(262 days)
Not Found
No
The device description is for a mechanical injection needle and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies focus on biocompatibility and mechanical function.
Yes
The device is described as an "Injection Needle" intended for "endoscopic vascular or submucosal injection in the GI tract," which are therapeutic procedures.
No
The device is an injection needle intended for therapeutic procedures (endoscopic vascular or submucosal injection) in the GI tract, not for diagnosing conditions.
No
The device description explicitly details physical components made of materials like stainless steel, PP, and ABS, and describes their dimensions and specifications. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform endoscopic vascular or submucosal injection in the GI tract." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a physical instrument (a needle) used for injection. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic/procedural device used for direct intervention within the body.
N/A
Intended Use / Indications for Use
The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained doctors or technicians / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance test conclusion:
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.
Clinical test conclusion:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Cytotoxicity: No cytotoxicity
Irritation: No intracutaneous reactivity
Sensitization: No skin sensitization
Systemic Toxicity: No systemic toxicity
Pyrogen: No Pyrogen
Hemolysis Properties: No Hemolysis
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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: 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.
1
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.
2
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
3
Indications for Use
Submission Number (if known)
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)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 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.
- PRINCIPLE OF OPERATION
5
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.
-
- 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 |
6
7
8
9
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.
-
- 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:
- Comparison of technological characteristics with the predicate device
| ITEM | Proposed Device | Predicate Device
K213914 | Remark |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product | Disposable Injection
Needles | 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 intended
to be used with an
endoscope to perform
endoscopic vascular or
submucosal injection in
the GI tract. | The device is intended
to be used with an
endoscope to perform
endoscopic vascular or
submucosal injection in
the GI tract. | Same |
| | | | |
| Configuration | Needle tube, Inner tube,
Outer tube, Protective
sleeve, Handle,
Limitation ring, Buckle,
Conical connector,
Booster tube. | needle, connector tube,
guiding head, inner
tube, outer tube,
protective sleeve, front
handle, injection
handle, front handle
cover, boosting tube. | Difference |
| Environment of use | Hospital | Hospital | Same |
| Intended users | The device must be
used by trained doctors
or technicians. | The device must be
used by trained doctors
or technicians. | Same |
| Single Use | Single Use | Single Use | Same |
| Label/Labeling | Complied with 21 CFR
part 801 | Complied with 21 CFR
part 801 | Same |
| Specifications | | | |
| Working Length | 1200mm,1600mm,
1800mm,2000mm
2300mm | 1200mm, 1800mm,
2300mm, 3000mm | Difference |
| Minimum working
channel | 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 |
| Patient
contact
material | Needle tube :Stainless
steel (06Cr19Ni10)
Inner tube :PP
Outer tube:PP
Booster tube:Stainless
steel (06Cr19Ni10)
Conical connector:ABS | Needle: S30400
Guiding Head: S30300
Inner Tube: PTFE or PP
Outer Tube: PTFE or PP
Injection Handle: ABS
Boosting Tube: S30400 | Difference |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity | Same |
| Irritation | No intracutaneous
reactivity | No intracutaneous
reactivity | Same |
| Sensitization | No skin sensitization | No skin sensitization | Same |
| Systemic Toxicity | No systemic toxicity | No systemic toxicity | Same |
| Pyrogen | No Pyrogen | No Pyrogen | Same |
10
11
| 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.
12
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).