner tube :PPOuter tube:PPBooster tube:Stainlesssteel (06Cr19Ni10)Conical connector:ABS	Needle: S30400Guiding Head: S30300Inner Tube: PTFE or PPOuter Tube: PTFE or PPInjection Handle: ABSBoosting Tube: S30400	Difference
Biocompatibility
Cytotoxicity	No cytotoxicity	No cytotoxicity	Same
Irritation	No intracutaneousreactivity	No intracutaneousreactivity	Same
Sensitization	No skin sensitization	No skin sensitization	Same
Systemic Toxicity	No systemic toxicity	No systemic toxicity	Same
Pyrogen	No Pyrogen	No Pyrogen	Same

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Hemolysis Properties	No Hemolysis	No Hemolysis	Same


Sterilization
Method	EO Sterilized	EO Sterilized	Same
SAL	10-e	10-6	Same
Endotoxin Limit	20 EU per device	20 EU per device	Same

9. Performance data

Non-clinical performance test conclusion

Biocompatibility

Biocompatibility testing was performed on the proposed device in accordance with the following standards:

ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

ISO 10993-10:2021 Biological evaluation of medical devices — Part 10: Tests for skin sensitization

ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation

ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials

ASTM F2382-18 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

ASTM F2888-19 Standard Practice for Platelet Leukocyte Count--An In-Vitro Measure for

Hemocompatibility Assessment of Cardiovascular Materials

Performance bench testing

The basic safety and essential performance comparison test were evaluated based on as following standards:

ISO 20695:2020 Enteral feeding systems-Design and testing (tensile strength, fracture force).

ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices-Requirements and test methods.

ISO 13402:1995 Surgical and dental hand instruments-Determination of resistance against autoclaving, corrosion and thermal exposure.

ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications.

ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test methods

Testing for patency, injection residue and needle retraction suitability was performed.

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Clinical test conclusion

No clinical study is included in this submission.

10. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device Injection Needle (K213914).

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.