Disposable Endoscope Injection Needle

K220292 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · FBK · Aug 19, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K220292
• Device Name: Disposable Endoscope Injection Needle
• Applicant: Yangzhou Fartley Medical Instrument Technology Co., Ltd.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Aug 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to: · introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system; · aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures; · control non-variceal hemorrhage.

Device Story

Disposable endoscope injection needle; used for delivery of therapeutic agents (sclerosing agents, vasoconstrictors) into gastrointestinal mucosa/submucosa. Device consists of handle, sheath, booster tube, and needle tip. Operated by physician during endoscopic procedures (EMR, ESD, polypectomy, hemorrhage control). Input: manual injection of fluids via handle hub. Output: delivery of fluid to target site via needle tip. Benefits: enables localized treatment of bleeding lesions and assists in tissue resection procedures.

Clinical Evidence

No clinical data included. Substantial equivalence supported by bench testing, including appearance, dimension, connection strength, leakage, cleanliness, compatibility, puncture force, corrosion resistance, lumen patency, durability, needle stiffness/breakage resistance, pressure testing, and flow rate. Biocompatibility per ISO 10993-1.

Technological Characteristics

Disposable endoscopic injection needle; components include sheath, handle, booster tube, and needle tip. Available in 19G, 22G, 23G, 25G gauges; 1.8mm/2.4mm outer diameters; various working lengths. Sterilized via Ethylene Oxide (EO) to SAL 10^-6. Biocompatible per ISO 10993-1. Mechanical device; no software or electronic components.

Indications for Use

Indicated for endoscopic injection into gastrointestinal mucosa and submucosa in patients requiring sclerotherapy, vasoconstrictor administration, or assistance with EMR, ESD, or polypectomy procedures, and for control of non-variceal hemorrhage.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Interject™ Injection Therapy Needle Catheter (K171454)

Submission Summary (Full Text)

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August 19, 2022

Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 CHINA

Re: K220292

Trade/Device Name: Disposable Endoscope Injection Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: July 11, 2022 Received: July 18, 2022

Dear Ethan Liu:

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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K220292

Device Name Disposable Endoscope Injection Needle

The Disposable Endoscope Injection Need for endoscopic into gastrointestinal mucosa and submucosa to:

· introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system;

· aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), or polypectomy procedures;

· control non-variceal hemorrhage.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

# 5.1 Submitter

| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd. |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| | Address:Beizhou Road, Lidian Town, Guangling District,<br>Yangzhou 225106 Jiangsu, China |
| Contact<br>Person: | Ethan Liu<br>RA Specialist |
| | Shanghai Thinkwell Consulting Co., Ltd<br>Address: Room 211/6F, Xinling Road, Minhang Districtt,<br>Shanghai, China. |
| | Phone: [phone]<br>Email: [e-mail] |
| Date<br>Prepared: | July 5, 2022 |

### 5.2 Device

| Device Name: | Disposable Endoscope Injection Needle | | |
|----------------------|---------------------------------------|-----------|---------|
| Classification Name: | Endoscopic | Injection | Needle, |
| | Gastroenterology-Urology | | |
| Regulatory Class: | II | | |
| Regulation Number: | 21 CFR 876.1500 | | |
| Regulation Name: | Endoscope and Accessories | | |
| Product Code: | FBK | | |

# 5.3 Predicate Device

| Device Name: | Interject TM Injection Therapy Needle Catheter | | |
|----------------------|------------------------------------------------------------|-----------|---------|
| | K171454 | | |
| Manufacturer: | Boston Scientific Corporation | | |
| Classification Name: | Endoscopic | Injection | Needle, |
| | Gastroenterology-Urology | | |
| Regulatory Class: | II | | |
| Regulation Number: | 21 CFR 876.1500 | | |
| Regulation Name: | Endoscope and Accessories | | |
| Product Code: | FBK | | |

# 5.4 Device Description

The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle,

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K220292

Handle, Booster tube, Handle end cap, Outer tube, Inner tube, Metal end cap and injection needle tip. It is available in a variety of configurations with varying needle lengths, gauges and working lengths.

# 5.5 Indication for Use:

The Disposable Endoscope Injection Needle is used for endoscopic injection into gastrointestinal mucosa and submucosa to:

- introduce a sclerosing agent, vasoconstrictor, or other solutions into selected sites . to control actual or potential bleeding lesions in the digestive system;
- aid in Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection . (ESD), or polypectomy procedures;
- control non-variceal hemorrhage. o

# 5.6 Comparison of Technological Characteristics

The Disposable Endoscope Injection Needle has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.

| Item | Disposable Endoscope<br>Injection<br>Needle(Proposed<br>Device) | Interject™ Injection<br>Therapy<br>Catheter<br>K171454 | Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indication for Use | The Disposable Endoscope Injection<br>Needle is used for endoscopic injection<br>into gastrointestinal mucosa and<br>submucosa to:<br>• introduce a<br>sclerosing agent,<br>vasoconstrictor, or<br>other solutions<br>into selected sites<br>to control actual or<br>potential bleeding<br>lesions in the<br>digestive system;<br>• aid in Endoscopic | The Interject™ Injection Therapy<br>Needle Catheter is<br>used for endoscopic<br>injection into<br>gastrointestinal<br>mucosa and<br>submucosa to:<br>• introduce a<br>sclerosing agent,<br>vasoconstrictor, or<br>other solutions<br>into selected sites<br>to control actual<br>or potential<br>bleeding lesions in<br>the digestive<br>system; | Same |
| Item | Disposable Endoscope<br>Injection<br>Needle(Proposed<br>Device) | Interject™<br>Therapy<br>Catheter<br>K171454 | Injection Needle Discussion |
| | Mucosal Resection<br>(EMR),<br>Endoscopic<br>Submucosal<br>Dissection (ESD),<br>or polypectomy<br>procedures;<br>control<br>non-variceal<br>hemorrhage. | • aid in Endoscopic<br>Mucosal<br>Resection (EMR),<br>Endoscopic<br>Submucosal<br>Dissection (ESD),<br>or polypectomy<br>procedures;<br>• control<br>non-variceal<br>hemorrhage. | |
| Configuration(Inclu<br>ding Material) | The Disposable<br>Endoscope Injection<br>Needle consists of<br>Sheath, Handle buckle,<br>Handle, Booster tube,<br>Handle end cap, Outer<br>tube, Inner tube, Metal<br>end cap and injection<br>needle tip | The Interject™<br>Injection Therapy<br>Needle Catheter is a<br>catheter that consists<br>of a handle with a hub<br>for injection, a<br>catheter sheath, and a<br>needle | Substantia<br>lly<br>equivalent |
| Needle Gauge | 19G, 22G, 23G, 25G | 23G, 25G | Similar |
| Out Diameter(mm) | 1.8, 2.4 | 1.8, 2.3 | Similar |
| Working<br>Length(mm) | 600, 1200, 1600,<br>1800,2300, 2500 | 2000, 24000 | Similar |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO<br>10993-1 | Comply with ISO<br>10993-1 | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |

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K220292 Page 3 of 4

Image /page/5/Picture/1 description: The image features the logo for "ARTLEY UNIQUE ENDOSCOPY". The word "ARTLEY" is displayed in a stylized, italicized blue font, with a yellow accent mark above the "Y". Below "ARTLEY", the words "UNIQUE ENDOSCOPY" are written in a smaller, sans-serif blue font. The overall design is clean and modern, suggesting a company that specializes in advanced medical technology.

## 5.7 Non-clinical Performance Data

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" .

The following bench tests were performed on Disposable Endoscope Injection Needle: Appearance, Dimension, performance, Connection strength, Leakage, Cleanliness,

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Image /page/6/Picture/0 description: The image shows the brand logo for "ARTLEY UNIQUE ENDOSCOPY". The logo is in blue and has a stylized font. There is a yellow streak on the right side of the logo.

K220292

Compatibility, Puncture force,Corrosion resistance,Patency of lumen, Durability, Stiffness test of needle, Resistance of needle to breakage, Positive pressure liquid leakage, Sub-atmospheric pressure air Leakage, Stress cracking, Resistance to separation from axial load, Resistance to overriding and Resistance to separation from unscrewing and flow rate. The results of all testing were passing.

### 5.8 Clinical Test Data

No Clinical Study is included in this submission.

### 5.9 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Endoscope Injection Needle is substantially equivalent to Boston Scientific Corporation's currently marketed Interject™ Injection Therapy Needle Catheter K171454.