The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
Device Story
Disposable Sclerotherapy Needle; used for endoscopic injection into gastrointestinal mucosa. Device consists of Luer connector, handle, molding metal tube, inner sheath, outer sheath, and needle. Operated by clinician via endoscope clamp; outer sheath inserted to lesion site; Luer connector pushed to expose needle; needle inserted into lesion for injection of therapeutic agents. Single-use; EO sterilized. Benefits include targeted delivery of solutions to gastrointestinal sites.
Clinical Evidence
No clinical data. Bench testing only: appearance and physical properties testing performed; all results passed. Biocompatibility evaluation conducted per ISO 10993; sterilization validated per ISO 11135-1 and ISO 10993-7.
Indicated for endoscopic injection into the gastrointestinal mucosa in patients requiring such procedures.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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February 27, 2020
Hangzhou AGS MedTech CO., Ltd Yangping Fu RA Specialist Building 5, Building 6, Kangxin Road No.597 Yuhang District 311106 Hangzhou, Zhejiang CHINA
Re: K190032
Trade/Device Name: Disposable Sclerotherapy Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: February 20, 2020 Received: February 26, 2020
Dear Yangping Fu:
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.
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
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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-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 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-device-safety/medical-device-reportingmdr-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/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,
Shanil P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K190032
Device Name
Disposable Sclerotherapy Needle
Indications for Use (Describe)
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle around a green center. To the right of the circular design, the text "AGS MEDTECH" is written in a simple, sans-serif font. Below that, there are Chinese characters, likely representing the company's name in Chinese.
### 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: | Hangzhou AGS MedTech CO., Ltd.<br>Building 5, Building 6, No.597 Kangxin Road,<br>Yuhang District, 311106 Hangzhou, Zhejiang, China |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3010288205 |
| Owner/Operator Number: | 10052959 |
| Contact Person: | Yanping Fu<br>Phone: +86-571--87671223<br>Fax: +86-571--87671225<br>Email:fuyp@bioags.com |
| Date Prepared: | Jan 3, 2019 |
# 5.2 Proposed Device
| Trade Name: | Disposable Sclerotherapy Needle |
|--------------------|-------------------------------------------------------|
| Common Name: | Disposable Sclerotherapy Needle |
| Classification: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Product Code: | FBK |
| Product Code Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
#### 5.3 Predicate Device
| Trade Name: | Injection Therapy Needle Catheter |
|--------------------|-------------------------------------------------------|
| Common Name: | Injection Therapy Needle Catheter |
| Manufacturer: | Boston Scientific Corporation |
| 510(k) Number: | K171454 |
| Classification: | Class II |
| Regulation Number: | 876.1500 |
| Regulation Name: | Endoscope and accessories |
| Product Code: | FBK |
| Product Code Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
## 5.4 Device Description
The Disposable Sclerotherapy Needle device consists of: Luer connector, handle, molding metal tube, Inner sheath connection limit tube, Fixing sleeve, Outer sheath, Inner sheath, connection tube, metal cap, needle. EO Sterilization and use for single use only. The material expected to come into contact with the patient is SUS304 、
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Image /page/4/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.
SUS303、PP/PE.
## 5.5 Indication for Use:
The Disposable Sclerotherapy Needle is intended for endoscopic injection into the gastrointestinal mucosa.
# 5.6 Comparison of Technology Characteristics
The Disposable Sclerotherapy 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.
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| Item | Proposed Device | Predicate device(K171454) | Comment |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication<br>for Use | The Disposable Sclerotherapy Needle<br>is intended for endoscopic injection<br>into the gastrointestinal mucosa. | The InterjectTM Injection Therapy Needle<br>Catheter is used for endoscopic injection<br>into gastrointestinal mucosa and submucosa<br>to:<br>introduce a sclerosing agent,<br>vasoconstrictor, or other solutions<br>into selected sites to control actual or<br>potential bleeding lesions in the<br>digestive system aid in Endoscopic Mucosal Resection<br>(EMR), Endoscopic Submucosal<br>Dissection (ESD), or polypectomy<br>procedures control non-variceal hemorrhage | Similar:<br>Both can<br>be used<br>for<br>gastrointes<br>tinal<br>mucosal<br>injection. |
| Configurat<br>ion | Luer connector, handle, molding metal<br>tube, Inner sheath connection limit<br>tube, Fixing sleeve, Outer sheath, Inner<br>sheath, connection tube, metal cap,<br>needle | The InterjectTM Injection Therapy Needle<br>Catheter is a catheter that consists of a<br>handle<br>with a hub for injection, a catheter sheath,<br>and a needle. | Similar |
| Photograp<br>hs | Disposable Sclerotherapy Needle:<br>Image: Disposable Sclerotherapy Needle diagram<br>Image: Disposable Sclerotherapy Needle close up<br>5311 Series ( with tip forming ) :<br>Image: Disposable Sclerotherapy Needle with tip forming | Interject Clear Single-Use Injection<br>Therapy Needle Catheters:<br>Image: Interject Clear Single-Use Injection Therapy Needle Catheters<br>Interject Contrast Single-Use Injection<br>Therapy Needle Catheters:<br>Image: Interject Contrast Single-Use Injection Therapy Needle Catheters | Similar |
| Item | Proposed Device | Predicate device(K171454) | Comment |
| | 5311 Series (with metal cap):<br>Image: [5311 Series (with metal cap)]<br><br>5313 Series (with metal cap):<br>Image: [5313 Series (with metal cap)] | Image: [Predicate device(K171454)] | |
| Sheath<br>diameter | 2.4mm | 1.8mm,2.3mm | Similar |
| Needle<br>size: | 21G, 22G, 23G, 24G, 25G | 23G, 25G | Similar |
| Outer<br>tubing | For 5311 series: PP;<br>For 5313 series: SUS 304 covered by PE. | For clear sheath design: unknown;<br>For contrast sheath design: unknown. | May be<br>different<br>: We<br>conducted<br>a<br>biocompat<br>ibility<br>evaluation<br>of the<br>device.<br>The<br>results<br>show the<br>device is<br>safe in the<br>aspect of<br>biocompat<br>ibility<br>evaluation |
| Working<br>Length | 1600mm, 2000mm, 2300mm | 2000mm ,2400mm | Similar |
| Packaging | Single-use EO sterilized Tyvek pouch | Single-use EO sterilized | Similar |
| Item | Proposed Device | Predicate device(K171454) | Comment |
| | with one device per pouch. | | |
| Materials | Luer connector: PC;<br>Handle: PC;<br>Molding metal tube: SUS304;<br>Inner sheath connection limit tube:<br>PTFE;<br>Fixing sleeve: ABS;<br>Outer sheath: PP( 5311series); SUS<br>304 and PE (5313 series);<br>Inner sheath: PP;<br>Connection tube: SUS 304;<br>Metal cap: SUS303;<br>Needle: SUS304.<br>The material expected to come into<br>contact with the patient is SUS304,<br>SUS303 and PP, or SUS304、SUS303<br>and PE. | Unknown | Different:<br>This<br>difference<br>does not<br>alter the<br>suitability<br>of the<br>proposed<br>device for<br>its<br>intended<br>use. We<br>conducted<br>a<br>biocompat<br>ibility<br>evaluation<br>of the<br>device.<br>The<br>results<br>show the<br>device is<br>safe in the<br>aspect of<br>biocompat<br>ibility<br>evaluation |
| Principle<br>of<br>operation | The outer sheath of the product is<br>inserted into the endoscope clamp.<br>When the front part of the outer sheath<br>tube is placed on the lesion site, push<br>the Luer connector, the needle tube is<br>exposed to the outer sheath, and the<br>needle is inserted into the lesion site, | The catheter sheath of the product is<br>inserted into the endoscope clamp. When<br>the front part of the catheter sheath is<br>placed on the lesion site, push the handle<br>with a hub for injection, the needle is<br>exposed to the catheter sheath, and the<br>needle is inserted into the lesion site, then | Similar |
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Image /page/6/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company.
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Image /page/7/Picture/0 description: The image contains a logo with the text "AGS MEDTECH" and "安杰思医学". The logo consists of a circular design with three curved shapes in blue, forming a triangle in the center. The central triangle is filled with green color. The text "AGS MEDTECH" is written in English, while "安杰思医学" is written in Chinese.
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Image /page/8/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The overall design is clean and professional, suggesting a company in the medical technology field.
# 5.7 Applicable Guidance Document
NA
# 5.8 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 Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
# 5.9 Clinical Test
No Clinical test is included in this submission.
# 5.10 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS Medtech Co., Ltd has demonstrated that proposed device Disposable Sclerotherapy Needle is substantially equivalent to Boston Scientific Corporation's Injection Therapy Needle Catheter, K171454.
