(199 days)
Not Found
No
The device description and performance studies focus on the mechanical and physical properties of a disposable injection needle, with no mention of AI or ML.
No.
The device is an injection needle used to deliver substances for procedures, not to directly treat a disease or condition itself.
No
The device is described as an injection needle used for introducing solutions or controlling bleeding, and aiding in procedures like EMR or ESD. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly lists multiple physical components (Sheath, Handle buckle, Handle, etc.) and the performance studies describe bench tests on these physical components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Endoscope Injection Needle is a tool used during an endoscopic procedure to deliver substances directly into the gastrointestinal tissue. It is a surgical/interventional device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended uses listed (controlling bleeding, aiding in EMR/ESD/polypectomy) are all therapeutic or procedural interventions, not diagnostic activities.
Therefore, this device falls under the category of a surgical or interventional medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FBK
Device Description
The Disposable Endoscope Injection Needle consists of Sheath, Handle buckle, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa and submucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The following bench tests were performed on Disposable Endoscope Injection Needle: Appearance, Dimension, performance, Connection strength, Leakage, Cleanliness, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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 ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.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.
3
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, | |
| Yangzhou 225106 Jiangsu, China | |
| Contact | |
| Person: | Ethan Liu |
| RA Specialist | |
| Shanghai Thinkwell Consulting Co., Ltd | |
| Address: Room 211/6F, Xinling Road, Minhang Districtt, | |
| Shanghai, China. | |
| Phone: 0086-15216699240 | |
| Email: xtdeepwater@126.com | |
| Date | |
| 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,
4
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
Injection
Needle(Proposed
Device) | Interject™ Injection
Therapy
Catheter
K171454 | Discussion |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| 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 | The Interject™ Injection Therapy
Needle Catheter 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; | Same |
| Item | Disposable Endoscope
Injection
Needle(Proposed
Device) | Interject™
Therapy
Catheter
K171454 | Injection Needle Discussion |
| | Mucosal Resection
(EMR),
Endoscopic
Submucosal
Dissection (ESD),
or polypectomy
procedures;
control
non-variceal
hemorrhage. | • aid in Endoscopic
Mucosal
Resection (EMR),
Endoscopic
Submucosal
Dissection (ESD),
or polypectomy
procedures;
• control
non-variceal
hemorrhage. | |
| Configuration(Inclu
ding Material) | The Disposable
Endoscope Injection
Needle consists of
Sheath, Handle buckle,
Handle, Booster tube,
Handle end cap, Outer
tube, Inner tube, Metal
end cap and injection
needle tip | The Interject™
Injection Therapy
Needle Catheter is a
catheter that consists
of a handle with a hub
for injection, a
catheter sheath, and a
needle | Substantia
lly
equivalent |
| Needle Gauge | 19G, 22G, 23G, 25G | 23G, 25G | Similar |
| Out Diameter(mm) | 1.8, 2.4 | 1.8, 2.3 | Similar |
| Working
Length(mm) | 600, 1200, 1600,
1800,2300, 2500 | 2000, 24000 | Similar |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO
10993-1 | Comply with ISO
10993-1 | Same |
| Sterilization Method | EO Sterilization | EO Sterilization | Same |
5
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,
6
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.
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.