K212668 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · FBK · Feb 23, 2022 · Gastroenterology, Urology
Device Facts
Record ID
K212668
Device Name
Sclerotherapy Needle
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product Code
FBK · Gastroenterology, Urology
Decision Date
Feb 23, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
Device Story
Sclerotherapy needle device; consists of Luer connector, handle, sheath, infusion tube, fixed button, and needle. Used by physicians during endoscopic procedures; device passes through endoscope working channel (min 2.8mm). Principle: catheter sheath inserted into endoscope channel to lesion site; Luer connector pushed to expose needle from sheath; needle inserted into lesion for drug injection. Single-use; EO sterilized. Benefits: enables targeted delivery of sclerosing agents to control gastrointestinal bleeding.
Clinical Evidence
No clinical data. Bench testing only. Device met requirements of ISO 10993 (biocompatibility), ISO 11135:2014 (EO sterilization), and ISO 10993-7 (EO residuals). Performance testing included appearance and physical properties; all results passed.
Indicated for endoscopic injection into gastrointestinal mucosa or introduction of sclerosing agents to control actual or potential bleeding lesions in the digestive system. No specific age or gender restrictions provided.
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 23, 2022
Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long, RA Manager Building 50, No. 650 Hongfeng Road Donghu Street Yuhang District, Hangzhou, 311100 CHINA
Re: K212668
> Trade/Device Name: Sclerotherapy Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: August 24, 2021 Received: January 27, 2022
Dear Lucius Long:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
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
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# Indications for Use
510(k) Number (if known) K212668
Device Name Sclerotherapy Needle
Indications for Use (Describe)
The device is used for endoscopic into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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K212668 Page 1 of 5
Image /page/3/Picture/1 description: The image contains a logo with a geometric shape on the left, resembling a stylized hexagon with a gradient from green to blue. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in a combination of blue and green. The overall design appears to represent a company or organization, possibly in the medical or technological field, given the name and the clean, modern aesthetic.
g Medical Technology Co., LTD.
Page: 1 / 5
510(k) Summary( 21CFR 807.92)
#### 1. Submitter's information
Name: Zhejiang Chuangxiang Medical Technology Co., LTD.
Address: Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province, 311100, P.R. China
Contact person: Lucius.Long Email: lucius.long@med-nova.com Telephone: 86-571-89167088 Fax: 86-571-89167086
#### 2. Date of Submission
09-Aug- 2021
### 3. Device
Trade/Device Name: Sclerotherapy Needle Regulation name: Endoscope and accessories Regulation class: II Regulation number:876.1500 Panel: Gastroenterology/Urology Product code: FBK
### 4. Predicative device
4.1) 510(k) Number: K190032 Device Name: Disposable Sclerotherapy Needle
### 5. Device description
The Sclerotherapy Needle device consists of Luer connector, handle, sheath, infusion tube, fixed button connection tube and needle. EO sterilization and use for single use only.
The Sclerotherapy Needle device is designed to pass through the channel of endoscope to mark the lesions of the digestive tract and use it for injection. Compatibility with endoscopes, working lengths are 1200mm,1800mm, 2000mm, 2300mm, and the minimum working channel is ф 2.8 mm.
#### 6. Indications for use
The device is used for endoscopic injection into gastrointestinal mucosa, or to endoscopically introduce a sclerosing agent into selected sites to control actual or potential bleeding lesions in the digestive system.
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Image /page/4/Picture/1 description: The image contains a logo with a geometric shape on the left, transitioning from green to blue. To the right of the logo, there is text in blue, followed by the word "MEDNOVA" in a smaller font size, with the letters transitioning from green to blue. The text appears to be a company or organization name, with the logo serving as its visual identifier.
Zhejiang Chuangxiang Medical Technology Co., LTD.
Page:
# 7. Comparison of Technological Characteristics:
The Sclerotherapy Needle has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Hangzhou AGS's Disposable Sclerotherapy Needle ,K190032.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 | Proposed device | Predicate device | Comparison to<br>Predicate Devices |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Device name | Sclerotherapy Needle | Disposable Sclerotherapy Needle | / |
| Indications<br>for Use | The device is used for<br>endoscopic injection into<br>gastrointestinal mucosa, or to<br>endoscopically introduce a<br>sclerosing agent into selected<br>sites to control actual or<br>potential bleeding lesions in<br>the digestive system. | The Disposable Sclerotherapy<br>Needle is intended for endoscopic<br>injection into the<br>gastrointestinal mucosa. | Substantial<br>Equivalence |
| Configuration | Luer connector,Handle,<br>Infusion tube,Sheath,Fixed<br>button,Connection tube,Needle | Luer connector, handle, molding<br>metal tube, Inner sheath<br>connection limit tube, Fixing<br>sleeve, Outer sheath, Inner<br>sheath, connection tube, metal<br>cap, needle | Similar |
| Photographs | Sclerotherapy Needle:<br>Image: [Sclerotherapy Needle A Standard type]<br>1. Luer connector 2. Handle 3. Drive Pipe 4. Sheath<br><br>Image: [Sclerotherapy Needle B simple type]<br>1. Luer connector 2. Handle 3. Drive Pipe 4. Sheath | Disposable Sclerotherapy Needle:<br>Image: [Disposable Sclerotherapy Needle]<br>5311 Series ( with tip forming ) : | Similar |
| Zhejiang Chuangxiang Medical Technology Co., LTD. | | | Page: 3 / 5 |
| | Image: Diagram of tip structure with labels "Infusion tube", "connection tube Needle", and "Fixed button".<br>The tip structure<br>With fixed button:<br>Image: Syringe with fixed button<br>Image: Syringe with fixed button in packaging | Image: Syringe with metal cap<br>5311 Series (with metal cap):<br>Image: Syringe with metal cap | |
| | Without fixed button:<br>Image: Syringe without fixed button<br>Image: Syringe without fixed button | Image: Green syringe with metal cap<br>5313 Series (with metal cap):<br>Image: Green syringe with metal cap | |
| Sheath diameter | 1.8mm,2.4mm | 2.4mm | Similar |
| Needle size: | 19G,21G, 23G,25G | 21G, 22G, 23G, 24G, 25G | Similar |
| Outer tubing | PTFE | For 5311 series: PP;<br>For 5313 series: SUS 304 covered by PE. | Similar: We conducted a Biocompatibility |
| | | | Page: 4 / 5 |
| | | | evaluation of the<br>device. The results<br>show the device is<br>safe in the aspect of<br>biocompatibility<br>evaluation |
| Working<br>Length | 1200mm,1800mm, 2000mm,<br>2300mm | 1600mm, 2000mm, 2300mm | Similar |
| Packaging | Single-use EO sterilized<br>paper-plastic pouch with one<br>device per pouch. | Single-use EO sterilized Tyvek<br>pouch with one device per pouch. | Similar |
| Materials | Luer connector: ABS<br>Handle: ABS<br>Infusion tube: PP<br>Sheath: PTFE<br>Fixed button: Y12Cr18Ni9Cu3<br>Connection tube:<br>SUS304(06Cr19Ni10 )<br>Needle:X5CrNi18-9 | Luer connector: PC;<br>Handle: PC;<br>Molding metal tube: SUS304;<br>Inner sheath connection limit<br>tube: PTFE;<br>Fixing sleeve: ABS;<br>Outer sheath: PP( 5311series);<br>SUS 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<br>into contact with the patient is<br>SUS304, SUS303 and PP, or<br>SUS304、SUS303 and PE. | Similar |
| Principle of<br>operation | The catheter sheath of the<br>product is inserted into the<br>endoscope channel. When<br>the front part of the catheter<br>sheath is placed on the lesion<br>site, push the Luer connector<br>for injection, the needle is<br>exposed to the catheter sheath,<br>and the needle is inserted into<br>the lesion site, then drug<br>injection. | The outer sheath of the product is<br>inserted into the endoscope<br>clamp. When the front part of the<br>outer sheath tube is placed on the<br>lesion site, push the Luer<br>connector, the needle tube is<br>exposed to the outer sheath, and<br>the needle is inserted into the<br>lesion site, then normal saline<br>injection. | Similar |
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Image /page/5/Picture/1 description: The image contains a logo with a geometric shape on the left, followed by text. The geometric shape is a hexagon with a gradient fill, transitioning from green at the bottom to blue at the top. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in blue and green. The word "MED" is in blue, while "NOVA" is in green.
Zhejiang Chuangxiang Medical Technology Co., LTD.
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Image /page/6/Picture/1 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a smaller hexagon inside, and it is colored with a gradient from green to blue. To the right of the shape, there are Chinese characters in blue, followed by the word "MEDNOVA" in blue and green. The logo appears to represent a company or organization, possibly in the medical or technology field.
Zhejiang Chuangxiang Medical Technology Co., LTD.
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K212668 Page 5 of 5
Image /page/7/Picture/1 description: The image contains a logo for Zhejiang Chuangxiang Medical Technology Co., LTD. The logo features a geometric shape in shades of green and blue, along with the text "MEDNOVA" in green. The company name is written below the logo in black text.
5 / 5 Page: Page
## 8. Applicable Guidance Document
NA
## 9. Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing", ISO 11135:2014 "Sterilization of Health Care products Ethylene Oxide - 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 Sclerotherapy Needle: Appearance, Physical properties. The results of all testing were passing.
### 10. Clinical Test Conclusion
No clinical study is included in this submission.
### 11. Conclusions
Chuangxiang medical has demonstrated that the proposed device Sclerotherapy Needle is substantially equivalent to Hangzhou AGS MedTech CO., Ltd. currently marketed Disposable Sclerotherapy Needle (K190032).
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
