(199 days)
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.
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.
The provided text is a 510(k) summary for a medical device called the "Disposable Endoscope Injection Needle." It describes the device, its intended use, comparison to a predicate device, and non-clinical performance data. However, it explicitly states that "No Clinical Study is included in this submission."
Therefore, I cannot provide information about acceptance criteria and a study that proves the device meets clinical performance acceptance criteria, as no such clinical study was conducted or presented in this document. The submission relies solely on non-clinical (bench) testing and substantial equivalence to a predicate device.
Here's what I can extract regarding acceptance criteria and performance based only on the non-clinical data provided:
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Implied by "passing") | Reported Device Performance |
|---|---|---|
| Appearance | (Implied: Meets visual/design spec) | Passing |
| Dimension | (Implied: Meets dimensional spec) | Passing |
| Performance | (Implied: Meets functional spec) | Passing |
| Connection strength | (Implied: Meets strength spec) | Passing |
| Leakage | (Implied: No leakage) | Passing |
| Cleanliness | (Implied: Meets cleanliness spec) | Passing |
| Compatibility | (Implied: Compatible with endoscopy) | Passing |
| Puncture force | (Implied: Meets force spec) | Passing |
| Corrosion resistance | (Implied: Resists corrosion) | Passing |
| Patency of lumen | (Implied: Lumen is clear/unobstructed) | Passing |
| Durability | (Implied: Durable for intended use) | Passing |
| Stiffness test of needle | (Implied: Meets stiffness spec) | Passing |
| Resistance of needle to breakage | (Implied: Resists breakage) | Passing |
| Positive pressure liquid leakage | (Implied: No leakage under pressure) | Passing |
| Sub-atmospheric pressure air Leakage | (Implied: No air leakage under vacuum) | Passing |
| Stress cracking | (Implied: Resists stress cracking) | Passing |
| Resistance to separation from axial load | (Implied: Resists axial separation) | Passing |
| Resistance to overriding | (Implied: Resists overriding) | Passing |
| Resistance to separation from unscrewing | (Implied: Resists unscrewing separation) | Passing |
| Flow rate | (Implied: Meets flow rate spec) | Passing |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Sterilization (Ethylene Oxide) | Comply with ISO 11135-1, ISO 10993-7 | Comply with ISO 11135-1, ISO 10993-7 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the non-clinical (bench) tests. The data provenance is implied to be from Yangzhou Fartley Medical Instrument Technology Co., Ltd. in China, where the device is manufactured. These are all prospective bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. These were non-clinical, objective bench tests, not clinical evaluations requiring expert interpretation of results or establishment of ground truth in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as these were objective bench tests, not subjective interpretations requiring adjudication.
5. 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. This device is a physical medical instrument (an injection needle), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" was defined by engineering specifications, industrial standards (like ISO 10993, ISO 11135), and the physical properties required for safe and effective function of such a device.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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 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.
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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 (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
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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 ( 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.
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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,Yangzhou 225106 Jiangsu, China | |
| ContactPerson: | Ethan LiuRA Specialist |
| Shanghai Thinkwell Consulting Co., LtdAddress: Room 211/6F, Xinling Road, Minhang Districtt,Shanghai, China. | |
| Phone: 0086-15216699240Email: xtdeepwater@126.com | |
| DatePrepared: | 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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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 EndoscopeInjectionNeedle(ProposedDevice) | Interject™ InjectionTherapyCatheterK171454 | Discussion |
|---|---|---|---|
| Indication for Use | The Disposable Endoscope InjectionNeedle is used for endoscopic injectioninto gastrointestinal mucosa andsubmucosa to:• introduce asclerosing agent,vasoconstrictor, orother solutionsinto selected sitesto control actual orpotential bleedinglesions in thedigestive system;• aid in Endoscopic | The Interject™ Injection TherapyNeedle Catheter isused for endoscopicinjection intogastrointestinalmucosa andsubmucosa to:• introduce asclerosing agent,vasoconstrictor, orother solutionsinto selected sitesto control actualor potentialbleeding lesions inthe digestivesystem; | Same |
| Item | Disposable EndoscopeInjectionNeedle(ProposedDevice) | Interject™TherapyCatheterK171454 | Injection Needle Discussion |
| Mucosal Resection(EMR),EndoscopicSubmucosalDissection (ESD),or polypectomyprocedures;controlnon-varicealhemorrhage. | • aid in EndoscopicMucosalResection (EMR),EndoscopicSubmucosalDissection (ESD),or polypectomyprocedures;• controlnon-varicealhemorrhage. | ||
| Configuration(Including Material) | The DisposableEndoscope InjectionNeedle consists ofSheath, Handle buckle,Handle, Booster tube,Handle end cap, Outertube, Inner tube, Metalend cap and injectionneedle tip | The Interject™Injection TherapyNeedle Catheter is acatheter that consistsof a handle with a hubfor injection, acatheter sheath, and aneedle | Substantiallyequivalent |
| Needle Gauge | 19G, 22G, 23G, 25G | 23G, 25G | Similar |
| Out Diameter(mm) | 1.8, 2.4 | 1.8, 2.3 | Similar |
| WorkingLength(mm) | 600, 1200, 1600,1800,2300, 2500 | 2000, 24000 | Similar |
| SAL | 10-6 | 10-6 | Same |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 | 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.
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.
§ 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.